Mixed LOF

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian cell study: DNA damage and/or repair

Remarks:

Type of genotoxicity: DNA damage and/or repair

Type of information:

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

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable well-documented study report performed on an analgoue material under GLP conditions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

EPA OPPTS 870.5915 (In Vivo Sister Chromatid Exchange Assay)

GLP compliance:

yes

Type of assay:

sister chromatid exchange assay

Test material

Test material information

Constituent 1

Reference substance name:

Naphtha (petroleum), light catalytic cracked

EC Number:

265-056-2

EC Name:

Naphtha (petroleum), light catalytic cracked

Cas Number:

64741-55-5

IUPAC Name:

Naphtha (petroleum), light catalytic cracked

Constituent 2

Reference substance name:

Light catalytic cracked naphtha

IUPAC Name:

Light catalytic cracked naphtha

Test animals

Species:

mouse

Strain:

B6C3F1

Sex:

male/female

Administration / exposure

Route of administration:

intraperitoneal

Vehicle:

corn oil

Duration of treatment / exposure:

20 to 22 hours

Doses / concentrations

Remarks:

Doses / Concentrations:
3 Test groups: 200, 1200 and 2400 mg/kg
Basis:

No. of animals per sex per dose:

5/sex/dose

Positive control(s):

Positive control group: 10 mg/kg of cyclophosphamide.

Results and discussion

Test results

Sex:

male/female

Genotoxicity:

positive

Toxicity:

no effects

Vehicle controls validity:

not specified

Negative controls validity:

not specified

Positive controls validity:

not specified

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): positive
The in vivo sister chromatid exchange assay of light catalytic cracked naphtha (API 81-03) was positive. This finding alone does not warrant the classification of light catalytic cracked naphtha as a genotoxin under the new Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.

Executive summary:

Light catalytic cracked naphtha (API 81-03) was examined for its potential to induce sister chromatid exchange in mouse bone marrow erythrocytes from mice dosed intraperitoneally with the test material for 20 or 22 hours at concentrations of 200, 1200, and 2400 mg/kg in corn oil. Vehicle control animals were dosed with clean air alone, and positive control animals were dosed intraperitoneally with 10 mg/kg of cyclophosphamide. The test substance induced a significant dose-dependent increase in bone marrow sister chromatid exchanges in B6C3F1 mice. No clinical signs of toxicity were observed.  The in vivo sister chromatid exchange assay of light catalytic cracked naphtha (API 81-03) was positive. This finding alone does not warrant the classification of light catalytic cracked naphtha as a genotoxin under the new Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.