Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Key study: Based on read-across approach from analogue substance P0310, the substance P-1057 is considered to be non-mutagenic in this Salmonella typhimurium and Escherichia coli reverse mutation assay.
Key study: Based on read-across approach from analogue substance P0310, the substance P-1057 is considered to be non-clastogenic in this chromosome aberration test with and without metabolic activation.
Key study: Based on read-across approach from analogue substance P0310, the substance P-1057 is considered to be non-mutagenic in the mouse lymphoma assay.
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-1057 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-1057 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-1057 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-1057 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-1057 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-1057 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
Genetic toxicity in vitro
Key study: 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-1057 is also considered to be non-mutagenic in the Salmonella typhimurium and Escherichia coli reverse mutation assay.
Key study: 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-1057 is also considered to be non-clastogenic with and without metabolic activation in the chromosome aberration test.
Key study: 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-1057 is also considered to be non-mutagenic in the mouse lymphoma assay.
Justification for classification or non-classification
Based on the available information, the substance is not classified for genetic toxicity according to CLP Regulation.
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