Registration Dossier

Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Sensitization of guinea-pig skin to phenylhydrazine
Author:
Jadassohn
Year:
1930
Bibliographic source:
Klinische Wochenschrift, 9:551; cited in WHO 2000, Phenylhydrazine. CICAD 19, Wissenschaftliche Verlagsgesellschaft mbH
Reference Type:
secondary source
Title:
Concise International Assessment Document 19: Phenylhydrazine
Author:
WHO
Year:
2000
Bibliographic source:
Wissenschaftliche Verlagsgesellschaft mbH, Stuttgart, ISBN 92 4 153019 7; ISSN 1020-6167

Materials and methods

Principles of method if other than guideline:
The skin of guinea pigs were painted with phenylhydrazine. After 2 - 3 weeks the not pretreated skin was painted with a 10 % alcoholic solution of phenylhydrazine.
GLP compliance:
no
Type of study:
skin painting test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): "Phenylhydrazin", phenylhydrazine

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
no data

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, open
Vehicle:
other: alcohol
Concentration / amount:
10 %
Challengeopen allclose all
Route:
epicutaneous, open
Vehicle:
other: alcohol
Concentration / amount:
10 %
No. of animals per dose:
no data
Details on study design:
RANGE FINDING TESTS: no data

MAIN STUDY
A. INDUCTION EXPOSURE
- two to three weeks before the challenge exposure, the skin was treated with undiluted phenylhydrazine.

B. CHALLENGE EXPOSURE
- 10 % solution phenylhydrazine in alcohol was painted on an area other than the pretreated skin site.
Challenge controls:
no data
Positive control substance(s):
no

Results and discussion

Positive control results:
no data

Any other information on results incl. tables

A very intense erythema and swelling, followed by scaling and encrustation, were consistently seen within 24 hours. This response to 10% phenylhydrazine was more severe than that described in animals that had not been pretreated.

Applicant's summary and conclusion