Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
not applicable
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
No guideline is mentioned at the study report, but methodology of an earlier report is mentioned.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
additive
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
The material is an intermediate in the synthesis of ceftazimide and was received from Dr P.C. Nicholson on 8 February 1982. Before use, the material was stored at room temperature and protected from the light.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Not available

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
100 mg material per rabbit
Duration of treatment / exposure:
Not specified
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
Not specified
Details on study design:
Study design and methodology are based on an earlier internal report.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 hour
Score:
ca. 7.3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
probability of weak irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24 h
Score:
ca. 2
Reversibility:
fully reversible within: 72 hours
Remarks on result:
probability of weak irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
72 h
Score:
ca. 0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
7 d
Score:
ca. 0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1 hour
Score:
ca. 0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
7 d
Score:
ca. 0
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1 hour
Score:
>= 0
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
7 d
Score:
ca. 0
Remarks on result:
no indication of irritation
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 1 hour
Score:
ca. 7.3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
probability of weak irritation
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
24 h
Score:
ca. 2
Reversibility:
fully reversible within: 72 hours
Remarks on result:
probability of weak irritation
Irritant / corrosive response data:
Slight reaction was observed at 1 hour at conjuctivae. Very slight reaction was observed at 24 hours. No effects were observed on the iris or the cornea.

Any other information on results incl. tables

  Maximum score possible Mean score at:
1 hr. 24 hr. 72 hr. 7 days 14 days
Conjunctivae 20 7.3 2.0 0.0 0.0 -
Iris 10 0.0 0.0 0.0 0.0 -
Cornea 80 0.0 0.0 0.0 0.0  
OVERALL MEAN SCORE 7.3 2.0  

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the results at one hour, the test material presented a negligible risk of irritancy.
Executive summary:

The substance was tested for acute eye irritancy in New Zealand White rabbits. The results indicated that the material presented a negligible risk of eye irritancy.