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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
Study period:
1971
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1971
Report Date:
1971

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: USDA Regulation (Federal Register 34, No. 64, April 4, 1969)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals / tissue source

Species:
rabbit
Strain:
other: Albino rabbits

Test system

Controls:
other: untreated eye
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
24, 48 and 72 hours
Number of animals or in vitro replicates:
6 albino rabbit

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: irritation
Basis:
animal: 21 and 27
Time point:
24/48/72 h
Score:
0
Remarks on result:
other:
Remarks:
Irritation effects: positive after 24 h; negative after 48 h and 72 h.
Irritation parameter:
other: irritation
Basis:
animal: 22, 23, 24 and 26
Time point:
24/48/72 h
Score:
0
Remarks on result:
other:
Remarks:
Irritation effects: positive after 24, 48 and 72 h.

Any other information on results incl. tables

The results are shown in the following table.

Animal number

Irritant effect on the eye

after

24 hours

after

48 hours

after

72 hours

21

pos.

neg.

neg.

22

pos.

pos.

pos.

23

pos.

pos.

pos.

24

pos.

pos.

pos.

26

pos.

pos.

pos.

27

pos.

neg.

neg.

Result: distinct irritant effect on the mucosa

Applicant's summary and conclusion

Interpretation of results:
other: classified as an eye irritant according to the CLP Regulation (EC) No.1272/2008
Conclusions:
The test item caused distinct irritation of the mucosa of the eye in the rabbit.
Executive summary:

The eye irritation potential of the substance was evaluated following the USDA Regulation (Federal Register 34, No. 64, April 4, 1969). Six albino rabbits were exposed to the substance for 72 hours; the untreated eye was used as a control. The eyes of the rabbits were evaluated at 24 -48 -72 hours.

The test item caused distinct irritation of the mucosa of the eye in the rabbit.