Alkenes, C13-14, hydroformylation products, low boiling

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration

Remarks:

Type of genotoxicity: chromosome aberration

Type of information:

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

Adequacy of study:

key study

Study period:

1984

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Conducted in accordance with general scientific principles.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

publication

Title:

Lack of mutagenic activity of white spirit

Author:

Gochet B., de Meester C., Leonard A., Deknudt G.

Year:

1984

Bibliographic source:

International Archives of Occupational and Environmental Health 53: 359-364

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)

GLP compliance:

not specified

Type of assay:

micronucleus assay

Test material

Test material information

Constituent 1

Reference substance name:

White Spirits

IUPAC Name:

White Spirits

Details on test material:

white spirit
boiling temperature: 120-190 deg C

Test animals

Species:

mouse

Strain:

Balb/c

Sex:

male/female

Details on test animals or test system and environmental conditions:

The animals weighed 30 ± 3 g

Administration / exposure

Route of administration:

other: i.p. and inhalation

Vehicle:

none

Details on exposure:

The animals were sacrified 30 h after i.p. injection of 0.l, 0.05 or 0.01 ml of white spirit. In addition, male animals were allowed to inhale 50 g/m3 of white spirit, during 5 periods of 5 min spaced by intervals of 5min. According to Carpenter et al. (1975) 50 g/m3 represents about 50 times the limit of toxicity. Animals given 200 mg cyclophosphamide per kg b.w. were used as positive controls.

Carpenter C. P., Kinkead E. R., Geary, Jr. D. L., Sullivan L. J., and King J. M. Petroleum Hydrocarbon Toxicity Studies. Ill. Animal and Human Response to Vapors of Stoddard Solvent. 1975. Toxicology and Applied Pharmacology. 32: 282-297.20 ani

Duration of treatment / exposure:

Experiment #1 - 30 h after i.p. injection of 0.l, 0.05 or 0.01 ml of white spirit
Experiment #2 - male animals were allowed to inhale 50 g/m3 of white spirit, during 5 periods of 5 min spaced by intervals of 5min

Frequency of treatment:

Experiment #1 - once, animals were sacrificed 30 h after i.p. injection
Experiment #2 - 5 periods of 5 min spaced by intervals of 5min

Post exposure period:

none

Doses / concentrations

Doses / concentrations 1

Remarks:

Doses / Concentrations:
0, 0.l, 0.05, or 0.01 ml
Basis:
other: i.p. injection

Doses / concentrations 2

Remarks:

Doses / Concentrations:
0, 50 g/m3
Basis:
nominal conc.
inhalation

No. of animals per sex per dose:

20 animals

Control animals:

yes, sham-exposed

Positive control(s):

Animals given 200 mg cyclophosphamide per kg b.w. were used as positive controls.

Examinations

Tissues and cell types examined:

micronucleus test; 3000 cells examined per dose

Details of tissue and slide preparation:

no data

Evaluation criteria:

micronuclei

Statistics:

Mann Whitney U-test

Results and discussion

Test results

Sex:

male/female

Genotoxicity:

negative

Toxicity:

no effects

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

see table

Any other information on results incl. tables

Treatment	Cells with micronuclei (%)
	Male	Female
Negative controls	3.8	4.3
Cyclophosphamide (200 mg/kg)	36	31
White Spirit (0.01mL i.p.)	4.4	3.7
White Spirit (0.05mL i.p.)	4.2	4.1
White Spirit (0.1mL i.p.)	4	4
White Spirit (50g/m3 by inhalation)	4.1	N/A

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): negative
White spirit did not produce chromosomal aberrations in vivo.

Executive summary:

The ability of white spirit to produce chromosomal aberrations in vivo in mammalian somatic cells was studied by examining eight-week-old BALB/c male and female mice for the presence of micronuclei in the polychromatic erythrocytes from bone marrow.

The animals were sacrified 30 h after i.p. injection of 0.l, 0.05 or 0.01 ml of white spirit. In addition, male animals were allowed to inhale 50 g/m3 of white spirit, during 5 periods of 5 min spaced by intervals of 5min. According to Carpenter et al. (1975) 50 g/m3 represents about 50 times the limit of toxicity. Animals given 200 mg cyclophosphamide per kg b.w. were used as positive controls. When compared to control animals, it was concluded that white spirits are not mutagenic or clastogenic.

 

Carpenter C. P., Kinkead E. R., Geary, Jr. D. L., Sullivan L. J., and King J. M. Petroleum Hydrocarbon Toxicity Studies.Animal and Human Response to Vapors of Stoddard Solvent. 1975. Toxicology and Applied Pharmacology. 32: 282-297.