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Diss Factsheets
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EC number: 200-922-5 | CAS number: 75-98-9
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study wqs conducted according to O.E.C.D. Testing Guideline 407 following the GLP regulations with analytical verification of concentration and stability.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Pivalic acid
- EC Number:
- 200-922-5
- EC Name:
- Pivalic acid
- Cas Number:
- 75-98-9
- Molecular formula:
- C5H10O2
- IUPAC Name:
- 2,2-dimethylpropanoic acid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Details on oral exposure:
- Vehicle = water/PEG 200 50/50 (v/v). Samples prepare once per week.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Analysis showed that achieved concentrations and stability were acceptable in all cases.
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- 5.0 ml/kg/day
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
10 mg/kg/d
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
30 mg/kg/d
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
100 mg/kg/d
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
300 mg/kg/d
Basis:
actual ingested
- No. of animals per sex per dose:
- 7
- Control animals:
- yes
- Positive control:
- 5.0 ml/kg/d vehicle = water/PEG 200 50/50 (v/v
Results and discussion
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 30 mg/kg bw/day (actual dose received)
- Sex:
- male/female
- Basis for effect level:
- other: NOAEL for systemic endpoints was 30 mg/kg/day. The NOAEL for local irritational events was 30 mg/kg/day.
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
There was no treatment related effect on survival.
The only clinical sign seen in this study was atransient effect. Immediately after dosing the 100 or 300 mg/kg/day test formulations, rats were observed to sneeze and produce a dark nasal discharge. This transient behaviour probably resulted from a mild irritant effect of the volatile acid test substance on nasal mucosa.
A slightly lower bodyweight in the 300 mg/kg/day dose group females was considered to be of uncertain relation to treatment.
There was no effect on male bodyweight , food intake, haematological parameters, or histopathological observations at any dose level.
Changes in alkaline phosphatase, cholesterol, creatinine and bilirubin in females suggested a slight change in liver function at the 100 and 300 mg/kg/day dose level, however, there was no associated histopathalogical changes.
Minor differences in hepatic macroscopic appearance, liver weight and kidney weight were not accompanied by any histopathological change. These differences were considered to be related to adaptive or functional changes and not a toxic effect.
There was no evidence of a cumulative toxic effect at any dose level. However, transient irritancy or adaptive changes were seen at 30, 100 and 300 mg/kg/day.
Additionaly, minor differences in liver and kidney weight were seen at 10 mg/kg/day, these were of uncertain relationship with treatment.
The no adverse effect level for treatment with pivalic acid was 30 mg/kg/day for systemic and 30 mg/kg/day for local irritation
Applicant's summary and conclusion
- Conclusions:
- The NOAEL for systemic effects was 30 mg/kg/day. The NOAEL for local irritational effects was 30 mg/kg/day.
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.
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