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Diss Factsheets
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EC number: 229-962-1 | CAS number: 6864-37-5
- 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
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Endpoint summary
Administrative data
Description of key information
Toxicity to soil macroorganisms
Effects of Hydrogenation products of 4-[(4-amino-3-methyl-phenyl)methyl]-2-methyl-aniline (CAS 6864-37-5, DMDC) on the reproducibility of earthworms (E. fetida) were studied in a GLP guideline study following OECD 222. Based on nominal concentrations, the EC10 for effects on reproduction was 228 mg/kg soil dw (95% CL: 115.6 / 450.8) (BASF, 2013; report No. 68E0695/00G009).
Toxicity to terrestrial arthropods
A long-term study with earthworm was performed according to OECD 222 (see IUCLID Ch. 6.3.1); therefore, the trophic level of invertebrates is sufficiently covered. No further testing is performed.
Toxicity to terrestrial plants
In Annex X Section 9.4 of Regulation (EC) No 1907/2006, it is laid down that tests on terrestrial organisms shall be proposed by the registrant if the chemical safety assessment indicates the need to investigate further the effects on terrestrial organisms. According to Annex IX and X, the choice of the appropriate tests depends on the outcome of the chemical safety assessment. Since invertebrates were the most sensitive group as indicated from aquatic short-term and long-term toxicity data, a chronic earthworm study was performed to cover this endpoint in accordance with REACh guidance for compounds in soil hazard category 3 (ECHA, Guidance on Information Requirements and Chemical Safety Assessment, Version 3.0, June 2017, Chapter R.7c, Table R.7.11 -2). In addition, the toxicity to soil microorganisms was tested in a nitrogen transformation test according to OECD 216. In Annex XI Section 3, it is laid down that testing in accordance with Annex IX and Annex X may be omitted, based on the exposure scenario(s) developed in the Chemical Safety Report (“Substance-Tailored Exposure-Driven Testing”). In accordance with Annex XI Section 3, it can be demonstrated in the risk assessment that the manufacture and the use of the substance do not pose an unacceptable risk for all environmental compartments as the risk characterization ratios (RCRs) of the chemical safety assessment are below 1 for all compartments (see Chemical Safety Report Ch. 10). Consequently, no further tests on soil organisms are performed. The PNEC was derived using the available experimental data on terrestrial toxicity.
Toxicity to soil microorganisms
A nitrogen transformation test according to OECD 216 was performed under GLP to determine the effects of the test substance to soil microorganisms (BASF SE, 2013; project no. 37G0695/00X032). Negative effects on the nitrate formation were not found, therefore no effect concentrations could be calculated. Nitrate concentration in treated soil was significantly higher than the nitrate concentration of the solvent control soil at concentrations of greater than or equal to 62.5 mg/kg soil dw on day 0 and greater than or equal to 125 mg/soil dw on day 28 of the test.
The derived NOEC is based on the increase of nitrate in soil due to additional nitrate derived from the test substance: NOEC = 62.5 mg/kg soil, negative effects were lacking at the tested concentrations. It is assumed that the increase in nitrate content was due to the amount of nitrate entering the soil via the test substance.
A 28-d EC10 greater than 1000 mg/kg will be used for the environmental risk assessment.
Long-term toxicity to birds
In Annex X, section 9.6.1 of the Regulation (EC) No 1907/2006 REACH concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), it is suggested, that in case of long term toxicity testing to birds "any need for testing should be carefully considered taking into account the large mammalian dataset that is usually available at this tonnage level." Furthermore, ECHA (2008) states in the "Guidance on information requirements and chemical safety assessment Chapter R.7c" (R.7.10.6) that "given that mammalian toxicity is considered in detail for human health protection, the need for additional data for birds must be considered very carefully – new tests are a last resort in the data collection process." In addition, based on the low log Kow and the low measured and estimated BCF values, significant bioaccumulation in organisms is not to be expected (see IUCLID Ch. 5.3.1). Hence, secondary poisoning is of no concern. Taking this into account, long-term or reproductive toxicity tests on birds do not need to be conducted due to the facts that a mammalian dataset is available.
Additional information
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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