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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: Animal experimental study, predates implementation of GLP and/or development of study guidelines, limitations in design and/or reporting but otherwise adequate for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report Date:
1974

Materials and methods

Principles of method if other than guideline:
According to BASF-internal standard: Two White Vienna rabbits received 50 mg of the test substance in the conjunctival sac of one eye. The adjacent eye received talcum powder as a control. The animals were scored 1, 24 h and 8 days after application.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Dioxyäthyl-anilin

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 3.0 and 3.4 kg

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: talcum powder, in the other eye of same animal
Amount / concentration applied:
ca. 50 mg
Duration of treatment / exposure:
Single application to the conjunctival sac of the eye
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
2
Details on study design:
REMOVAL OF TEST SUBSTANCE: substance was not removed
SCORING SYSTEM: readings were performed 1 h, 24 h, and 8 d after application

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 8 days
Irritant / corrosive response data:
Test substance:
- 1 h after application: Slight redness, marked edema, slight to marked corneal opacity and corneal release was observed in both animals.
- 24 h after application: Slight redness, slight edema, and slight corneal opacity were observed in both animals. A foamy discharge was observed in one animal and secretion in the other.
- 8 days after application: Slight redness and slight corneal opacity observed in both animals.

Control substance (talcum):
- 1 h after application: Slight redness observed in both animals. Slight edema observed in one animal.
- 24 h after application: Slight redness observed in both animals.
- 8 days after application: no effects observed.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Based on the results after 8 days, slight redness an slight corneal opacity, the test substance has to be classified as irreversible effects on the eye.