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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions (test substance purity not specified, methodological differences, only 0.05 mL test substance evaluated, only 24-h reading, only 24-h observation period).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
test substance purity not specified, methodological differences, only 0.05 mL test substance evaluated, only 24-h reading, only 24-h observation period
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Only trade name given
- Analytical purity: no data

Test animals / tissue source

Species:
rabbit
Strain:
other: New Zealand

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The untreated left eye served as control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.05 mL undiluted test substance
Duration of treatment / exposure:
single eye instillation
Observation period (in vivo):
24 hours

Reading time points: 2, 6 and 24 h after instillation
Number of animals or in vitro replicates:
2 (male)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
out of all 2 animals
Time point:
other: 24 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of all 2 animals
Time point:
other: 24 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
out of all 2 animals
Time point:
other: 24 h
Score:
0
Max. score:
3
Reversibility:
other: reversibility: not applicable
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
out of all 2 animals
Time point:
other: 24 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritant / corrosive response data:
One animal showed mild conjunctival erythema 2 hours after instillation, which disapperaed completely within 6 hours.

Applicant's summary and conclusion

Conclusions:
The test substance was not irritating in this test, however, observation period was only 24 hours long.