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EC number: 203-892-1 | CAS number: 111-65-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
There is no in vitro genetic toxicity data available for Octane. However, data is available for structural analogues Heptane and 2,2,4-trimethylpentane. 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.
The read across genetic toxicity tests listed below had negative results for Octane.
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
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1982-1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions
- 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 471 (Bacterial Reverse Mutation Assay)
- Principles of method if other than guideline:
- No specific method or guideline was noted; similar to OECD guideline 471; limited documentation
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- His-operon (Salmonellla), Trp-operon (E. coli)
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- S. typhimurium TA 1538
- Species / strain / cell type:
- E. coli WP2
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix of livers from Aroclor1254-pretreated rats
- Test concentrations with justification for top dose:
- max. conc. tested: 250 µg/mL
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Tween80/ethanol
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: benzo[a]pyrene in DMSO, 4-nitroquinoline-N-oxide in DMSO, sodium azide, neutral red, potassium dichromate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation
DURATION
- Preincubation period: no data
- Exposure duration: not applicable, preincubation method
- Expression time (cells in growth medium): 48-72 hours
DETERMINATION OF CYTOTOXICITY
- Method: other: toxicity screening test - Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative
The purpose of this study was to determine the mutagenicity of the test substance Normal-Heptane. A reverse mutation assay was done using S. typhimurium strains TA 1535, TA 1537, TA 1538, TA 98 and TA 100, and E. coli strains WP2 and WP2 uvr A. The strains were exposed to concentrations of 0, 3.91, 7.81, 15.6, 31.3, 62.5, 125, and 250 ug/mL for 48 -72 hrs both with and without metabolic activation. The number of revertant colonies was then counted.
No significant increases in the ratio of mutations over controls was seen. The test substance is not mutagenic in either the presence or absence of metabolic activation. - Executive summary:
The purpose of this study was to determine the mutagenicity of the test substance Normal-Heptane. A reverse mutation assay was done using S. typhimurium strains TA 1535, TA 1537, TA 1538, TA 98 and TA 100, and E. coli strains WP2 and WP2 uvr A. The strains were exposed to concentrations of 0, 3.91, 7.81, 15.6, 31.3, 62.5, 125, and 250 ug/mL for 48 -72 hrs both with and without metabolic activation. The number of revertant colonies was then counted.
No significant increases in the ratio of mutations over controls was seen. The test substance is not mutagenic in either the presence or absence of metabolic activation.
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1982-1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions
- 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 473 (In Vitro Mammalian Chromosome Aberration Test)
- Principles of method if other than guideline:
- No guideline stated; similar to OECD guideline 473; rat hepatocytes with intrinsic metabolic activity, therefore no metabolic activation system added, only 100 cells from each culture analyzed.
- GLP compliance:
- not specified
- Type of assay:
- in vitro mammalian chromosome aberration test
- Target gene:
- not applicable
- Species / strain / cell type:
- hepatocytes: rat liver (RL4) cells
- Details on mammalian cell type (if applicable):
- The rat liver cell line, RL4, an epithelial-type cell line, was derived in this laboratory following the procedure described by Williams et al. (1971). RL4 was initiated in 1978 from a 10-day-old Wistar rat as described in Dean and Hodson-Walker (1979).
- Metabolic activation:
- not applicable
- Metabolic activation system:
- not necessary, liver cells
- Test concentrations with justification for top dose:
- 2.5, 5, 10 µg/ml
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Tween 80/ethanol
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: 7,12-dimethylbenzanthracene in DMSO, ethyl methanesulphonate, cyclophosphamide
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 22 hours
- Fixation time (start of exposure up to fixation or harvest of cells): 22 hours + 2 hours fixation
SPINDLE INHIBITOR (cytogenetic assays): colcemid
STAIN (for cytogenetic assays): Giemsa
NUMBER OF REPLICATIONS: no data
NUMBER OF CELLS EVALUATED: 100 cells from each culture - Evaluation criteria:
- Significant or dose-related increase in chromosome damage.
- Key result
- Species / strain:
- hepatocytes: Rat liver (RL4) cells
- Metabolic activation:
- not applicable
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative
This study examined the potential for the test substance Heptane to cause chromosomal aberrations in rat liver RL4 cells. Cells were exposed to concentrations of 0, 2.5, 5, and 10 ug/ml of test substance, and then examined for chromosomal aberrations including polyploidy, chromatid gaps, and chromatid exchanges. The positive control substance was 7,12 -dimethylbenzanthracene. A significant increase in chromatid gaps (7) was seen at the 10 ug/ml concentration. Though greater than the solvent control frequency, this was not accompanied by an increase in any other aberrations and is not considered to be treatment related. Under the conditions of this study, the test material was not clastogenic. - Executive summary:
This study examined the potential for the test substance Normal-Heptane to cause chromosomal aberrations in rat liver RL4 cells. Cells were exposed to concentrations of 0, 2.5, 5, and 10 ug/ml of test substance, and then examined for chromosomal aberrations including polyploidy, chromatid gaps, and chromatid exchanges. The positive control substance was 7,12 -dimethylbenzanthracene. A significant increase in chromatid gaps (7) was seen at the 10 ug/ml concentration. Though greater than the solvent control frequency, this was not accompanied by an increase in any other aberrations and is not considered to be treatment related. Under the conditions of this study, the test material was not clastogenic.
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of 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 publication which meets 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:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- yes
- Remarks:
- - using microtiter plates
- GLP compliance:
- not specified
- Type of assay:
- mammalian cell gene mutation assay
- Target gene:
- thymidine kinase
- Species / strain / cell type:
- human lymphoblastoid cells (TK6)
- Details on mammalian cell type (if applicable):
- - Type and identity of media: RPMI 1640 medium supplemented with 15% heat-inactivated horse serum
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- with Aroclor induced-rat liver homogenate
- Test concentrations with justification for top dose:
- 5 % v/v TMP in DMEM medium, administered undiluted or as 50 % (1:1 saturated to normal medium)
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMEM medium
- Untreated negative controls:
- yes
- Remarks:
- with and without S9
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMEM medium
- Positive controls:
- yes
- Remarks:
- for S9 activated cultures
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- Migrated to IUCLID6: 15 µM
- Untreated negative controls:
- yes
- Remarks:
- with and without S9
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMEM medium
- Positive controls:
- yes
- Remarks:
- for non-activated cultures
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- Migrated to IUCLID6: 0.2 mM
- Details on test system and experimental conditions:
- see "any other information on materials and methods"
- Key result
- Species / strain:
- human lymphoblastoid cells (TK6)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- TMP did not induce significant increases in the mutation frequency at the thymidine kinase locus.
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Cell survival in TMP-saturated medium with and without metabolic activation was greater than 50-60 %.
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- The elevated mutation frequencies of positive control compounds were as expected.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
Cell survival in positive control treated cultures was 40 or 30% for benzo(a)pyrene and EMS, respectively - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative
Based on the study design there is no incidence of increased genetic toxicity caused by the test substance. - Executive summary:
Based on the study design there is no incidence of increased genetic toxicity caused by the test substance.
Referenceopen allclose all
The addition of heptane at amounts up to 250 µg per mL to cultures of Escherichia coli WP2 and WP2 uvr A, Salmonella typhimurium TA 1535, TA 1537, TA 1538, TA 98, and TA 100 did not lead to an increase in the reverse gene mutation frequency in any of these strains, either in the presence or in the absence of rat liver S9 fraction.
Table: Relative Reverse Mutation Rate – E. coli
Concentration (µg/ml) |
E. coliWP2 Assay 1 |
E. coliWP2 Assay 2 |
E. coliWP2 Assay 3 |
E. coliWP2 uvr A Assay 1 |
E. coliWP2 uvr A Assay 2 |
Without S9 |
|||||
3.91 |
- |
1.6 |
0.9 |
- |
0.9 |
7.81 |
- |
2.3 |
1.0 |
- |
0.9 |
15.6 |
1.2 |
1.3 |
0.8 |
0.5 |
0.8 |
31.3 |
1.1 |
1.4 |
0.7 |
0.8 |
0.6 |
62.5 |
1.0 |
1.0 |
0.8 |
0.9 |
0.5 |
125 |
0.7 |
0.6 |
1.2 |
0.3 |
0.5 |
250 |
0.5 |
0.8 |
1.0 |
0.2 |
0.5 |
4-nitroquinoline-N-oxide |
31.7 |
7.7 |
4.8 |
1.9 |
6.3 |
With S9 |
|||||
3.91 |
- |
1.5 |
0.9 |
- |
1.0 |
7.81 |
- |
2.4 |
0.9 |
- |
1.4 |
15.6 |
0.7 |
3.1 |
1.0 |
1.8 |
0.9 |
31.3 |
0.7 |
2.8 |
0.8 |
0.8 |
0.9 |
62.5 |
1.0 |
2.4 |
0.6 |
1.0 |
0.9 |
125 |
0.9 |
2.2 |
1.1 |
2.0 |
0.9 |
250 |
0.7 |
1.3 |
0.9 |
- |
0.8 |
4-nitroquinoline-N-oxide |
1.0 |
3.9 |
0.7 |
9.0 |
19.7 |
Table: Relative Mutation Rate – S. typhimurium TA 1535, TA 1537, TA 1538
Concentration (µg/ml) |
TA 1535 Assay 1 |
TA 1535 Assay 2 |
TA 1537 Assay 1 |
TA 1537 Assay 2 |
TA 1538 Assay 1 |
TA 1538 Assay 2 |
TA 1538 Assay 3 |
Without S9 |
|||||||
3.91 |
- |
- |
- |
- |
- |
- |
- |
7.81 |
- |
1.2 |
- |
0.7 |
- |
0.8 |
1.0 |
15.6 |
1.6 |
1.2 |
1.3 |
0 |
0.5 |
1.0 |
1.0 |
31.3 |
0.1 |
0.6 |
0.4 |
0 |
0 |
0.4 |
0.7 |
62.5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
125 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
250 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Sodium azide 1.7 µg |
48.0 |
73.1 |
- |
- |
- |
- |
- |
Benzo(a)-pyrene 6.7 µg |
- |
- |
- |
- |
1.4 |
1.1 |
0.9 |
Neutral red 6.7 µg |
- |
- |
1.5 |
1.6 |
- |
- |
- |
With S9 |
|||||||
3.91 |
- |
- |
- |
- |
- |
- |
- |
7.81 |
- |
0.9 |
- |
0.7 |
- |
- |
0.8 |
15.6 |
2.1 |
1.0 |
2.4 |
0.7 |
1.5 |
- |
1.0 |
31.3 |
1.4 |
0.9 |
1.3 |
0.9 |
2.1 |
- |
0.7 |
62.5 |
1.7 |
0.6 |
1.8 |
0.9 |
1.8 |
- |
1.0 |
125 |
1.7 |
1.3 |
2.1 |
0.6 |
1.2 |
- |
1.1 |
250 |
1.1 |
0.7 |
2.3 |
0.8 |
1.3 |
- |
0.9 |
Sodium azide 1.7 µg |
19.3 |
78.3 |
- |
- |
- |
- |
- |
Benzo(a)-pyrene 6.7 µg |
- |
- |
- |
- |
2.4 |
- |
10.6 |
Neutral red 6.7 µg |
- |
- |
3.0 |
6.0 |
- |
- |
- |
Table: Relative Mutation Rate – S. typhimurium TA 98, TA 100
Concentration (µg/ml) |
TA 98 Assay 1 |
TA 98 Assay 2 |
TA 100 Assay 1 |
TA 100 Assay 2 |
Without S9 |
||||
3.91 |
- |
0.5 |
- |
1.1 |
7.81 |
- |
0.1 |
- |
1.0 |
15.6 |
0.6 |
0 |
1.1 |
0.8 |
31.3 |
0 |
0 |
1.1 |
0.1 |
62.5 |
0 |
0 |
1.0 |
0 |
125 |
0 |
0 |
1.2 |
0 |
250 |
0 |
0 |
0.6 |
0 |
Benzo(a)-pyrene 6.7 µg |
0.8 |
1.2 |
1.6 |
1.0 |
With S9 |
||||
3.91 |
- |
0.8 |
- |
1.0 |
7.81 |
- |
1.1 |
- |
0.9 |
15.6 |
0.9 |
1.1 |
0.9 |
1.0 |
31.3 |
0.9 |
1.0 |
0.8 |
1.1 |
62.5 |
0.8 |
0.9 |
0.7 |
0.9 |
125 |
0.7 |
0.8 |
0.9 |
1.2 |
250 |
0.4 |
0.5 |
0.9 |
0.9 |
Benzo(a)-pyrene 6.7 µg |
12.6 |
4.7 |
2.8 |
5.4 |
There was no significant or dose-related increase of chromosome damage in any of the cultures exposed.
Table: Metaphase chromosome analysis of RL4cells
0 µg/ml |
2.5 µg/ml |
5.0 µg/ml |
10.0 µg/ml |
1.0 µg/ml 7,12-dimethylbenzanthracene |
|
Polyploidy (% cells) |
3.7 |
2.0 |
2.7 |
1.3 |
1.5 |
Chromatid gaps (% cells) |
1.3 |
1.7 |
1.0 |
2.3 |
6.0 |
Multiple aberrations (% cells) |
- |
- |
- |
- |
0.5 |
Severe damage (% cells) |
- |
- |
- |
- |
0.5 |
Chromatid aberrations (% cells) |
0.3 |
- |
- |
- |
4.0 |
Chromosome aberrations (frequency per cell) |
- |
- |
- |
- |
- |
Chromatid gaps (frequency per cell) |
0.013 |
0.017 |
0.010 |
0.027 |
0.085 |
Chromatid breaks (frequency per cell) |
0.003 |
- |
- |
- |
0.005 |
Chromatid exchange (frequency per cell) |
- |
- |
- |
- |
0.05 |
Chromosome breaks (frequency per cell) |
- |
- |
- |
- |
0.005 |
Chromosome exchange (frequency per cell) |
- |
- |
- |
- |
- |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Description of key information
There is no in vivo genetic toxicity data available for Octane. However, data is available for structural analogues, Hydrocarbons, C9-C11, n-alkanes, isoalkanes, cyclics, <2% aromatics, Hydrocarbons, C10-C13, n-alkanes, isoalkanes, cyclics, <2% aromatics and Hydrocarbons, C10-C13, n-alkanes, <2% aromatics. 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.
The read across genetic toxicity tests listed below had negative results for Octane.
Genetic Toxicity in vivo – Mammalian Erythrocyte Micronucleus Test (equivalent/similar to OECD 474)
Genetic Toxicity in vivo – Rodent Dominant Lethal Test (equivalent/similar to OECD 478)
Link to relevant study records
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented study report equivalent or similar to OECD guideline 474: GLP
- 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
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Principles of method if other than guideline:
- According to US EPA Guideline 84-2
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories
- Age at study initiation: ca. 8-9 weeks
- Weight at study initiation: 21-40 grams
- Assigned to test groups randomly: [no/yes, under following basis: computer generated, body weight sorting program
- Housing: individual
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: 28 days
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 68-76
- Humidity (%): 40-70
- Photoperiod (hrs dark / hrs light): 12/12
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: corn oil
- Amount of vehicle (if gavage or dermal): not to exceed 1ml/100 grams bw
- Purity: assumed to be 100% pure - Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
The test material was weighted out and on the day of dosing, mixed with the carrier to provide stock solutions such that individual animal dose volumes did not exceed 1ml/100grams body weight. The mice were administered 1.25, 2.5, or 5.0 grams of test material/kg of body weight. Corn oil served as the carrier for the test material and was dosed at the same volume as the test material.
- Duration of treatment / exposure:
- Animals were treated once by oral gavage and sacrificed 24h, 48h or 72h after dosing.
Positive control animals were sacrificed 24 hours after injection - Frequency of treatment:
- Animals were treated once by oral gavage and sacrificed 24h, 48h or 72h after dosing
- Post exposure period:
- Animals were treated once by oral gavage and sacrificed 24h, 48h or 72h after dosing
- Remarks:
- Doses / Concentrations:
5.0 g/kg/bw
Basis:
nominal conc. - Remarks:
- Doses / Concentrations:
2.5g/kg/bw
Basis:
nominal conc. - Remarks:
- Doses / Concentrations:
1.25 g/kg/bw
Basis:
nominal conc. - No. of animals per sex per dose:
- 30 animals (5 male; 5 female)/dose; 10/timepoint
- Positive control(s):
- cyclophosphamide;
- Route of administration: intraperitoneal injection
- Doses / concentrations:40 mg/kg using water as the carrier - Tissues and cell types examined:
- Bone marrows were collected and extracted, smear preparations made and stained. Polychromatic erythrocytes (PCE) and normochromatic erythrocytes (NCE) were scored for each animal.
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: Range finding study was performed using 5.0, 2.5, and 1.0 gram of test material per kg of body weight. Two males and two females were used for each dose group. All animals survived and were sacrificed 24 hours after dosing. bome marrow was removed and slides were prepared. Slides were evaluated for percent of polychromatic erythrocytes in 1000 erythrocytes and for number of micronucleated polychromatic erythrocytes per 1000 polychromatic erythrocytes.
DETAILS OF SLIDE PREPARATION: After sacrifice, both femurs were removed. The bone marrow was then removed and suspended in fetal bovine serum. After the suspension was centrifuged, the pellet was resuspended and smears were prepared (two slides per animal). Slides were labeled with blind coding. Slides were stained using acridine orange. 1000 polychromatic erythrocytes from each animal were examined for the presence of micronuclei, and the ratio of PCE’s to NCE’s determined
METHOD OF ANALYSIS: staining color, and circular appearance and a diameter between 1/20 and 1/5 of the cell's diameter
- Statistics:
- Statistical analysis included calculation of means and standard deviations of the micronuclei data and a test of equality of group means by a standard one way analysis of variance at each time period. When the ANOVA was significant, comparisons of carrier control to dosed group means were made according to Duncan’s Multiple Range Test. A standard regression analysis was performed to test for a dose response. Residuals from the ANOVA were analyzed for normality by Wilk’s Criterion. The residuals were normally distributed (values were greater than 0.01 level of significance) in more than 25% of the analyses. Therefore nonparametric analysis were not performed. Sexes were analyzed separately
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- No deaths or clinical signs of toxicity were observed in animals dosed with the test material up to the maximum recommended dose of 5g/kg
- Conclusions:
- Interpretation of results: negative
The in vivo micronucleus assay of MRD-89-582 in mice was negative. This finding does not warrant the classification of the test material as a genotoxin under EU GHS guidelines and does not warrant classification under the EU requirements for dangerous substances and preparations. - Executive summary:
MRD-89-582 was examined for its potential to induce chromosomal damage in bone marrow erythrocytes in mice dosed by oral gavage at concentrations of 5.0,2.5, and 1.25 g/kg. Vehicle and positive control animals received corn oil and cyclophosphamide, respectively. Bone marrow samples were collected and evaluated for micronucleus formation 24, 48 and 72 hours after dosing. MRD-89-582 did not induce a statistically significant change in the PCE/NCE ratio in any of the test material dose groups when compared to their concurrent vehicle control groups. The positive control material (cyclophosphamide) produced a marked increase in the frequency of micronucleated PCE when compared to the concurrent vehicle control group The test material was considered to be non-genotoxic and non-clastogenic under the conditions of the test. This finding does not warrant the classification of the test material as a genotoxin under EU GHS guidelines and does not warrant classification under the EU requirements for dangerous substances and preparations guidelines.
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1990/10/24 - 1990/11/30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: According to or similar to OECD Guideline 474. GLP
- 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
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Principles of method if other than guideline:
- According to US EPA Guideline 84-2
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
Source: Charles River Breeding Laboratories, Inc.
Sex: Male (65), Female (65)
Age at study initiation: Approximately 9-10 weeks
Weight at study initiation: 23-39g
Housing: Individually
Diet (e.g. ad libitum): Purina Certified Rodent 5002 chow (pellets), ad libitum
Water (e.g. ad libitum): Automatic watering system, ad libitum
Acclimation period: 7d
ENVIRONMENTAL CONDITIONS
Temperature (°F): 68-76
Humidity (%): 40-70%
Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- Corn oil was used. Dose volume did not exceed 1.0 ml/100 g bw.
- Details on exposure:
- The test material and the carrier were administered by oral gavage as a single dose. The carrier was dosed at a volume equal to the test material dose volume. The individual animal dose volumes did not exceed 1.0 ml/100 g body weight; animals were administered 1.0, 2.5, 5.0 g test material/ kg body weight. The positive control, cyclophosphamide was administered as a single dose of 40 mg/kg using water as a carrier.
- Duration of treatment / exposure:
- Animals were sacrificed 24, 48, and 72 hours after dose administration.
- Frequency of treatment:
- One dose was given at either 1.0, 2.5, 5.0 g test material/ kg body weight. Cyclophosphamide was dosed at 40 mg/kg.
- Post exposure period:
- Animals were sacrificed 24, 48, and 72 hours after dose administration.
- No. of animals per sex per dose:
- Male (65), Female (65) ; 5 Males and 5 Females per treatment group
- Positive control(s):
- The positive control, cyclophosphamide was administered as a single intraperitoneal injection (40 mg/kg) using water as a carrier.
- Tissues and cell types examined:
- Erythrocytes derived from femur bone marrow.
- Details of tissue and slide preparation:
- Immediately following the sacrifice of the animals, both femurs were removed and the bone marrow was removed and suspended in fetal bovine serum. After the suspension was centrifuged the pellet was resuspended and smears were prepared (two slides per animal).
- Evaluation criteria:
- Slides were stained using acridine orange; polychromatic erythrocytes (PCE) stained red/orange, nonchromatic erythrocytes (NCE) are unstained (dull green), and micronuclei stain bright yellow. Additional criteria for scoring micronuclei are a circular appearance and a diameter between 1/20 and 1/5 of the cell’s diameter. 1000 PCE from each animal were examined for the presence of micronuclei and the ratio of PCE to NCE was determined for each animal by counting 1000 erythrocytes (PCE and NCE).
- Statistics:
- Calculation of means and standard deviations of the micronuclei data and a test of equality of group means by a standard one way analysis of variance at each time period (ANOVA). When ANOVA was significant, comparisons of carrier control to dosed group means were made according to Duncan’s Multiple Range Test.
A standard regression analysis was performed to test for a dose response.
Residuals from the ANOVA were analyzed for normality by Wilk’s Criterion. The residuals were normally distributed (values were greater than 0.01 level of significance). Therefore nonparametric analysis was not performed.
Sexes were analyzed separately. - Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- The positive control (cyclophosphamide) induced a statistically significant increase in the mean number of micronucleated polychromatic erythrocytes, indicating that the positive control was clastogenic and was responding in an appropriate manner. Carrier control values for the mean percent of polychromatic erythrocytes and for the mean number of micronucleated polychromatic erythrocytes are within the normal range for the corn oil control. MRD-90-874 did not induce a statistically significant decrease in the mean percent of polychromatic erythrocytes which is a measure of bone marrow toxicity. MRD-90-874 did not induce a statistically significant increase in the mean number of micronucleated polychromatic erythrocytes. MRD-90-874 did not induce a significant increase in the mean number of micronucleated polychromatic erythrocytes. MRD-90-874 was not cytotoxic at doses up to 5.0 g/kg to mouse bone marrow under the conditions of this test.
- Conclusions:
- Interpretation of results: negative
These data indicate that MRD-90-874 is not cytotoxic and is not clastogenic in CD-1 mouse bone marrow cells at doses up to and including 5.0 g/kg of body weight. - Executive summary:
The test material, MRD-90-874 was tested in the mammalian bone marrow micronucleus assay using CD-1 mice. MRD-90-874 was tested at 24, 48, and 72 hour intervals following exposure and did not induce a statistically significant decrease in the mean percent of polychromatic erythrocytes or an increase in the mean number of micronucleated polychromatic erythrocytes. Both the positive (cyclophosphamide) and the negative (carrier) controls behaved in an appropriate manner. These data indicate that MRD-90-874 is not cytotoxic and is not clastogenic in CD-1 mouse bone marrow cells at doses up to and including 5.0 g/kg.
- Endpoint:
- in vivo mammalian germ cell study: cytogenicity / chromosome aberration
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1978
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented study report equivalent or similar to OECD guideline 478.
- 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
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 478 (Genetic Toxicology: Rodent Dominant Lethal Test)
- GLP compliance:
- no
- Type of assay:
- rodent dominant lethal assay
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories
- Age at study initiation: Males (7-8 weeks); females pre-treatment mating period (8-9 weeks); females post treatment mating period (7-8 weeks)
- Housing: males were house individiually during the treatment period and housed with two females per week during the 2 week pretreatment mating period and the 6 week post-treatment mating period. Females were housed individually during the pre-mating and post-mating periods and housed with males in a 2:1 ratio during mating.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum - Route of administration:
- inhalation: vapour
- Details on exposure:
- TYPE OF INHALATION EXPOSURE: whole body
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
MRD-77-44 was transferred from a reservoir using a metering pump into a heated flask and flash evaporated. A stream of clean air was also passed through the flask and the vapor laden air transferred to a port in the chamber air inlet where it was diluted with normal chamber intake air to give the desired concentration.
- Exposure apparatus: inhalation chamber
- Rate of air: 125 liters/minute
- Air flow rate: 125 liters/minute
- Air change rate: 8 minutes
- Method of particle size determination:
- Treatment of exhaust air:
TEST ATMOSPHERE
- Brief description of analytical method used: Wilks Scientific Corp, Miran IA Ambient Air Analyzer (long path infrared)
- Samples taken from breathing zone: no - Duration of treatment / exposure:
- MRD-77-44 was administered by vapor inhalation for six hours/day for five consecutive days.
Negative control (chamber air) was administered 6 hours/day for five consecutive days
Triethylenemelamine was administered by intraperitoneal injection (normal saline) as a single dose. - Frequency of treatment:
- MRD-77-44 was administered by vapor inhalation for six hours/day for five consecutive days.
Negative control (chamber air) was administered 6 hours/day for five consecutive days
Triethylenemelamine was administered by intraperitoneal injection (normal saline) as a single dose. - Post exposure period:
- Following exposure, the males were mated with unexposed females (two female rats were mated with each male rat per week) for 6 consecutive weeks. The females were sacrificed 12 days after the last day of cohabitation
- Remarks:
- Doses / Concentrations:
900 ppm
Basis:
nominal conc. - Remarks:
- Doses / Concentrations:
300 ppm
Basis:
nominal conc. - No. of animals per sex per dose:
- Negative control: 10 males; 120 females during six week post-treatment mating period (two females/male/week)
Positive control: 10 males; 120 females during six week post-treatment mating period (two females/male/week)
300ppm MRD-77-44: 10 males; 120 females during six week post-treatment mating period (two females/male/week)
900ppm MRD-77-44: 10 males; 120 females during six week post-treatment mating period (two females/male/week) - Control animals:
- yes
- Positive control(s):
- triethylenemelamine
- Route of administration: Intraperitoneal injection
- Doses / concentrations: 0.5mg/kg/bw - Tissues and cell types examined:
- Males: seminal vesicle, epididymides, prostate, and any abnormal lesion or tissue masses, testes.
Females: reproductive tissues examined (uterine horns preserved, implantation sites, resorption sites) - Statistics:
- Comparisons were made during the treatment and post-treatment periods between negative control, positive control and test substance-treated groups by the chi-square method where applicable. Absolute data were compared using the F-test and Students t-test. When variances differed significantly, Students T-test was appropriately modified using Cochran’s approximation.
- Key result
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Conclusions:
- Interpretation of results: negative
When administered by vapor inhalation, MRD-77-44 is not mutagenic by the dominant lethal test. This finding does not warrant classification of the test material as a genotoxin under EU GHS guidelines and does not warrant classification under the EU requirements for dangerous substances and preparations. - Executive summary:
In a dominant lethal assay, MRD-77-44 was administered by vapor inhalation for six hours/day for five consecutive days to male rats at dose levels of 300 and 900 ppm to test for mutagenic potential. Included in the study was a negative (chamber exposed) control group and a positive control group. The latter received 0.5mg/kg of triethylenemelamine administered intraperitoneally on a single day, two hours prior to mating. Each group contained 10 proven fertile rats. Following exposure, the males were mated with unexposed females (two female rats were mated with each male rat per week) for 6 consecutive weeks. The females were sacrificed 12 days after the last day of cohabitation. Exposure of males to MRD-77-44 produced no adverse effects on mortality or body weight gain during the post-treatment mating period. Overall, the number of pregnant females, number of implantations per litter, number of live fetuses, number of dead implantations, and the number of resorptions were unaffected by MRD-77-44 exposure. Exposures to male rats had no effect on their ability to mate and impregnate females, and to produce live fetuses. Based on these data, MRD-77-44 when administered by vapor inhalation to male rats is not considered mutagenic by the dominant lethal test. This finding does not warrant the classification of MRD-77-44 as a genotoxin under EU GHS guidelines and does not warrant classification under the EU requirements for dangerous substances and preparations.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
There is no genetic toxicity data available for Octane. However, in vitro data is available for structural analogues Heptane and 2,2,4-trimethylpentane, and in vivo data is available for structural analogues Hydrocarbons, C9-C11, n-alkanes, isoalkanes, cyclics, <2% aromatics, Hydrocarbons, C10-C13, n-alkanes, isoalkanes, cyclics, <2% aromatics and Hydrocarbons, C10-C13, n-alkanes, <2% aromatics. 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
Heptane
A bacterial reverse mutation assay (Ames test) (Shell Chemicals, 1983; Brooks et al., 1988) was conducted with normal-heptane following a protocol similar to OECD 471. The pre-incubation procedure was performed with Salmonella typhimurium strains TA 1535, TA 1537, TA 1538, TA 98 and TA 100, and Escherichia coli strains WP2 and WP2 uvr A. The strains were exposed to concentrations of 0, 3.91, 7.81, 15.6, 31.3, 62.5, 125, and 250 µg/mL for 48 -72 h both with and without metabolic activation. No significant increases in the ratio of mutations over controls was seen. Therefore, the test substance was not mutagenic in either the presence or absence of metabolic activation.
In vitro Chromosome Aberration in Mammalian Cells
Heptane
The potential of normal-heptane to cause chromosomal aberrations in rat liver RL4 cells was tested with a method comparable to OECD 473 (Shell Chemicals, 1983; Brooks et al., 1988). Cells were exposed to concentrations of 0, 2.5, 5, and 10 µg/mL of test substance for 22 h, and then examined for chromosomal aberrations including polyploidy, chromatid gaps, and chromatid exchanges. No cytotoxicity was observed. A significant increase in chromatid gaps was seen at 10 µg/mL. However, this effect was neither dose-dependent nor accompanied by an increase in any other aberration type, and therefore not considered to be treatment-related. Under the conditions of this study, the test material was not clastogenic.
In vitro Gene Mutation study in Mammalian Cells
2,2,4-trimethylpentane
In a key study (Richardson et al., 1986), 2,2,4-trimethylpentane was tested in a mammalian cell gene mutation assay performed according to OECD 476. The test material was prepared by adding iso-octane at a final concentration of 5 % v/v in culture (DMEM) medium and stirred overnight at room temperature in a foil wrapped, capped parafilm-sealed bottle to saturate the medium. Human lymphoblastoid cells (TK6) were exposed to 100 or 50 % of this saturated DMEM medium with and without metabolic activation for 3 h and allowed for expression for 4 to 8 days. Both with and without metabolic activation, 2,2,4-trimethylpentane did not induce significant increases in the mutation frequency at the thymidine kinase locus and cell survival in 2,2,4-trimethylpentane-saturated medium was greater than 50-60 %. Based on the study design there was no incidence of increased genetic toxicity caused by the test substance.
In Vivo
Hydrocarbons, C9-C11, n-alkanes, isoalkanes, cyclics, <2% aromatics
In a dominant lethal assay (ExxonMobil, 1978), the test material (Hydrocarbons, C9-C11, n-alkanes, isoalkanes, cyclics, < 2% aromatics) was administered by vapor inhalation for six hours/day for five consecutive days to male rats at dose levels of 300 and 900 ppm to test for mutagenic potential. Included in the study was a negative (chamber exposed) control group and a positive control group. The latter received 0.5 mg/Kg of triethylenemelamine administered intraperitoneally on a single day, two hours prior to mating. Each group contained 10 proven fertile rats. Following exposure, the males were mated with unexposed females (two female rats were mated with each male rat per week) for 6 consecutive weeks. The females were sacrificed 12 days after the last day of cohabitation. Exposure of males to the test material produced no adverse effects on mortality or body weight gain during the post-treatment mating period. Overall, the number of pregnant females, number of implantations per litter, number of live fetuses, number of dead implantations, and the number of resorptions were unaffected by exposure to the test material. Exposures to male rats had no effect on their ability to mate and impregnate females, and to produce live fetuses. Based on these data, Hydrocarbons, C9-C11, n-alkanes, isoalkanes, cyclics, < 2% aromatics when administered by vapor inhalation to male rats is not considered mutagenic by the dominant lethal test. This finding does not warrant the classification as a genotoxin under EU GHS guidelines.
Hydrocarbons, C10-C13, n-alkanes, < 2% aromatics
The test material (Hydrocarbons, C10-C13, n-alkanes, < 2% aromatics) was tested in the mammalian bone marrow micronucleus assay using CD-1 mice (ExxonMobil, 1991). The test material was tested at 24, 48, and 72 hour intervals following exposure and did not induce a statistically significant decrease in the mean percent of polychromatic erythrocytes or an increase in the mean number of micronucleated polychromatic erythrocytes. Both the positive (cyclophosphamide) and the negative (carrier) controls behaved in an appropriate manner. These data indicate that Hydrocarbons, C10-C13, n-alkanes, < 2% aromatics is not cytotoxic and is not clastogenic in CD-1 mouse bone marrow cells at doses up to and including 5.0 g/kg.
Hydrocarbons, C10 -C13, n-alkanes, isoalkanes, cyclics, <2% aromatics
In a key cytogenicity/ erythrocyte micronucleus study (ExxonMobil, 1991), the test material (Hydrocarbons, C10-C13, n-alkanes, isoalkanes, cyclics, <2% aromatics) was examined for its potential to induce chromosomal damage in bone marrow erythrocytes in mice dosed by oral gavage at concentrations of 5.0,2.5, and 1.25 g/kg. Vehicle and positive control animals received corn oil and cyclophosphamide, respectively. Bone marrow samples were collected and evaluated for micronucleus formation 24, 48 and 72 hours after dosing. The test material did not induce a statistically significant change in the PCE/NCE ratio in any of the test material dose groups when compared to their concurrent vehicle control groups. The positive control material (cyclophosphamide) produced a marked increase in the frequency of micronucleated PCE when compared to the concurrent vehicle control group. The test material was considered to be non-genotoxic and non-clastogenic under the conditions of the test.
Justification for classification or non-classification
The negative results of in vitro and in vivo genotoxicity assays from structural analogues do not warrant the classification of Octane as genotoxic under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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