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Diss Factsheets
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EC number: 817-828-0 | CAS number: 80322-82-3
- 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
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Genetic toxicity: in vivo
Administrative data
- Endpoint:
- genetic toxicity in vivo, other
- Remarks:
- Combined in vivo comet assay and micronucleus test for detection of test item potential to induce chromosomal aberrations or gene mutations in vivo
- Type of information:
- experimental study planned
- Study period:
- 2023-2024 // The study will be conducted after a decision on the requirement to carry out the proposed test has been taken according to the procedure laid down in Regulation (EC) 1907/2006, and a deadline to submit the information required has been set
- Justification for type of information:
- TESTING PROPOSAL ON VERTEBRATE ANIMALS
A testing proposal for an in vivo combined comet assay and micronucleus test according to the OECD guidelines 489 and 474, respectively, has been submitted by the registrant in order to meet the information required of Section 8.4 of Annex VII and VIII of the REACH Regulation.
An Ames test in accordance with OECD Guideline 471 was performed using Salmonella typhimurium strains TA98, TA100, TA1535 and TA1537 and Escherichia coli strain WP2 uvrA with and with metabolic activation. The study showed positive results in Salmonella typhimurium strains TA100 and TA1535 with and without metabolic activation. Therefore, the Ames test was concluded to be positive. Furthermore, an in vitro mammalian cell micronucleus test was performed in accordance with OECD Guideline 487. The test item induced biologically and statistically significant increases breakage and /or chromosomal loss in L5178Y cells after 4- and 24-hours treatment both in the absence and in the presence of metabolic activation when compared to the negative and the historical controls, and was therefore considered as genotoxic in the in vitro micronucleus test.
Due to the positive in vitro study results, further in vivo testing is deemed required in accordance with column 2 of Annex VIII of the REACH Regulation. In line with the ECHA recommendation on standard information requirements for Mutagenicity for substances which raise concerns for both gene mutation and chromosomal aberration, the registrant considers the testing proposal for a combined in vivo comet assay (OECD Test Guideline 489) and an in vivo micronucleus test (OECD TG 474) as justified.
NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out: 2-[2-(2-hydroxyethoxy)ethoxy]ethanol,methanesulfonic acid
CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION [please address all points below]:
- Available GLP studies: no GLP studies available to cover this endpoint
- Available non-GLP studies: no non-GLP studies available to cover this endpoint
- Historical human/control data: no historical human data available to cover this endpoint
- (Q)SAR: (Q)SAR methods are not expected to generate data which prevent the need for in vivo testing of the substance
- In vitro methods: both in vitro tests gave positive results, therefore further in vivo testing is required
- Weight of evidence: no appropriate weight of evidence information is available to cover this endpoint
- Grouping and read-across: read-across was considered; however it has been concluded that no appropriate information from related or appropriate source substances is available to cover this endpoint
- Substance-tailored exposure driven testing [if applicable]: not applicable
- Approaches in addition to above [if applicable]: not applicable
- Other reasons [if applicable]: not applicable
CONSIDERATIONS THAT THE SPECIFIC ADAPTATION POSSIBILITIES OF ANNEXES VI TO X (AND COLUMN 2 THEREOF) OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- There are no adequate specific adaptation possibilities that allow generation of the necessary information.
FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed: the proposed testing will be run according to OECD Guidelines 489 (in vivo mammalian alkaline comet assay) and OECD Guideline 474 (mammalian erythrocyte micronucleus test).
Data source
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Version / remarks:
- 29 Jul 2016
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 489 (In vivo Mammalian Alkaline Comet Assay)
- Version / remarks:
- 29 Jul 2016
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- other: combined in vivo comet assay (OECD Test Guideline 489) and an in vivo micronucleus test (OECD TG 474)
Test material
- Reference substance name:
- 2-[2-(2-hydroxyethoxy)ethoxy]ethanol,methanesulfonic acid
- Cas Number:
- 80322-82-3
- Molecular formula:
- C8H18O8S2
- IUPAC Name:
- 2-[2-(2-hydroxyethoxy)ethoxy]ethanol,methanesulfonic acid
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- Oxidane
- Reference substance name:
- 1,2-Ethandiylbis(oxy-2,1-ethandiyl)-monomethanesulfonat
- IUPAC Name:
- 1,2-Ethandiylbis(oxy-2,1-ethandiyl)-monomethanesulfonat
- Test material form:
- liquid
- Details on test material:
- Appearance: Dark yellow liquid
Batch No.: 01110008
Storage: -5 – 40 °C, container tightly closed, protected from light
Constituent 1
impurity 1
impurity 2
Test animals
- Species:
- rat
Administration / exposure
- Route of administration:
- oral: gavage
Results and discussion
Applicant's summary and conclusion
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.
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