Registration Dossier
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EC number: 241-624-5 | CAS number: 17639-93-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- Not specified
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was based on EEC methodology and performed at a reputable testing facility, however no information on GLP was provided in the test report.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Report states that the study was in accordance with EEC methodology however no specific method was cited.
- GLP compliance:
- not specified
- Remarks:
- No information on GLP was provided in the test report.
Test material
- Reference substance name:
- 2-Chloropropionic acid methyl ester
- IUPAC Name:
- 2-Chloropropionic acid methyl ester
- Details on test material:
- - Name of test material (as cited in study report): MeACPA/ 2-Chloropropionic acid methyl ester
- Physical state: Liquid
- Analytical purity: 99.4%
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- not specified
- Vehicle:
- not specified
- Controls:
- not specified
- Duration of treatment / exposure:
- Four hour exposure period
- Observation period:
- Eight days after dosing
- Number of animals:
- Three
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: Over 72 hours observation
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 9 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: Over 72 hours observation
- Score:
- 0.86
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
Any other information on results incl. tables
A summary of the results is presented in Table 1.
Rabbit Number |
E=Erythema O = Oedema |
Day |
||||||||
1* |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
||
17 |
E O |
1 1 |
2 2 |
2 2 |
2 1 |
1 1 |
1 1 |
1 0 |
1 0 |
0 0 |
18 |
E O |
1 1 |
1 1 |
1 1 |
1 1 |
1 0 |
1 0 |
1 0 |
1 0 |
0 0 |
589 |
E O |
1 1 |
0 0 |
0 0 |
0 0 |
|
|
|
|
|
*Approximately 60 minutes after removal of the dressing.
All rabbits used in the study were female.
Scores at reading times of 24, 48 and 72 hours were used to calculate the mean scores.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Conclusions:
- Methyl-2-chloropropionic acid elicited a slight to very well defined dermal irritation after four hours exposure to rabbit skin. This irritation is not sufficient to require classification as ‘irritating to skin’.
- Executive summary:
The effect of Methyl-2-chloropropionic acid on rabbit skin was evaluated in a study in accordance with EEC methodology. The test substance (0.5 ml) was applied to three New Zealand white rabbits under a semi-occlusive dressing. After a four-hour exposure period the dressings and test substance were removed and the test sites assessed for a period of eight days after dosing.
The application resulted in a mean erythema score of 1 over the 72 hour period after dosing and a mean oedema score of 0.86 for the same time period.
These scores are insufficient to trigger classification as irritating to skin, according to the CLP classification criteria.
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