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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Guideline study to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- yes
- Remarks:
- China National Accreditation Services for Conformity Assessment (CNAS) and proved to be in compliance with CNAS/CL01:2006 'Accreditation Criteria for Testing and Calibration Laboratories
- Limit test:
- no
Test material
- Reference substance name:
- -
- EC Number:
- 423-630-1
- EC Name:
- -
- Cas Number:
- 62435-71-6
- Molecular formula:
- C7H14O2
- IUPAC Name:
- 2-(ethoxymethyl)oxolane
- Details on test material:
- - Sample No: ZL0902374
- Supplied by: Thomas Swan & Co,. Ltd
- Physical appearance: Clear colourless liquid, soluble in water and plant oil
- Storage - test substance was stored in its original container that supplied by Thomas Swan & Co,. Ltd at toom temperature
- Handling - The test substance was handled with necessary protective methods and all recommended safety measures were followed.
-
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- - Supplier: Guangdong Medical Laboratory Animal Center [certified animal number SCXK (Guangdong) 2008-0002].
- Number of animals used: 200 male and 200 female
- Number of groups: 5 groups ( a negative control, a positive control, a low-dose, a medium-dise, a high-dose)
- Number of animal in each group: 145 young adult nulliparous female rats were successfully mated with the males of the same species and strain, and then they were randomly divided into 5 groups (29 mated females in each group).
- Body weight at start of experiment: 200 ~ 290g before mating
- Identification of animals: Tags marked with animal group number and treatment detaisl were attached to cages. Each animal was given a unique number.
- Acclimatisation: 5 days prior to the experiment in the test room
- Randomisation: Animals were randomly assigned to 5 groups based on their body weights.
- Test Room: SPF animal lab in the Center.
- Animal house condition: The SPF test facility was an air-conditioned room with 12 hours artifical fluorescent light and 12 hours dark
- Temp range: 20~25°C
- Humidity Range: 40~70%
- Caging: Stainless steel cages were used at first. when animals were mated, the females were housed in plastic cages in small numbers.
- Water bottle: Each cage was supplied with a polypropylene water bottle with a stainless steel nozzle.
- Sanitation: Sterilised bedding material was changed 3 times a week. Corncob Laboratory Animal Bedding was supplied by Guangzhou Sebiona Bio-Tech Co,. Ltd.
- Food and Water: Standard pellet feed supplied by Guangdong Medical Laboratory Animal Center and ultra-pure filtered sterilized water were provided to the animals freely.
-Freq. of providing feed and drinking water: Both drinking water and feed were provided ad libitum.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- From day 6 to day 15 of pregnancy
- Frequency of treatment:
- Daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 25 mg/kg bw/day (nominal)
- Dose / conc.:
- 125 mg/kg bw/day (nominal)
- Dose / conc.:
- 632 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 29 females in each group
- Control animals:
- yes, concurrent vehicle
- other: Positive
Examinations
- Maternal examinations:
- General condition, weights, embryonic reabsorption
- Ovaries and uterine content:
- Immediately after termination or as soon as possible after death, the uteri were removed and the pregnancy status of the animals ascertained. Uteri that appear non-gravid should be further macroscopically examined to confirm the non-pregnant status. Gravid uteri (foetuses attached and not-attacthed) including the cervix were weighed. The number of corpora lutea was counted for the pregnant animals. The uterine contents were examined for numbers of embryonic or foetal deaths and viable foetuses. The degree of resorption was described in order to estimate the relative time of death of the conceptus. Net weight increase of a dam was then calculated (bw on day 20 - bw on day 6 - weight of gravid uteri attached foetuses).
- Fetal examinations:
- The sex, body weight, body length and tail length of each foetus were determined. Each foetus was examined for external alterations. Then 2/3 of the foetuses were prepared (mainly including transparent and dyeing steps) amd examined for skeletal alterations with dissection microscope. The remainder foetuses were examined for soft tissue alterations (e.g. variations and malformations or anomalies) using appropriate serial sectioning methods and observed with dissection microscope. Categorisation of foetal alterations were listed.
- Statistics:
- Statistical method:Numerical results were evaluated by statistical method ofF testor x2 test using the litter as the unit for data analysis.
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- no effects observed
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Other effects:
- no effects observed
Maternal developmental toxicity
- Number of abortions:
- effects observed, treatment-related
- Pre- and post-implantation loss:
- effects observed, treatment-related
- Description (incidence and severity):
- dose related
- Total litter losses by resorption:
- not examined
- Description (incidence and severity):
- Individual animal data not presented in report
- Early or late resorptions:
- effects observed, treatment-related
- Description (incidence and severity):
- Significant increase at 630 mg/kg/day
- Dead fetuses:
- effects observed, treatment-related
- Description (incidence and severity):
- Significant increase at 630 mg/kg/day
- Changes in pregnancy duration:
- no effects observed
- Changes in number of pregnant:
- no effects observed
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Remarks:
- Maternal health
- Effect level:
- > 630 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Dose descriptor:
- NOAEL
- Remarks:
- Reproductive indices
- Effect level:
- ca. 25 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- dead fetuses
- early or late resorptions
- number of abortions
- pre and post implantation loss
Maternal abnormalities
- Abnormalities:
- no effects observed
Results (fetuses)
- Fetal body weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Significant at 630 mg/kg/day
- Reduction in number of live offspring:
- effects observed, treatment-related
- Description (incidence and severity):
- Significant at 630 mg/kg/day
- Changes in sex ratio:
- effects observed, non-treatment-related
- Description (incidence and severity):
- No considered significant
- Changes in litter size and weights:
- effects observed, treatment-related
- Description (incidence and severity):
- Significant increase at 630 mg/kg/day
- Changes in postnatal survival:
- not examined
- External malformations:
- effects observed, treatment-related
- Description (incidence and severity):
- Tail kinks
- Skeletal malformations:
- effects observed, treatment-related
- Description (incidence and severity):
- At 630 mg/kg/day
- Visceral malformations:
- no effects observed
- Description (incidence and severity):
- No soft-tissue malformations noted
- Other effects:
- no effects observed
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 25.28 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- skeletal malformations
Fetal abnormalities
- Abnormalities:
- effects observed, treatment-related
- Localisation:
- external: tail
- skeletal: clavicle
- skeletal: sternum
- skeletal: rib
- skeletal: vertebra
- Description (incidence and severity):
- Significant only at 630 mg/kg/day
Overall developmental toxicity
- Developmental effects observed:
- yes
- Lowest effective dose / conc.:
- 630 mg/kg bw/day (nominal)
- Treatment related:
- yes
- Relation to maternal toxicity:
- developmental effects in the absence of maternal toxicity effects
- Dose response relationship:
- yes
- Relevant for humans:
- not specified
Any other information on results incl. tables
RESULTS
Status of gestation: 29 young adult nulliparous female rats in each group were successfully mated but the actually pregnant numbers in each group were between 23-27 (Table 3). The embryonic resorptions in low-, medium- and high-level groups were significantly increased, while the viable foetuses were decreased (P<0.05 or P<0.01). In medium- and high-dose groups, the foetal deaths were observed to be higher than that of the control(尸<0.01). Compared with those of the control, the increased embryonic resorption rate, increased foetal deaths and decreased viable foetus rate in the positive group were significantly different (P<0.01). There were no differences between sex ratio of the foetuses in all dose groups.
Foetus growth: Compared with those of the control, the body weight, body length and tail length of the foetuses in the high dose group and in the positive group were significantly decreased (P<0.01)
Foetuses external alterations:Short-tailed, kinked-tailed, acaudate and malrotated-foot foetuses were found in the positive group (P<0.01). Some signs were also found in dose groups but without any signicant difference with the contros(P>0.05)
Foetuses soft tissue alterations:No soft tissue alterations were observed in all dose groups. One case of ventriculomegaly was found in the high dose group but without difference with the controls (P>0.05). Some malformations were found in the positive group(尸<0.05 or尸<0.01), showing N,N'-Methylene bis -(2 -amino -1,3,4 -thiadiazole) could induce soft tissue alterations in rats
Foetuses skeletal alterations:Some types of malformations were found in the high dose group, which partly were significantly different with those of the control (^O.OS or尸<0.01). The skeletal alterations were mainly including enlarged fontanel, abnormal upper occipital morphology, dysostosis of parietal bones and os incae, bipartite ossification of cervical arch and sternum, and abnormal metacarpal ossification (Table 7).
Some malformations were found in the positive group with high incidence(尸<0.05 or P<0.01), showing N,N'-Methylene bis -(2 -amino -1,3,4 -thiadiazole) could induce skeletal alterations in rats.
Evaluation of Results:
(1) Maternal toxic response: No obvious maternal toxic response was observed under designed dose levels.
(2) Embryonic toxic response: Definite embryonic toxic responses were observed at the low-, medium- and high-dose groups under the existing test conditions.
(3) Teratogenicity: Under the existing test conditions, 632.0mg/kgethyl tetrahydrofurfuryl etherelicited the increase of skeletal malformations. The minimum teratogenic dose was 632.0mg/kg and theNo Observed Adverse Effect Level (NOAEL)ofethyl tetrahydrofurfuryl ether(supplied by Thomas Swan&Co. Ltd.) was 126.4mg/kg on SPF SD rats. Based onThe Guidelines for the Testing of Chemicals (No. 414’ Teratogenicity)of the State Environmental Protection Administration of China, theTeratogenicity Indexwas calculated to be 5 (3160mg/kg/632.0mg/kg), indicating this test material was categorized as "Basically Non-teratogenic".
Applicant's summary and conclusion
- Conclusions:
- The minimum teratogenic dose was 632.0mg/kg
The No Observed Adverse Effect Level (NOAEL) of theyl tetrahydrofurfuryl ether (was 126.4mg/kg on rats.
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.