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EC number: 232-489-3 | CAS number: 8052-41-3 A colorless, refined petroleum distillate that is free from rancid or objectionable odors and that boils in a range of approximately 148.8°C to 204.4°C (300°F to 400°F).
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
There are conclusive but not sufficient data for the classification of substance Stoddard solvent with regard to mutagenicity/genetic toxicity. It is concluded that the substance Stoddard solvent does not meet the criteria to be classified for human health hazards for Mutagenicity-Genetic Toxicity
In vitro summary: Mutagenicity testing results for Stoddard solvent has been reported in several studies using bacterial and mammalian cells. There was no indication of genotoxicity in any of the studies.
In vivo summary: Mutagenicity testing showed no evidence of genotoxicity.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- Stoddard solvent; boiling range, 157-204°C; 19% aromatics
- Target gene:
- histidine
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- With and without Aroclor induced rat liver S9
- Test concentrations with justification for top dose:
- 0.001-5 µg/plate and 3.38-25 µl/ml
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: acetone
- Justification for choice of solvent/vehicle: not stated - Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 1103
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium; in agar (plate incorporation)
DURATION
- Preincubation period: not applicable
- Exposure duration: 48 hours
NUMBER OF REPLICATES: duplicate test, each performed with triplicate plates
DETERMINATION OF CYTOTOXICITY
- Method: growth of bacterial lawn - Evaluation criteria:
- For a substance to be considered positive, it should have induced a concentration-related and statistically significant increase in mutation rate in one or more starins of bacteria in the presence and/or absence of S9 in both experiments at sub-toxic concentrations. To be considered negative the number of induced revertants compared to spontaneous revertants should be less than two-fold at each concentration employed.
- Statistics:
- Methods recommended by the United Kingdom Environmental Mutagen Society and normally Dunnett's method of linear regression
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: no data
- Effects of osmolality: no data
- Evaporation from medium: no data
- Water solubility: no data
COMPARISON WITH HISTORICAL CONTROL DATA: vehicle control results said to be "within the normal range"
ADDITIONAL INFORMATION ON CYTOTOXICITY: no further data - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results :negative
In a reliable study, performed according to OECD guideline 471, the Stoddard solvent did not increase the reverse mutation rate in histidine dependent bacterial strains of Salmonella typhimurium in the presence or absence of metabolic activation at dose levels of 0.001-5 µg/plate and 3.38-25 µl/ml . This concentration was not cytotoxic. - Executive summary:
Interpretation of results :negative
In a reliable study, performed according to OECD guideline 471, the Stoddard solvent did not increase the reverse mutation rate in histidine dependent bacterial strains of Salmonella typhimurium in the presence or absence of metabolic activation at dose levels of 0.001-5 µg/plate and 3.38-25 µl/ml . This concentration was not cytotoxic.
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- 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
- Specific details on test material used for the study:
- Stoddard solvent; 15% aromatics
- Target gene:
- histidine
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- With and without Aroclor induced rat liver S9
- Test concentrations with justification for top dose:
- 0.001-5 µg/plate and 3.38-25 µl/ml
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: acetone
- Justification for choice of solvent/vehicle: not stated - Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 1103
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium; in agar (plate incorporation)
DURATION
- Preincubation period: not applicable
- Exposure duration: 48 hours
NUMBER OF REPLICATES: duplicate test, each performed with triplicate plates
DETERMINATION OF CYTOTOXICITY
- Method: growth of bacterial lawn - Evaluation criteria:
- For a substance to be considered positive, it should have induced a concentration-related and statistically significant increase in mutation rate in one or more starins of bacteria in the presence and/or absence of S9 in both experiments at sub-toxic concentrations. To be considered negative the number of induced revertants compared to spontaneous revertants should be less than two-fold at each concentration employed.
- Statistics:
- Methods recommended by the United Kingdom Environmental Mutagen Society and normally Dunnett's method of linear regression
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: no data
- Effects of osmolality: no data
- Evaporation from medium: no data
- Water solubility: no data
COMPARISON WITH HISTORICAL CONTROL DATA: vehicle control results said to be "within the normal range"
ADDITIONAL INFORMATION ON CYTOTOXICITY: no further data - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results :negative
In a reliable study, performed according to OECD guideline 471, the Stoddard solvent did not increase the reverse mutation rate in histidine dependent bacterial strains of Salmonella typhimurium in the presence or absence of metabolic activation at dose levels of 0.001-5 µg/plate and 3.38-25 µl/ml . This concentration was not cytotoxic. - Executive summary:
Interpretation of results :negative
In a reliable study, performed according to OECD guideline 471, the Stoddard solvent did not increase the reverse mutation rate in histidine dependent bacterial strains of Salmonella typhimurium in the presence or absence of metabolic activation at dose levels of 0.001-5 µg/plate and 3.38-25 µl/ml . This concentration was not cytotoxic.
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- Principles of method if other than guideline:
- Well-conducted study according to protocol very similar to OECD guideline 473
- GLP compliance:
- not specified
- Type of assay:
- in vitro mammalian cell micronucleus test
- Target gene:
- not applicable
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Details on mammalian cell type (if applicable):
- - Type and identity of media: minimum essential medium
- Properly maintained: no data
- Periodically checked for Mycoplasma contamination: no data
- Periodically checked for karyotype stability: no data
- Periodically "cleansed" against high spontaneous background: no data - Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- liver microsomal fraction from male rats prepared according to Ames et al., 1977
- Test concentrations with justification for top dose:
- Doses:
0, 0.007, 0.013, 0.025, 0.05 uL/mL (without activation)
0, 0.05, 0.1, 0.2, 0.4 uL/mL (with activation) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol
- Justification for choice of solvent/vehicle: solubility - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- without metabolic activation
- Positive control substance:
- ethylmethanesulphonate
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- with metabolic activation
- Positive control substance:
- cyclohexylamine
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Preincubation period: not applicable
- Exposure duration: 4 hours
- Expression time (cells in growth medium): not applicable
- Selection time (if incubation with a selection agent): not applicable
- Fixation time (start of exposure up to fixation or harvest of cells): 7 and 24 (or 28) hours @ 20 ug/ml, 18 hours @ 0.6, 10 and 20 ug/ml
SPINDLE INHIBITOR (cytogenetic assays): colcemia, 0.2 ug/ml
STAIN (for cytogenetic assays): Giemsa
NUMBER OF REPLICATIONS: 2 cultures per concentration
NUMBER OF CELLS EVALUATED: 100 per slide, 200 per concentration
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index
OTHER EXAMINATIONS:
- Determination of polyploidy: no data
- Determination of endoreplication: no data - Evaluation criteria:
- To be considered positive, either a statistically significant, concentration-related increase in the number of structural chromosome aberrations, or a statistically signficant positive response at one of the concentrations
- Statistics:
- Chi-squared test performed for cells with aberration (excluding gaps)
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: no data
- Effects of osmolality: no data
- Evaporation from medium: no data
- Water solubility: insoluble
- Precipitation: no data
- Other confounding effects: no data
RANGE-FINDING/SCREENING STUDIES: yes, but no data presented
COMPARISON WITH HISTORICAL CONTROL DATA: no data - Remarks on result:
- other: negative for Chinese hamster Ovary (CHO)(all strains/cell types tested);
- Conclusions:
- Interpretation of results:negative
In a reliable study, according to a protocol that is similar to OECD 473, Stoddard solvent did not increase the incidence of chromosome aberrations in Chinese hamster Ovary (CHO) cells in the presence or absence of metabolising fraction at concentrations up to 0.4 ug/ml. There was no evidence of cytotoxicity at this dose level. - Executive summary:
Interpretation of results:negative
In a reliable study, according to a protocol that is similar to OECD 473, Stoddard solvent did not increase the incidence of chromosome aberrations in Chinese hamster Ovary (CHO) cells in the presence or absence of metabolising fraction at concentrations up to 0.4 ug/ml. There was no evidence of cytotoxicity at this dose level.
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- (Q)SAR
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification
- Justification for type of information:
- QSAR prediction:QSAR method for chemicals properties assessment. Relevant for in vitro (Ames test) mutagenicity endpoints.
- Qualifier:
- according to guideline
- Guideline:
- other: ToxTree: Benigni/Bossa rules for carcinogenicity and mutagenicity
- Principles of method if other than guideline:
- This profiler is based on the Mutagenicity/Carcinogenicity module of the software Toxtree. It works as a decision tree for estimating in vitro (Ames test) mutagenicity, based on a list of 30 structural alerts (SAs). The SAs for mutagenicity are molecular functional groups or substructures known to be linked to the mutagenic activity of chemicals. As one or more SAs embedded in a molecular structure are recognised, the system flags the potential mutagenicity of the chemical. The present list of SAs is a subset of the original Toxtree list, obtained by eliminating the SAs for nongenotoxic carcinogenicity.
- GLP compliance:
- no
- Remarks:
- not applicable. QSAR model in vitro (Ames test) mutagenicity, based on a list of 30 structural alerts (SAs) relevant for in vitro (Ames test) mutagenicity endpoints.
- Type of assay:
- other: QSAR model
- Target gene:
- This profiler is based on the Mutagenicity/Carcinogenicity module of the software Toxtree. It works as a decision tree for estimating in vitro (Ames test) mutagenicity, based on a list of 30 structural alerts (SAs).
- Species / strain / cell type:
- S. typhimurium TA 100
- Test concentrations with justification for top dose:
- QSAR model in vitro (Ames test) mutagenicity, based on a list of 30 structural alerts (SAs) relevant for in vitro (Ames test) mutagenicity endpoints.
- Untreated negative controls:
- other: QSAR model
- Negative solvent / vehicle controls:
- other: QSAR model
- True negative controls:
- other: QSAR model
- Positive controls:
- other: QSAR model
- Details on test system and experimental conditions:
- This profiler is based on the Mutagenicity/Carcinogenicity module of the software Toxtree.
- Evaluation criteria:
- This profiler is based on the Mutagenicity/Carcinogenicity module of the software Toxtree. It works as a decision tree for estimating in vitro (Ames test) mutagenicity, based on a list of 30 structural alerts (SAs). The SAs for mutagenicity are molecular functional groups or substructures known to be linked to the mutagenic activity of chemicals. As one or more SAs embedded in a molecular structure are recognised, the system flags the potential mutagenicity of the chemical. The present list of SAs is a subset of the original Toxtree list, obtained by eliminating the SAs for nongenotoxic carcinogenicity.
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- other: QSAR model
- Untreated negative controls validity:
- other: QSAR model
- Additional information on results:
- Benigni/Bossa rules for carcinogenicity and mutagenicity:
- Structural Alert for genotoxic carcinogenicity NO
- Potential S. typhiunium TA100 mutagen based on QSAR NO
- Negative for genotoxic carcinogenicity YES - Conclusions:
- Interpretation of results ):negative
No alert found.The query structure is not recognized among the in vitro mutagenicity (Ames test) alerts by ISS.
The query structure is not recognized among the in vitro mutagenicity (Ames test) alerts by ISS and therefore Stoddard solvent does not cause in vitro mutagenicity (Ames test) - Executive summary:
The query structure is not recognized among the in vitro mutagenicity (Ames test) alerts by ISS and does not cause in vitro mutagenicity (Ames test).
No mutagenic activity in the (Q)SAR study, In vitro mutagenicity (Ames test) alerts by ISS for Stoddard solvent and does not cause in vitro mutagenicity (Ames test) .This QSAR method is Relevant for in vitro (Ames test) mutagenicity endpoints.
Referenceopen allclose all
1.6. Profiling results:
DNA binding by OECD
No alert found
Est rogen Receptor Binding
Non binder, non cyclic structure
OECD HPV Chemical Categories
C9-13 Aliphatics hydrocarbon solvents (less than 2 percent aromatics)
Protein binding by OECD
No alert found
Protein binding potency
Not possible to classify according to these rules (GSH)
Superfragments
No superfragment
Toxic hazard classification by Cramer (original)
Low (Class I)
US-EPA New Chemical Categories
Not categorized.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Description of key information
There are conclusive but not sufficient data for the classification of substance Stoddard solvent with regard to mutagenicity/genetic toxicity. It is concluded that the substance Stoddard solvent does not meet the criteria to be classified for human health hazards for Mutagenicity-Genetic Toxicity
In vitro summary: Mutagenicity testing results for Stoddard solvent has been reported in several studies using bacterial and mammalian cells. There was no indication of genotoxicity in any of the studies.
In vivo summary: Mutagenicity testing showed no evidence of genotoxicity.
Link to relevant study records
- Endpoint:
- in vivo mammalian germ cell study: cytogenicity / chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)
- Deviations:
- no
- GLP compliance:
- not specified
- Type of assay:
- micronucleus assay
- Specific details on test material used for the study:
- White Spirits containing 15% aromatics with an initial boiling point of 160°C to 161°C
- Species:
- mouse
- Strain:
- Balb/c
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:mouse (Balb/c) male/female
- Age at study initiation: 7-8 weeks
- Weight at study initiation: males 21-27 g, females 21-26 g
- Assigned to test groups randomly: yes, under following basis: allocated to treatment groups according to randomization table generated by computer programme or manually
- Fasting period before study: yes, overnight until 3-4 hours after dosing
- Housing: males, 1/cage, macrolon cages type I; females, <=3/cage, macrolon cages type II; filled with clean softwood bedding
- Diet (e.g. ad libitum): standard animal diet, Altromin No. 1314, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: >=6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 25 +- 3 (occasionally 20-25)
- Humidity (%): 40 - 50 (occasionally 45-70)
- Air changes (per hr): no data, except "air-conditioned room"
- Photoperiod (hrs dark / hrs light): 12 / 12
I - Route of administration:
- intraperitoneal
- Details on exposure:
- Intraperitoneal injections of 0.1, 0.05 and 0.01 ml of white spirit (initial boiling point, 160°C; 15% aromatics) were given to 10 animals each, while inhalation of 50 g/m3 for 5 lots of 5 min (each exposure period was separated by 5 min without exposure) was performed with five mice.
- Duration of treatment / exposure:
- single administration
- Frequency of treatment:
- single administration
- Post exposure period:
- 2-4 hours post exposure , animals were sacrificed
- Remarks:
- Doses / Concentrations:0.1, 0.05 and 0.01 ml
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- cyclophosphamide
- Justification for choice of positive control(s): not stated - Tissues and cell types examined:
- bone marrow
- Statistics:
- Method used: Kastenbaum & Bowman
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- no cytogenic damage in a micronucleus test conducted with BALB/c mice.
- Conclusions:
- Interpretation of results : negative
no cytogenic damage in a micronucleus test conducted with BALB/c mice.
Genotoxicity: negative (male/female); toxicity: no effects
Mutagenicity testing of Stoddard solvent showed no evidence of genotoxicity. - Executive summary:
Mutagenicity testing of Stoddard solvent showed no evidence of genotoxicity.
- Endpoint:
- in vivo mammalian germ cell study: cytogenicity / chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)
- Deviations:
- no
- GLP compliance:
- not specified
- Type of assay:
- micronucleus 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, Inc.
- Age at study initiation:
- Weight at study initiation:
- Assigned to test groups randomly: yes
- Fasting period before study:
- Housing: up to 4 rats per cage.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum - Route of administration:
- intraperitoneal
- Vehicle:
- - Vehicle(s)/solvent(s) used: none
- Details on exposure:
- Three groups of 15 male and 15 female rats were given a single i.p. dose of either 0.3, 1 or 3 g
- Duration of treatment / exposure:
- 6 to 48 hours
- Frequency of treatment:
- single i.p. dose
- Remarks:
- Doses / Concentrations:
0, 0.3 g/kg, 1.0 g/kg, 3.0 g/kg - No. of animals per sex per dose:
- Three groups of 15 male and 15 female rats
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- triethylenemelamine
- Route of administration: i.p
- Doses / concentrations: single dose/ 0.8 mg/kg - Tissues and cell types examined:
- bone marrow
- Details of tissue and slide preparation:
- DETAILS OF SLIDE PREPARATION:
After centrifugation was repeated and cells were left overnight, the fixative cells were dropped onto glass slides and air dried. Spreads were stained with 5% Giemsa at pH 6.8. After drying, slides were coverslipped.
METHOD OF ANALYSIS:
slides were coded and scored for chromosomal aberrations. - Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Interpretation of results : negative
In a rat bone marrow micronucleus assay 15 males were treated via intraperitonea with Stoddard solvent at doses of
0.3, 1 and 3 g/kg. Bone marrow cells were harvested 24 hours after 48 hour treatment.
There were no signs of toxicity during the study. The positive control induced the appropriate response.
There was not a significant increase in the frequency of micronucleated polychromatic erythocytes in bone marrow after any treatment time. - Conclusions:
- Interpretation of results : negative
In a rat bone marrow micronucleus assay 15 males were treated via intraperitonea with Stoddard solvent at doses of
0.3, 1 and 3 g/kg. Bone marrow cells were harvested 24 hours after 48 hour treatment.
There were no signs of toxicity during the study. The positive control induced the appropriate response.
There was not a significant increase in the frequency of micronucleated polychromatic erythocytes in bone marrow after any treatment time. - Executive summary:
Mutagenicity testing of Stoddard solvent showed no evidence of genotoxicity.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Justification for classification or non-classification
Justification for classification or non classification:
Based on the hazard assessment of Stoddard solvent in section 2.1 and 2.2. in IUCLID6., available data for the substance and following the “Guidance on Information Requirement and Chemical Safety Assessment R.8. Characterisation of dose [concentration]- response for human health”, according to the EU’s list of dangerous substances (OJEC No L200/130.7.99) and according to the criteria described in Directive 67/548 and in the CLP Regulation:
Directive 67/548 |
Mutagenicity-Genetic Toxicity Muta. Cat. 1; R46 May cause heritable genetic damage. Muta. Cat. 2; R46 May cause heritable genetic damage. Muta. Cat. 3; R68 Possible risk of irreversible effects. |
CLP |
Germ cell mutagenicity Muta. 1A Muta. 1B Muta. 2 H340: May cause genetic defects <state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard>. H341: Suspected of causing genetic defects <state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard>. |
It is concluded that the substance Stoddard solvent does not meet the criteria to be classified for human health hazards for Mutagenicity-Genetic Toxicity
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