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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: in compliance with guideline, but no GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report date:
1975

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: FDA guideline, Vol 38, no 187 (1973)
Principles of method if other than guideline:
Method: other: FDA-Guideline, see freetext ME
0.1 ml of the undiluted Ts was applied into the conjunctival sac of one eye of each of the 6 rabbits. reading was carried out1, 7, 24, 48 and 72 hrs and 7 and 14 days post application. After the 24 hour reading the eyes were rinsed and additionally examined by addition of 1 drop of fluorescein. The total observation period was 14 days. The findings were evaluated according to federal Register 38, No.187, 1973
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
4-chlorotoluene
EC Number:
203-397-0
EC Name:
4-chlorotoluene
Cas Number:
106-43-4
Molecular formula:
C7H7Cl
IUPAC Name:
4-chlorotoluene
Details on test material:
p-chlorotoluene (no data on purity)

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
undiluted
Amount applied: 0.1 ml
Duration of treatment / exposure:
24 hour(s)
Observation period (in vivo):
14 days
Number of animals or in vitro replicates:
6
Details on study design:
Comment: rinsed after (see exposure time)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at any time point
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: score = 0 at any time point
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, and 72 hours
Score:
0.72
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, and 72 hours
Score:
0.5
Max. score:
4
Reversibility:
not fully reversible within: 7 days

Any other information on results incl. tables

Number of animals with changes:
cornea // iris // conjunc. redness // conjunc. swelling
 1 hr : 0/6 //0/6 //6/6(grade 1 of 3)// 4/6(grade 1 of 4)
 7 hrs: 0/6 //0/6 //6/6(grade 1 of 3)// 3/6(grade 1 of 4)
24 hrs: 0/6 //0/6 //6/6(grade 1 of 3)// 3/6(grade 1 of 4)
48 hrs: 0/6 //0/6 //4/6(grade 1 of 3)// 3/6(grade 1 of 4)
72 hrs: 0/6 //0/6 //3/6(grade 1 of 3)// 3/6(grade 1 of 4) 
 7 d  : 0/6 //0/6 //0/6              // 0/6 
14 d  : 0/6//0/6//0/6                // 0/6

Total irritation index is not given.

Applicant's summary and conclusion

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

method: 0.1 ml of the undiluted test-substance was applied into the conjunctival sac of one eye of each of the 6 rabbits. reading was carried out 1, 7, 24, 48 and 72 hrs and 7 and 14 days post application. The total observation period was 14 days.

result: slightly irritating