Stoddard solvent

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian germ cell study: cytogenicity / chromosome aberration

Type of information:

experimental study

Adequacy of study:

key study

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 Type:

publication

Title:

Lack of mutagenic activity of white spirit.

Author:

Gochet B, de Meester C, Léonard A, & Deknudt G

Year:

1984

Bibliographic source:

Int Arch Occup Environ Health, 53: 359-364.

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)

Deviations:

no

GLP compliance:

not specified

Type of assay:

micronucleus assay

Test material

Test material information

Constituent 1

Reference substance name:

Stoddard solvent

EC Number:

232-489-3

EC Name:

Stoddard solvent

Cas Number:

8052-41-3

Molecular formula:

C10H22

IUPAC Name:

stoddard solvent

Test material form:

liquid

Specific details on test material used for the study:

White Spirits containing 15% aromatics with an initial boiling point of 160°C to 161°C

Test animals

Species:

mouse

Strain:

Balb/c

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source:mouse (Balb/c) male/female
- Age at study initiation: 7-8 weeks
- Weight at study initiation: males 21-27 g, females 21-26 g
- Assigned to test groups randomly: yes, under following basis: allocated to treatment groups according to randomization table generated by computer programme or manually
- Fasting period before study: yes, overnight until 3-4 hours after dosing
- Housing: males, 1/cage, macrolon cages type I; females, <=3/cage, macrolon cages type II; filled with clean softwood bedding
- Diet (e.g. ad libitum): standard animal diet, Altromin No. 1314, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: >=6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 25 +- 3 (occasionally 20-25)
- Humidity (%): 40 - 50 (occasionally 45-70)
- Air changes (per hr): no data, except "air-conditioned room"
- Photoperiod (hrs dark / hrs light): 12 / 12

I

Administration / exposure

Route of administration:

intraperitoneal

Details on exposure:

Intraperitoneal injections of 0.1, 0.05 and 0.01 ml of white spirit (initial boiling point, 160°C; 15% aromatics) were given to 10 animals each, while inhalation of 50 g/m3 for 5 lots of 5 min (each exposure period was separated by 5 min without exposure) was performed with five mice.

Duration of treatment / exposure:

single administration

Frequency of treatment:

single administration

Post exposure period:

2-4 hours post exposure , animals were sacrificed

Doses / concentrations

Remarks:

Doses / Concentrations:0.1, 0.05 and 0.01 ml

No. of animals per sex per dose:

10

Control animals:

yes, concurrent vehicle

Positive control(s):

cyclophosphamide
- Justification for choice of positive control(s): not stated

Examinations

Tissues and cell types examined:

bone marrow

Statistics:

Method used: Kastenbaum & Bowman

Results and discussion

Test results

Sex:

male/female

Genotoxicity:

negative

Toxicity:

no effects

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

no cytogenic damage in a micronucleus test conducted with BALB/c mice.

Applicant's summary and conclusion

Conclusions:

Interpretation of results : negative
no cytogenic damage in a micronucleus test conducted with BALB/c mice.
Genotoxicity: negative (male/female); toxicity: no effects
Mutagenicity testing of Stoddard solvent showed no evidence of genotoxicity.

Executive summary:

Mutagenicity testing of Stoddard solvent showed no evidence of genotoxicity.