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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:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
Data is from safety assessment report

Data source

Reference
Reference Type:
secondary source
Title:
SIDS Dossier for the test chemical
Author:
OECD SIDS
Year:
2003
Bibliographic source:
OECD SIDS, 2003

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Draize method.
Principles of method if other than guideline:
An eye irritation study was conducted on rabbits to assess the degree of eye irritancy caused by the chemical according to Draize method.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
- Name of test material (as cited in study report):l-Menthol- Molecular formula :C10H20O- Molecular weight :156.267 g/mol- Substance type:Organic - Physical state:Solid - InChI: 1S/C10H20O/c1-7(2)9-5-4-8(3)6-10(9)11/h7-11H,4-6H2,1-3H3/t8-,9+,10-/m1/s1- Smiles: C1[C@H]([C@@H](C[C@@H](C)C1)O)C(C)C

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
No Data Available

Test system

Vehicle:
other: Olive oil
Controls:
not specified
Amount / concentration applied:
60% (1ml)
Duration of treatment / exposure:
1 minute
Observation period (in vivo):
1 minute
Number of animals or in vitro replicates:
8
Details on study design:
Substance was initially applied in 10, 20 and 30 % solution. The eyes of 4 animals were rinsed 1 minute after application with physiological saline, substance remained in the eyes of 4 animals. In a second step animals were treated with concentration of 40, 50 and 60 %.

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1 minute
Score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No signs of eye irritation were observed.

Applicant's summary and conclusion

Interpretation of results:
other: Not irritating
Conclusions:
No signs of eye irritation were observed. Hence, the chemical was considered to be not irritating to the eyes of rabbits.
Executive summary:

An eye irritation study was conducted on rabbits to assess the degree of eye irritancy caused by the chemical according to Draize method.

The test substance was initially applied in 10, 20 and 30 % solution. The eyes of 4 animals were rinsed 1 minute after application with physiological saline, substance remained in the eyes of 4 animals. In a second step animals were treated with concentration of 40, 50 and 60 %.

 

No signs of eye irritation were observed. Hence, the chemical was considered to be not irritating to the eyes of rabbits.