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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 904-919-6 | 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
Ames test (OECD TG 471): negative
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 30 May 2001 - 18 June 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 21 July 1997
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- - S. typhimurium: Histidine gene
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver S9-mix induced by a combination of phenobarbital and ß-naphthoflavone.
- Test concentrations with justification for top dose:
- - Dose range finding test (direct plate and pre-incubation):
TA 98 and TA 100 (without and with S9): 3, 10, 33, 100, 333, 1000, 2500 and 5000 µg/plate
- Experiment 1:
TA 1535, TA 1537, TA 98, TA 100 and TA 102 (without and with S9): 33, 100, 333, 1000, 2500 and 5000 µg/plate
- Experiment 2:
Due to toxicity in the pre-incubation dose range finding test the following dose levels were used:
TA 1535, TA 1537 and TA 102 (without and with S9): 3, 10, 33, 100, 333 and 1000 µg/plate
TA 98 and TA 100 (without and with S9): 33, 100, 333, 1000, 2500 and 5000 µg/plate - Vehicle / solvent:
- - Solvent used: Ethanol
- Justification for choice of solvent: The test substance was dissolved in ethanol. The solvent was chosen because of its solubility properties and its relative non-toxicity to the bacteria. - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- (100 µL/plate ethanol)
- Positive controls:
- yes
- Positive control substance:
- other: see section "Any other information on materials and methods incl. tables"
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
- Experiment 1: in agar (plate incorporation)
- Experiment 2: preincubation
DURATION
- Preincubation period: 60 minutes
- Exposure duration: at least 48 hours
NUMBER OF REPLICATIONS:
- Doses of the test substance were tested in triplicate in each strain.
DETERMINATION OF CYTOTOXICITY
- Method: on the basis of a decline in the number of spontaneous revertants, a thinning of the background lawn or a microcolony formation. - Evaluation criteria:
- A test item is considered as positive if a biologically relevant and dose related increase in the number of revertants is induced.
A test item producing neither a dose related increase in the number of revertants nor a biologically relevant positive response at any one of the test points is considered non mutagenic in this system.
A biologically relevant response is described as follows:
A test item is considered mutagenic if in strains TA 98, TA 100, and TA 102 the number of reversions will be at least twice as high and in strains TA 1535 and TA 1537 at least three times higher as compared to the spontaneous reversion rate.
Also, a dose-dependent and reproducible increase in the number of revertants is regarded as an indication of possibly existing mutagenic potential of the test item regardless whether the highest dose will induce the above described enhancement factors or not. - Statistics:
- A statistical analysis of the data is not required.
- Key result
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: No precipitation was observed up to and including the top dose of 5000 µg/plate
RANGE-FINDING/SCREENING STUDIES:
- Toxicity was observed in both TA 98 and TA 100 in the pre-incubation assay up to and including 5000 µg/plate, both in the absence and presence of S9 mix.
COMPARISON WITH HISTORICAL CONTROL DATA:
- Appropriate reference mutagens were used as positive controls and showed a distinct increase of induced revertant colonies.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
In experiment I, toxic effects, evident as a reduction in the number of revertants, were observed in strain TA 1537 with 59 mix and in strain TA 100 with and without 59 mix. In experiment II, toxic effects were observed in strains TA 1535, 1537, 98, and 100 with and without 59 mix.
Irregular background growth was observed in strains TA 1537 and TA 98 in the second experiment at 333 µg/plate and above with metabolic activation and at 1000 µg/plate and above in strain TA 100 without metabolic activation. - Conclusions:
- The substance is not mutagenic in the Salmonella typhimurium reverse mutation assay performed according to OECD 471 guideline and GLP principles.
- Executive summary:
The mutagenic activity of the substance was evaluated in accordance with OECD 471 guideline and according to GLP principles. The test was performed in two independent experiments, the first in agar (plate incorporation) and the second a pre-incubation experiment, both in the absence and presence of S9-mix up to and including 5000 μg/plate. Adequate negative and positive controls were included.
In experiment I, toxic effects, evident as a reduction in the number of revertants, were observed in strain TA 1537 with S9 mix and in strain TA 100 with and without S9 mix. In experiment II, toxic effects were observed in strains TA 1535, 1537, 98, and 100 with and without S9 mix. Irregular background growth was observed in strains TA 1537 and TA 98 in the second experiment at 333 µg/plate and above with metabolic activation and at 1000 µg/plate and above in strain TA 100 without metabolic activation.
The substance did not induce a significant dose-related increase in the number of revertant (His+) colonies in each of the five S. typhimurium tester strains (TA1535, TA1537, TA98, TA100 and TA102), both in the absence and presence of S9-metabolic activation. These results were confirmed in independently repeated experiments. Based on the results of this study it is concluded that the substance is not mutagenic in the Salmonella typhimurium reverse mutation assay.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Ames test (OECD TG 471):
The mutagenic activity of the substance was evaluated in accordance with OECD 471 guideline and according to GLP principles. The test was performed in two independent experiments, the first in agar (plate incorporation) and the second a pre-incubation experiment, both in the absence and presence of S9-mix up to and including 5000 μg/plate. Adequate negative and positive controls were included.
In experiment I, toxic effects, evident as a reduction in the number of revertants, were observed in strain TA 1537 with S9 mix and in strain TA 100 with and without S9 mix. In experiment II, toxic effects were observed in strains TA 1535, 1537, 98, and 100 with and without S9 mix. Irregular background growth was observed in strains TA 1537 and TA 98 in the second experiment at 333 µg/plate and above with metabolic activation and at 1000 µg/plate and above in strain TA 100 without metabolic activation.
The substance did not induce a significant dose-related increase in the number of revertant (His+) colonies in each of the five S. typhimurium tester strains (TA1535, TA1537, TA98, TA100 and TA102), both in the absence and presence of S9-metabolic activation. These results were confirmed in independently repeated experiments. Based on the results of this study it is concluded that the substance is not mutagenic in the Salmonella typhimurium reverse mutation assay.
Justification for classification or non-classification
Based on the results of the Ames test, the substance does not have to be classified for genotoxicity in accordance with Regulation (EC) No 1272/2008 and its updates.
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.