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Toxicological information

Repeated dose toxicity: dermal

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Administrative data

Endpoint:
short-term repeated dose toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Limited documentation

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
On the relation between the chemical constitution and pharmacological action of phenylhydrazine derivatives.
Author:
von Oettingen W, Deichmann-Gruebler W
Year:
1936
Bibliographic source:
Journal of industrial hygiene and toxicology, 18:1–16; cited in WHO 2000, Phenylhydrazine. CICAD 19, Wissenschaftliche Verlagsgesellschaft mbH, Stuttgart, ISBN 92 4 153019 7; ISSN 1020-6167
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
Reference Type:
secondary source
Title:
Unnamed
Year:
1994

Materials and methods

Principles of method if other than guideline:
An ointment of 1% phenylhydrazine in vaseline was applied to the shaved backs of rats on alternate days for four weeks.
GLP compliance:
no

Test material

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

Test animals

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

Administration / exposure

Type of coverage:
not specified
Vehicle:
other: vaseline
Details on exposure:
TEST SITE
- Area of exposure: shaved back

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not done

TEST MATERIAL
- Concentration: 1 %
- Constant volume or concentration used: yes

VEHICLE
- vaseline
Analytical verification of doses or concentrations:
not specified
Details on analytical verification of doses or concentrations:
no data
Duration of treatment / exposure:
4 weeks
Frequency of treatment:
once every second day
Doses / concentrations
Remarks:
Doses / Concentrations:
1 %
Basis:
no data
No. of animals per sex per dose:
5 per group
Control animals:
not specified
Details on study design:
no data
Positive control:
no data

Examinations

Observations and examinations performed and frequency:

BODY WEIGHT: Yes

HAEMATOLOGY: No

CLINICAL CHEMISTRY: No

Sacrifice and pathology:
no data
Other examinations:
no data
Statistics:
no data

Results and discussion

Results of examinations

Details on results:
BODY WEIGHT AND WEIGHT GAIN
no weight gain during the entire period; reduction in body weight.

GROSS PATHOLOGY and HISTOPATHOLOGY
Internal organs were normal, with the exception of follicular hyperplasia of the spleen.

Local changes of the skin at the site of the application were limited almost entirely to the surface epithelium, consisting in keratinization, proliferation of squamous epithelium and infiltration with leucocytes in various stages of degeneration.

Effect levels

Dose descriptor:
dose level:
Effect level:
1 other: %
Sex:
not specified
Basis for effect level:
other: reduction in body weight; follicular hyperplasia of the spleen; local changes of the skin: keratinization, proliferation of squamous epithelium, leucocyte infiltration.

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion