Registration Dossier

Administrative data

Endpoint:
additional toxicological information
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: meets generally accepted scientific standards, well documented and acceptable for assessment

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Induction of Haemolytic Anaemia by Substituted Phenylhydrazines
Author:
Itano HA, Hosokawa K, Hirota K
Year:
1976
Bibliographic source:
British Journal of Haematology 33: 99-104
Reference Type:
publication
Title:
Mechanism of induction of haemolytic anaemia by phenylhydrazine
Author:
Itano HA, Hirota K, Hosokawa K
Year:
1975
Bibliographic source:
Nature 256: 665-667

Materials and methods

Type of study / information:
The induction of anaemia and reticulocytosis by 4-chlorophenylhydrazine and other substances was investigated.
Principles of method if other than guideline:
Female rabbits were used for the induction of anaemia and reticulocytosis. Subcutaneous injections were administered day 1 to 4 after a baseline sample of blood was taken. Additional samples of blood were taken 2, 5, and 7 days after the baseline sample. Packed cell volume, reticulocyte count and erythrocyte count were determined.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 4-chlorophenylhydrazine
no further data

Results and discussion

Any other information on results incl. tables

Unsubstituted phenylhydrazine was the most effective inducer of anaemia and reticulocytosis. The relative effectiveness of the substituted compounds corresponded primarily with position and secondarily with number of substituents.

The most effective of the substituted compounds were those with one or two chlorine atoms at ring positions meta (3- or 5 -) or para (4 -) to the hydrazino group, namely the 3- or 4 -chloro- and the 3,4- or 3,5 -dichlorophenylhydrazines.

4 -chlorophenylhydrazine was therefore an effective inducer of anaemia and reticulocytosis.

Applicant's summary and conclusion