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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 452-110-7 | 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
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:
- 2003-15-04 to 2003-18-09
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study performed in accordance to recognized testing guidelines with no deviations to study protocol
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- Principles of method if other than guideline:
- NA
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- Strain Target mutation Mutation type
TA 1535 hisG46 Base-pair substitution
TA 100 hisG46 Base-pair substitution
TA 98 hisD3052 Frame shift
TA 102 hisG428 Frame shift
TA 1537 hisC3076 Base-pair substitution
WP2 uvrA trp-, uvrA- Base-pair substitution - Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Details on mammalian cell type (if applicable):
- NA
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital/beta-naphthoflavone induced rat liver S9.
- Test concentrations with justification for top dose:
- Concentration range in the main test (with and without metabolic activation): 33, 100, 333, 1000, 2500, 5000 µg/plate
- Vehicle / solvent:
- Solvent: DMSO (MERCK, D-64293 Darmstadt; purity > 99 %).
Justification: Solubility properties and non-toxicity to bacteria. No precipitation at highest tested dose level. - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 2-aminoanthracene, 4-nitro-o-phenylene-diamine
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: direct plate incorporation method and the preincubation method
DURATION
- Preincubation period: none in range-finder method and plate incorporation method, 1 hour in the pre-incubation method.
- Exposure duration: at least 48 hours
- Expression time (cells in growth medium): NA
- Selection time (if incubation with a selection agent): NA
- Fixation time (start of exposure up to fixation or harvest of cells): NA
SELECTION AGENT (mutation assays): No data
NUMBER OF REPLICATIONS: triplicate plates
NUMBER OF CELLS EVALUATED: no data
DETERMINATION OF CYTOTOXICITY
- Method: inspection of background bacterial lawn of the plates
OTHER EXAMINATIONS:
- Determination of polyploidy: NA
- Determination of endoreplication: NA
- Other: NA - Evaluation criteria:
- The Salmonella typhimurium and Escherichia coli reverse mutation assay was considered acceptable if it meets the following criteria:
- regular background growth in the negative and solvent control
- the spontaneous reversion rates in the negative and solvent control are in the range of our historical data
- the positive control substances should produce a significant increase in mutant colony frequencies
A mutagen response was concluded based on the following observations:
- A test item is considered as a mutagen if a biologically relevant increase in the number of revertants exceeding the threshold of twice (strains TA 98, TA 100, and WP2 uvrA) or thrice (strains TA 1535 and TA 1537) the colony count of the corresponding solvent control is observed.
- A dose dependent increase is considered biologically relevant if the threshold is exceeded at more than one concentration.
- An increase exceeding the threshold at only one concentration is judged as biologically relevant if reproduced in an independent second experiment.
- A dose dependent increase in the number of revertant colonies below the threshold is regarded as an indication of a mutagenic potential if reproduced in an independent second experiment. However, whenever the colony counts remain within the historical range of negative and solvent controls such an increase is not considered biologically relevant. - Statistics:
- No statistical evaluation of data performed (not required)
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (> 5000 µg/plate)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (> 5000 µg/plate)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: No data but in accordance to OECD 471
- Effects of osmolality: No data but in accordance to OECD 471
- Evaporation from medium: No data but in accordance to OECD 471
- Water solubility: No data, but AAA reaction product stable in water for 180 days
- Precipitation: No precipitation at highest tested dose level
- Other confounding effects: NA
RANGE-FINDING/SCREENING STUDIES:
COMPARISON WITH HISTORICAL CONTROL DATA: Revertants for negative, solvent and positive controls were within the observed historical controls obtained at RCC.
ADDITIONAL INFORMATION ON CYTOTOXICITY: No data - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'. Remarks: Plate incorporation test
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
The mutagenic potential of AAA reaction product was evaluated in salmonella typhimurium and E-coli strains with and without metabolic activation in accordance to OECD 471. AAA reaction product did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used and was therfore considered to be non-mutagenic in this reverse mutation assay. - Executive summary:
The mutagenic potential of AAA reaction product was evaluated in accordance to OECD 471. The study was performed to investigate the potential of AAA reaction product to induce gene mutations in the plate incorporation test (experiment I) and the pre-incubation test (experiment II) using the Salmonella typhimurium strains TA 1535, TA 1537, TA 98, and TA 100, and the Escherichia coli strain WP2 uvrA. The assay was performed in two independent experiments both with and without liver microsomal activation. The concentration, including the controls, was tested in triplicate. AAA reaction product was tested at the following concentrations: 33; 100; 333; 1000; 2500; and 5000 µg/plate.
The plates incubated with the AAA reaction product showed normal background growth up to 5000 µg/plate with and without metabolic activation in both independent experiments. No toxic effects, evident as a reduction in the number of revertants, occurred with and without metabolic activation. No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with AAA reaction product at any dose level, neither in the presence nor absence of metabolic activation (S9 mix). There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological relevance. Appropriate reference mutagens were used as positive controls and showed a distinct increase of induced revertant colonies.
In conclusion, AAA reaction product did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used. Therefore, AAA reaction product is considered to be non-mutagenic in this Salmonella Typhimurium and Escherichia coli reverse mutation assay.
Reference
Initially, a pre-experiment was performed with strains TA 98 and TA 100 to evaluate the toxicity of AAA reaction product. Eight concentrations (3-5000 µg/plate) were tested for toxicity and mutation induction with three plates each. The pre-experiment is reported as part of the plate-incorporation experiment since no toxic effects were observed and 5000 µg/plate were chosen as maximal concentration. The concentration range included two logarithmic decades. The following concentrations were tested in the main experiments: 33; 100; 333; 1000; 2500; and 5000 µg/plate
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Data from two in vitro genotoxicity studies are available:
The mutagenic potential of AAA reaction product was evaluated in salmonella typhimurium and E-coli strains with and without metabolic activation in accordance to OECD 471. AAA reaction product did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used and was therfore considered to be non-mutagenic in this reverse mutation assay.
The clastogenic potential of AAA reaction product was evaluated in vitro in V79 cells (Chinese hamster cell line) with and without metabolic activation in accordance to OECD 473. AAA reaction product did not induce structural chromosome aberrations at highest tested concentration and was therfore considered to be non-clastogenic in this assay.
Overall, based on the available in vitro data AAA reaction product does not have mutagenic nor clastogenic properties.
No further experimental testing for genetic toxicity (in vitro/in vivo) of AAA reaction product is considered scientifically justified based on exposure assessment i.e. exposure based waiving (Adaption to column 2 - Annex XI section 3 "Substance-Tailored Exposure-Driven Testing"): AAA reaction product is only used in indistrial settings under conditions with very low potential human exposure (worker). No exposure to the general population. A full description of the exposure can be found in the attached CSR (section 13). In the CSR it is concluded that for all industrial uses, very low exposure levels are identified and RCRs below xxx compared to a DNEL of xxx . Any combination of uses will result in an RCR below xxx. Workers will not be exposed at any critical level.
Justification for classification or non-classification
Based on the available in vitro data AAA reaction product does not have mutagenic nor clastogenic properties and are therefore not classified in accordane to GHS/CLP regulations.
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.