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Diss Factsheets
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EC number: 202-777-3 | CAS number: 99-66-1
- 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:
- chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1975-1976
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Only Summary, but Basic data given
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Sprague Dawley rats were dosed orally with valproic acid during 6 months.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Valproic acid
- IUPAC Name:
- Valproic acid
- Details on test material:
- - Name of test material (as cited in study report): Valproic acid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- corn oil
- Remarks:
- 2%
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 6 months
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0, 79, 168, 341 mg/kg/day for males
Basis:
nominal in diet
- Remarks:
- Doses / Concentrations:
0, 97, 197,416 mg/kg/day for females
Basis:
nominal in diet
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent vehicle
Results and discussion
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 341 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: Clinical examination, Bodyweight changes, Food and water intake, Hematology, Blood chemistry, Urinalysis, Myelograms, Organ weights, Macroscopic and microscopic examination
- Dose descriptor:
- NOAEL
- Effect level:
- 416 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: Clinical examination, Bodyweight changes, Food and water intake, Hematology, Blood chemistry, Urinalysis, Myelograms, Organ weights, Macroscopic and microscopic examination
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
After 6 months, all doses including the high dose were well tolerated and without toxic effect in the rat.
The only noteworthy findings were as follows :
- increased blood potassium after 3 months in male (341 mg/kg/day) and female (197 and 416 mg/kg/day),
- decrease in total protein and serum albumin in females (197 and 416 mg/kg) throughout the study, decrease in total protein in high-dose males and in albuminin males from all groups after 4.5 months,
- lymphocytosis after 3 months in mid-and high-dose females and after 4.5 months in mid-and high-dose males,
- increase in thymus weight in all treated females and in relative kidney weight in all treated males with no apparent toxicological significance.
Applicant's summary and conclusion
- Conclusions:
- In a 6-month study, a NOAEL of 341 mg/kg/day was found for male Sprague-Dawley rats and a NOAEL of 416mg/kg/day for female Sprague-Dawley rats.
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