Hydrocarbons, C10-C13, n-alkanes, isoalkanes, cyclics, aromatics (2-25%)

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

The read across genetic toxicity tests listed below had negative results for Hydrocarbons, C10-C13, n-alkanes, isoalkanes, cyclics, aromatics (2-25%).

Genetic Toxicity in vitro – Bacterial reverse mutation assay (OECD 471)

Genetic Toxicity in vitro – Mammalian Chromosome Aberration Test (OECD TG 473)

Genetic Toxicity in vitro – Mammalian Cell Gene Mutation Test (OECD TG 476)

Link to relevant study records

Reference

Reference 1

Endpoint:

in vitro gene mutation study in bacteria

Type of 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: Basic data given:comparable to guidelines/standards.

Justification for type of information:

The justification for read across is provided as an attachment in IUCLID Section 13.

Reason / purpose for cross-reference:

read-across: supporting information

Reason / purpose for cross-reference:

reference to same study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Species / strain / cell type:

S. typhimurium, other: TA 1535, TA 1537, TA 1538, TA 98 and TA 100

Additional strain / cell type characteristics:

other: histidine dependent

Metabolic activation:

with and without

Metabolic activation system:

S-9 mix derived from rat liver

Test concentrations with justification for top dose:

8-5000 μg/plate

Positive controls:

yes

Positive control substance:

benzo(a)pyrene

Remarks:

Migrated to IUCLID6: 2-nitrofluorene, 2-aminoanthracene, 9-aminoacridine, N-methyl-N'-nitro-N-nitrosoguanidine

Details on test system and experimental conditions:

NUMBER OF REPLICATIONS: 2

Evaluation criteria:

Increases in reversion to prototrophy.

Key result

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Positive controls validity:

valid

Key result

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Positive controls validity:

valid

Key result

Species / strain:

S. typhimurium TA 1538

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Positive controls validity:

valid

Key result

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Positive controls validity:

valid

Key result

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Conclusions:

Interpretation of results: negative

The test substance is not mutagenic both in the presence and absence of S-9.

Executive summary:

An Ames Salmonella typhimurium assay was performed to assess the mutagenicity of BP 8313. Duplicate testing was performed on the strains TA 1535, TA 1537, TA 1538, TA 98, and TA 100, both in the presence and absence of metabolic activation. Test concentrations were between 8-5000 ug/plate. Positive controls substances were benzo(a)pyrene, 2 -nitrofluorene, 2 -aminoanthracene, 9 -aminoacridine, and N-methyl-N'-nitro-N-nitrosoguanadine. Positive control cultures had significantly increased number of revertant colonies. Test substance cultures exhibited no increase in the number of revertant colonies as compared to negative controls in cultures either with or without metabolic activation. The test substance is not mutagenic.

Reference 2

Endpoint:

in vitro cytogenicity / chromosome aberration study in mammalian cells

Type of 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: Basic data given:comparable to guidelines/standards.

Justification for type of information:

The justification for read across is provided as an attachment in IUCLID Section 13.

Reason / purpose for cross-reference:

read-across: supporting information

Reason / purpose for cross-reference:

reference to same study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)

GLP compliance:

not specified

Type of assay:

in vitro mammalian chromosome aberration test

Species / strain / cell type:

other: human peripheral lymphocytes

Metabolic activation:

with and without

Metabolic activation system:

S-9 derived from rat livers

Test concentrations with justification for top dose:

1.2, 6.0, 30.0 μg/ml

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Remarks:

ethanol

Positive controls:

yes

Positive control substance:

cyclophosphamide

Details on test system and experimental conditions:

DURATION
- Exposure duration: 24 hrs

NUMBER OF REPLICATIONS: 2

NUMBER OF CELLS EVALUATED: 100 metaphases examined per culture

Evaluation criteria:

Mitotic indexes were calculated for every culture. Gross toxcity was determined by the number of metaphases per 1000 cells scored. 100 metaphases were examined per culture and chromosomal aberrations recorded. Metaphases were analyzed for frequency of cells with aberrations, and aberrations other than gaps.

Statistics:

Statistical analysis was done on the frequencies of aberrant metaphases, both with and without gap type aberrations. Since there was no significant difference between cultures with and without metabolic acitivation, the data was pooled.

Key result

Species / strain:

other: human peripheral lymphocytes

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

140 μg/ml caused a marked reduction in cell growth, 28 μg/ml caused a 58% reduction in mitotic index, 30 μg/ml caused a slight reduction in mitotic index

Vehicle controls validity:

valid

Positive controls validity:

valid

Conclusions:

Interpretation of results: negative

The test substance caused no significant chromosomal damage to human peripheral lymphocytes, therefore the test substance in non-clastogenic.

Executive summary:

An in vitro cytogenic assay was performed on human peripheral lymphocytes to evaluate the clastogenicity of BP 8313. The cells were exposed to 1.2, 6.0, or 30.0 µg/ml of the test substance for 24 hrs, both with and without metabolic activation. Cyclophosphamide was used as a positive control. 100 metaphases were examined from each culture for chromosomal aberrations, and the mitotic index calculated. Since there was little difference in results for cultures with and without metabolic activation, the data were pooled for the statistical analysis. The positive control substance induced significant increases in chromosomal aberrations. The test substance did not increase the number of aberrations in human peripheral lymphocytes as compared to negative controls. The test substance is not clastogenic either in the presence or absence of S-9.

Reference 3

Endpoint:

in vitro gene mutation study in mammalian cells

Type of information:

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

Adequacy of study:

key study

Study period:

1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: According to basic scientific principles.

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: supporting information

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)

GLP compliance:

not specified

Type of assay:

mammalian cell gene mutation assay

Species / strain / cell type:

mouse lymphoma L5178Y cells

Additional strain / cell type characteristics:

not applicable

Metabolic activation:

not applicable

Test concentrations with justification for top dose:

up to 0.1 uL/mL

Vehicle / solvent:

DMSO

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

True negative controls:

no

Positive controls:

no

Positive control substance:

no

Key result

Species / strain:

mouse lymphoma L5178Y cells

Metabolic activation:

not applicable

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

not applicable

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Conclusions:

Interpretation of results: negative

Stoddard solvent was judged not mutagenic in the L5178Y mouse lymphoma assay.

Executive summary:

Stoddard solvent was judged not mutagenic in the L5178Y mouse lymphoma assay.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Genetic toxicity in vivo

Description of key information

The read across genetic toxicity test listed below had negative results for Hydrocarbons, C10-C13, n-alkanes, isoalkanes, cyclics, aromatics (2 -25%).

Genetic Toxicity in vivo – Mammalian Bone Marrow Chromosome Aberration Test (OECD TG 475)

Link to relevant study records

Reference

Endpoint:

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

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: According to basic scientific principles.

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: supporting information

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)

GLP compliance:

not specified

Type of assay:

chromosome aberration assay

Species:

rat

Strain:

not specified

Sex:

not specified

Route of administration:

intraperitoneal

Vehicle:

DMSO

Remarks:

Doses / Concentrations:
0, 0.087, 0.289, 0.868 mL/kg DMSO
Basis:
nominal conc.

Control animals:

yes, concurrent vehicle

Sex:

not specified

Genotoxicity:

negative

Toxicity:

no effects

Vehicle controls validity:

valid

Negative controls validity:

not applicable

Positive controls validity:

not applicable

Conclusions:

Interpretation of results: negative
Stoddard Solvent did not induce significant chromosomal abnormalities.

Executive summary:

Stoddard Solvent did not induce significant chromosomal abnormalities.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Additional information

There is no in vitro or in vivo genetic toxicity data available for Hydrocarbons, C10-C13, n-alkanes, isoalkanes, cyclics, aromatics (2-25%). However, in vitro and in vivo genetic toxicity data is available for structural analogues, Hydrocarbons, C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%) and Stoddard Solvent. This data is read across to based on analogue read across and a discussion and report on the read across strategy is provided as an attachment in IUCLID Section 13.

In Vitro

In vitro gene mutation study in bacteria

Hydrocarbons, C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%)

An Ames Salmonella typhimurium assay was performed to assess the mutagenicity of hydrocarbons, C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%) (DHC, 1984a). Duplicate testing was performed on the strains TA 1535, TA 1537, TA 1538, TA 98, and TA 100, both in the presence and absence of metabolic activation. Test concentrations were between 8-5000 ug/plate. Positive controls substances were benzo(a)pyrene, 2 -nitrofluorene, 2 -aminoanthracene, 9 -aminoacridine, and N-methyl-N'-nitro-N-nitrosoguanadine. Positive control cultures had significantly increased number of revertant colonies. Test substance cultures exhibited no increase in the number of revertant colonies as compared to negative controls in cultures either with or without metabolic activation. The test substance was not mutagenic.

Stoddard Solvent

Stoddard solvent did not significantly increase the numbers of revertants in the Ames Salmonella assay (Conaway et al., 1982a).

 

In Vitro Chromosome Aberration in Mammalian Cells

Hydrocarbons, C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%)

An in vitro cytogenic assay was performed on human peripheral lymphocytes to evaluate the clastogenicity of hydrocarbons, C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%) (DHC, 1984a). The cells were exposed to 1.2, 6.0, or 30.0 µg/ml of the test substance for 24 hrs, both with and without metabolic activation. Cyclophosphamide was used as a positive control. 100 metaphases were examined from each culture for chromosomal aberrations, and the mitotic index calculated. Since there was little difference in results for cultures with and without metabolic activation, the data were pooled for the statistical analysis. The positive control substance induced significant increases in chromosomal aberrations. The test substance did not increase the number of aberrations in human peripheral lymphocytes as compared to negative controls. The test substance was not clastogenic either in the presence or absence of S-9.

 

In vitro Gene Mutation study in Mammalian Cells

Stoddard Solvent

Stoddard solvent was judged not mutagenic in the L5178Y mouse lymphoma assay (Conaway et al., 1982b).

 

In Vivo

Stoddard Solvent

Stoddard Solvent did not induce significant chromosomal abnormalities (Conaway et al., 1982c).

Justification for classification or non-classification

The negative results in in vitro and in vivo genotoxicity assays from structural analogues do not warrant the classification of Hydrocarbons, C10-C13, n-alkanes, isoalkanes, cyclics, aromatics (2-25%) as genotoxic under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).