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Diss Factsheets
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EC number: 220-036-2 | CAS number: 2611-82-7
- 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
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Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Bacterial reverse mutation in Ames assay: negative
Gene mutation in mammalian cells in mouse lymphoma assay: negative
Chromosome aberrations assay in Chinese hamster lung fibroblasts: weakly positive
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Description of key information
Micronucleus assay in mouse: negative
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Mutagenicity testing strategy is reported in ECHA Guidance Chapter R.7a: Endpoint specific guidance, Version 5.0 – December 2016.
A preliminary assessment of mutagenicity normally includes data from a gene mutation test in bacteria unless existing data for analogous substances indicates this would be inappropriate. To complete the assessement as for requirements in Annex VIII of the REACH Regulation (EC 1907/2006), in vitro studies in mammalian cells should then be performed.
As a first step, an in vitro cytogenicity study is usually carried out to assess the potential for test substance to induce chromosomal aberrations. In case of a positive result, an in vivo cytogenicity assay is generally required to prove the in vivo relevance of in vitro results.
An in vitro gene mutation assay usually completes the assessment, especially in case of negative results in the bacterial gene mutation test and the first study in mammalian cells.
The substance was tested to assess its potential to induce: bacteria reverse mutation, gene mutation and chromosomal aberration in vitro as well as micronucleus in vivo.
A part from an Ames assay, for which a study report was available, all data used in the assessment derive from literature publications. Details on studies performance and result were available and were found to be consistent generally accepted scientific principles.
It should be noted that literature data was also a main part of the assessment on Acid Red 018 made by authorities, such as SCCNFP (SCCNFP/0792/04) and EFSA (EFSA Journal 7(11) 1328, 2009), and toxicological consultancy company (bibra ltd.).
As for bacteria reverse mutation, an experimental study report (2005) was selected as key study as it was performed on all strains as recommended by the OECD guideline 471 and it was well documented. The target substance resulted as non mutagenic in this assay.
Available literature data confirmed the lack of mutagenic potential in such type of assay, generally carried out on some, but not all, strains required by the guideline. In particular, a study from 1987 was included as supporting evidence.
In a chromosomal aberration assay on Chinese hamster lung fibroblasts without metabolic activation, the test item showed an incidence of structural aberrations of 13 and 12 % after 24 and 48 hr, respectively. At the dose of 3.06 mg/ml, 20 % of observed metaphases showed structural aberrations. Overall, the result was considered as positive (threshold value 10 %). However, as the CA assay was only conducted without metabolic activation, the relevance of such result with respect to mammalian in vivo conditions could not be proved.
In addition, the potential of the substance to induce chromosomal aberrations was assayed by an in vivo micronucleus test in bone marrow cells of male mice. Test animals were dosed intraperitoneally at concentrations ranging for 300 to 2400 mg/kg as single injections and at concentration of 300 mg/kg , repeated 4 times at 24 -hour intervals. Vehicle and positive controls were adequate. Overall, there was no evidence of increased micronucleus formation in the bone marrow upon exposure either as single dose or as four separate aliquots.
A mouse lymphoma assay on L5178Y TK+/- cells was carried out to assess the potential of the target substance to induce gene mutations in mammalian cells. In this assay, an increase in mutant frequency comparable to spontaneous control frequency was seen, thus the response was considered as negative.
Justification for classification or non-classification
According to the CLP Regulation (EC 1272/2008), Annex I, Part 3, substances which cause concern for humans owing to the possibility that they may induce heritable mutations in the germ cells of humans are classified in Category 2. This classification is based on positive evidence obtained in:
— somatic cell mutagenicity tests in vivo, in mammals; or
— other in vivo somatic cell genotoxicity tests which are supported by positive results from in vitro mutagenicity assays.
Note: substances which are positive in in vitro mammalian mutagenicity assays, and which also show chemical structure activity relationship to known germ cell mutagens, shall be considered for classification as Category 2 mutagens.
In vitro mutagenicity tests are the following:
— in vitro mammalian chromosome aberration test;
— in vitro mammalian cell gene mutation test;
— bacterial reverse mutation tests.
The overall assessement on the genotoxic potential of test substance was based on: negative outcome in bacterial reverse mutation assay (AMES test), weakly positive outcome in in vitro chromosome aberration assay without metabolic activation and negative result in in vivo micronucleus test in bone marrow cells of mouse. A further negative result was obtained in an in vitro gene mutation assay.
Based on these results, test susbstance was considered as non genotoxic and it was not classified within the CLP Regulation (EC 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.
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.
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