Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
November 1994
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
Himalayan

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
physiological saline
Controls:
no
Amount / concentration applied:
0.5 g test article with 0.5 ml physiological saline
Duration of treatment / exposure:
4 hours
Observation period:
up to one week after treatment
Number of animals:
2 m and 2 f

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: Cumulative Irritation Index
Basis:
animal #1
Time point:
other: 1 week
Score:
>= 0
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
other: Cumulative Irritation Index
Basis:
animal #2
Time point:
other: 1 week
Score:
>= 0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
other: Cumulative Irritation Index
Basis:
animal #3
Time point:
other: 1 week
Score:
>= 0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
other: Cumulative Irritation Index
Basis:
animal #4
Time point:
other: 1 week
Score:
ca. 0
Max. score:
1
Reversibility:
fully reversible
Irritant / corrosive response data:
The results indicate that the test article has a slight irritant effect on intact skin following application of 500 mg.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
SND 919 Propinylthiazol does not require any labellig from the point of view of skin irritation.