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EC number: 224-867-1 | CAS number: 4531-49-1
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- 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
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- 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
- Toxic effects on livestock and pets
- Additional toxicological data
![](https://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
The sensitisation potential of the test item was assessedin female guinea pig (20 animals in the test and 10 animals in the control group)using amethod based on that described by Buehler (1965).Following challenge with 60%, 30%, 10% and 3% w/v preparations of the test material in corn oil, all application sites were stained yellow preventingassessment of erythema. On this basisskin samples from all application sites and untreated sites were excisedand fixed in Bouin's fixative. Skin samples from all the challenge sites, together with samples of untreated skin were processed and examined using light microscopy. Histopathological examination revealed a background level of minimalirritation to the skin for all the concentrations used at challenge. Therewas considered to be no significant difference in the skin response betweentest and control animals.In a positive control study, challenge of previously induced guinea pigs with an undiluted preparation of hexylcinnamaldehyde elicited a moderateskin sensitisation response, confirming the validity of the assay. |
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March and April 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Remarks:
- according to the method described by Buehler
- Qualifier:
- according to guideline
- Guideline:
- other: method described by Buehler
- Version / remarks:
- E.V. Buehler, delayed contact hypersensitivity in the guinea pig, Arch. Dermatol. 91, 1965, S. 171 - 177
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The substance has been tested comparable to the OECD Guideline 406, Bühler method before the LLNA test model was selected to be the preferred test system under the REACH Regulation.
- Species:
- guinea pig
- Strain:
- other: Hsd/Poc:DH
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Porcellus, Firgrove Farm, Heathfield, Sussex, UK
- Age at study initiation: "young adults"
- Weight at study initiation: 403-537g
- Housing: individually ind stainless steel cages
- Diet: RGP Diet, ad libitum
- Water: ad libitum
- Acclimation period: at least six days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 +/- 2
- Humidity (%): 55 +/- 15
- Air changes (per hr): 25-30
- Photoperiod (hrs dark / hrs light): 12 hrs/12 hrs - Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- Induction: 60% (w/v)
Challenge: 3%, 10%, 30%, 60% (w/v) - Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- Induction: 60% (w/v)
Challenge: 3%, 10%, 30%, 60% (w/v) - No. of animals per dose:
- 10 animals in the control group
20 animals in the test group - Details on study design:
- RANGE FINDING TESTS:
- Induction stage: Concentrations of 30% and 60% (highest achievable concentration) (w/v) were applied to the flanks of two females (one concentration per animal) in a similar fashion as described in the main study. Yellow staining of the application site prevented assessment of erythema. In the absence of any other signs of irritation, the 60% (w/v) preparation was used in the main study.
- Challenge stage: Concentrations of 3%, 10%, 30% and 60% (highest achievable concentration) (w/v) in corn oil were applied to each of two females as described in the main study. Application sites were stained yellow by the test material, preventing assessment of erythema.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: two weeks
- Test groups: 400 mg of 60% (w/v) preparation in corn oil
- Control group: 0.4 ml of vehicle
- Site: scapular region
- Frequency of applications: 7-day intervals
- Duration: 6 hrs
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: two weeks after the final induction exposure
- Exposure period: one day
- Duration: at least 6 hrs
- Site: both flanks
- Concentrations: 3%, 10%, 30%, 60% (w/v) in corn oil, appr. 200 mg, animals received four patches with different concentrations.
- Evaluation: 24 and 48 hrs after removal of the dressings
OTHER: Yellow discoloration of the application sites prevented assessment of erythema. Therefore, skin samples were submitted for histopathological examination.
- skin samples from the challenge sites of test and control animals and untreated skin were examined
- fixation in Bouin's solution and wax,
- staining with haematoxylin and eosin
- light microscope - Challenge controls:
- - none
- Positive control substance(s):
- yes
- Remarks:
- hexylcinnamaldehyde
- Positive control results:
- The positive control substance stained the skin of all test animals yellow during the induction phase, but this did not prevent the assessment of irritation. Signs of slight irritation were seen in the test animals during the induction phase. There were no signs of irritation in any of the control animals.
After challenge with an undiluted sample of the positive control substance scattered mild redness was seen in seven out of twenty animals (scattered mild redness in 7/20 animals at first reading after 24 hours; in 5/20 animals at second reading after 48 hours). No reactions were observed in the control animals. The net percentage response was calculated to be 35%. - Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 3%, 10%, 30%, 60% preparation in corn oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Staining by the test material prevented a clinical assessment of erythema. Histopathological investigation revealed a low grade skin irritation reaction.
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 3%, 10%, 30%, 60% preparation in corn oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Staining by the test material prevented a clinical assessment of erythema. Histopathological investigation revealed a low grade skin irritation reaction.
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 3%, 10%, 30%, 60% preparation in corn oil
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Staining by the test material prevented a clinical assessment of erythema. Histopathological investigation revealed a low grade skin irritation reaction.
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 3%, 10%, 30%, 60%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Staining by the test material prevented a clinical assessment of erythema. Histopathological investigation revealed a low grade skin irritation reaction.
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 100%
- No. with + reactions:
- 7
- Total no. in group:
- 20
- Clinical observations:
- no effects
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 100%
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Clinical observations:
- no effects
- Remarks on result:
- positive indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Remarks:
- regulation (EC) no 1272/2008
- Conclusions:
- The test item is non-sensitising under the conditions of the test.
- Executive summary:
The sensitisation potential of the test item was assessed in female guinea pig (20 animals in the test and 10 animals in the control group) using a method based on that described by Buehler (1965). Following challenge with 60%, 30%, 10% and 3% w/v preparations of the test material in corn oil, all application sites were stained yellow preventing assessment of erythema. On this basis skin samples from all application sites and untreated sites were excised and fixed in Bouin's fixative. Skin samples from all the challenge sites, together with samples of untreated skin were processed and examined using light microscopy. Histopathological examination revealed a background level of minimal irritation to the skin for all the concentrations used at challenge. There was considered to be no significant difference in the skin response between test and control animals. In a positive control study, challenge of previously induced guinea pigs with an undiluted preparation of hexylcinnamaldehyde elicited a moderate skin sensitisation response, confirming the validity of the assay.
Therefore, the test item has not to be classified as skin sensitiser according to Regulation (EC) No 1272/2008.
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- March and April 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Remarks:
- according to the method described by Buehler
- Justification for type of information:
- Please see read across document in chapter 13
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- other: method described by Buehler
- Version / remarks:
- E.V. Buehler, delayed contact hypersensitivity in the guinea pig, Arch. Dermatol. 91, 1965, S. 171 - 177
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The substance has been tested comparable to the OECD Guideline 406, Bühler method before the LLNA test model was selected to be the preferred test system under the REACH Regulation.
- Species:
- guinea pig
- Strain:
- other: Hsd/Poc:DH
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Porcellus, Firgrove Farm, Heathfield, Sussex, UK
- Age at study initiation: "young adults"
- Weight at study initiation: 403-537g
- Housing: individually ind stainless steel cages
- Diet: RGP Diet, ad libitum
- Water: ad libitum
- Acclimation period: at least six days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 +/- 2
- Humidity (%): 55 +/- 15
- Air changes (per hr): 25-30
- Photoperiod (hrs dark / hrs light): 12 hrs/12 hrs - Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- Induction: 60% (w/v)
Challenge: 3%, 10%, 30%, 60% (w/v) - Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- Induction: 60% (w/v)
Challenge: 3%, 10%, 30%, 60% (w/v) - No. of animals per dose:
- 10 animals in the control group
20 animals in the test group - Details on study design:
- RANGE FINDING TESTS:
- Induction stage: Concentrations of 30% and 60% (highest achievable concentration) (w/v) were applied to the flanks of two females (one concentration per animal) in a similar fashion as described in the main study. Yellow staining of the application site prevented assessment of erythema. In the absence of any other signs of irritation, the 60% (w/v) preparation was used in the main study.
- Challenge stage: Concentrations of 3%, 10%, 30% and 60% (highest achievable concentration) (w/v) in corn oil were applied to each of two females as described in the main study. Application sites were stained yellow by the test material, preventing assessment of erythema.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: two weeks
- Test groups: 400 mg of 60% (w/v) preparation in corn oil
- Control group: 0.4 ml of vehicle
- Site: scapular region
- Frequency of applications: 7-day intervals
- Duration: 6 hrs
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: two weeks after the final induction exposure
- Exposure period: one day
- Duration: at least 6 hrs
- Site: both flanks
- Concentrations: 3%, 10%, 30%, 60% (w/v) in corn oil, appr. 200 mg, animals received four patches with different concentrations.
- Evaluation: 24 and 48 hrs after removal of the dressings
OTHER: Yellow discoloration of the application sites prevented assessment of erythema. Therefore, skin samples were submitted for histopathological examination.
- skin samples from the challenge sites of test and control animals and untreated skin were examined
- fixation in Bouin's solution and wax,
- staining with haematoxylin and eosin
- light microscope - Challenge controls:
- - none
- Positive control substance(s):
- yes
- Remarks:
- hexylcinnamaldehyde
- Positive control results:
- The positive control substance stained the skin of all test animals yellow during the induction phase, but this did not prevent the assessment of irritation. Signs of slight irritation were seen in the test animals during the induction phase. There were no signs of irritation in any of the control animals.
After challenge with an undiluted sample of the positive control substance scattered mild redness was seen in seven out of twenty animals (scattered mild redness in 7/20 animals at first reading after 24 hours; in 5/20 animals at second reading after 48 hours). No reactions were observed in the control animals. The net percentage response was calculated to be 35%. - Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 3%, 10%, 30%, 60% preparation in corn oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Staining by the test material prevented a clinical assessment of erythema. Histopathological investigation revealed a low grade skin irritation reaction.
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 3%, 10%, 30%, 60% preparation in corn oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Staining by the test material prevented a clinical assessment of erythema. Histopathological investigation revealed a low grade skin irritation reaction.
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 3%, 10%, 30%, 60% preparation in corn oil
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Staining by the test material prevented a clinical assessment of erythema. Histopathological investigation revealed a low grade skin irritation reaction.
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 3%, 10%, 30%, 60%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Staining by the test material prevented a clinical assessment of erythema. Histopathological investigation revealed a low grade skin irritation reaction.
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 100%
- No. with + reactions:
- 7
- Total no. in group:
- 20
- Clinical observations:
- no effects
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 100%
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Clinical observations:
- no effects
- Remarks on result:
- positive indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Remarks:
- regulation (EC) no 1272/2008
- Conclusions:
- The test item is non-sensitising under the conditions of the test.
- Executive summary:
The sensitisation potential of the test item was assessed in female guinea pig (20 animals in the test and 10 animals in the control group) using a method based on that described by Buehler (1965). Following challenge with 60%, 30%, 10% and 3% w/v preparations of the test material in corn oil, all application sites were stained yellow preventing assessment of erythema. On this basis skin samples from all application sites and untreated sites were excised and fixed in Bouin's fixative. Skin samples from all the challenge sites, together with samples of untreated skin were processed and examined using light microscopy. Histopathological examination revealed a background level of minimal irritation to the skin for all the concentrations used at challenge. There was considered to be no significant difference in the skin response between test and control animals. In a positive control study, challenge of previously induced guinea pigs with an undiluted preparation of hexylcinnamaldehyde elicited a moderate skin sensitisation response, confirming the validity of the assay.
Therefore, the test item has not to be classified as skin sensitiser according to Regulation (EC) No 1272/2008.
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
Referenceopen allclose all
Staining by the test material prevented a clinical assessment of erythema. Histopathological investigation revealed a low grade skin irritation reaction: A predominantly minimal to slight inflammatory reaction with acanthosis and inflammatory cell infiltration was recorded in approximately equal proportions in skin samples from control and test animals treated with 3%, 10% or 30% (w/v) preparations of the test material in corn oil. There was considered to be no significant difference in the frequency of this effect between test and control samples. Following application of the 60% (w/v) preparation in corn oil only a very minor effects was observed in the test group.
Additional investigations were performed on skin irritation potential of corn oil, the vehicle used in this study, under Buehler challenge conditions. There were no skin reactions visible on clinical examination. Histopathological findings were similar to those reported in this test with the test item.
Staining by the test material prevented a clinical assessment of erythema. Histopathological investigation revealed a low grade skin irritation reaction: A predominantly minimal to slight inflammatory reaction with acanthosis and inflammatory cell infiltration was recorded in approximately equal proportions in skin samples from control and test animals treated with 3%, 10% or 30% (w/v) preparations of the test material in corn oil. There was considered to be no significant difference in the frequency of this effect between test and control samples. Following application of the 60% (w/v) preparation in corn oil only a very minor effects was observed in the test group.
Additional investigations were performed on skin irritation potential of corn oil, the vehicle used in this study, under Buehler challenge conditions. There were no skin reactions visible on clinical examination. Histopathological findings were similar to those reported in this test with the test item.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
No classicfication
The test item did not sensitise the skin of Guinea pigs after repeated exposure in vivo (Buehler-Method)
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Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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