Hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics

Genetic toxicity: in vivo

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

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

2003

Reference 2

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

Test material information

Constituent 1

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.