Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: reliability score "2" adopted from OECD SIDS, restrictions: purity unknown, limited documentation, open coverage

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Principles of method if other than guideline:
A volume of 0.5 ml n-propyl acetate was applied to the clipped, abraded skin of 4 rabbits. Application sites (one each on left and right of each
animals) were examined after 72 hours for evidence of irritation.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Purity unknown

Test animals

Species:
rabbit
Strain:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
male & female animals were used; no further data


ENVIRONMENTAL CONDITIONS
not reported

Test system

Type of coverage:
open
Preparation of test site:
abraded
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
not reported
Observation period:
72 h
Number of animals:
4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 72 h
Remarks on result:
other: very slight erythema observed
Irritation parameter:
erythema score
Basis:
animal: #2 - #4
Time point:
other: 72 h
Score:
0
Reversibility:
other: no effect
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 h
Score:
0
Reversibility:
other: no effect

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS