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EC number: 423-630-1 | CAS number: 62435-71-6
- 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
- Toxic effect type:
- dose-dependent
Effects on fertility
Description of key information
Research has demonstrated a NOAEL for parental and reproductive/developmental toxicity to be 50 mg/kg/day.
The impact on testes and sperm parameters is consistent with reproduction and repeat dose toxicity studies in rats and dogs, suggesting reproductive toxicty
This is consistent with furans (cyclic ether)
Link to relevant study records
- Endpoint:
- one-generation reproductive toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Up to 52 day dosing period, extending to day 4 lactation
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Justification for type of information:
- Research working closely in line with OECD 415
Testing performed on major metabolite tetrahydrofurfuryl alcohol which is considered a suitable substitute for the ether. - Reason / purpose for cross-reference:
- read-across: supporting information
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 415 [One-Generation Reproduction Toxicity Study (before 9 October 2017)]
- Principles of method if other than guideline:
- Rats were given tetrahydrofurfuryl alcohol (THFA) by gavage.
Males were dosed for 47 days, beginning 14 days before mating, and females were dosed for 42–52 days beginning 14 days before mating to day 4 of lactation
throughout the mating and gestation period - GLP compliance:
- not specified
- Limit test:
- no
- Justification for study design:
- Follows accepted scientific principles
- Specific details on test material used for the study:
- 99.5% purity
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- 21.9–22.4 C,
Relative humidity of 49–57%,
12-h light/dark cycle - Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Details on exposure:
- Twelve male and female rats per group were given tetrahydrofurfuryl alcohol (THFA) by gavage at 0, 15, 50, 150 or 500 mg/kg/day. Males were
dosed for 47 days, beginning 14 days before mating, and females were dosed for 42–52 days beginning 14 days before mating to day 4 of lactation
throughout the mating and gestation period - Details on mating procedure:
- After 14 days pre-,ating exposure, male and female rats (1:1) were placed in seperate cages
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The concentrations in the formulations were confirmed to be 97.7–103.0% of nominal (gas chromatography).
- Duration of treatment / exposure:
- 14 days prior to mating (males and females) and up to 4 days after birth (females)
- Frequency of treatment:
- Daily
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Remarks:
- Vehicle only
- Dose / conc.:
- 15 mg/kg bw/day (nominal)
- Dose / conc.:
- 50 mg/kg bw/day (nominal)
- Dose / conc.:
- 150 mg/kg bw/day (nominal)
- Dose / conc.:
- 500 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 12 males and 12 females
- Control animals:
- yes, concurrent vehicle
- Positive control:
- No
- Parental animals: Observations and examinations:
- All animals were observed for clinical signs at least twice a day.
The body weight was recorded at least once a week - Oestrous cyclicity (parental animals):
- Yes
- Sperm parameters (parental animals):
- Yes
- Litter observations:
- Yes
- Postmortem examinations (parental animals):
- Gross necropsy and more detailed pathology on reproductive organs
- Postmortem examinations (offspring):
- Viabilty, weight and gross necropsy
- Reproductive indices:
- Yes
- Offspring viability indices:
- Yes
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Reduced activity in higher dose groups
- Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- One male died on Day 15 in a mid group. Not considered to be treatment related.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Reduced bodyweight gain at 500 mg/kg/day
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- Reduced food consumptionin higher treatment levels
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- effects observed, treatment-related
- Description (incidence and severity):
- Reduced activity in higher groups
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Significant increases in the incidence of seminiferous tubular atrophy and hyperplasia of interstitial cells in the testes, and cell debris and decreased sperm at 500 mg/kg/day
- Histopathological findings: neoplastic:
- no effects observed
- Other effects:
- no effects observed
- Reproductive function: oestrous cycle:
- effects observed, treatment-related
- Description (incidence and severity):
- Oestrous cycle at 500 mg/kg prolonged
- Reproductive function: sperm measures:
- effects observed, treatment-related
- Description (incidence and severity):
- Reduced sperm parameters at 500 mg/kg/day
- Reproductive performance:
- effects observed, treatment-related
- Description (incidence and severity):
- No young from highest doese goup and reduced at 150 mg/kg/day
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 50 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- organ weights and organ / body weight ratios
- gross pathology
- reproductive function (sperm measures)
- reproductive performance
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 150 mg/kg bw/day (nominal)
- System:
- male reproductive system
- Organ:
- kidney
- spleen
- testes
- Treatment related:
- yes
- Dose response relationship:
- yes
- Clinical signs:
- no effects observed
- Mortality / viability:
- no mortality observed
- Description (incidence and severity):
- Live pups survived until termination
- Body weight and weight changes:
- no effects observed
- Gross pathological findings:
- no effects observed
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Critical effects observed:
- no
- Reproductive effects observed:
- yes
- Lowest effective dose / conc.:
- 150 mg/kg bw/day (nominal)
- Treatment related:
- yes
- Relation to other toxic effects:
- reproductive effects in the absence of other toxic effects
- Dose response relationship:
- yes
- Relevant for humans:
- not specified
- Conclusions:
- The research demonstrated a NOAEL for parental and reproductive/developmental toxicity to be 50 mg/kg/day.
The impact on testes and sperm parameters is consistent with other repeat dose toxicity studies in rats and dogs, suggesting reproductive toxicty
This result is consistent with furan (cyclic ether)
Reference
Effect on fertility: via oral route
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 50 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Justification for classification or non-classification
Additional information
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.
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