Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Remarks:
This study dates from 1981 and was conducted in a jurisdiction where toxicity testing on cosmetic ingredients was legally required to be conducted on vertebrate animals.
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Justification for type of information:
This study dates from 1981 and was conducted in a jurisdiction where toxicity testing on cosmetic ingredients was legally required to be conducted on vertebrate animals.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
EPA OPP 81-4 (Acute Eye Irritation)
Deviations:
not specified
GLP compliance:
no
Remarks:
The study was conducted in the USA in 1981, before the adoption of the OECD Principles of GLP in 1992.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
7 days
Details on study design:
Six (6) New Zealand white rabbits, free from visible ocular defects, each received a single intraocular application of 0.1 milliliter of the test article in one eye. The contralateral eye, remaining untreated, served as a control. The eyes of all animals remained unwashed for 24 hours. Observations of corneal opacity, iritis, and conjunctivitis were recorded 20, 48, and 72 hours after treatment, and at 4 and 7 days if irritation persisted. The test article was used as received.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24 h
Score:
0.3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
48 h
Score:
0
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
72 h
Score:
0

Any other information on results incl. tables

Group Draize scores
24 h 48 h 72 h 4 d 7 d
Unwashed 0.3 0 0 - -

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test material is not an ocular irritant to rabits under the conditions of the test.
Executive summary:

In this guideline equivalent study (EPA OPP 81 -4), conducted prior to the adoption of the OECD principles of GLP in 1992, the test material (EC 205-363-0) was not considered an ocular irritant to the rabbit. Six New Zealand White rabbits were treated with 0.1ml of the unchanged substance in one eye, the contralateral eye served as a control. Rabbits were observed for corneal opacity, iritis, and conjunctivitis at 24, 48, and 72 hours after treatment, and again 4 day and 7 days after treatment. Results were scored accoring to the Draize criteria. The test material induced a mean overal irritation score of 0.3 at 24 hours, this was fully reversible at the 48 hour observation.