Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
November 1976
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: limited justification

Data source

Reference
Title:
Unnamed
Year:
1976

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Consumer Product Safety Commission of the U.S.A. in The Code of Federal Regulotions, Title 16 1 Section 1500.41
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
impurity
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
Sample code n°: 507-43

Test animals / tissue source

Species:
rabbit
Strain:
not specified

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
79 mg
Observation period (in vivo):
28, 48, 72 h for scores analysis
Number of animals or in vitro replicates:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: for #1 to #6
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal: for #1 to #6
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal: form #1 to #6
Time point:
24/48/72 h
Score:
> 0 - < 1
Max. score:
1
Reversibility:
fully reversible within: 14 days
Remarks on result:
probability of mild irritation
Irritation parameter:
chemosis score
Basis:
animal: form #1 to #6
Time point:
24/48/72 h
Score:
> 0 - < 1
Max. score:
1
Reversibility:
fully reversible within: 2 days
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
The numerical scores awarded to the ocular reactions elicited by 507-43 are given in Table 1.
None of the animals gave a “positive” reaction.
Mild conjunctival reactions were observed in all six animals.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Sample 507-43 gave a negative test for eye irritation, according to the definition given in the Code of Federal Regulations.
Executive summary:

EXPERIMENTAL PROCEDURE

The procedure employed was that prescribed by The Consumer Product Safety Commission of the U.S.A in the Code of Federal Regulations; Title 16, Section 1500.42, a transcript of which is attached as an Appendix to this report.

On this occasion 79 mg of sample 507-43 was instilled into one eye of each six animals.

RESULT

The numerical scores awarded to the ocular reactions elicited by 507-43 are given in Table 1.

None of the animals gave a “positive” reaction.

Mild conjunctival reactions were observed in all six animals.

CONCLUSION

Sample 507-43 gave a negative test for eye irritation, according to the definition given in the Code of Federal Regulations.