Registration Dossier
Registration Dossier
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EC number: 429-630-8 | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
The test item was considered to be non-mutagenic in S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2 uvr A in study performed according to Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria).
The test item was tested negative in an in vitro cytogenicity / chromosome aberration study with V79 cells in a study performed according to EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test).
The test item was tested negative in an in vitro gene mutation study with mouse lymphoma L5178Y cells in a study performed according to OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test).
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- Identification: ELDEW PS-203
Description: pale yellow liquid
Batch: 808010
Expiry date: 31.03.2000
Purity: 100 % - Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- 33 - 5000 µg/plate
- Vehicle / solvent:
- acetone
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 4-NOPD, 2-AA
- Details on test system and experimental conditions:
- Two experiments were performed: plate incorporation test (experiment I) and pre-incubation test (experiment II)
- Evaluation criteria:
- According to guideline
- Key result
- Species / strain:
- other: S. typhimurium TA 1535, TA 1537, TA 98, TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Plate incorporation assay: no cytotoxicity in all tested strains. Pre-incubation assay: -S9 mix: TA 1535 (>= 1000 µg/plate), TA 1537 (>= 33 µg/plate), TA 98 (5000 µg/plate), TA 100 (1000 µg/plate); +S9 mix: TA 1537 (1000 µg/plate)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive 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
- Conclusions:
- The test item was considered to be non-mutagenic in S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2 uvr A in study performed according to Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria).
- Executive summary:
The test item was considered to be non-mutagenic in S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2 uvr A in study performed according to Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria).
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosomal Aberration Test)
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
- Specific details on test material used for the study:
- Identification: ELDEW PS-203
Description: pale yellow liquid
Batch: 808010
Expiry date: 31.03.2000
Purity: 100 % - Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- Without S9 mix: 78.1 - 2500 µg/mL
With S9 mix: 9.4 - 2500 µg/mL - Vehicle / solvent:
- acetone
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- ethylmethanesulphonate
- Details on test system and experimental conditions:
- see below
- Evaluation criteria:
- According to guideline
- Key result
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Remarks:
- >= 2500 µg/mL
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- The test item was tested negative in an in vitro cytogenicity / chromosome aberration study with V79 cells in a study performed according to EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test).
- Executive summary:
The test item was tested negative in an in vitro cytogenicity / chromosome aberration study with V79 cells in a study performed according to EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test).
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- mammalian cell gene mutation assay
- Specific details on test material used for the study:
- Identification: ELDEW PS-203
Description: pale yellow liquid
Batch: 012104
Expiry date: 10.12.2013
Purity: 100 % - Target gene:
- Forward mutation at the thymidine kinase locus of mouse lymphoma L5178Y/TK+/- cells
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Details on mammalian cell type (if applicable):
- clone 3.7.2C(heterozygous at the normally diploid TK locus)
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- 10 - 5000 µg/mL (with and without S9 mix)
2 independent cultures for each treatment (replicates A and B) - Vehicle / solvent:
- Negative control media with 150 µg/mL soy lecithin (S75) and 50 µg/mL Tween 80 (vehicle control)
- Untreated negative controls:
- yes
- Remarks:
- control media with 150 µg/mL soy lecithin (S75) and 50 µg/mL Tween 80
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- methylmethanesulfonate
- Key result
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- The test item was tested negative in an in vitro gene mutation study with mouse lymphoma L5178Y cells in a study performed according to OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test).
- Executive summary:
The test item was tested negative in an in vitro gene mutation study with mouse lymphoma L5178Y cells in a study performed according to OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test).
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
Justification for classification or non-classification
The test item was considered to be non-mutagenic in S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2 uvr A in study performed according to Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria).
The test item was tested negative in an in vitro cytogenicity / chromosome aberration study with V79 cells in a study performed according to EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test).
The test item was tested negative in an in vitro gene mutation study with mouse lymphoma L5178Y cells in a study performed according to OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test).
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