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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 692-561-9 | CAS number: 19444-84-9
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- January 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Acute oral toxicity was determined according to OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 3-hydroxyoxolan-2-one
- EC Number:
- 692-561-9
- Cas Number:
- 19444-84-9
- Molecular formula:
- C4H6O3
- IUPAC Name:
- 3-hydroxyoxolan-2-one
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
-Number: nine nulliparous and non-pregnant female rats were received at CIT between 25 August and 08 September 2011.
-Strain and Sanitary status: Sprague-Dawley rat, Rj Han: SD, Indemn of Organism Pathogen Specific Han (IOPS Han).
-Breeder: Janvier, Le Genest-Saint-Isle, France.
-Age/Weight: on the day of treatment, the females were approximately 8 weeks old and had a mean body weight of 204 g (range: 188 g to 216 g).
-Receipt: on arrival, the animals were given a clinical examination to ensure that they were in good condition.
-Acclimation: the animals were acclimated to the study conditions for a period of 5 or 6 days before treatment.
-Allocation to groups: the day before treatment, the required number of animals (three females per treatment step) were allocated to the groups according to a computerized random procedure.
-Identification: the day before treatment, the animals were individually identified by ear notches (unique identity number).
The animal room conditions were set as follows:
-temperature : 22 ± 2°C,
-relative humidity : 50 ± 20%,
-light/dark cycle : 12h/12h (7:00 - 19:00),
-ventilation : approximately 12 cycles/hour of filtered, non-recycled air.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- No. of animals per sex per dose:
- 3 females: 300mg/Kg
3 females: 2000mg/Kg
3 females: 2000mg/Kg - Control animals:
- no
- Details on study design:
- -Duration of observation period following administration: 14 days.
-Frequency of observations : . at least once during the first 30 minutes, . periodically during the first 4 hours, . then once a day, at approximately same time, for the recording of clinical signs.
-Necropsy of survivors performed: yes.
-Other examinations performed: clinical signs and body weight.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No unscheduled deaths occurred during the study.
- Clinical signs:
- other: No clinical signs were observed at 300 mg/kg and 2000 mg/kg.
- Gross pathology:
- No macroscopic post-mortem findings were observed.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the experimental conditions of this study, the oral LD50 of the test item, 2-Hydroxy Gamma ButyroLactone, was higher than 2000 mg/kg in rats.
Therefore, the test item should not be classified as toxic by oral route according to the criteria of CLP Regulation.
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.