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:
key study
Study period:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: FDA Fed.Reg. 28 (119), 5582, 1963
Deviations:
not specified
GLP compliance:
not specified

Test material

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

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
upon application eye closed for one second and subsequently not rinsed
Observation period (in vivo):
eyes examined at 24, 48, 72 hr and 7 days after instillation
Number of animals or in vitro replicates:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible

Any other information on results incl. tables

Individual scores awarded to the ocular lesions elicited by benzonitril using FDA-scoring scale

 

 

 

Conjunctivae

Rabbit No.

Cornea

Iris

Redness

Chemosis

After 24 hours

13

0

0

1

0

14

0

0

1

0

15

0

0

1

0

16

0

0

1

1

17

0

0

1

0

18

0

0

1

1

After 48 hours

13

0

0

0

0

14

0

0

0

0

15

0

0

1

0

16

0

0

1

0

17

0

0

1

0

18

0

0

1

0

After 72 hours

13

0

0

0

0

14

0

0

0

0

15

0

0

1

0

16

0

0

1

0

17

0

0

1

0

18

0

0

1

0

After 7 days

13

0

0

0

0

14

0

0

0

0

15

0

0

0

0

16

0

0

0

0

17

0

0

0

0

18

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Criteria used for interpretation of results: US CPSC / US FDA
Conclusions:
Upon application into the eye benzonitril caused slight lesions of the conjunctivae in all 6 rabbits. After seven days all treated eyes were normal again.
Executive summary:

In a primary eye irritation study 0,1 ml of benzonitril as provided by the study owner without vehicle was instilled into the conjunctival sac of one eye of an adult New Zealand rabbits (in total 6) secured for one second (eyes subsequently not washed). The animal eyes were then examined after 24, 48 and 72 hours and finally after 7 days.  Irritation was scored by the method of FDA-scoring scale.

 

Upon application into the eye benzonitril caused slight lesions of the conjunctivae in all (six) rabbits. After seven days all treated eyes were normal again. According to the FDA-standards benzonitril is not considered to be an eye irritant.