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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 from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted on readacross substance. However reliability and applicability high, supported by Category documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Section 1500.42-Hazardous Substance and Articles, Administration and Enforcement Regulations, Federal Register, Vol 38, No. 187, P 27019, 27 September 1973.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Undiluted liquid

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
1.66
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0.17
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
2.05
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
3.1
Reversibility:
not fully reversible within: 21 days
Irritant / corrosive response data:
The eyes were examined at 1, 2, 3, 4, 7, 14, and 21 days following instillation in accordance with the Draize method. The mean (24, 48, and 72 hours) cornea opacity, iritis, conjunctival redness and conjunctival edema scores were 1.66, 0.17, 2.05, and 3.1 respectively. Corneal opacity, iritis, conjunctivae redness and chemosis did not resolve by 21 days.

Any other information on results incl. tables

Cornea score:

1.66 of max. 4 (mean) (Time point: 24, 48 72 hours) (not reversible) (Effects did not clear in 4/6 animals at 21 days)

Iris score:

0.17 of max. 2 (mean) (Time point: 24, 48, 72 hours) (not reversible) (Effects were not clear in 2/6 animals at 21 days)

Conjunctivae score:

2.05 of max. 3 (mean) (Time point: 24, 48, 72 hours) (not reversible) (Effects did not clear in 5/6 animals at 21 days)

Chemosis score:

3.1 of max. 4 (mean) (Time point: 24, 48, 72 hours) (not reversible) (Effects did not clear in 6/6 animals at 21 days)

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study, the test material caused ocular irritation that persisted through day 21. In accordance with Directive 67/548/EEC and EU CLP (Regulation (EC) No. 1272/2008) classification of this substance is required for eye irritation. The results from this substance can be read across to the registration substance.
Executive summary:

The substance was instilled into the conjunctival sac of six New Zealand white rabbits. The eyes were examined at 1, 2, 3, 4, 7, 14, and 21 days following instillation in accordance with the Draize method. The mean (24, 48, and 72 hours) cornea opacity, iritis, conjunctival redness and conjunctival edema scores were 1.66, 0.17, 2.05, and 3.1 respectively. Corneal opacity, iritis, conjunctivae redness and chemosis did not resolve by 21 days. Under the conditions of this study, the test material caused ocular irritation that persisted through day 21.