Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 943-406-1 | CAS number: -
- 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
A bacterial reverse mutation assay (Ames test) according to OECD guideline 471 was performed with the test substance (Verspeek-Rip, 2016). In this test the histidine-deficient Salmonella typhimurium strains TA1535, TA1537, TA98 and TA100 and the tryptophan-deficient Escherichia coli strain WP2uvrA were exposed to various test substance concentrations from 1.7 up to 5000 µg/plate in the absence and presence of a metabolising system (5 or 10% Aroclor 1254-induced rat liver S9-mix) in two independent experiments. Additional experiments were performed once with strains TA1535, TA1537, TA98 and TA100 and twice with strain TA98 alone in order to verify previous observations. In a preliminary range finding experiment the histidine-deficient Salmonella typhimurium strain TA100 and the tryptophan-deficient Escherichia coli strain WP2uvrA were exposed to test substance concentrations ranging from 1.7 to 5000 µg/plate in the absence and presence of 5% S9-mix. Based on the observations for cytotoxicity in this range finder the test substance was additionally tested in the strains TA1535, TA1537 and TA98 at concentrations ranging from 5.4 to 1600 µg/plate in the absence and from 17 to 1600 µg/plate in the presence of 5% S9-mix. Cytotoxicity evidenced by decrease of revertant numbers and/or reduction of background lawn was observed in all strains. No increase of revertant numbers was observed. The range finder in the tester strains TA100 and WP2uvrA combined with the additional results from strains TA1535, TA1537 and TA98 were regarded as Experiment 1. In a second experiment the test substance was tested at a concentration range of 154 to 2800 µg/plate in the absence and presence of 10% S9-mix in the S. typhimurium strains TA1535, TA1537, TA98 and TA100 and at 492 to 5000 µg/plate in the absence and presence of 10% S9-mix in the E. coli strain WP2uvrA. Cytotoxicity was observed in the S. typhimurium strains, but not in the E. coli strain. No increase in revertant numbers was observed in this experiment, either.
Since there were not enough analysable dose levels available in the second experiment due to cytotoxicity in various strains either with or without metabolic activation, an additional experiment was performed with the S. typhimurium strains TA1535, TA1537, TA98 and TA100 with lower test substance concentrations in the absence and presence of metabolic activation. Except for TA98 cytotoxiciy was observed in all tested strains in this third experiment. Furthermore, the test substance induced a 3.3-fold increase of revertants in strain TA98 without metabolic activation in this experiment. Therefore, an additional fourth experiment was performed with TA98 in the absence of metabolic activation up to 878 µg/plate. In this experiment no cytotoxicity and no increase of revertant numbers were observed. As there had been insufficient cytotoxicity in the absence of precipitation on the plates in this experiment, a fifth mutation experiment with TA98 without metabolic activation up to the dose level of 5000 µg/plate was performed. Cytotoxicity was observed, but there was no increase in the numbers of revertants in this confirmatory experiment, either.
Thus, the increase of revertant numbers observed in the third experiment could not be reproduced and was considered to be an isolated finding without biological relevance. In conclusion, the test substance was considered to be not mutagenic in the bacterial reverse mutation assay in Salmonella typhimurium and Escherichia coli.
Justification for selection of genetic toxicity endpoint
There is only one study available.
Short description of key information:
Mutagenicity in bacteria (Ames), OECD 471: negative
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
According to the criteria of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2015) (including all amendments) and Regulation (EC) No 1271/2008 on classification, labelling and packaging of items and mixtures (including all amendments) the test substance does not have to be classified for genetic toxicity. The available data is conclusive but not sufficient for classification.
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.