Registration Dossier
Registration Dossier
Diss Factsheets
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EC number: 202-507-4 | CAS number: 96-47-9
- 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

Toxicity to reproduction
Administrative data
- Endpoint:
- extended one-generation reproductive toxicity - basic test design (Cohorts 1A, and 1B without extension)
- Type of information:
- experimental study planned
- Study period:
- The study period is to be confirmed following confirmation of the testing proposal by ECHA
- Justification for type of information:
- TESTING PROPOSAL ON VERTEBRATE ANIMALS
- Name of the substance on which testing is proposed to be carried out: Tetrahydro-2-methylfuran (MeTHF)
CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- Available GLP studies:
No GLP data are available to address this endpoint (reproductive toxicity. Repeated dose toxicity studies performed to GLP are not sufficient to address this endpoint, but do not indicate any specific concerns of relevance to reproductive toxicity.
- Available non-GLP studies:
No non-GLP studies are available to adequately address the reproductive toxicity endpoint for MeTHF.
- Historical human data:
No historical human data are available for MeTHF.
- (Q)SAR:
(Q)SAR models for the reproductive toxicity endpoint are not sufficiently validated for regulatory acceptance
- In vitro methods
No validated in vitro methods are available for the reproductive toxicity endpoint; models are not sufficiently reliable for regulatory acceptance.
- Weight of evidence
Insufficient reliable data are available to complete the data requirements as a weight of evidence approach.
- Grouping and read-across:
No substances with data suitable for grouping and read-across are identified.
- Substance-tailored exposure driven testing
Not applicable
- Approaches in addition to above
Not applicable
- Other reasons
Not applicable
FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- It is proposed to conduct an EOGRTS in the rat using the registered substamce according to OECD TG 443 and using the (preferred) oral route of exposure.
The proposed study will include extension of the F0 pre-mating exposure period to 10 weeks.
In the absence of specific triggers or concerns, extension of cohort 1B to include the F2 generation is not proposed. The substance does not display genotoxic effects in somatic cell mutagenicity tests in vivo which could lead to classification as Mutagen Category 2 There is no indication that the internal dose for the substance and/or any of its metabolites will reach steady state only after extended exposure. Furthermore, there are no indications of relevant modes of action related to endocrine disruption.
It is not proposed to include Cohorts 2A or 2B in the absence of any specific triggers or concerns. There is no evidence from the existing dataset, from a MoA or from any analogous substance that MeTHF has any (developmental) neurotoxicity potential.
It is not proposed to include Cohort 3 in the absence of any specific triggers or concerns. There is no evidence from the existing dataset, from a MoA or from any analogous substance that MeTHF has any (developmental) immunotoxicity potential.
Data source
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 443 (Extended One-Generation Reproductive Toxicity Study)
- Version / remarks:
- 2018
- Justification for study design:
- SPECIFICATION OF STUDY DESIGN FOR EXTENDED ONE-GENERATION REPRODUCTION TOXICITY STUDY WITH JUSTIFICATIONS
- Premating exposure duration for parental (P0) animals: 10 weeks, to cover a complete spermatogenic cycle
- Basis for dose level selection: dose levels will be selected based on existing toxicity data, taking into account the MTD and recommendations of the study guideline
- Inclusion/exclusion of extension of Cohort 1B: In the absence of specific triggers or concerns, extension of Cohort 1B to include the F2 generation is not proposed. The substance does not display genotoxic effects in somatic cell mutagenicity tests in vivo which could lead to classification as Mutagen Category 2 There is no indication that the internal dose for the substance and/or any of its metabolites will reach steady state only after extended exposure. Furthermore, there are no indications of relevant modes of action related to endocrine disruption.
- Termination time for F2: not applicable (extension of Cohort 1B to include the F2 generation is not proposed)
- Inclusion/exclusion of developmental neurotoxicity Cohorts 2A and 2B: It is not proposed to include Cohorts 2A or 2B in the absence of any specific triggers or concerns. There is no evidence from the existing dataset, from a MoA or from any analogous substance that MeTHF has any (developmental) neurotoxicity potential.
- Inclusion/exclusion of developmental immunotoxicity Cohort 3: It is not proposed to include Cohort 3 in the absence of any specific triggers or concerns. There is no evidence from the existing dataset, from a MoA or from any analogous substance that MeTHF has any (developmental) immunotoxicity potential.
- Route of administration: oral
- Other considerations, e.g. on choice of species, strain, vehicle and number of animals: not applicable
Test material
- Reference substance name:
- Tetrahydro-2-methylfuran
- EC Number:
- 202-507-4
- EC Name:
- Tetrahydro-2-methylfuran
- Cas Number:
- 96-47-9
- Molecular formula:
- C5H10O
- IUPAC Name:
- 2-methyltetrahydrofuran
- Details on test material:
- - Name of test material (as cited in study report): 2-methyltetrahydrofuran; MeTHF CAS 96-47-9
- Substance type: Monoconstituent substance
- Physical state: no information
- Analytical purity: no information
Constituent 1
Test animals
- Species:
- rat
Administration / exposure
- Route of administration:
- oral: unspecified
- Details on exposure:
- details to be provided
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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