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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report Date:
2003

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
EPA OPP 81-4 (Acute Eye Irritation)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
Ken-React KR TTS Lot 22059
Reddish-brown liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
1 hr
Observation period (in vivo):
24, 48, 72 hr
Number of animals or in vitro replicates:
3 animals. 1 male, 2 females

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1 hr
Score:
ca. 10
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24 h
Score:
ca. 0.7
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
48 h
Score:
ca. 0
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
72 h
Score:
ca. 0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The target substance is classified as minimally irritating to the eye.