Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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: 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