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EC number: 701-392-2 | CAS number: -
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Remarks:
- The test substance is surface active and with long alkyl chain, limitations for surfactant hat have been identified for the LLNA, thus the modified Buehler assay was adopted for the evaluation of sensitizing potential of the test substance.
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012-07-02 to 2012-08-31
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- This study was conducted prior to the adoption of the in vitro/in chemico methods.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Conducted for other purposes outside of REACH.
The test substance is surface active and with long alkyl chain, limitations for surfactant hat have been identified for the LLNA, thus the modified Buehler assay was adopted for the evaluation of sensitizing potential of the test substance.
Test material
- Reference substance name:
- 2-tetradecyloxirane, reaction products with boric acid
- EC Number:
- 701-392-2
- IUPAC Name:
- 2-tetradecyloxirane, reaction products with boric acid
- Test material form:
- not specified
- Details on test material:
- - Physical state: Tan solid
- Analytical purity: 100 %
- Date of receipt: 2012-06-18
- Expiration date of the lot/batch: 2013-06-18
- Storage condition of test material: Stored in a controlled room temperature area, protected from light
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Saint Constant, Quebec.
- Age at study initiation: First range-finding study (male: ca 5 weeks; female: ca 6 weeks); Second range-finding study (male: ca 9 weeks; female: ca 10 weeks); Main test (male: ca 6 weeks; female: ca 7 weeks)- Weight at study initiation: First range-finding study (male: 348 to 364 g; female: 329 to 356 g); Second range-finding study (male: 453 to 500 g; female: 476 to 545 g); Main test (male: 363 to 433 g; female: 340 to 437 g)
- Housing: Animals were paired housed throughout the study in solid bottom cages containing direct bedding material. As an alternative, guinea pigs were individually housed in solid bottom cages containing direct bedding material.
- Diet: PMI Nutrition International Certified Guinea Pig Chow® No. 5026, ad libitum
- Water: Municipal tap water following treatment by reverse osmosis and ultraviolet irradiation was available ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20-22 °C
- Humidity: 53-65 %
- Air changes: 10 or more air changes per hour with 100 % fresh air
- Photoperiod: 12 h light / 12 h dark
IN-LIFE DATES: From: 2012-07-02 To: 2012-08-31
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.3 mL placed on a 25 mm Hilltop Chamber
- Day(s)/duration:
- 1, 7 and 14
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: mineral oil
- Concentration / amount:
- 25 %
- Day(s)/duration:
- 28
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- - Range-finding test: 2 males and 2 females
Main test: 10 males and 10 females for test group; 5 males and 5 females for challenge control - Details on study design:
- RANGE FINDING TESTS:- On Day 0, up to 4 closed chambers at 4 different concentrations of the test substance were prepared and a 0.33 g (100% concentration only) and 0.3 mL dose of each concentration was applied to the clipped area of each topical range-finding animal. The chambers were applied to the clipped surface as quickly as possible. The trunk of the animal was wrapped with elastic wrap which was secured with adhesive tape to prevent removal of the chambers and the animal was returned to its cage.- Approximately 6 hours after chamber application, the binding materials were removed. The test sites were then wiped 2 times with gauze moistened in mineral oil, followed by dry gauze and then wiped with gauze moistened in deionized water, followed by dry gauze, to remove test substance residue, and the animals were returned to their cages.MAIN STUDYA.
INDUCTION EXPOSURE:- No. of exposures: Three (Day 1, 7 and 14)- Exposure period: 6 hours- Test groups: 0.33 g (100 % concentration only) of the test substance was placed on a 25 mm Hilltop chamber backed by adhesive tape (occlusive patch). - Control group: None- Site: Left side of test animals- Frequency of applications: Once- Duration: Days 1-27- Concentrations: 100 %- Evaluation (hr after induction): 24 and 48 hoursB.
CHALLENGE EXPOSURE:- No. of exposures: One- Day(s) of challenge: Day 28- Exposure period: 6 hours- Test groups: 0.3 mL dose of the appropriate test substance was placed on a 25 mm Hilltop chamber backed by adhesive tape (occlusive patch). - Control group: 0.3 mL dose of the appropriate test substance was placed on a 25 mm Hilltop chamber backed by adhesive tape (occlusive patch). - Site: Right side of test animals- Concentrations: 25 %- Evaluation (hr after challenge): 24 and 48 hoursOTHER: - Mortality/moribundity checks: Animals were observed for general health/mortality and moribundity twice daily, once in the morning and afternoon, throughout the study.
- Dermal Observations: Test sites were graded for irritation at approximately 24 and 48 hours after chamber application (induction) or chamber removal (challenge) using the Macroscopic Dermal Grading System.
- Body Weights: Each topical range-finding animal was weighed on the day prior to dosing (Day -1). Each main study animal was weighed on the day prior to the first induction (Day -1), and on the day prior to challenge dosing for the appropriate test and challenge control animals.
- Scheduled Euthanasia: Following the 48-hour scoring interval, all surviving range-finding/main study animals were euthanized by carbon dioxide inhalation and discarded. - Challenge controls:
- 10 previously untreated (naive) challenge control guinea pigs were topically treated with 25 % test material (w/w) in mineral oil.
- Positive control substance(s):
- yes
- Remarks:
- HCA (Study no. 20029555)
Results and discussion
- Positive control results:
- Study No. 20029555, an HCA positive control study, demonstrated that a valid test was performed and indicated that the test design would detect potential contact sensitizers.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100 % w/w induction and 25 % w/w challenge application
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Clinical observations:
- dermal scores of 1 were noted
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100 % w/w induction and 25 % w/w challenge application . No with. + reactions: 5.0. Total no. in groups: 20.0. Clinical observations: dermal scores of 1 were noted .
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100 % w/w induction and 25 % w/w challenge application
- No. with + reactions:
- 16
- Total no. in group:
- 20
- Clinical observations:
- dermal scores of 1 or 2 were noted
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100 % w/w induction and 25 % w/w challenge application . No with. + reactions: 16.0. Total no. in groups: 20.0. Clinical observations: dermal scores of 1 or 2 were noted .
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25 % in mineral oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- 2 males and 1 female with dermal irritation outside of the test site (likely due to binding tape).
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25 % in mineral oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- 1 male and 1 female with dermal irritation outside of the test site (likely due to binding tape). 1 male and 1 female with slight patchy erythema.
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- other: Positive control study
- Group:
- positive control
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- The positive control study demonstrated a valid test was performed.
Any other information on results incl. tables
Table 1: Individual challenge data
Group |
Animal no./sex |
Dermal scores |
|
Test |
25%a |
||
24 hours |
48 hours |
||
G5857/M |
±IT |
1 |
|
G5858/M |
± |
1 |
|
G5859/M |
± |
1 |
|
G5860/M |
0 |
1 |
|
G5861/M |
1 |
2ED-1 |
|
G5862/M |
1 |
1 |
|
G5865/M |
± |
1 |
|
G5866/M |
0 |
± |
|
G5867/M |
± |
1 |
|
G5868/M |
1 |
1 |
|
G5883/F |
± |
± |
|
G5884/F |
0 |
0 |
|
G5885/F |
± |
1 |
|
G5886/F |
± |
1 |
|
G5887/F |
1 |
1 |
|
G5888/F |
± |
1 |
|
G5889/F |
± |
1 |
|
G5890/F |
± |
± |
|
G5891/F |
± |
1 |
|
G5892/F |
1 |
1 |
|
Mean |
0.6 |
0.9 |
|
Challenge control |
G5869/M |
0 |
0 |
G5870/M |
0IT |
± |
|
G5871/M |
0 |
0 |
|
G5872/M |
0 |
0 |
|
G5875/M |
0IT |
0IT |
|
G5893/F |
0 |
0 |
|
G5894/F |
0 |
0 |
|
G5895/F |
0 |
± |
|
G5896/F |
0IT |
0IT |
|
G5897/F |
0 |
0 |
|
Mean |
0.0 |
0.0 |
athe vehicle used was mineral oil; for purposes of calculation, ± = 0.5; ED-1: Edema - Grade 1 (Very slight edema (barely perceptible); IT: Dermal Irritation - Outside of the Test Site
Table 2: 1st Range Finding Test (topical irritation)
Animal |
Concentration |
|||||||
100% |
75% |
50% |
25% |
|||||
24 hours |
48 hours |
24 hours |
48 hours |
24 hours |
48 hours |
24 hours |
48 hours |
|
Male G5855 |
0 |
± |
0 |
± |
0 |
0 |
0 |
0 |
Male G5856 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Female G5881 |
0 |
± |
0 |
0 |
0 |
0 |
0 |
0 |
Female GF882 |
± |
1 |
0 |
± |
0 |
± |
0 |
± |
Vehicle: Mineral oil |
Table 3: 2nd Range Finding Test (topical irritation)
Animal |
Concentration |
|||||||
50% |
30% |
20% |
10% |
|||||
24 hours |
48 hours |
24 hours |
48 hours |
24 hours |
48 hours |
24 hours |
48 hours |
|
Male G5873 |
± |
± |
0 |
± |
± |
± |
0(IT) |
±(IT) |
Male G5874 |
0 |
± |
0 |
0 |
0(IT) |
0(IT) |
0(IT) |
0(IT) |
Female G5905 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Female GF5906 |
0 |
0 |
0 |
0 |
0(IT) |
0(IT) |
0(IT) |
0(IT) |
Vehicle: Mineral oil |
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under these test conditions is classified as sensitizing to the skin according to the CLP Regulation (EC) No. 1272/2008.
- Executive summary:
Test Guidance
In a Guinea Pigs-Modified Buehler test performed according to OECD Guideline 406 and in compliance with GLP.
Method and materials
10 male and 10 female Hartley derived albino guinea pigs were topically treated with 100% (as received) once per week, for 3 consecutive weeks. Following a 2-week rest period, a challenge was performed whereby the 20 test and 10 previously untreated (naive) challenge control guinea pigs were topically treated with 25 % (w/w) in mineral oil. Challenge responses in the test animals were compared to those of the challenge control animals. Exposure to test material at concentrations of 25, 50, 75 and 100 % resulted in dermal scores of 0, ±, or 1. Therefore, induction was determined to be acceptable at 100 % (as received). A second range-finding study conducted at concentrations of 10, 20, 30 and 50 % to determine an appropriate challenge level resulted in dermal scores of 0 or ±. Therefore, challenge was determined to be acceptable at 25 % (w/w) in mineral oil, based on the results of the 2 range-finding studies.
Results
No mortality was observed during the study. Following challenge with 25 % test material in mineral oil, dermal scores of 1 were noted in 5/20 test animals at the 24 -hour scoring interval and dermal scores of 1 or 2 were noted in 16/20 test animals at the 48 -hour scoring interval. Group mean dermal scores were higher in the test animals compared to the challenge control animals. Historical data on positive control (HCA) demonstrated a validity of the test.
Conclusions
Under these test conditions, test item is classified as sensitizing to the skin according to the CLP Regulation (EC) No.1272/2008.
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