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Registration Dossier
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EC number: 261-245-9 | CAS number: 58430-94-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 1982-03-08 to 1982-04-24
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- dorsal surface clipped 3-4 days before the test started instead of 24 h before start of test as indicated in the guideline. No information on the housing is given. No data about reversibility of effects.
- GLP compliance:
- no
Test material
- Reference substance name:
- 3,5,5-trimethylhexyl acetate
- EC Number:
- 261-245-9
- EC Name:
- 3,5,5-trimethylhexyl acetate
- Cas Number:
- 58430-94-7
- Molecular formula:
- C11H22O2
- IUPAC Name:
- .
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 9-12 weeks
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped 3-4 days before start of test. Animals in the telogen phase of hair growth used in the test.
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- immediately after treatment, at 24, 48 and 72 h
- Number of animals:
- 8
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm square
- Type of wrap if used: zinc oxide plaster
REMOVAL OF TEST SUBSTANCE
- Washing: wiped clean of excess material
- Time after start of exposure: 4 h
SCORING SYSTEM: from 0 to 4 (maximum possible)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.6
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.6
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 3.7
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 3.7
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- erythema score
- Basis:
- animal: #7
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- edema score
- Basis:
- animal: #7
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- no data
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- The substance was irritant to rabbits in a covered patch skin irritation test. According to CLP, this substance is considered as irritating to the skin and is classified into skin irritation Category 2.
- Executive summary:
3,5,5-trimethylhexyl acetate was tested in a non-GLP study slightly deviating from OECD TG 404 "covered patch skin irritation test". Eight New Zealand White rabbits were exposed to the undiluted test item for 4 hours under individual semi-occlusive patches. The irritation reactions were assessed immediately after removal of the patch and after 24, 48 and 72 hours. The mean values of erythema score at 24, 48 and 72 hours were between 2.3 and 3.7 in all tested animals. According to the CLP Regulation, this test item should be classified as a skin irritant, Category 2.
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