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EC number: 445-090-6 | CAS number: 5614-37-9
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 2012-11-06 to 2013-10-31
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, non GLP, but in compliance with China National Metrology Accreditation, in which the test parameters documented are based on testing guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- non GLP, but in compliance with China National Metrology Accreditation
- Limit test:
- no
Test material
- Reference substance name:
- -
- EC Number:
- 445-090-6
- EC Name:
- -
- Cas Number:
- 5614-37-9
- Molecular formula:
- C6 H12 O
- IUPAC Name:
- Cyclopentyl methyl ether
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Batch No.: 2820246
Purity: 99.9%
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Zhejiang center of laboratory animals
- Age at study initiation: 3 months old
- Weight at study initiation: 200-240 g for female and 350-450 g for male
- Fasting period before study:
- Housing: Suspended, wire bottom, stainless steel cage, no more than 5 rats per cage
- Diet (e.g. ad libitum): Conventional laboratory diet
- Water (e.g. ad libitum): Tap water by aseptic filtration, ad libitum
- Acclimation period: more than 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3°C
- Humidity (%): 30-70%
- Air changes (per hr): 12 air changes/hour
- Photoperiod (hrs dark / hrs light): 12 hours light/dark cycle
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
The weighed sample is added to tween-80 and distilled water to form emulsion, add distilled water to the nominal dose.
Exposure pathway is gavage exposure and gavage volume is 5 mL/kg. - Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- Female and male rats should be mated in a cage on the ration of 1:1 at 4:00 pm daily, check the vaginal plug or vaginal smear the next morning.
Day 0 of pregnancy is defined as the day a vaginal plug or sperm are found. - Duration of treatment / exposure:
- 6-15 days after conception
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 50 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 200 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 800 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 140 SD rats with 40 male and 100 female were applied. Four groups were assigned.
The number of pregnant rats in control group, low dose level group, intermediate dose level group and high dose level group was 22, 24, 25 and 21 respectively. - Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: based on acute LD50 value 3160 mg/kg in female rats
- Rationale for animal assignment (if not random): randomly
- Other:
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: once daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: once daily
BODY WEIGHT: Yes
- Time schedule for examinations: weigh female rats once every 3 days from conception
POST-MORTEM EXAMINATIONS: Yes
Females showing signs of abortion or premature delivery prior to scheduled termination should be killed and subjected to a thorough macroscopic examination. - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: Yes
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes
- Other: - Fetal examinations:
- - External examinations: Yes, each fetus is examined for external anomalies during caesarean section.
- Soft tissue examinations: Yes, one third of each litter was immersed in Bouin's solution and examined for viscera anomalies.
- Skeletal examinations: Yes, the remainder was immersed in 90% ethanol and examined for skeletal alterations. - Statistics:
- Method
Each group of pregnant rats’ body weight, body length, tail length and body weight was compared with the control group applying Dennett’s t test. The rate of fetal resorptions, mortality and teratogenic rate deal with the chi-square test. Significance level α=0.05, chi-square test corrected significance level a=0.0170 (low, intermediate and high dose group compared with the control group, respectively).
Analysis of indicators
The number of experimental animal, average weight, number of pregnant animals, the number of corpus luteum, implantation, absorption fetus, number of live births, the number and percentage of stillbirth, fetal situation (sex, weight, placental weight, body length, tail length), teratogenic types (including appearance, bones and internal organs), the number and percentage.
Teratogenic rate:
Total teratogenic rate of each treatment group (%) = (total live fetuses of teratogenic / total live fetuses) *100%
(It was treated as a terata when live fetuses had more than one malformation)
It should be calculated for the single teratogenic rate when terata based on one or a few defects.
Single teratogenic rate of each treatment group (%) = (total terata / total live fetuses) *100%
Teratogenic index:
If total teratogenic rate or single teratogenic rate of group was significantly higher than the control group. It indicates that the dose had teratogenic effect.
Teratogenic index = LD50 of female animal/minimum teratogenic dose.
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Body weight of high dose group from day 9 were lower than the control group, body weight gain during pregnancy and absolute gain of high dose group were lower than the control group, the differences were statistically significant.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Water consumption and compound intake (if drinking water study):
- no effects observed
Maternal developmental toxicity
- Early or late resorptions:
- no effects observed
- Dead fetuses:
- no effects observed
- Changes in pregnancy duration:
- no effects observed
- Changes in number of pregnant:
- no effects observed
- Other effects:
- effects observed, treatment-related
- Description (incidence and severity):
- Formation of rat embryos and fetal growth and development status:
In high dose group the weight of uterus (with fetal), the average fetal body weight, body length and tail length were lower than the control group, the differences were statistically significant.
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 200 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- body weight and weight gain
- maternal abnormalities
Maternal abnormalities
- Abnormalities:
- no effects observed
Results (fetuses)
- Fetal body weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- In high dose group the weight of uterus (with fetal), the average fetal body weight, body length and tail length were lower than the control group, the differences were statistically significant.
- External malformations:
- effects observed, non-treatment-related
- Description (incidence and severity):
- In high-dose group a fetal was found gastroschisis with no tail and left hind foot valgus. But litters or fetuses as statistical unit compared with the control group, the difference was not statistically significant.
In high dose group two fetal malformations were found (different nest), a fetal with gastroschisis, no tail and left hind foot valgus, other one with rib deletion. But litters or fetuses as statistical unit compared with the control group, the difference was not statistically significant. - Skeletal malformations:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Some fetuses appears with hypoplastic supraoccipitals, hypoplastic interparietals and agenesis of other skull bone in high, intermediate and low dose level group. But litters or fetuses as statistical unit compared with the control group, the differences were not statistically significant.
A fetal with the right rib 13 deletion was found in high-dose group. But litters or fetuses as statistical unit compared with the control group, the differences were not statistically significant. - Visceral malformations:
- no effects observed
- Other effects:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Total teratogenic rate of high dose group was 0.8%, the difference was not statistically significant compared with the control group.
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 200 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- external malformations
- skeletal malformations
- visceral malformations
Fetal abnormalities
- Abnormalities:
- effects observed, non-treatment-related
Overall developmental toxicity
- Developmental effects observed:
- no
- Lowest effective dose / conc.:
- 800 mg/kg bw/day (actual dose received)
- Treatment related:
- no
Applicant's summary and conclusion
- Conclusions:
- The results of teratogenicity study for this substance to pregnant rats repeated exposed by oral in 6 to 15 days of pregnancy showed that no obvious symptoms of poisoning was observed in all dose group (including period of exposure and the observation period). Compared with the control group, in the high dose level group, body weight gain of pregnant rats in later pregnancy was slower, the weight of uterus (with fetal), the average fetal body weight, body length and tail length were lower, the differences were significant. In high dose group two fetal malformations were found (different nest), a fetal with gastroschisis, no tail and left hind foot valgus, other one with rib deletion. But litters or fetuses as statistical unit compared with the control group, the difference was not statistically significant. The low-dose group and intermediate dose level group showed no abnormal compared with the control group. The results show that under the experimental conditions, the tested sample to the SD rats had no significant teratogenic effects. The NOAEL for maternal toxicity and the NOAEL for offspring developmental toxicity were both 200mg/(kg.d).
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