Registration Dossier
Registration Dossier
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EC number: 202-501-1 | CAS number: 96-34-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline similar to OECD guideline and no GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, FDA, Austin, Texas, p 51 (1975)
- Deviations:
- not specified
- GLP compliance:
- no
Test material
- Reference substance name:
- Methyl chloroacetate
- EC Number:
- 202-501-1
- EC Name:
- Methyl chloroacetate
- Cas Number:
- 96-34-4
- Molecular formula:
- C3H5ClO2
- IUPAC Name:
- methyl 2-chloroacetate
- Details on test material:
- - Name of test material (as cited in study report): monochloressigsäuremethylester
- Physical state: colourless liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: own breeding
- Weight at study initiation: 1.5-2.5 kg
- Diet (e.g. ad libitum): ERKA 8300 (Futtermittelwerk Robert Koch oHG, Hamm/Westf), ad libitum
- Water (e.g. ad libitum): ad libitum
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the right eye served in each case as an untreated control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 1, 7, 24, 48 and 72 hours
- Number of animals or in vitro replicates:
- 6 animals
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): the eyes were rinsed with physiological saline solution.
- Time after start of exposure: 24 hours
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.22
- Max. score:
- 3
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.17
- Max. score:
- 3
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.22
- Max. score:
- 3
- Reversibility:
- not specified
Any other information on results incl. tables
Table 7.3.2 -1: Eye irritation scores
|
24 h |
48 h |
72 h |
Mean 24-72 h |
|||||||||||||||
Animal No. |
Animal No. |
Animal No. |
|||||||||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
1 |
2 |
3 |
4 |
5 |
6 |
1 |
2 |
3 |
4 |
5 |
6 |
||
Cornea |
1
|
2 |
2 |
2 |
2 |
3 |
2 |
2 |
2 |
2 |
2 |
3 |
2 |
3 |
3 |
2 |
2 |
3 |
2.22 |
Iris |
0
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Conjunctiva-redness |
2 |
2 |
2 |
2 |
2 |
2 |
2 |
2 |
2 |
2 |
2 |
2 |
3 |
3 |
2 |
2 |
3 |
2 |
2.17 |
Conjunctiva-chemosis |
2 |
2 |
2 |
2 |
2 |
2 |
2 |
2 |
2 |
3 |
3 |
3 |
2 |
2 |
2 |
3 |
2 |
2 |
2.22 |
Applicant's summary and conclusion
- Interpretation of results:
- other: There is no information on the reversibility of the observed damage.
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The mean scores for 24-72 h for eye irritation are 2.22, 2.17 and 2.22 for cornea opacity, conjunctiva redness and conjunctiva chemosis, respectively. However, there is no information on the reversibility of the observed damage.
- Executive summary:
Single samples of 0.1 ml of methyl chloroacetate were instilled into one eye of each of six rabbits. Observations were made 1, 7, 24, 48 and 72 hours after instillation. The mean scores for 24-72 h for eye irritation are 2.22, 2.17 and 2.22 for cornea opacity, conjunctiva redness and conjunctiva chemosis, respectively. However, there is no information on the reversibility of the observed damage.
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