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EC number: 203-569-5 | CAS number: 108-29-2
- 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:
- short-term repeated dose toxicity: oral
- Remarks:
- 14-day repeated-dose oral toxicity study
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 2019-09-24 to 2019-11-06
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Justification for type of information:
- A 14-day range-finding test with non-pregnant animals was conducted previous to an OECD 422 study with gamma-Valerolactone. The combined repeated dose toxicity study with the reprod./develop. tox. screening test, OECD 422, rats (gavage) is ongoing, the results will be submitted as soon as the data are available.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- yes
- Remarks:
- Not all parameters indicated in the guideline were investigated and a shorter period of time (14 days) was chosen.
- Principles of method if other than guideline:
- - Principle of test: 14-day range-finding test study to obtain initial information on the effect of the test substance after repeated oral administration (gavage) to non-pregnant, female Wistar rats before the beginning of subsequent maternal and prenatal toxicity studies.
- Short description of test conditions: Not all parameters indicated in the guideline were investigated. - GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- γ-valerolactone
- EC Number:
- 203-569-5
- EC Name:
- γ-valerolactone
- Cas Number:
- 108-29-2
- Molecular formula:
- C5H8O2
- IUPAC Name:
- 5-methyloxolan-2-one
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch number of test material: Zimmerma 00003
- Expiration date of the batch: 12 Aug 2021
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on species / strain selection:
- The rat is the preferred animal species for repeated dose toxicity studies according to the various test guidelines. This Wistar rat strain (Crl:Wl(Han)) is selected because extensive historical control data is available for these rats.
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH
- Females non-pregnant: Yes
- Age at study initiation: About 15 weeks
- Housing: Polysulfonate cages Typ 2000P (H-Temp) with dust-free wooden bedding. Cages were enriched with wooden gnawing blocks and large play tunnels.
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: 29 days
DETAILS OF FOOD AND WATER QUALITY:
The food used in the study was assayed for chemical and microbial contaminants. Fed. Reg. Vol. 44, No. 91 (09 May 1979), p 27354 (EPA), served as the guideline for maximum tolerable contaminants. Additionally, the levels of phytoestrogens should not exceed 350 μg of genistein equivalents/gram. According to recommendations of the GVSOLAS, the total amount of bacteria must not exceed 1*10^5 per g food.
The drinking water is regularly assayed for chemical contaminants both by the municipal authorities of Frankenthal and by the Environmental Analytics Water/Steam Monitoring Department of BASF SE as well as for bacteria by a contract laboratory. The Drinking Water Regulation will serve as the guideline for maximum tolerable contaminants.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 45-65
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From day 0 to day 14
Administration / exposure
- Route of administration:
- oral: gavage
- Details on route of administration:
- The oral administration of a test substance has been proven useful worldwide in numerous studies for discovering a potential toxicological profile.
- Vehicle:
- water
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
For the test substance preparation, the specific amount of test substance is weighed, topped up with deionized water in a graduated flask and intensely mixed with a magnetic stirrer until it is completely dissolved. Before and during administration, the preparations is kept homogeneous with a magnetic stirrer.
VEHICLE
- Concentration in vehicle: 3 g/100 mL (for 300 mg/kg bw group) and 10 g/100 mL (for 1000 mg/kg bw group)
- Amount of vehicle: 10 mL/kg bw - Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- From day 0 to day 14
- Frequency of treatment:
- Daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- Dose / conc.:
- 300 mg/kg bw/day (nominal)
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 3 animals per sex per dose
- Control animals:
- yes
- Details on study design:
- - Dose selection rationale: Low and high dose levels as requested by the sponsor
- Rationale for animal assignment: According to their weight - Positive control:
- No positive control included
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Twice daily (mondays-fridays) or once daily (saturdays, sundays and public holidays)
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Within 2 hours and between 2 and 5 hours after the administration, afterwards daily observations
BODY WEIGHT: Yes
- Time schedule for examinations: Body weights are recorded on days 0, 3, 7, 10, and 13.
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: No
CLINICAL CHEMISTRY: No
PLASMA/SERUM HORMONES/LIPIDS: No
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No
IMMUNOLOGY: No - Sacrifice and pathology:
- One day after the last administration, the animals were anesthetized with isoflurane, sacrificed by decapitation and assessed by gross pathology.
- Optional endpoint(s):
- Optional endpoints: No
- Statistics:
- Body weight and body weight change: DUNNETT-test (two-sided)
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Females of the 300 and 1000 mg/kg bw group, effects not further specified
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Endocrine findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not examined
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not examined
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
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.