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: Adopted according to OECD SIDS (public available peer reviewed source) and respective study summary. The original source is not available and has not been reviewed.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
2003
Reference Type:
secondary source
Title:
OECD SIDS - Category: C7-9 Aliphatic Hydrocarbon Solvents. Draft, 28 October 2009
Author:
IHSC, American Chemistry Councli
Year:
2009
Bibliographic source:
SIDS Initial Assessment Report for SIAM 30, Paris, 20-23 April 2010 drafted by members of the IHSC and reviewed by the U.S. Environmental Protection Agency (EPA)
Report date:
2009

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
Hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics
EC Number:
920-750-0
Cas Number:
none available
Molecular formula:
None available - not a single isomer - see remarks
IUPAC Name:
Hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics
Details on test material:
- Name of test material (as cited in study report): SBP 100/140
- Physical state: colourless liquid
- Analytical purity: 100% pure commercial product

Test animals

Species:
mouse
Strain:
CD-1
Sex:
male

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
- Vehicle(s)/solvent(s) used: corn oil (dried)
- 10 mL/kg
Duration of treatment / exposure:
one single application
Frequency of treatment:
single dose
Post exposure period:
24 and 48 hours
Doses / concentrations
Remarks:
Doses / Concentrations:
2000 mg/kg
Basis:
nominal conc.
No. of animals per sex per dose:
10
Control animals:
yes, concurrent vehicle
Positive control(s):
cyclophosphamide
- Doses / concentrations: 65 mg/kg

Examinations

Tissues and cell types examined:
bone marrow cells
Details of tissue and slide preparation:
see "Any other information on materials and methods"
Statistics:
Analysis of variance and Student's t-test on transformed data [square root transformation for micronucleated polychromatic erythrocytes and double arcsine transformation for % polychromatic erythrocytes].

Results and discussion

Test results
Sex:
male
Genotoxicity:
negative
Remarks:
No statistically or biologically significant increases in micronucleated PCE were observed at either sampling time.
Toxicity:
not specified
Vehicle controls validity:
valid
Positive controls validity:
valid
Additional information on results:
NOEL > 2,000 mg/kg.
No effects were observed at either sampling time. There was no significant reduction in PCEs.
No statistically or biologically significant increases in micronucleated PCE were observed at either sampling time.
Cyclophosphamide induced the expected significant increases in micronucleated PCE.
No treatment-related effects were observed in mortality, in-life physical observations, or necropsy observations in any treated males.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
Based on the study design the test substance showed no genetic toxicity.
Executive summary:

Based on the study design the test substance showed no genetic toxicity.