Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
test material is applied to 6 rather than 3 rabbit eyes; test material is removed (washed) from 3 of 6 eyes, to evaluate the effect of washing on subsequent development of irritant response
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
several crystals; dry

Test animals / tissue source

Species:
rabbit
Strain:
not specified

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
several crystals
Duration of treatment / exposure:
acute
Observation period (in vivo):
10 days
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
other: group
Time point:
other: 1 hour
Score:
2
Reversibility:
fully reversible
Remarks on result:
other: 2=moderate irritation
Irritation parameter:
overall irritation score
Basis:
other: group
Time point:
other: 24 hours
Score:
2
Reversibility:
fully reversible
Remarks on result:
other: 2=moderate irritation
Irritation parameter:
overall irritation score
Basis:
other: group
Time point:
other: 48 hours
Score:
1
Reversibility:
fully reversible
Remarks on result:
other: 1=slight irritation
Irritant / corrosive response data:
In the eye of rabbits exposed to test article without subsequent washing, 3 of 3 demonstrated moderate irritation of the conjunctiva and nicitating membrane at 1 and 24 hours after exposure; at 24 hours, irritation was accompanied by moderate corneal opacity, and positive adnexa and corneal staining was observed in 3 of 3 eyes. At 48 hours after exposure, slight irritation was observed in 3 of 3 eyes, accompanied by moderate corneal opacity. At 7 days after exposure, irritation was present in 2 of 3 eyes, wherein slight irritation was accompanied by slight corneal opacity. At 10 days after exposure, 3 of 3 eyes appeared normal.

In eyes of rabbits exposed to test article followed by washing, slight irritation was observed in the conjunctiva and nicitating membrane in 3 or 3 eyes at 1, 24, and 48 hours after exposure. At 24 hours after exposure, positive adnexa staining was observed in 3 of 3 eyes, while corneal staining was not observed. At 7 and 10 days after exposure, 3 of 3 eyes appeared normal.

Applicant's summary and conclusion

Conclusions:
moderate eye irritant; washing was palliative
Executive summary:

The test article (1,4 - cyclohexane dicarboxylic acid; CHDA) was instilled into both eyes of 3 rabbits, and for each rabbit, the test article was removed from one eye by washing. Each eye was evaluated for evidence of irritation at 1, 24, and 48 hours after instillation, and after 7 and 10 days. In the unwashed eyes, moderate irritation was observed in 3 of 3 eyes at 1 and 24 hours after instillation, and slight irritation was observed in 3 of 3 eyes at 48 hours after instillation. Irritation was accompanied by moderate corneal opacity at 24 and 48 hours after instillation and by slight corneal opacity after 7 days. By 10 days after test article instillation, 3 of 3 eyes appeared normal. In the washed eyes, slight irritation was observed in 3 of 3 eyes at 1, 24, and 48 hours after instillation, and by 7 days after test article instillation,3 of 3 eyes appeared normal.