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EC number: 204-004-5 | CAS number: 112-76-5
- 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
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:
- other: see 'Remark'
- Remarks:
- The study was conducted according to OECD 471 with one acceptable restriction (TA102 or E.Coli WP2uvrA were not tested. However, this acid chloride is not supposed to have any oxidizing or crosslinking propertiers. Beyond this, a mixture containing high ammounts of stearic acid chloride was negative for E.Coli WP2uvrA).
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- TA102 or E.Coli WP2uvrA were not tested
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- His -
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- Liver S9 mix of at least 5 male Sprague-Dawley rats treated with a single ip dose of 500 mg Aroclor 1254/kg bw 5 days prior to sacrifice
- Test concentrations with justification for top dose:
- 0, 20, 100, 500, 2500 and 5000 µg/plate
- Vehicle / solvent:
- acetone
- Untreated negative controls:
- yes
- Remarks:
- untreated (sterility control)
- Negative solvent / vehicle controls:
- yes
- Remarks:
- acetone
- Positive controls:
- yes
- Remarks:
- strain specific controls were used
- Positive control substance:
- other: Positive control were with S9-mix 2-aminoanthracene (TA 1535, TA 1537, TA 98, TA 100); without S9-mix N-methyl-N'-nitro-N-nitrosoguanidine (TA 100, TA1535) 4-nitro-o-phenylendiamine (TA 98), 9-aminoacridine chloride monohydrate (TA 1537) .
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: standard plate assay and preincubation test
DURATION
- Preincubation period: 20 min
- Test: 48 h
NUMBER OF REPLICATIONS: 3
NUMBER OF CELLS EVALUATED:
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other:
- Evaluation criteria:
- Positive results
- doubling ot the spontaneous mutation rate
- dose response relation ship
- reprocibility of thze result - Statistics:
- Mean and standard deviation calculated
- 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:
- cytotoxicity
- Remarks:
- A bacteriotoxic effect was observed depending on the strain and test conditions from about 500 µg - 2500 µg/plate onward .
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: precipitation of test substance was seen fom about 500 µg/plate onward
COMPARISON WITH HISTORICAL CONTROL DATA:
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'. Remarks: S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Executive summary:
The study is conducted according to the OECD Guideline 471 with acceptable restrictions (not tested in S. typhimurium TA102 or E. coli WP2uvrA). Steaorylchloride was tested in the standard plate test as well as in the preincubation assay with and without metabolic activation (MA) in S. typhimurium TA98, TA100, TA1535, and TA1537 at dose levels of 20 -5000 μg/plate. No increase in the number of revertants was detected in any strain with and without MA. Vehicle, negative and positive controls were valid.
The test substance was not tested in TA102 or E. coli WP2uvrA, however, no oxidizing or cross-linking activity of the test substance is expected. Conclusion: Stearoylchloride has no mutagenic activity in S. typhimurium TA98, TA100, TA1535, and TA1537 with and without metabolic activation at dose levels up to 5 mg/plate.
Conclusion
Stearoyl chloride has no mutagenic activity in S. typhimurium TA98, TA100, TA1535, and TA1537 with and without metabolic activation at dose levels up to 5 mg/plate.
Reference
Valid vehicle controls as well as valid positive and negative controls were demonstrated in experiment 1 & 2. Positive control were with S-9 mix 2-aminoanthracene (TA 1535, TA 1537, TA 98, TA 100); without S-9 mix N-methyl-N'-nitro-N-nitrosoguanidine
(TA 100, TA1535) 4-nitro-o-phenylendiamine (TA 98), 9-aminoacridine chloride monohydrate (TA 1537) .
Controls gave expected results. In the standard plate test as well as in the preincubation assay no increase in the number of revertants was detected in any strain with and without MA.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
The study is conducted according to the OECD Guideline 471 with acceptable restrictions (not tested in S. typhimurium TA102 or E. coli WP2uvrA). Stearoylchloride was tested in the standard plate test as well as in the preincubation assay with and without metabolic activation (MA) in S. typhimurium TA98, TA100, TA1535, and TA1537 at dose levels of 20 -5000 μg/plate. No increase in the number of revertants was detected in any strain with and without MA. Vehicle, negative and positive controls were valid. The test substance was not tested in TA102 or E. coli WP2uvrA, however, no oxidizing or cross-linking activity of the test substance is expected. Conclusion: Stearoylchloride has no mutagenic activity in S. typhimurium TA98, TA100, TA1535, and TA1537 with and without metabolic activation at dose levels up to 5 mg/plate.
Justification for classification or non-classification
No classification suggested for mutagenicity as criteria of regulation 1272/2008/EC are not met.
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.
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