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: scientifically acceptable and sufficient documented

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
500 mg of the test substance were semiocclusively applied once to the intact skin of 3 female adult New Zealand White rabbit (3-4.3 kg) for an exposure period of 4 hours. Evaluation of skin irritation was made until day 7 according to Draize
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Bayplast Gelb 5G

Test animals

Species:
rabbit
Strain:
other: HC:NZW

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: shorn
Vehicle:
water
Controls:
not required
Duration of treatment / exposure:
4 hours
Observation period:
7 days
Number of animals:
3 animals

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable - score = 0 at any time point
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable - score = 0 at any time point

Any other information on results incl. tables

no erythema and no edema was evident (score = 0 at any time point)

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Executive summary:

500 mg of the test substance were semiocclusively applied once to the intact skin of 3 female adult New Zealand White rabbit (3-4.3 kg) for an exposure period of 4 hours. Evaluation of skin irritation was made until day 7 according to Draize. No erythema and no edema was evident (score = 0 at any time point).

Bayplast Gelb 5G = Nickel, 5,5'-azobis-2,4,6(1H,3H,5H)-pyrimidinetrione complexe was 'not irritating to the skin' (exposure period: 4 hrs).