Registration Dossier
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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

Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study planned
- Study period:
- Upon ECHA approval and final decision
- Justification for type of information:
- Not a CMR.
No widespread use, professional or consumer use.
Hazard endpoint for which vertebrate testing was proposed:
Developmental toxicity (oral rat study) with the registered substance.
Considerations that the general adaptation possibilities of Annex XI of the REACH Regulation were not adequate to generate the necessary information:
available GLP studies
No available developmental GLP studies on the substances for the endpoint ‘developmental toxicity’.
available non-GLP studies
No reliable non-GLP studies are avaialable for the endpoint ‘ developmental toxicity’.
historical human data
No human data suggesting developmental toxicity are available for this substance.
(Q)SAR
No validated (Q)SAR’s exist for this endpoint for this substance
in vitro methods
In accordance with ECHA’s guidance on the information requirements and chemical safety assessment , chapter R7a. With regards to in vitro studies for developmental toxicity, the regulatory acceptance of these studies and approaches to replace the animal testing for developmental toxicity has not been achieved as they do not provide equivalent information and thus, cannot be used alone for classification and labelling and/or risk assessment.
weight of evidence
No study exists for developmental toxicity
grouping and read-across
No study exists for an analogous substance.
substance-tailored exposure driven testing [if applicable]
Based on existng exposure senario information on pivalic acid does not qualify for this exemption.
[approaches in addition to above [if applicable]
Not applicable
other reasons [if applicable]
Not applicable
Considerations that the specific adaptation possibilities of Annexes VI to X (and column 2 thereof) were not applicable:
Adaptation options as defined in Annexes VI to X were not applicable for this substance and this endpoint.
Data source
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
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
- Details on test material:
- - Name of test material (as cited in study report): MRD-64-1
- Substance type: white crystalline powder
Constituent 1
Test animals
- Species:
- rat
Results and discussion
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.

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