Registration Dossier

Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
GLP compliance:
yes
Type of assay:
micronucleus assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Analytical purity: 99.5 %

Test animals

Species:
mouse
Strain:
NMRI
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River GmbH WIGA , Sulzfeld
- Weight at study initiation: 26 g (mean)
- Housing: 5 animals per cage
- Diet (e.g. ad libitum): Kliba Haltungsdiaet; Klingenmuehle AG
- Water (e.g. ad libitum): tap water

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
- Vehicle used: water
Duration of treatment / exposure:
single oral administration
Frequency of treatment:
once
Doses / concentrations
Remarks:
Doses / Concentrations:
100, 200, 400 mg/kg in 10 ml/kg distilled water
Basis:
analytical conc.
No. of animals per sex per dose:
5
Control animals:
yes
Positive control(s):
- Doses / concentrations: 20 mg/kg bw cyclophosphamide
- Doses / concentrations: 0.15 mg/Kg bw vincristine

Examinations

Tissues and cell types examined:
Bone marrow
Statistics:
Statistical evaluation was performed using the program system MUKERN (BASF AG).

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
negative
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid

Any other information on results incl. tables

According to the results of the present study, the single oral administration of 2-Butene-1,4-diol did not lead to any increase in the number of polychromatic erythrocytes containing either small or large micronuclei.

 

No inhibition of erythropoiesis determined from the ratio of polychromatic to normochromatic erythrocytes was detected.

 

Under the experimental conditions chosen here, the test substance does not have any chromosome-damaging (clasto- genic) effect, and there were no indications of any impairment of chromosome distribution in the course of mitosis.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative