Registration Dossier

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: limited documentation and some deviations to OECD 405. The study is, however suffient for substance evaluation.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
only 50 µl applied
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Chlorameisensäure methyl ester (chloroformic acid-methyl ester)
- Physical state: liquid
- no further data

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Germany
- Weight at study initiation: 2.79 and 2.80 kg

ENVIRONMENTAL CONDITIONS
no data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µl
Duration of treatment / exposure:
eyes remained unwashed
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
2
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing done

SCORING SYSTEM: descriptive scoring systen comparable to the Draize score.
TOOL USED TO ASSESS SCORE: fluorescein to proof absebnce of any effect

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 27-48 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24-48
Score:
0.5
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24-48 h
Score:
1.5
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24-48 h
Score:
1
Max. score:
4
Reversibility:
not reversible
Irritant / corrosive response data:
irreversible demage to the eyes

Any other information on results incl. tables

Descriptive scores of the raw data have been converted to Draize numerical scores.

Animal

Reading

Opacity

Iritis

Redness

Chemosis

Comment

1

1 h

2

0

1

0

 

2

1 h

2

0

1

0

 

1

24 h

2

0

1

3

 

2

24 h

1

0

1

0

 

1

48 h

2

2

1

3

suppuration

2

48 h

3

0

1

0

suppuration, corrossion

1

8 d

3

2

2

3

staphyloma/suppuration

2

8 d

3

0

2

3

staphyloma/suppuration

mean

24 - 48 h

2.0

0.5

1.0

1.5

 

 

Applicant's summary and conclusion

Conclusions:
risk of serious damage to eyes