Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
03.11.1994 to 10.11.1994
Reliability:
1 (reliable without restriction)

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
checked and confirmed
IUPAC Name:
checked and confirmed
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

Species:
rabbit
Strain:
Himalayan

Test system

Type of coverage:
other: occlusive and semi.occlusive
Preparation of test site:
shaved
Vehicle:
physiological saline
Controls:
no
Duration of treatment / exposure:
4 hours
Observation period:
1 week
Number of animals:
2 male and 2 female

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: cumulative irritation index
Basis:
animal #1
Time point:
other: 1 hour to 1 week
Score:
0
Max. score:
0
Reversibility:
no data
Irritation parameter:
other: cumulative irritation index
Basis:
animal #2
Time point:
other: 1 hour to 1 week
Score:
0
Max. score:
0
Reversibility:
no data
Irritation parameter:
other: cumulative irritation index
Basis:
animal #3
Time point:
other: 1 hour to 1 week
Score:
0
Max. score:
0
Reversibility:
no data
Irritation parameter:
other: cumulative irritation index
Basis:
animal #4
Time point:
other: 1 hour to 1 week
Score:
0
Max. score:
0
Reversibility:
no data
Irritant / corrosive response data:
No changes were observed on the skin of all 4 rabbits.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
Sunstance is not dermal irritating.
Executive summary:

On the baasis of the criteria of assessment of skin irritancy employed in this study, SND 919 CL2 Y Precursor 2 (SND 855 BS Y) was evaluated as having no irritant potential.