Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 204-198-1 | CAS number: 117-57-7
- 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
- negative: Ames test with Salmonella typhimurium TA 1535, TA 1537, TA 98 and TA 100 (met. Act.: with and without) (OECD TG 471 (adopted 1983); GLP); REL2; cytotoxicity: no
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:
- March 1990
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted 1983
- GLP compliance:
- no
- Remarks:
- Study conducted prior to implementation of GLP
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: P. 231/89
- Test substance No.: 89/881
- Degree of purity: >92% - Target gene:
- histidine locus
- Species / strain / cell type:
- S. typhimurium TA 1535
- Species / strain / cell type:
- S. typhimurium TA 1537
- Species / strain / cell type:
- S. typhimurium TA 98
- Species / strain / cell type:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 Mix
- Test concentrations with justification for top dose:
- 1st Experiment (standard plate test; TA 1535, TA1537): 0, 20, 100, 500, 2500 and 5000 µg/plate
2nd Experiment (standard plate test; TA100, TA98): 0, 20, 100, 500, 2500 and 5000 µg/plate
3rd Experiment (pre-incubation test; TA1535, TA 100, TA 1537, TA 98): 0, 20, 100, 500, 2500 and 5000 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: complete solubility of the test substance - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- other: With S9 Mix: 2-aminoanthracene in DMSO (for strains TA 100, TA98, TA 1537, TA 1535; without S9-Mix: N-methyl-N'-nitro-N-nitroso-guanidine in DMSO (for strains TA 100 and TA 1535), 4-nitro-o-phenylendiamine in DMSO (for strain TA98)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
Plate incorporation tests (experiments 1 and 2);
Preincubation test (experiment 3)
DURATION
- Preincubation period: bacterial suspension with S9 Mix incubated for 20 min at 37°C
- Exposure duration: 48 hours in the dark
NUMBER OF REPLICATIONS: 3 test plates per dose or per control
DETERMINATION OF CYTOTOXICITY
- reduced his- background growth - Evaluation criteria:
- substance characterized as positive in the Ames test was based on the following requirements:
- doubling of the spontaneous mutation rate (control)
- dose-response relationship
- reproducibility of the results - 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 100
- 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
- Conclusions:
- The test item was evaluated in the bacterial reverse mutation assay (Ames test) using Salmonella typhimurium strains TA 1535, TA 1537, TA 98 and TA 100 in the presence and absence of rat liver S9 mix. Under the conditions of the study, the test substance was negative for mutagenic potential.
- Executive summary:
In a reverse gene mutation assay in bacteria according to OECD guideline 471 (adopted 1983), Salmonella typhimurium strains TA 1535, TA 1537, TA 98 and TA 100 were exposed to the test substance in DMSO in concentrations of 0 (control), 20, 100, 500, 2500 and 5000µg/plate in the presence and absence of mammalian metabolic activation (rat liver S9 mix) in a plate incorporation test and in concentrations of 0 (control), 20, 100, 500, 2500 and 5000µg/plate in the presence and absence of mammalian metabolic activation (rat liver S9 mix) in a pre-incubation test.
Each concentration and the controls were tested in triplicates.
The plates incubated with the test item showed normal background growth up to 5000µg/plate with and without S9 mix in all strains used.
No toxic effects, evident as a reduction in his- background growth, occurred in the test groups with and without metabolic activation.
No substantial increase in revertant colony numbers of any of the four tester strains was observed following treatment with the test substance at any concentration level, neither in the presence nor in the absence of metabolic activation (S9 mix). l increase in revertant colony numbers of any of the four tester strains was observed following treatment with the test substance at any concentration level, neither in the presence nor in the absence of metabolic activation (S9 mix).
Appropriate reference mutagens were used as positive controls. They showed a distinct increase in induced revertant colonies.
The adopted OECD TG 471 (1997) requires at least 5 test strains and the use of E. coli WP2 strains or Salmonella typhimurium TA 102 to detect certain oxidizing mutagens, cross-linking agents and hydrazines. However, the test substance is not a highly reactive agent and is therefore not expected to be a cross-linking agent, has no oxidizing properties and is no hydrazine. Thus, a test according to EU Method B.13/14 (Version Commission Directive 92/69/EEC without E. coli WP2 strains or Salmonella typhimurium TA 102 is considered as sufficient to evaluate the mutagenic activity of the test substance in this bacterial test system.
Under the conditions of the study, the test substance was negative for mutagenic potential.
Reference
Number of revertants per plate (mean of 3 plates; Standard Plate Test) | ||||||||||||
[Strain TA 1535] | [Strain TA 100] | [Strain TA 1537] | [Strain TA 98] | |||||||||
Conc. | — MA | + MA | Cytotoxic | — MA | + MA | Cytotoxic | — MA | + MA | Cytotoxic | — MA | + MA | Cytotoxic |
[µg] | (yes/no) | (yes/no) | (yes/no) | (yes/no) | ||||||||
0* | 12 | 14 | no | 115 | 114 | no | 9 | 12 | no | 28 | 38 | no |
20 | 21 | 18 | no | 101 | 102 | no | 10 | 13 | no | 23 | 39 | no |
100 | 15 | 15 | no | 108 | 101 | no | 5 | 14 | no | 29 | 40 | no |
500 | 22 | 12 | no | 113 | 99 | no | 7 | 16 | no | 27 | 42 | no |
2500 | 15 | 14 | no | 81 | 102 | no | 5 | 12 | no | 26 | 40 | no |
5000 | 13 | 12 | no | 112 | 112 | no | 8 | 13 | no | 16 | 38 | no |
Positive control | 1883 | 231 | 323 | 1940 | 633 | 325 | 1280 | 1333 | ||||
*solvent control with DMSO |
Number of revertants per plate (mean of 3 plates; Pre-incubation Test) | ||||||||||||
[Strain TA 1535] | [Strain TA 100] | [Strain TA 1537] | [Strain TA 98] | |||||||||
Conc. | — MA | + MA | Cytotoxic | — MA | + MA | Cytotoxic | — MA | + MA | Cytotoxic | — MA | + MA | Cytotoxic |
[µg] | (yes/no) | (yes/no) | (yes/no) | (yes/no) | ||||||||
0* | 17 | 18 | no | 118 | 110 | no | 10 | 11 | no | 25 | 37 | no |
20 | 19 | 18 | no | 124 | 110 | no | 8 | 12 | no | 28 | 35 | no |
100 | 20 | 21 | no | 120 | 116 | no | 10 | 13 | no | 28 | 36 | no |
500 | 17 | 21 | no | 125 | 108 | no | 9 | 14 | no | 23 | 39 | no |
2500 | 14 | 19 | no | 121 | 119 | no | 14 | 12 | no | 27 | 32 | no |
5000 | 15 | 20 | no | 116 | 108 | no | 11 | 13 | no | 26 | 26 | no |
Positive control | 1297 | 230 | 1783 | 1307 | 707 | 111 | 820 | 918 | ||||
*solvent control with DMSO |
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
Based on reliable, relevant and adequate data on the test substance is considered to be not mutagenic (negative).
According to Regulation EC No. 1272/2008, no classification and labelling for mutagenicity is required.
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.