Registration Dossier
Registration Dossier
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EC number: 239-263-3 | CAS number: 15206-55-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Scientifically acceptable method, minor deficiencies in reporting details compared to current OECD test report requirements. Study performed prior to GLP requirements.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Federal Register 38, No. 187, §1500.41, S. 27029 (1973)
- Principles of method if other than guideline:
- Further testing: 2 animals were tested applying the test substance for 5 min and 2 hours under occlusive conditions, respectively. The test substance was rinsed with Lutrol and observed after 24, 48 hours and 8 days.
- GLP compliance:
- no
Test material
- Reference substance name:
- Methyl benzoylformate
- EC Number:
- 239-263-3
- EC Name:
- Methyl benzoylformate
- Cas Number:
- 15206-55-0
- Molecular formula:
- C9H8O3
- IUPAC Name:
- methyl oxo(phenyl)acetate
- Details on test material:
- - Physical state: liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: mean: female: 3.44 kg
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: abraded and intact
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- 5min, 2h or 24 hours
- Observation period:
- 24, 72 hours and 8 days
- Number of animals:
- 3 (24h exposures)
2 (5min and 2h exposure) - Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 72 hours
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: intact skin (24h exposure)
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 72 hours
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: intact skin (24h exposure)
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 72 hours
- Score:
- 2.8
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: abraded skin (24h exposure)
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 72 hours
- Score:
- 2.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: abraded skin (24h exposure)
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48h
- Remarks on result:
- other: intact skin (2h exposure), slight scales at the 8h reading
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48h and 8 days
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: intact skin (2h exposure)
- Other effects:
- Scaling was found in all animals on day 8 of observation.
Any other information on results incl. tables
Results for 24h exposure:
|
reading time |
animal 1 |
animal 2 |
animal 3 |
erythema |
|
|
|
|
intact skin |
24h |
2 |
2 |
2 |
|
72h |
3 |
2 |
3 |
|
8d |
2 S |
0 S |
2 S o |
|
mean 24,72h |
2.5 |
2 |
2.5 |
abraded skin |
24 h |
3 |
3 |
2 |
|
72h |
3 |
3 |
3 o |
|
8d |
2 S |
1 S |
2 sS o |
|
mean 24,72h |
3 |
3 |
2.5 |
edema |
|
|
|
|
intact skin |
24 h |
2 |
0 |
2 |
|
72h |
2 |
1 |
2 |
|
8d |
0 |
0 |
0 |
|
mean 24,72h |
2 |
0.5 |
2 |
abraded skin |
24 h |
2 |
2 |
2 |
|
72h |
3 |
3 |
3 o |
|
8d |
0 |
0 |
0 |
|
mean 24,72h |
2.5 |
2.5 |
2.5 |
S: scaling; sS: strong scaling; overall
Results for internal method: After 2 hour exposure with the test substance to the skin of two rabbits erythema of score 1 was observed 24 hours later. This effect was fully reversible within 48 hours (score 0). 8 days after application scaling was still observed. No edema was observed at any reading time point.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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