Alkanes, C7-8

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:

read-across from supporting substance (structural analogue or surrogate)

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.

Justification for type of information:

A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.

Cross-reference

Reason / purpose for cross-reference:

read-across: supporting information

Reference

Endpoint:

in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus

Remarks:

Type of genotoxicity: chromosome aberration

Type of information:

read-across from supporting substance (structural analogue or surrogate)

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.

Justification for type of information:

A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.

Reason / purpose for cross-reference:

read-across source

Key result

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.

Conclusions:

Interpretation of results: negative
Based on the study design the test substance showed no genetic toxicity.

Executive summary:

This data is being read across from the source study that tested Hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics based on analogue read across.

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

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

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

Before the current ECHA nomenclature rules became effective, we adopted the IUPAC name Hydrocarbons, C7-9, n-alkanes, isoalkanes, cyclics (EC number 920-750-0) as the identifier for the substance and this was the name that was used during the pre-registration phase of REACH. Also during this time, samples of the product were collected and the required physicochemical studies were conducted. The resulting robust studies summaries were entered into the IUCLID dossier using this name and EC number.

Between 2008 and 2009 ECHA issued a specific document about the nomenclature to be used under REACH, the so called REACH Implementation Project 3.10. The implications of this document to the appropriate nomenclature for the registered substance were only fully understood by us beginning in late 2009/early 2010.

As such, during the creation of the robust study summaries in IUCLID, the discrepancy with the substance naming was not noticed. As a result, it appears in IUCLID that the tested substance indicated is not the same as the registered one; however, if robust study summaries and/or associated study reports use the substance name “Hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics,” they are actually referring to the registered substance “Hydrocarbons, C7-C8, n-alkanes” according to the revised REACH nomenclature rules.

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

Key result

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: 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.