Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

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: Only study summary availiable

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
J.H. Draize, "Dermal Toxicity", Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, (The Association of Food and Drug Officials of the United States, (1975), pp. 52 - 54.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Divinyl ether of 1,4-cyclohexane, dimethanol

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: CAMM Research (Wayne, NJ, USA)
- Age at study initiation: approx. 3 month
- Weight at study initiation: approx. 2 kg
- Housing: single
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 3 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.3 - 23,9 °C (65 - 75 ° F)
- Photoperiod (hrs dark / hrs light): 12 h

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
The eyes of six (6) animals remained unwashed for 24 hours; the eyes of the remaining three (3) animals were washed out 30 seconds after instillation of the test article.
Observation period (in vivo):
Observations of corneal opacity, iritis, conjunctivitis, and other effects were recorded 24, 48, and 72 hours after treatment, and at day 4.
Number of animals or in vitro replicates:
9
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 30 Minutes after start of exposure 3 rabbits and 24 h after start of exposure 6 rabbits.
SCORING SYSTEM:
Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 - 72
Score:
0
Max. score:
0
Remarks on result:
other: only unwashed eyes data
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24-72
Score:
0
Max. score:
0
Remarks on result:
other: only unwashed eyes data
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24-72
Score:
0
Max. score:
0
Remarks on result:
other: only unwashed eyes data
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 - 72
Score:
0.2
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other: only unwashed eyes data; reverible within 4 days
Irritant / corrosive response data:
Only minimal irritation effects were observed

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Executive summary:

The study is a guideline study according to US cosmetics regulation. However, the study is reliable with restriction because there is only a summary availiable which provides poor information concerning the test substance identity.

Nine New Zealand white rabbits, free from visible ocular defects, each received a cingle intraocular application of 0.1 milliliter of the test article. The contralateral eye, remaining untreated, served as a control. The eyes of six animals remained unwashed for 24 hours; the eyes of the remaining three animals were washed out 30 seconds after instillation of the test article. Observations of corneal opacity, iritis, conjunctivitis, and other effects were recorded 24, 48, and 72 hours after treatment, and at day 4.

The instillation of 1,4 dimethylol-divinylether cyclohexane resulted in a slight erythema (mean 0.2), but no other effect was observed for the unwashed eye. Therefore 1,4 dimethylol-divinylether cyclohexane was considered not irritating to the eyes (score 0.3 of max 110) .