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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 241-793-5 | CAS number: 17832-28-9
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- repeated dose toxicity: oral, other
- Remarks:
- combined repeated dose and reproduction / developmental screening
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
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 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
- Reference substance name:
- 4-(vinyloxy)butan-1-ol
- EC Number:
- 241-793-5
- EC Name:
- 4-(vinyloxy)butan-1-ol
- Cas Number:
- 17832-28-9
- Molecular formula:
- C6H12O2
- IUPAC Name:
- 4-(ethenyloxy)butan-1-ol
- Details on test material:
- purity: 99.4%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- test animal source: Male and female Wistar rats, strain Crl:WI(Han), Charles River Laboratories, Research Models and Services, Germany GmbH
housing temperature: 20-24 °C
humidity: 30-70%
air change rate: 15 times per hour
day/night cycle: 12 hours light from 6:00 h to 18:00 h and 12 hours dark from 18:00 h to 6:00 h
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The analyses of the test substance preparations were carried out at the Analytical Chemistry Laboratory of Experimental Toxicology and Ecology of BASF SE. The stability of the test substance in Olive oil Ph. Eur./DAB at room temperature was given for a period of 7 days (analytical report: Project No.: 01Y0107/098019).
- Duration of treatment / exposure:
- males: 30 days
females: 53 days - Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 50, 150, 450 mg/kg bw/day
Basis:
other: Olive oil Ph. Eur./DAB
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- The duration of treatment covered a 2-week pre-mating and mating period in both sexes, approximately 1 week postmating in males, and the entire gestation period as well as 4 days of lactation in females. After 2 weeks of premating treatment the F0 animals were mated to produce F1 generation pups. Mating pairs were from the same test group. Mating was discontinued as soon as sperm was detected in the vaginal smear. F0 animals were examined for their reproductive performance including determination of the number of implantation sites and the calculation of postimplantation loss for all F0 females.
Examinations
- Observations and examinations performed and frequency:
- A detailed clinical observation (DCO) was performed in all animals before initial test substance administration and, as a rule, thereafter at weekly intervals. Food consumption of the F0 parents was determined once weekly during premating. In dams food consumption was determined for gestation days 0-7, 7-14, 14-20 and lactation days 1-4. Body weights of F0 parents were determined once a week, in males throughout the study
and in females during premating and mating. During gestation and lactation period, F0 females were weighed on gestation days (GD) 0, 7, 14 and 20, on the parturition day (postnatal day [PND] 0) and on PND 4. The pups were sexed and examined for macroscopically evident changes on PND 0. They
were weighed on PND 1 and on PND 4. Their viability was recorded. At necropsy on PND 4, all pups were sacrificed with CO2 and examined macroscopically for external and visceral findings. Clinicochemical and hematological examinations as well as urinalyses were performed in 5
randomly selected parental animals of either sex towards the end of the administration period. At the end of the administration period a functional observational battery was performed and motor activity was measured in 5 randomly selected parental males and females per group. - Sacrifice and pathology:
- All surviving F0 parental animals were sacrificed by decapitation, under isoflurane anesthesia, and were assessed by gross pathology. Weights of selected organs were recorded and a histopathological examination was performed. At necropsy on PND 4, all pups were sacrificed with CO2 and examined macroscopically for external and visceral findings.
Results and discussion
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 450 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: reproductive performance, fertility and developmental toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 150 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: systemic toxicity (adverse clinical findings (males + females), decreased body weight gain (males))
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
450 mg/kg bw/d
F0 Parental animals (clinical examinations/reproductive performance/clinical pathology/pathology): Abdominal position after first treatment in 2 male and in 3 female animals; decreased body weight gain in male animals during study week 3-4 and in summary for the entire treatment; decreased motor activity in male animals in interval 4 and in summation (intervals 1-12)
F1 pups (clinical examinations/gross findings): no test substance-related adverse findings
150 mg/kg bw/d
F0 Parental animals: no test substance-related adverse findings
F1 pups: no test substance-related adverse findings
50 mg/kg bw/d
F0 Parental animals: no test substance-related adverse findings
F1 pups: no test substance-related adverse findings
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this reproduction/developmental toxicity screening test the NOAEL (no observed adverse effect level) for reproductive performance, fertility and for developmental toxicity is 450 mg/kg body weight/day, the highest dose tested.
The NOAEL for general, systemic toxicity of the test substance is 150 mg/kg body weight/day for the F0 parental animals based on adverse clinical findings (males + females) and decreased body weight gain (males) at 450 mg/kg body weight/day. - Executive summary:
The test substance was administered orally via gavage to groups of 10 male and 10 female Wistar rats (F0 animals) at doses of 50, 150, and 450 mg/kg body weight/day. Control animals were dosed daily with the vehicle (Olive oil Ph. Eur./DAB). The duration of treatment covered a 2-week pre-mating and mating period in both sexes, approximately 1 week postmating in males, and the entire gestation period as well as 4 days of lactation in females. No adverse effects on fertility of the F0 parental animals of both sexes at dose levels of 50, 150 and 450 mg/kg bw/d were observed. The test substance caused also no impairments of the reproductive performance. Mating behaviour, conception, gestation, parturition, as well as sexual organ weights and gross and histopathological findings of these organs were not influenced. Slight general systemic toxicity was noted in the F0 parents at 450 mg/kg bw/d. Some males and females showed abdominal position exclusively when they were treated with the test substance for the first time. Furthermore, motor activity was slightly decreased in the high-dose males. Although no other effects were noted in daily cageside, detailed clinical examinations in an open field and detailed observations in a functional observational battery (FOB) these findings might indicate a minimal sedative potential of Hydroxybutylvinylether. They are considered as treatment-related. An additional clinical finding was a decreased body weight gain in high-dose males. Concerning clinical pathology no treatment-related, adverse effects were observed up to a dose of 450 mg/kg bw/d. Regarding pathology there were no substance-related organ weight changes, gross lesions, or microscopic findings. Under the conditions of this study the NOAEL for reproductive performance, fertility and for developmental toxicity is 450 mg/kg body weight/day, the highest dose tested. The NOAEL for general, systemic toxicity of the test substance is 150 mg/kg body weight/day for the F0 parental animals based on adverse clinical findings (males + females) and decreased body weight gain (males) at 450 mg/kg body weight/day.
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.