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EC number: 812-739-3 | CAS number: 157357-30-7
- 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
Additional information
Table 7.6/1: Summary of genotoxicity tests
Test n° |
Substance tested |
Test / Guideline Reliability |
Focus |
Strains tested |
Test concentration |
Statement |
1
Safpharm 2008 |
Registered substance |
Ames Test (OECD 471) K, rel. 1 |
Gene mutation |
TA 1535, TA 1537, TA 98, TA 100 E.coli WP2 uvrA |
Up to cytotoxic concentration |
-S9 : non mutagenic +S9 : non mutagenic |
2
WIL Research Europe BV, 2014 |
Read-across 2-Pentyl cyclopentan-1-one |
L5178YTK+/-/MLA test (OECD 476) K, rel. 2 |
Gene mutation |
L5178Y tk+/-(3.7.2C) mouse lymphoma cells |
Up to cytotoxic concentration |
-S9 : non mutagenic +S9 : non mutagenic |
3
RCC, 2008 |
Registered substance |
In vitro CAT (OECD 473) K, rel.1 |
Chromosomal aberration |
Human lymphocyte |
Up to cytotoxic concentration |
-S9 : non clastogenic +S9 : non clastogenic |
Gene mutation Assays (Tests n° 1 -2):
- A Bacterial Reverse mutation Assay (Ames test) was performed according to OECD test guideline No 471 with the substance (See Table 1). No significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose, either in the presence or absence of metabolic activation. The substance does not induce gene mutations in bacteria under the test condition whereas all positive control chemicals (with and without metabolic activation) induced significant increase of colonies. The substance is therefore considered as non-mutagenic according to the Ames test.
- Inability to produce gene mutation was confirmed in mammalian cells using an in vitro gene mutation assay in L5178Y tk+/-(3.7.2C) mouse lymphoma cells (L5178Y TK+/- /MLA test)(Test n°2). None of the dose levels up to the cytotoxicity limit with the supporting substance (see IUCLID section 13 for read-across justification), either in the presence or absence of metabolic activation, induced significant mutant frequency increases in the initial or repeat experiments whereas both positive control chemicals (with and without metabolic activation) induced significant mutant frequency increases. Therefore the supporting and the registered substance are considered as negative for inducing gene mutations at the TK locus in L5178Y mouse lymphoma cells under activation and non-activation conditions used in this assay. This result confirms the results of the Ames test and extends the non-mutagenic effect of both substances to mammalian cells.
Chromosomal aberration (Test n°3)
The clastogenic potential of the test material was determined using an in vitro chromosome aberration test in Human lymphocytes, which measures the potential of a substance to increase the incidence of structural chromosome aberrations in cultured Human lymphocytes.
None of the dose levels up to the cytotoxicity limit or the precipitating limit with the substance, either with or without metabolic activation, induced significant increases in the frequency of cells with aberrations in either of two experiments. The substance does not induce structural aberrations in the chromosomes of Human lymphocytes under activation and non-activation conditions, whereas both positive control chemicals (with and without metabolic activation) induced significant increases in the frequency of aberrant cells. Therefore the registered substance is considered as negative for inducing chromosomal mutations in Human lymphocytes in vitro under activation and non-activation conditions used in this assay.Justification for selection of genetic toxicity endpoint
No study was selected, since all in vitro and in vivo studies performed on the substance itself or on supporting substances were negative and of high quality.
Short description of key information:
- Ames Test (OECD 471, GLP, K, rel. 1): non mutagenic up to cytotoxic concentration in S. typhimurium TA 1535, TA 1537, TA 98, TA 100 & E.coli WP2uvrA.
- L5178Y/MLA Mammalian Cell Gene Mutation Assay (OECD 476, GLP, Read-across, K, rel. 2): non mutagenic.
- Human lymphocytes chromosome aberration test (OECD 473, GLP, K, rel. 1): non clastogenic.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Harmonized classification:
The test material has no harmonized classification for human health according to the Regulation (EC) No. 1272/2008.
Self-classification:
Based on the available data, no additional classification is proposed regarding germ cell mutagenicity according to the Annex VI of the Regulation (EC) No. 1272/2008 (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.
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