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Administrative data

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

Referenceopen allclose all

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.

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.

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).