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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:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1964
Report Date:
1964

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Before OECD Guideline 405 was established, eye irritation was tested using an internal method (BASF test). Approximately 50 µL (one drop) of the test substance were applied to the conjunctival sac of one eye in 2 animals. The eyes were not washed out after 24 hours as specified in OECD Guideline 405.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
tert. Butylacrylate, stabilized with 0.02 % hydroquinone

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.2 - 2.36 kg

ENVIRONMENTAL CONDITIONS
not reported

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The saline-treated adjacent eye served as control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 50 µL
Duration of treatment / exposure:
Treatment was once. The eye was left unwashed.
Observation period (in vivo):
2/3 d depending on observed complete reversibility
Number of animals or in vitro replicates:
2
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not rinsed

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
(2 animals)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
iris score
Basis:
mean
Remarks:
(2 animals)
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
(2 animals)
Time point:
24/48/72 h
Score:
0.16
Max. score:
3
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: In one animal, pinhead-sized bleedings of the nictitating membrane were observed after 24 and 48 h, but were reversible within 72 h.
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
(2 animals)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritant / corrosive response data:
Slight conjunctivae redness and chemosis were observed in both animals at the 10 min, 1 h and 3 h readings. Additionally, reversible myosis (1 h and 3 h reading) and questionable corneal opacity (3 h) were observed in one animal.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met