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Toxicological information

Eye irritation

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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:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
according to
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
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): monochloressigsäuremethylester
- Physical state: colourless liquid

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:
other: 24-72 h
Score:
2.22
Max. score:
3
Reversibility:
not specified
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24-72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24-72 h
Score:
2.17
Max. score:
3
Reversibility:
not specified
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24-72 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.