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Toxicological information

Genetic toxicity: in vivo

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Administrative data

Endpoint:
in vivo mammalian germ cell study: gene mutation
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guidelinestudy under GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 484 (Genetic Toxicology: Mouse Spot Test)
GLP compliance:
yes
Type of assay:
mouse spot test

Test material

Constituent 1
Reference substance name:
10217-52-4
Cas Number:
10217-52-4
IUPAC Name:
10217-52-4
Constituent 2
Reference substance name:
hydrazine hydrate
IUPAC Name:
hydrazine hydrate
Details on test material:
IUCLID4 Test substance: other TS : hydrazine hydrate 100% purity
containing 64 % hydrazine and 36 % water

Test animals

Species:
mouse
Strain:
C57BL
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: females: 10 weeks
- Housing: females after mating: individually
- Diet ad libitum
- Water ad libitum
- Acclimation period: 2 weeks


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 55
- Air changes (per hr): 15-20 per hour
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
phosphate buffer pH = 7.4
Details on exposure:
single intraperitoneal injection
Duration of treatment / exposure:
once on gestation day 9
Frequency of treatment:
once
Post exposure period:
yes until birth of F1-generation
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 40, 80 mg/kg/bw
Basis:
analytical conc.
No. of animals per sex per dose:
200 females
Control animals:
yes, concurrent vehicle
Positive control(s):
30 mg/kg bw ethylnitrosourea and historical control data

Examinations

Tissues and cell types examined:
fur of F1 animals were examined
Details of tissue and slide preparation:
fur of F1 animals were examied
Evaluation criteria:
At an age of 3 1/2 to 4 weeks the offsprings are observed for color spots: evaluation refering to spots of genetic relevance (SGR).
Statistics:
Fisher's exact one-tailed test

Results and discussion

Test results
Sex:
female
Genotoxicity:
other: non-significantly increased frequency of Spots of genetic relevance (SGR) but it was of biological relevance when compared to the historical control data of the performing institute
Toxicity:
yes
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
80 mg/kg bw: all treated female mice died

Any other information on results incl. tables

RS-Freetext:
in a 1st trial with 80 mg/kg bw all mice died; at 40 mg/kg
8/173 mother animals died; compared to the concurrent
control groups (experiment in duplicate) the increase in the
frequency of Spots of Genetic Relevance (SGR): 2% versus 0.5% in controls, was not statistically significant, but it was of biological
relevance when compared to historical controls of the same
institute.

The positive control ENU gave clearly positive results.

Applicant's summary and conclusion

Executive summary:

In the mouse spot test according to OECD TG the single intraperitoneal injection of 40 and 80 mg/kg bw hydrazine hydrate into pregnant female mice resulted in an non-significantly increased frequency of Spots of Genetic Relevance(SGR) but it was of biological relevance when compared to the historical control data of the performing institute (Bayer AG 1989)