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:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, Division of Pharmacology, FDA, Hautgiftigkeit nach Draize (1959)
Deviations:
not specified
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Vernetzer HC is the former name of BRUGGOLEN® C20.
BRUGGOLEN® C20 is a mixture of 80% N,N'-hexane-1,6-diylbis(hexa-hydro-2-oxo-1H-azepine-1-carboxamide with 20% epsilon-Caprolactam.

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
8

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: after 24h and after 72h; mean value is determined
Score:
0
Max. score:
0
Reversibility:
other: not applicable, no irritation occured

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: FDA
Conclusions:
The test item has not to be classified as "irritant".
Executive summary:

The test item has not to be classified as "irritant".