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Diss Factsheets
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EC number: 207-975-3 | CAS number: 503-74-2
- 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:
- sub-chronic toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented publication which meets basic scientific principles. Screening test method, accepted scientific standards, sufficiently documented, acceptable for assessment.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Method: other: see Method
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Sodium isovalerate
- EC Number:
- 208-723-5
- EC Name:
- Sodium isovalerate
- Cas Number:
- 539-66-2
- IUPAC Name:
- sodium 3-methylbutanoate
- Details on test material:
- The anhydrous acid was treated with NaOH to give sodium isovalerate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:
- Age at study initiation: 4 weeks
- Weight at study initiation: 90 g
- Housing: in groups of 5 or 6
- Diet: ad libitum (30% dextrose, 20% cormmeal; 20% soybeanmeal, 10% casein, 9% corn starch, 5% corn oil, 4% salt mixture, 2% mixture of vitamins in dextrose)
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: diet
- Details on oral exposure:
- DIET PREPARATION
no data - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 14 d (pilot study) and 90 d (main study)
- Frequency of treatment:
- continuous
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
5 % [= 50000 ppm)
Basis:
nominal in diet
- Remarks:
- Doses / Concentrations:
approx. 5000 mg/kg bw/day
Basis:
actual ingested
- No. of animals per sex per dose:
- 5 to 6 males
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- Post-exposure period: no
Results and discussion
Results of examinations
- Clinical signs:
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- weight gain 6.2g/day; identical to controls
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- 14g/day
- Haematological findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- no findings; 35 organs examined
- Histopathological findings: neoplastic:
- no effects observed
- Description (incidence and severity):
- no findings; 35 organs examined
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 50 000 ppm
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: 5% in feed = 50,000 ppm in feed
- Dose descriptor:
- NOAEL
- Effect level:
- 5 other: %
- Dose descriptor:
- NOAEL
- Effect level:
- 5 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: Calculated, assuming a food uptake of 100g/kg bw and day
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Range-finding study:
At
10-% TS, food consumption was markedly reduced, associated with substantial
weight loss.
Definitive
study:
At 5 % [approx. 5000 mg/(kg bw and day)], no adverse effects were noted
with respect to body weight development and organ weights, histology,
and blood parameters. No local effects (irritation) were observed at
that dose level.
The mean urinary pH value was 8.4 in animals ingesting isovaleric acid salt,
compared with 7.2 for the control animals (Amoore et al, 1978).
Applicant's summary and conclusion
- Conclusions:
- Despite the low number of animals it can be concluded that in light of the high dose applied the prolonged uptake of the TS is not associated with toxic effects in rats.
- Executive summary:
In a rat feeding study, neutralised isovaleric acid was fed to a group of 5 to 6 male SD rats for 90 days at 5% (50,000 ppm) in the diet. In a pilot study with 10%, the food intake was significantly reduced, rats lost significantly weight, and one rat dies. No effects were seen in the main study In the main study, the parameters examined (food consumption, bodyweight development, organ weights, haematology, blood chemistry, urinalysis, and histopathology of 35 organs) did not significantly differ from controls with the exception of a more basic urine in treated rats compared to controls (pH 8.4 versus 7.2). Based on the above the authors concluded that the NOAEL was 5% in diet or 5000 mg/kg bw/day in this study (Amoore et al, 1978).
The protocol of this pre-guideline, pre-GLP study is not fully comparable to current guideline studies since the animal number was low, only male rats were used, and because the documentation is brief. On the other hand side the study clearly showed that ingestion of even large amounts of isovaleric acid with the feed over a 3-months period did not cause local or systemic adverse effects. The study is therefore considered to be valid and suitable for assessment.
NOAEL of 5000 mg/kg for sodium isovalerate corresponds to an NOAEL of 4100 mg/kg for the free isovaleric acid.
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