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Diss Factsheets

Administrative data

Endpoint:
in vivo mammalian germ cell study: cytogenicity / chromosome aberration
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Documentation insufficient for assessment since reference is in a foreign language (adopted from OECD SIDS). Additionally, number of cells investigated was too few to correspond to scientific and regulatory requirements.

Data source

Reference
Reference Type:
secondary source
Title:
No information
Author:
Barylak, IR and Kosaschuk, SJ
Year:
1988
Bibliographic source:
Tsitol. Genet. 22, 49-52; cited in OECD SIDS IUCLID data set of Isononyl alcohol (16.03.2006)

Materials and methods

Principles of method if other than guideline:
Each 10 rats were investigated, 1 ml test article/rat was orally administered by gavage as a 40% suspension in water. Preparation of bone marrow 48 h
after administration and microscopic analysis of 50 cells per animal.
GLP compliance:
not specified
Type of assay:
chromosome aberration assay

Test material

Constituent 1
Reference substance name:
Nonan-1-ol
EC Number:
249-048-6
EC Name:
Nonan-1-ol
Details on test material:
- Name of test material (as cited in study report): Nonylalcohol
- Analytical purity: not stated

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
- Vehicle(s)/solvent(s) used: water
- Concentration of test material in vehicle: 40% suspension
Details on exposure:
1 ml test article/rat was orally administered
Duration of treatment / exposure:
48 h
Frequency of treatment:
no data
Post exposure period:
no data
Doses / concentrations
Remarks:
Doses / Concentrations:
2.26-12.8 mg/kg (1/5 LD50)
Basis:
no data
No. of animals per sex per dose:
10 animals / dose
Control animals:
yes

Examinations

Tissues and cell types examined:
Preparation of bone marrow 48 h after administration and microscopic analysis of 50 cells per animal.

Results and discussion

Test results
Sex:
not specified
Genotoxicity:
negative
Toxicity:
not specified
Vehicle controls validity:
not specified
Negative controls validity:
not specified
Positive controls validity:
not specified

Any other information on results incl. tables

3% of cells with aberration were observed, control group 0% of cells with aberrations.

Applicant's summary and conclusion