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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
Study period:
March 20 - May 21, 2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2008

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
2002-04-24
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
methyl cis-1-{[(2,5-dimethylphenyl)acetyl]amino}-4-methoxycyclohexanecarboxylate
EC Number:
606-524-1
Cas Number:
203313-47-7
Molecular formula:
C19H27NO4
IUPAC Name:
methyl cis-1-{[(2,5-dimethylphenyl)acetyl]amino}-4-methoxycyclohexanecarboxylate
Test material form:
solid: bulk

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Controls:
yes, concurrent no treatment
Duration of treatment / exposure:
24 h
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item did not cause eye irritation.
Executive summary:

The irritant / corrosive effects of the test item were tested on the eye of rabbits.


The method used complied with the OECD - Guideline for Testing of Chemicals No. 405 -"Acute Eye Irritation/Corrosion"; adopted: 24th April 2002; EEC Directive 67/548 Annex V - Method B.5. (1967) in its current version, and the principles of the EPA Health Effects Test Guidelines (OPPTS 870.2400), United States, EPA 712-C-98-195 (1998), with the exception that recognized differences exist between OECD - Guideline 405 and EPA - Guideline OPPTS 870.2400.


According to classification criteria the test item is not irritating to eyes.
There were no systemic intolerance reactions.