5-bromo-5-nitro-1,3-dioxane

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Reference 2

Reference Type:

publication

Title:

Final Report on the Safety Assessment of 5-Bromo-5-Nitro-1,3-Dioxane

Author:

Anonymous (Cosmetic Ingredient Review 10)

Year:

1990

Bibliographic source:

Journal of the American College of Toxicology, Volume 9, Number 2

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Method: According to W. Schmid (Mut. Res. 31, 9-15, 1975 )

GLP compliance:

no

Type of assay:

other: micronucleus assay

Test material

Test material information

Constituent 1

Reference substance name:

5-bromo-5-nitro-1,3-dioxane

EC Number:

250-001-7

EC Name:

5-bromo-5-nitro-1,3-dioxane

Cas Number:

30007-47-7

Molecular formula:

C4H6BrNO4

IUPAC Name:

5-bromo-5-nitro-1,3-dioxane

Specific details on test material used for the study:

10 % in 1,2 Propylene glycol

Test animals

Species:

mouse

Strain:

CF-1

Sex:

male/female

Administration / exposure

Route of administration:

intraperitoneal

Vehicle:

- Vehicle used: Olive oil

Doses / concentrations

Dose / conc.:

20 mg/kg bw (total dose)

No. of animals per sex per dose:

4

Control animals:

yes, concurrent vehicle

Examinations

Statistics:

Calculation according Kastenbaum und Bowmann

Results and discussion

Test results

Key result

Sex:

male/female

Genotoxicity:

negative

Toxicity:

not specified

Vehicle controls validity:

valid

Negative controls validity:

not examined

Positive controls validity:

not examined

Any other information on results incl. tables

Table: Result of test

	Sex	Number	Polychromatic erythrocytes	Polychromatic to normochromatic erythrocytes (mean)	Number of micro nucleated polychromatic erythrocytes mean (‰)	Range (‰)
Test substance	Male	4	4000	406 1000	1.75	1-4
Negative control	Male	4	4000	690 1000	1.0	0-2
Test substance	female	4	4000	493 1000	0.75	0-2
Negative control	Female	4	4000	761 1000	1.0	0-2