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EC number: 201-851-2 | CAS number: 88-68-6
- 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: GLP-compliant guideline study, available as unpublished report, limitations in design and reporting but adequate for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- , no replication experiment performed and only one positive control used to test efficacy of the S9-mix
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- - S. typhimurium: His-locus
- E. coli: Trp-locus - Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor-induced rat liver S-9 mix (Aroclor 1254)
- Test concentrations with justification for top dose:
- 20, 100, 500, 2500, 5000 µg/plate
- Vehicle / solvent:
- - Vehicle/solvent used: DMSO
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 2.5 µg ( E .coli WP2 uvrA: 60 µg)
- Positive control substance:
- other: 2-Aminoanthracene (2-AA)
- Remarks:
- all strains with metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 5.0 µg
- Positive control substance:
- other: N-methyl-N'- nitro-N-nitrosoguanidine (MNNG)
- Remarks:
- TA 1535, TA 100, without metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 100 µg
- Positive control substance:
- 9-aminoacridine
- Remarks:
- TA 1537 without metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 10 µg
- Positive control substance:
- other: 4-nitro-o-phenylenediamine (NOPD)
- Remarks:
- TA 98 without metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 5 µg
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- E .coli WP2 uvrA without metabolic activation
- Details on test system and experimental conditions:
- - METHOD: Standard plate test
- METHOD OF APPLICATION: in agar (plate incorporation)
- NUMBER OF REPLICATIONS: 3 test plates per dose or per control
- DETERMINATION OF CYTOTOXICITY: Toxicity detected by a decrease in the number of revertants, clearing or diminution of the background lawn (= reduced his- or trp- background growth), reduction in the titer. - 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:
- slight decrease in the number of reverant colonies
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- slight decrease in the number of reverant colonies
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: no test substance precipitation was found - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- According to the results obtained, the test substance is not mutagenic under these test conditions.
- Executive summary:
In a mutagenicity test, performed equivalent to OECD guideline 471, 4 Salmonella typhimurium strains (TA 1535, TA 1537, TA 98, and TA 100) and one E. Coli strain (WP2 uvrA) were used to test the mutagenic potential of the test substance both with and without metabolic activation. In the standard plate test strains were exposed to 0, 20, 100, 500, 2500, and 5000 µg/plate. No precipitation of the test substance was found. A slight bacteriotoxic effect was observed. An increase in the number of his+ or trp+ revertants was not observed either without S9 mix or after the addition of a metabolizing system. It was therefore concluded that the test substance is not mutagenic under these experimental conditions.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
In a mutagenicity test, performed equivalent to OECD guideline 471, 4 Salmonella typhimurium strains (TA 1535, TA 1537, TA 98, and TA 100) and one E. Coli strain (WP2 uvrA) were used to test the mutagenic potential of the test substance both with and without metabolic activation (BASF 1999). In the standard plate test strains were exposed to 0, 20, 100, 500, 2500, and 5000 µg/plate. No precipitation of the test substance was found. A slight bacteriotoxic effect was observed. An increase in the number of his+ or trp+ revertants was not observed either without S9 mix or after the addition of a metabolizing system. It was therefore concluded that the test substance is not mutagenic under these experimental conditions.
In addition, four publications were available investigating the effect of the inhibition of poly(ADP-Rib) polymerase by the test substance and the subsequent effect on sister chromatid exchange and unscheduled DNA synthesis. These studies have however major limitations in design and reporting and therefore could not be used for the assessment of the genotoxicity of the test substance.
In a sister chromatid exchange assay in a Chinese hamster Ovary K1 cell line the test substance was examined for its SCE inducing properties (Oikawa 1980). In addition, the inhibition of poly(ADP-Rib) polymerase by the test substance was evaluated. Significant induction in numbers of SCEs was observed and the test substance was observed to be a moderately strong inhibitor of poly(ADP-Rib) polymerase. It is hypothesized that the test substance induce SCE by inhibiting poly(ADP-Rib) polymerase.
Two studies were identified in which the test substance was evaluated for the effects of inhibiting poly(ADP-Rib) polymerase leading to unscheduled DNA synthesis after ultraviolet irradiation in human peripheral lymphocytes (Miwa 1981 and Sims 1982). Exposure of the test substance to human peripheral lymphocytes resulted in a 2.4 fold increase in [3H]dThd incorporation compared to the control after UV irradiation (Miwa 1981). Without UV irradiation a 1.5 fold increase in [3H]dThd incorporation compared to the control was observed. In the study by Sims (1982) an inhibition of poly-(ADP-ribose) polymerase (75% compared to control) and a stimulation of Unscheduled DNA synthesis (116% compared to control) after UV irradiation was observed.
In another study (Althaus 1982), the effect of the test substance on ADP-ribosyltransferase activity and Unscheduled DNA synthesis in response to the direct-acting carcinogen methyl methanesulfonat was determined hepatocytes. Unscheduled DNA synthesis was quantitated in cultured hepatocytes as the amount of [methyl-3H]thyimidine incorporated into nuclear DNA. Results showed an inhibition of ADP-ribosyltransferase activity with the test substance (ca 43% compared to control at 10 mM test substance) accompanied by an reduced DNA repair synthesis (ca 90% of the control value at 10 mM test substance) in response to the direct-acting carcinogen, methyl methanesulfonate.
Additionally, in the Opinion of the Scientific Committee on Food on the 16th additional list of monomers and additives for food contact materials (2001), it is written that teh test substance produced negative results in the gene mutation assay in bacteria, a chromosomal aberration assay in cultured mammalian cells, a gene mutation assay in cultured mammalian cells and in a mouse bone marrow assay. However, no original study reports are available for these statements.
Based on the curent information and available literature, a mutagenic potential of the test substance cannot be derived.
Justification for selection of genetic toxicity endpoint
The only GLP-compliant OECD guideline study available.
Justification for classification or non-classification
Based on the available information on the genetic toxicity (OECD 471 guideline study), the test substance does not need to be classified in accordance with EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008.
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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