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Diss Factsheets
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EC number: 417-220-1 | CAS number: 37441-29-5 ATIPACL
- 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
Results of available in vitro studies:
-Bacterial reverse mutation assay (OECD 471): positive
-Chromosome aberration assay (OECD 473): positive
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (positive)
Genetic toxicity in vivo
Description of key information
Results of available in vivo studies:
- In vivo rat liver DNA repair test: negative
-Mammalian erythrocytes micronucleus assay :negative
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Mode of Action Analysis / Human Relevance Framework
Ames test
The mutagenic effect of the test item was assessed according to OECD 471 and EU Method B14 guideline.
The test substance was tested in the Ames Salmonella/microsome plate test with four histidine-requi ring strains of Salmonella typhimurium (TA1535, TA1537, TA100 and TA98) in the absence and presence of metabolic activation. The test substance was found to be mutagenic in this assay.
Due to the positive response in the bacterial mutation assay, an available chromosomal aberration test is available. The test susbtance was assessed for potential to induce structural chromosome aberrations in cultured peripheral human lymphocytes in the presence and absence of a metabolic activation system accroding to OECD 473 and EU Method B10. It was concluded that the test substance is clastogenic in human lymphocytes under the experimental conditions.
The test substance was assessed for induction of DNA repair in hepatocytes following acute oral administration to Specific Pathogen Free outbred albino Hsd/Ola Sprague-Dawley male rats at dosages of 200, 1000 and 2000 mg/kg bodyweight
The test substance did not cause any substantial increases in either the gross nuclear grain count or the net nuclear grain count (ie the gross nuclear grain count minus the cytoplasmic grain count) at any dose level at either sampling time.
Positive control group animals showed a large and highly significant increase (P < 0.001) in the net nuclear grain count which was accompanied by a large increase in the gross nuclear grain count.
It is concluded that the test substance did not cause unscheduled DNA synthesis in the rat liver in this in vivo test system.
To complete the assessment the test substance was evaluated for the potential to induce micronuclei in polychromatic erythrocytes in th ebone marrow of the mouse, according to EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test).
It was concluded that the test substance is not mutagenic in the micronucleus test under the experimental conditions.
Additional information
Justification for classification or non-classification
The overall evaluation of the potential of the test substance to induce genetic toxicity was based on: positive responses in a bacterial reverse mutation assay and in vitro chromosomal aberration assay; negative responses in an in vivo micronucleus assay and in vivo rat liver DNA repair test.
According to ECHA Guidance R.7a, positive in vitro outcomes need to be further investigated in representative in vivo assays. As the in vivo micronucleus and in vivo rat liver DNA repair test outcomes were negative, thus the test substance is not classified for genetic toxicity 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.
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