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EC number: 453-460-3 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
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- Particle size distribution (Granulometry)
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- Endpoint summary
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
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- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
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- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
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- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
One reliable study is available. In this study (Sanders, 2013) performed under GLP according to OECD TG 429 and EC Method B.42, groups of CBA/Ca mice (4 females/dose) were topically applied with 50 µL (25 µL per ear) of the undiluted test item or the test item as a solution in acetone/olive oil 4:1 at concentrations of 50 % or 25 % v/v. A further group of four animals was treated with acetone/olive oil 4:1 alone. On Day 6, the animals received a single intravenous injection of tritiated methyl thymidine (3HTdR). Five hours later, the animals were sacrificed and the auricular lymph nodes were excised. The proliferation of lymphocytes in the lymph node draining the application site was measured by incorporation of 3HTdR. The results were expressed as disintegrations per minute (dpm) per group; dpm/node and the obtained values were used to calculate Stimulation Indices (SI). Animals were observed for mortality, clinical signs and body weight during the study. The test concentrations for the main study were determined from a preliminary study using one female mouse at the concentration of 100 %. No mortality and no clinical signs were observed during the observation period. Body weight of the animals was unaffected by the test item treatment. DPM per group for vehicle, 25, 50 and 100 % were 8967.55, 11288.98, 11444.45 and 13314.84, respectively. DPM per node for vehicle, 25, 50 and 100 % were 1120.94, 1411.12, 1430.56 and 1664.36, respectively. Stimulation index for 25, 50 and 100 % were 1.26, 1.28 and 1.48, respectively. Positive control (α-hexylcinnamaldehyde, 25%) exhibited evidence of sensitisation indicating the validity of the study. In this study, the substance is not a skin sensitizer in mice.
Supporting data are also available. Read-across to the toxicological properties of fatty acid polyols (Fatty acids, C5-9, esters with pentaerythritol (EC 270-290-3, CAS 68424-30-6) and Decanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol octanoate (EC 234-392-1, CAS 11138-60-6)) and their analogues is applicable based on the similarity in structure and physico-chemical properties.
The justification for read-across is presented in Section 13 Assessment reports- Read-across justification.
In a supporting study, a Guinea Pig Maximisation Test of Skin Sensitisation was performed with CAS No. 11138-60-6 (Decanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol octanoate) according to OECD Guideline 406 (Blanset, 1997). 20 male and female Dunkin-Harley guinea pigs were treated with the test substance and compared with 10 negative control animals. The sensitivity of the animal strain was tested using Hexylcinnamic aldehyde (HCA) as positive control substance. A 5% dilution of the test substance in propylene glycol was used for intradermal induction and 100% used for epidermal induction of the scapular region on days 1 and 8. 14 days after the last induction treatment, all animals were challenged epicutaneously with the undiluted test substance. 24 h after challenge one out of twenty animals showed a skin reaction compared to 2 out of ten for the positive control. 48 hours after challenge exposure all skin examination scores were zero in all test animals.
The
skin sensitization potential of the Fatty Acid Polyol with CAS No.
68424-31-7 (Fatty acids, C5-10, esters with pentaerythritol) was
evaluated in guinea pigs with a Buehler test for skin sensitisation
(Lees, 1991). 20 male albino guinea pigs were treated with the test
substance and compared with 10 control animals. Three epidermal
inductions were performed with 100 % test substance in weekly intervals
for 6 hours under occlusive conditions. 14 days after the last induction
treatment, all animals were challenged for 6 hours epicutaneously with
100% (left shorn flank) and 30% (right shorn flank) test substance
(diluted in corn oil) under occlusive conditions. Animals were evaluated
for skin reactions 24 and 48 h after challenge. No signs for irritation
or sensitisation were observed during induction and challenge of the
animals.
Migrated from Short description of key information:
Key (test item), Sanders, 2013, not sensitising
Supporting (EC 234-392-1), Blanset, 1997, not sensitising
Supporting (CAS 68424-31-7), Lees, 1991, not sensitising
Justification for selection of skin sensitisation endpoint:
Reliable study (k=1) performed on the substance itself.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2013-06-18 to 2013-07-02
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
- Justification for type of information:
- Conducted prior to 11 October 2016.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Principles of method if other than guideline:
- Ear thickness measurements were not taken.
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- other: CBA/Ca (CBA/CaOlaHsd)
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Oxon, UK.
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 15-23 g
- Housing: Animals were individually housed in suspended solid floor polypropylene cages furnished with softwood woodflakes.
- Diet: Food (2014C Teklad Global Rodent diet supplied by Harlan Laboratories UK Ltd., Oxon, UK), ad libitum
- Water: Mains tap water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 19-25 °C
- Humidity: 30-70 %
- Air changes: 15 changes per hour
- Photoperiod: 12 h dark / 12 h light
IN-LIFE DATES: From: 2013-06-18 To: 2013-07-02 - Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- Preliminary test: 100 %
Main test: 25 and 50 % v/v in acetone/olive oil 4:1 and 100 % - No. of animals per dose:
- Preliminary screening test: 1 female/dose
Main test: 4 females/dose - Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: Test item was used undiluted and freshly prepared as a solution at the concentrations of 25 and 50 % in acetone/olive oil 4:1
- Irritation: Mouse treated with undiluted test item for three consecutive days (Days 1, 2 and 3) showed no signs of systemic toxicity, visual local skin irritation or irritation indicated by an equal to or greater than 25% increase in mean ear thickness. Based on this information the undiluted test item and the test item at concentrations of 50% or 25% v/v in acetone/olive oil 4:1 were selected for the main test.
MAIN STUDY
- Name of test method: Local Lymph Node Assay
- Criteria used to consider a positive response: The test item will be regarded as a sensitizer if at least one concentration of the test item results in a threefold or greater increase in 3HTdR incorporation compared to control values. Any test item failing to produce a threefold or greater increase in 3HTdR incorporation will be classified as a "non-sensitizer."
TREATMENT PREPARATION AND ADMINISTRATION: The mice were treated by daily application of 25 µL of test material at concentrations of 0 (vehicle control), 25, 50 and 100 % to the dorsal surface of each ear for three consecutive days (Days 1, 2, 3). On Day 6, all mice were injected via the tail vein with 250 μL of phosphate buffered saline (PBS) containing 3H-methyl thymidine (3HTdR: 80 μCi/mL, specific activity 2.0 Ci/mmoL, ARC UK Ltd) giving a total of 20 μCi to each mouse. Five hours following the administration of 3HTdR all mice were killed by carbon dioxide asphyxiation. The draining auricular lymph nodes from the four mice were excised and pooled for each experimental group. For each group 1 mL of PBS was added to the pooled lymph nodes. A single cell suspension of pooled lymph node cells was prepared by gentle mechanical disaggregation through a 200-mesh stainless steel gauze. Lymph node cells were washed with PBS and precipitated with 5 % (w/v) trichloroacetic acid (TCA) for radioactive material at 4 °C. Pellets were re-suspended in 1 mL TCA and transferred to 10 mL of scintillation fluid (Optiphase ‘Trisafe’). 3HTdR incorporation was measured by β -scintillation counting. The proliferation response of lymph node cells was expressed as the number of radioactive disintegrations per minute per lymph node (disintegrations per minute/node) and as the ratio of 3HTdR incorporation into lymph node cells of test nodes relative to that recorded for the control nodes (Stimulation Index). - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- No data
- Positive control results:
- Stimulation index for α-hexylcinnamaldehyde at 25 % v/v in acetone/olive oil 4:1 was 7.33 and classified as a sensitiser.
- Parameter:
- SI
- Remarks on result:
- other: Stimulation index for 25, 50 and 100 % were 1.26, 1.28 and 1.48, respectively.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: DPM per group for vehicle, 25, 50 and 100 % were 8967.55, 11288.98, 11444.45 and 13314.84, respectively. DPM per node for vehicle, 25, 50 and 100 % were 1120.94, 1411.12, 1430.56 and 1664.36, respectively.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under these test conditions,the substance is not classified as sensitizing to the skin according to CLP Regulation (EC) No. 1272/2008
- Executive summary:
Test Guidance
OECD Guideline 429 and EC Method B.42 (Skin Sensitisation: Local Lymph Node Assay).
Method and materials
Groups of CBA/Ca (CBA/CaOlaHsd) mice (4 females/dose) were topically applied with 50 µL (25 µL per ear) of the undiluted test item or the test item as a solution in acetone/olive oil 4:1 at concentrations of 50 % or 25 % v/v. A further group of four animals was treated with acetone/olive oil 4:1 alone. On Day 6, the animals received a single intravenous injection of tritiated methyl thymidine (3HTdR). Five hours later, the animals were sacrificed and the auricular lymph nodes were excised. The proliferation of lymphocytes in the lymph node draining the application site was measured by incorporation of 3HTdR. The results were expressed as disintegrations per minute (dpm) per group; dpm/node and the obtained values were used to calculate Stimulation Indices (SI). Animals were observed for mortality, clinical signs and body weight during the study. The test concentrations for the main study were determined from a preliminary study using one female mouse at the concentration of 100 %.
Results
No mortality and no clinical signs were observed during the observation period. Body weight of the animals was unaffected by the test item treatment. DPM per group for vehicle, 25, 50 and 100 % were 8967.55, 11288.98, 11444.45 and 13314.84, respectively. DPM per node for vehicle, 25, 50 and 100 % were 1120.94, 1411.12, 1430.56 and 1664.36, respectively. Stimulation index for 25, 50 and 100 % were 1.26, 1.28 and 1.48, respectively. Positive control (α-hexylcinnamaldehyde, 25%) exhibited evidence of sensitisation indicating the validity of the study. In this study, the substance is not a skin sensitizer in mice.
Conclusion
Under these test conditions, the substance is not classified as sensitising to the skin according to the CLP Regulation (EC)No. 1272/2008).
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions.
- Justification for type of information:
- Read-across data conducted prior to the adoption of the LLNA test guideline and in vitro/in chemico test methods.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- ; no information on purity of the test material; both flanks were exposed during challange
- GLP compliance:
- not specified
- Type of study:
- Buehler test
- Species:
- guinea pig
- Strain:
- other: Albino
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 344-441 g - Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- Induction: 100%
Challenge: 30% and 100% - Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- Induction: 100%
Challenge: 30% and 100% - No. of animals per dose:
- 20 (10 for the controls)
- Details on study design:
- RANGE FINDING TESTS: No Data
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 h
- Test groups: Undiluted test sample
- Control group: Not stated, but very likely the control group recieved vehicle only.
- Site: scapular region
- Frequency of applications: 7 d interval
- Duration: 14 d
- Concentrations: undiluted
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: day 28, 14 d after final induction
- Exposure period: 6 h
- Test groups: undiluted (100%) and 30% (w/v in corn oil)
- Control group: undiluted (100%) and 30% (w/v in corn oil)
- Site: undiluted (100%) on left flank and 30% on right flank
- Concentrations: undiluted (100%) and 30% (w/v in corn oil)
- Evaluation (hr after challenge): 24 h and 48 h - Challenge controls:
- No
- Positive control substance(s):
- no
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 30%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 30%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions No positive control, basic data given
- Justification for type of information:
- Read-across data conducted prior to the adoption of the LLNA test guideline and in vitro/in chemico test methods.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- yes
- Remarks:
- No positive control, basic data given
- Principles of method if other than guideline:
- Local Lymph Node Assay according to Kimber 1989.
- GLP compliance:
- not specified
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- other: CBA/Ca
- Sex:
- female
- Vehicle:
- other: Acetone
- Concentration:
- 3%, 10% and 30%
- No. of animals per dose:
- 4
- Details on study design:
- RANGE FINDING TESTS: No Data
MAIN STUDY
- Name of test method: ß-scintillation counting
- Criteria used to consider a positive response:
1. The increase in isotope incorporation for at least one concentration tested must be three-fold or more compared to the control (vehicle treated) mice.
2. The data generated must not be incompatible with the biological dose response.
TREATMENT PREPARATION AND ADMINISTRATION:
Samples were administered to the dorsum of both ears using a micro-pipette.
Groups of 4 female mice were dosed with 25 µl of either vehicle (acetone) or a 30%, 10% or 3% preparation of the test item on three consecutive days on the dorsum of both ears. Five days after initial dosing, the animals received approx. 20 µCi of 3H-methyl thymidine, were sacrificed 5 h later and radioactive counts/lymph node were measured. - Parameter:
- SI
- Remarks on result:
- other: The stimulation index was 0.45 for the 3% application, 2.05 for 10% and 1.21 for the 30% application.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: No significant increase in isotope incorporation was detected after repeated application. The Cpm (Counts per minute) was 0.0022 Cpm and 0.0047 for the vehicle controls and 0.001, 0.0045 and 0.0057 for 3%, 10% and 30%, respectively.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- October 08th 1996 - January 21st, 1997
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study Body Weight was evaluated on the day of dosing.
- Justification for type of information:
- Read-across data conducted prior to the adoption of the LLNA test guideline and in vitro/in chemico test methods.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- Magnussen and Kligmann Method
- Deviations:
- yes
- Remarks:
- Bodyweight was evaluated on the day of dosing.
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: HRP inc. and Charles River Laboratories, USA
- Age at study initiation: 5-7 weeks
- Weight at study initiation: Male: 391-489 g; female 366 - 480 g
- Housing: Individually housed in suspended, stainless steel cages with wire mesh bottoms
- Diet (e.g. ad libitum): Agway Prolab Purina Guinea Pig Diet; ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: 15 d
ENVIRONMENTAL CONDITIONS
- Temperature and humidity was controlled daily
- Photoperiod (hrs dark / hrs light): 12/12 h - Route:
- intradermal and epicutaneous
- Vehicle:
- propylene glycol
- Concentration / amount:
- Induction: Intradermal injection 5%, epicutaneous application 100%
Challange: 100% - Route:
- epicutaneous, open
- Vehicle:
- propylene glycol
- Concentration / amount:
- Induction: Intradermal injection 5%, epicutaneous application 100%
Challange: 100% - No. of animals per dose:
- 20
- Details on study design:
- RANGE FINDING TESTS: Yes (Intradermal: October 1st 1996 - October 3rd 1996; Topical: October 1st 1996 - October 4th 1996)
Two animals were pre-treated with two intradermal injections of FCA/water emulsion (1:1) approx. one week prior to test material administration.
Animals were administered 0.1 mL of the test substance (5% w/v) in propylene glycol via injection on either side of the spinal column and observed for dermal irritation 24 h and 48 h after injection.
For the topical range-finding study animals (3 per sex) were dosed with 0.1 mL of four different concentrations (25%, 50%, 75% and 100% in ethyl alcohol) at different sites, two on either side of the column. Treatment was for 24 h under occlusive conditions and observed for dermal irritation 24 h and 48 h afterwards.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Test groups: 1
- Control group: 2 (positive and irritation control)
- Site: A row of three injections was made on each side in the shoulder region (Application scheme see Table 1).
- Frequency of applications: Days 1 and 8
- Duration: 25 days
- Concentrations: Intradermal induction: 5%, Topical induction: 100%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 14 d after last induction application
- Exposure period: 24 h (Application scheme see Table 1).
- Test groups: 1
- Control group: 2 (positive and irritation control)
- Site: Flank
- Concentrations: 100%
- Evaluation (hr after challenge): 24 and 48 h after removal of the patches - Positive control substance(s):
- yes
- Remarks:
- Hexylcinnamic aldehyde (HCA)
- Positive control results:
- In the range of the historical controls
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 100%
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 100%. No with. + reactions: 2.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 50%
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 50%. No with. + reactions: 3.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 1.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 100%
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 100%. No with. + reactions: 2.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 50%
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 50%. No with. + reactions: 2.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- To register EC453-460-3 under REACH program, a read-across approach for fulfillment of the endpoints has been adopted. EC453-460-3 is an aliphatic ester and fits the description of polyol esters category in HPV program (High Production Volume, US-EPA). The distinguishing feature of polyol esters category is that the fatty acids were linked to one or more of the multiple hydroxyl groups present in the polyol (alcohol portion of ester). The focus of this correspondence is to support read across to EC613-848-7 (target) which provided key studies to determine hazard profile of EC453-460-3 (target), published information on other structurally analogous polyol esters were served as supporting evidence.
- Reason / purpose for cross-reference:
- read-across source
- Positive control results:
- Stimulation index for α-hexylcinnamaldehyde at 25 % v/v in acetone/olive oil 4:1 was 7.33 and classified as a sensitiser.
- Parameter:
- SI
- Remarks on result:
- other: Stimulation index for 25, 50 and 100 % were 1.26, 1.28 and 1.48, respectively.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: DPM per group for vehicle, 25, 50 and 100 % were 8967.55, 11288.98, 11444.45 and 13314.84, respectively. DPM per node for vehicle, 25, 50 and 100 % were 1120.94, 1411.12, 1430.56 and 1664.36, respectively.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under these test conditions,the substance is not classified as sensitizing to the skin according to CLP Regulation (EC) No. 1272/2008
- Executive summary:
Test Guidance
OECD Guideline 429 and EC Method B.42 (Skin Sensitisation: Local Lymph Node Assay).
Method and materials
Groups of CBA/Ca (CBA/CaOlaHsd) mice (4 females/dose) were topically applied with 50 µL (25 µL per ear) of the undiluted test item or the test item as a solution in acetone/olive oil 4:1 at concentrations of 50 % or 25 % v/v. A further group of four animals was treated with acetone/olive oil 4:1 alone. On Day 6, the animals received a single intravenous injection of tritiated methyl thymidine (3HTdR). Five hours later, the animals were sacrificed and the auricular lymph nodes were excised. The proliferation of lymphocytes in the lymph node draining the application site was measured by incorporation of 3HTdR. The results were expressed as disintegrations per minute (dpm) per group; dpm/node and the obtained values were used to calculate Stimulation Indices (SI). Animals were observed for mortality, clinical signs and body weight during the study. The test concentrations for the main study were determined from a preliminary study using one female mouse at the concentration of 100 %.
Results
No mortality and no clinical signs were observed during the observation period. Body weight of the animals was unaffected by the test item treatment. DPM per group for vehicle, 25, 50 and 100 % were 8967.55, 11288.98, 11444.45 and 13314.84, respectively. DPM per node for vehicle, 25, 50 and 100 % were 1120.94, 1411.12, 1430.56 and 1664.36, respectively. Stimulation index for 25, 50 and 100 % were 1.26, 1.28 and 1.48, respectively. Positive control (α-hexylcinnamaldehyde, 25%) exhibited evidence of sensitisation indicating the validity of the study. In this study, the substance is not a skin sensitizer in mice.
Conclusion
Under these test conditions, the substance is not classified as sensitising to the skin according to the CLP Regulation (EC)No. 1272/2008).
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Justification for type of information:
- To register EC453-460-3 under REACH program, a read-across approach for fulfillment of the endpoints has been adopted. EC453-460-3 is an aliphatic ester and fits the description of polyol esters category in HPV program (High Production Volume, US-EPA). The distinguishing feature of polyol esters category is that the fatty acids were linked to one or more of the multiple hydroxyl groups present in the polyol (alcohol portion of ester). The focus of this correspondence is to support read across to EC613-848-7 (target) which provided key studies to determine hazard profile of EC453-460-3 (target), published information on other structurally analogous polyol esters were served as supporting evidence.
- Reason / purpose for cross-reference:
- read-across source
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 30%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 30%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Justification for type of information:
- To register EC453-460-3 under REACH program, a read-across approach for fulfillment of the endpoints has been adopted. EC453-460-3 is an aliphatic ester and fits the description of polyol esters category in HPV program (High Production Volume, US-EPA). The distinguishing feature of polyol esters category is that the fatty acids were linked to one or more of the multiple hydroxyl groups present in the polyol (alcohol portion of ester). The focus of this correspondence is to support read across to EC613-848-7 (target) which provided key studies to determine hazard profile of EC453-460-3 (target), published information on other structurally analogous polyol esters were served as supporting evidence.
- Reason / purpose for cross-reference:
- read-across source
- Parameter:
- SI
- Remarks on result:
- other: The stimulation index was 0.45 for the 3% application, 2.05 for 10% and 1.21 for the 30% application.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: No significant increase in isotope incorporation was detected after repeated application. The Cpm (Counts per minute) was 0.0022 Cpm and 0.0047 for the vehicle controls and 0.001, 0.0045 and 0.0057 for 3%, 10% and 30%, respectively.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Justification for type of information:
- To register EC453-460-3 under REACH program, a read-across approach for fulfillment of the endpoints has been adopted. EC453-460-3 is an aliphatic ester and fits the description of polyol esters category in HPV program (High Production Volume, US-EPA). The distinguishing feature of polyol esters category is that the fatty acids were linked to one or more of the multiple hydroxyl groups present in the polyol (alcohol portion of ester). The focus of this correspondence is to support read across to EC613-848-7 (target) which provided key studies to determine hazard profile of EC453-460-3 (target), published information on other structurally analogous polyol esters were served as supporting evidence.
- Reason / purpose for cross-reference:
- read-across source
- Positive control results:
- In the range of the historical controls
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 100%
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 100%. No with. + reactions: 2.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 50%
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 50%. No with. + reactions: 3.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 1.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 100%
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 100%. No with. + reactions: 2.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 50%
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 50%. No with. + reactions: 2.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
Referenceopen allclose all
Table 7.4.1/1: Results of skin sensitization
Concentration (% v/v) in acetone/olive oil 4:1 |
dpm |
dpm/Nodea |
Stimulation Indexb |
Result |
Vehicle |
8967.55 |
1120.94 |
na |
na |
25 |
11288.98 |
1411.12 |
1.26 |
Negative |
50 |
11444.45 |
1430.56 |
1.28 |
Negative |
100 |
13314.84 |
1664.36 |
1.48 |
Negative |
dpm = Disintegrations per minute
a= Disintegrations per minute/node obtained by dividing the disintegrations per minute value by 8 (total
number of lymph nodes)
b = Stimulation Index of 3.0 or greater indicates a positive result
na = Not applicable
Clinical observations and mortality data: There were no deaths. No signs of systemic toxicity were noted in the test or control animals during the test.
Body Weight: Body weight change of the test animals between Day 1 and Day 6 was comparable to that observed in the corresponding control group animals over the same period.
Test Concentration |
Cpm/Lymph Node (x 10-2) |
Test/Control Ratio |
Vehicle |
0.22 |
- |
3% w/v |
0.10 |
0.45 |
10% w/v |
0.45 |
2.05 |
Vehicle |
0.47 |
- |
30% w/v |
0.57 |
1.21 |
Table 7.4.1/1: Results of skin sensitization
Concentration (% v/v) in acetone/olive oil 4:1 |
dpm |
dpm/Nodea |
Stimulation Indexb |
Result |
Vehicle |
8967.55 |
1120.94 |
na |
na |
25 |
11288.98 |
1411.12 |
1.26 |
Negative |
50 |
11444.45 |
1430.56 |
1.28 |
Negative |
100 |
13314.84 |
1664.36 |
1.48 |
Negative |
dpm = Disintegrations per minute
a= Disintegrations per minute/node obtained by dividing the disintegrations per minute value by 8 (total
number of lymph nodes)
b = Stimulation Index of 3.0 or greater indicates a positive result
na = Not applicable
Clinical observations and mortality data: There were no deaths. No signs of systemic toxicity were noted in the test or control animals during the test.
Body Weight: Body weight change of the test animals between Day 1 and Day 6 was comparable to that observed in the corresponding control group animals over the same period.
Test Concentration |
Cpm/Lymph Node (x 10-2) |
Test/Control Ratio |
Vehicle |
0.22 |
- |
3% w/v |
0.10 |
0.45 |
10% w/v |
0.45 |
2.05 |
Vehicle |
0.47 |
- |
30% w/v |
0.57 |
1.21 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
Migrated from Short description of key information:
No data on respiratory sensitisation was available.
Justification for classification or non-classification
Based on the results of the mouse local lymph node assay, the substance EC 613 -848 -7 is not classified as sensitising to the skin.
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