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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 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
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Literature searched from 1962 through 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Fragrance raw materials monographs: γ-VALEROLACTONE
- Author:
- Opdyke D.L.J.
- Year:
- 1 980
- Bibliographic source:
- Food Cosmet. T.
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- - Principle of test: Modification of the maximization test with 25 human volunteers to imrove identification of moderate sensitizers
- Short description of test conditions: The test item was applied to the same site on the volar aspect of the forearms for five 48 hour periods. Following a ten day rest period, the subjects were challenged with a patch applied to a previously untreated site for 48 hours using an occlusive dressing.
- Parameters analysed / observed: Not specified.
Origial study from Kligman (1966), Kliman & Epstein (1975) and Kligman (1978) - GLP compliance:
- 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:
- No details given.
Method
- Type of population:
- other: Healthy adult black prisoners
- Ethical approval:
- not specified
- Subjects:
- - Number of subjects exposed: 25
- Age: 18-50 years
- Race: Black - Clinical history:
- Not specified
- Controls:
- Control patch in provocative testing, consisting of 1 hour SLS exposure (2.5-10%), followed by 48 hour application of petrolatum.
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST USED: Patch test
ADMINISTRATION
- Site: Forearm or the lower leg in the calf region (induction), lower back (challenge)
- Type of application: Occlusive
- Description of patch: "occlusive dressing"
- Vehicle / solvent: Diethyl phthalate
- Concentrations: 10% of the test item in diethyl phthalate
- Volume applied: 1 mL (induction), 0.4 mL (challenge)
- Testing/scoring schedule: Five 48-hour periods for induction, then 10 days resting period, following challenge for 48 hours. Reactions were evaluated 72 and 96 hours after challenge.
EXAMINATIONS
- Grading/Scoring system: See "Any other information on material and methods incl. tables"
Results and discussion
- Results of examinations:
- SYMPTOMS
- Frequency, level, duration of symptoms observed: Not specified, no indication of sensitisation observed.
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 25
RESULT OF CASE REPORT: The test item was found to be not sensitizing.
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.