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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:
May - July 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
2002
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
1967
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
480-410-8
EC Name:
-
Cas Number:
13482-23-0
Molecular formula:
Hill formula: C7H12O2 CAS formula: C7H12O2
IUPAC Name:
4-methoxycyclohexan-1-one

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
14 days
Number of animals or in vitro replicates:
3 animals

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
1.9
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
2.76
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
1.53
Max. score:
4
Reversibility:
fully reversible within: 14 days

Applicant's summary and conclusion

Interpretation of results:
irritating
Conclusions:
According to classification criteria the test item is irritating to eyes with full reversibility within 14 days.
There were no systemic intolerance reactions.
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 irritating to eyes with full reversibility within 14 days.
There were no systemic intolerance reactions.