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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 205-737-3 | CAS number: 149-32-6
- 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
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:
- 03/1990-07/1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar 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:
- Lot number : not identified
- Target gene:
- Histidine
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 activation system derived from male Wistar (Crl:W1 (WU)BR) rats (Charles River Wiga GmbH, Sulzfeld, Germany)
- Test concentrations with justification for top dose:
- Toxicity test: 0, 0.003, 0.03, 0.3, 3,0 and 30.0 mg/plate with and without S9 for all strains
First Mytagenicity Test : 0, 0.37, 1.11, 3.33, 10.0 and 30 mg/plate with and without S9 for all strains (in triplicate)
Repeat Mutagenicity Test : 0, 0.37, 1.11, 3.33, 10.0 and 30 mg/plate with and without S9 for all strains (in triplicate) - Vehicle / solvent:
- water
- Untreated negative controls:
- yes
- Remarks:
- untreated controls
- Negative solvent / vehicle controls:
- yes
- Remarks:
- vehicule control
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- Details on test system and experimental conditions:
- Method : plate incorporation method
Positives controls :
- sodium azide : TA1535 and TA100 in the absence of S9 mix
- 2-nitrofluorene : TA1538 and TA98 in th absence of S9 mix
- 9-aminoacridine TA 1537 in the absence of S9 mix - Evaluation criteria:
- - determination of spontaneous revertant numbers and viable cells/mL for untreated controls
- dertermination of revertants/plate and background lawn for treated cultures - Statistics:
- - number of revertants per plate determined by an Artek Electronic Counter
- positive response judged by the appearance of a 2-fold or greater increase in the mean number of revertants per plate in the treated cultures compared to the vehicle control treated cultures - Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- 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:
- not specified
- 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:
- not specified
- 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:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- Erythritol, both in absence or presence of an exogenous source of metabolic activation, showed no evidence of mutagenic activity in the ames test at concentrations up to 30 mg/plate
- Executive summary:
In an assay comparable to OECD 471 Ames test, Erythritol, both in absence or presence of an exogenous source of metabolic activation, showed no evidence of mutagenic activity in the ames test at concentrations up to 30 mg/plate
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- GLP compliance:
- not specified
- Type of assay:
- in vitro mammalian chromosome aberration test
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Test concentrations with justification for top dose:
- Nonactivated assay : 1.25, 2.5, 5.0, or 10.0 mM. (10mM = concentration as the maximum in cases when cell proliferation is not repressed)
Metabolic activation assay : 1.25, 2.5, 5.0, or 10.0 mM. - Vehicle / solvent:
- water
- Untreated negative controls:
- yes
- Remarks:
- saline
- Negative solvent / vehicle controls:
- yes
- Remarks:
- vehicule control
- True negative controls:
- not specified
- Positive controls:
- yes
- Remarks:
- DMSO
- Positive control substance:
- N-dimethylnitrosamine
- mitomycin C
- Details on test system and experimental conditions:
- Direct nonactivated assays : Positive control = mitomycin C
Metabolic activated assays : Positive control = N-nitrosodimethylamine
Non activated Assays : CHL/IU cells cultured at 37°C for 3 days, after which time erythritol or MMC was added and the culture continued for 24 or 48 hr. Two plates were used for each erythritol concentration
Metabolic activation assay : erythritol or DMN was added to the cell culture, followed by S-9 mix, and the cells were incubated for 6 hr. After the culture medium was changed, the cells were further incubated for 18 hr. - Statistics:
- reverse mutation assay: positive response judged by the appearance of a 2-fold or greater increase in the number of revertants per plate in the treated culture compared to the vehicule control treated culture
chromosome aberration test: positive response judged by X2-analysis of the difference in the incidence of abnormal and polyploid cells between the erythritol treated and the negative control groups - Key result
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- Erythritol exhibited no mutagenicity in the chromosome aberration tests using cultured cells
- Executive summary:
In an assay similar to OECD 473, Erythritol exhibited no mutagenicity in the chromosome aberration tests using cultured cells
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Justification for classification or non-classification
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.