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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: similar to respective guideline but reported only in brief

Data source

Reference
Reference Type:
other: short report
Title:
Unnamed
Year:
1972
Report Date:
1972

Materials and methods

Principles of method if other than guideline:
100 mg of the test substance was applied into the concunctival sac of the left eye of each of 2 rabbits. After one minute the left eye of one of the two rabbits was rinsed with physiological saline. The right eyes of each of the two rabbits served as control. The animals were observed for 7 days.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
IUCLID4 Test substance:
pure technical product

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
no data

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
one left eye : due to rinsing: 1 min, the other left eye was not rinsed
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
2
Details on study design:
100 mg of the test substance was applied into the concunctival sac of the left eye of each of 2 rabbits. After one minute the left eye of one of the two rabbits was rinsed with physiological saline. The right eyes of each of the two rabbits served as control. The animals were observed for 7 days.

Results and discussion

In vivo

Results
Irritation parameter:
other: irritational effects
Basis:
mean
Time point:
other: up to 8h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: slight conjunctival injections which do not lead to classification
Irritant / corrosive response data:
After 4 hours and after 8 hours slight conjunctival injections and slight discharge was observed. Within 24 hours both left treated eyes cleared and dis charge ceased wether it was rinsed eye or not-rinsed eye. Fluorescein test was without finding.

Applicant's summary and conclusion

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

100 mg of the test substance was applied into the concunctival sac of the left eye of each of 2 rabbits. After one minute the left eye of one of the two rabbits was rinsed with physiological saline. The right eyes of each of the two rabbits served as control. The animals were observed for 7 days. Four hours and 8 hours post application slight irritating effects were observed which were fully reversible within 24 hours, thus, not leading to classification. In addition, Fluorescein Test was without finding. Therefore, the overall evaluation is that Macrolex Rot is not irritating to the eyes of rabbits.