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Diss Factsheets
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EC number: - | 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
Genetic toxicity in vitro
Description of key information
Key study: Read-across from experimental data on an analogue. Test
method OECD Guideline 471. GLP study. The substance was not mutagenic in
bacterial cells in-vitro.
Key study: Read-across from experimental data on an analogue. Test
method OECD Guideline 473. GLP study. The substance was not clastogenic
in mammalian cells in-vitro.
Key study: Read-across from experimental data on an analogue. Test
method OECD Guideline 476. GLP study. The substance was not mutagenic in
mammalian cells in-vitro.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Read-across from an analogue substance for which a guideline study (Klimish 1) is available.
- Reason / purpose for cross-reference:
- read-across source
- Principles of method if other than guideline:
- Read-across approach from data on an analogue substance.
- Type of assay:
- bacterial reverse mutation assay
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: Based on a read-across from an analogue substance.
- Conclusions:
- Based on read-across approach from analogue substance P0310, the substance P-1401 is considered to be non-mutagenic in this Salmonella typhimurium and Escherichia coli reverse mutation assay.
- Executive summary:
Based on experimental results obtained in a study according to OECD 471 on analogue substance P0310 where the test item was considered to be non-mutagenic, the read-across approach is applied and the substance P-1401 is also considered to be non-mutagenic in the Salmonella typhimurium and Escherichia coli reverse mutation assay.
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Read-across from an analogue substance for which a guideline study (Klimish 1) is available.
- Reason / purpose for cross-reference:
- read-across source
- Principles of method if other than guideline:
- Read-across approach from data on an analogue substance.
- Type of assay:
- in vitro mammalian chromosome aberration test
- Key result
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (In Experiment II, in the absence of S9 mix, the concentration showing clear cytotoxicity was not scorable for cytogenetic damage).
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: Based on a read-across from an analogue substance.
- Conclusions:
- Based on read-across approach from analogue substance P0310, the substance P-1401 is considered to be non-clastogenic in this chromosome aberration test with and without metabolic activation.
- Executive summary:
Based on experimental results obtained in a study according to OECD 473 on analogue substance P0310 where the test item was considered to be non-clastogenic with and without metabolic activation, the read-across approach is applied and the substance P-1401 is also considered to be non-clastogenic with and without metabolic activation in the chromosome aberration test.
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Read-across from an analogue substance for which a guideline study (Klimish 1) is available.
- Reason / purpose for cross-reference:
- read-across source
- Principles of method if other than guideline:
- Read-across approach from data on an analogue substance.
- Type of assay:
- mammalian cell gene mutation assay
- Key result
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (Moderate cytotoxic effects indicated by a relative total growth of less than 50 % of survival in both parallel cultures were solely observed at the maximum concentration of 5300 μg/mL following 4 hours of treatment without metabolic activation).
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: Based on a read-across from an analogue substance.
- Conclusions:
- Based on read-across approach from analogue substance P0310, the substance P-1401 is considered to be non-mutagenic in the mouse lymphoma assay.
- Executive summary:
Based on experimental results obtained in a study according to OECD 476 on analogue substance P0310 where the test item was considered to be non-mutagenic, the read-across approach is applied and the substance P-1401 is also considered to be non-mutagenic in the mouse lymphoma assay.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Bacterial reverse mutation assay:
Key study: Read-across approach from experimental data on the analogue substance P0310. OECD Guideline 471 and EU method B.13/14. GLP study. In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used. Therefore, the test item is considered to be non-mutagenic in this Salmonella typhimurium and Escherichia coli reverse mutation assay.
Chromosomal aberrations:
Key study: Read-across approach from experimental data on the analogue substance P0310. OECD Guideline 473 and EU method B.10. GLP study. In conclusion, it can be stated that under the experimental conditions reported, the test item did not induce structural chromosome aberrations as determined by the chromosome aberration test in V79 cells (Chinese hamster cell line) in vitro. Therefore, the test item is considered to be non-clastogenic in this chromosome aberration test with and without S9 mix, when tested up to the highest required concentration in Experiment IA (with and without S9 mix), IB (with S9 mix), and Experiment II (with S9 mix) or to the highest scorable concentration in Experiment II (without S9 mix).
Gene mutation assay in mammalian cells:
Key study: Read-across approach from experimental data on the analogue substance P0310. OECD Guideline 476 and EU method B.17. GLP study. In conclusion it can be stated that during the mutagenicity test described and under the experimental conditions reported the test item did not induce mutations in the mouse lymphoma thymidine kinase locus assay using the cell line L5178Y in the absence and presence of metabolic activation. Therefore, the test item is considered to be non-mutagenic in this mouse lymphoma assay.
Justification for classification or non-classification
Based on the available information on genetic toxicity in vitro (bacterial reverse mutation assay, chromosome aberration and gene mutation in mammalian cells) the substance is considered to be negative for genetic toxicity, and therefore, the substance is not classified in accordance with CLP Regulation (EC) No. 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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