Registration Dossier

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other: Non-GLP, non guideline study, available as unpublished report, limitations in design and/or reporting but otherwise adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1971
Report Date:
1971

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
According to BASF-internal standard. Two rabbits (1 male, 1 female) were dermally exposed to the test substance followed by a 8 day observation period. Test areas where the back and the ear of the rabbit.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name of the test substance used in the study report: Anthranilsaeureamid

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
- Weight of female animal: 2.93 kg
- Weight of male animal: 3.4 kg

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Amount / concentration applied:
about 1 g of a 50 % aqueous preparation
Duration of treatment / exposure:
1, 5, and 15 minutes and 20 hours
Observation period:
8 days
Number of animals:
2
Details on study design:
TEST SITE
- Area of exposure: The back of the animals
- Application area: 2.5 x 2.5 cm:
- Type of wrap if used: Cotton pad for the back of the animals

REMOVAL OF TEST SUBSTANCE
- Washing: Lutrol 50%
- Time after start of exposure: 20 hours

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal 1 and 2
Time point:
other: 24, 48, 72
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: 20 hours exposure
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal 1 and 2
Time point:
other: 24, 48, 72
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: 20 hours exposure
Irritant / corrosive response data:
Also no effects observed after 1, 5, and 15 minute exposure.
Other effects:
None

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information