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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 213-116-3 | CAS number: 925-21-3
- 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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics
- Type of information:
- other: Evaluation based on all available information.
- Adequacy of study:
- key study
- Study period:
- The assessment was conducted in March 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
- Objective of study:
- toxicokinetics
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Summaries of studies were reviewed by a qualified toxicologist with a view to fulfilling the requirements of Annex VIII, point 8.8 of REACH.
- Deviations:
- not applicable
- GLP compliance:
- no
- Remarks:
- Not applicable.
Test material
- Reference substance name:
- Butyl hydrogen maleate
- EC Number:
- 213-116-3
- EC Name:
- Butyl hydrogen maleate
- Cas Number:
- 925-21-3
- Molecular formula:
- C8H12O4
- IUPAC Name:
- (2Z)-4-butoxy-4-oxobut-2-enoic acid
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): Butyl Hydrogen Maleate
- Physical state: Pale yellow liquid
Constituent 1
- Radiolabelling:
- no
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- Results of the repeated dose reproductive screening study showed evidence to support the gastric absorption of the test item. The test item is lipophobic in
nature and because of the high water solubility (37.0 g/L at 20°C + 0.5°C) and small molecular size of the substance absorption through passive diffusion is possible. This would suggest that the gastro-intestinal tract provides a route of absorption, following oral administration, before entering the circulatory system via the blood.
Limited absorption may also take place via the skin due to small molecular size and water solubility. The substance is corrosive therefore damage to the skin
surface may allow for increased penetration of the substance through the skin. The low vapour pressure value (0.2 Pa at 25°C) shows that the substance is not available as a vapour therefore inhalation is not a significant route of exposure. - Details on distribution in tissues:
- Systemic distribution is evident from the repeated dose reproductive screening study because of the organ changes observed.
Once absorbed, the substance may be distributed in serum due to the water solubility and may therefore be distributed systemically. The low log octanol/water partition coefficient (log10 Pow 1.39) and high water solubility (37.0 g/L) would also suggest that the test item is not lipophilic and would not accumulate in body fat.
- Details on excretion:
- The results of the repeated dose reproductive screening study would suggest that the most likely route of excretion is the kidney due to the likely systemic
distribution and water solubility of the test item. In addition to the high water solubility, a molecular weight of below 300 g/mol in the rat is also a characteristic favourable for urinary excretion. Any test item that is not absorbed from the gastro intestinal tract will be excreted in the faeces.
Metabolite characterisation studies
- Metabolites identified:
- not measured
- Details on metabolites:
- The results of the repeated dose reproductive screening study showed evidence of an adaptive response in the liver and thyroids in rats; which is normally
associated with enhanced metabolism. The results of the genotoxicity assays showed that genotoxicity is neither enhanced nor diminished in the presence of the S9 metabolising system.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): bioaccumulation potential cannot be judged based on study results
The available information suggests that absorption of the test substance from the gastrointestinal tract can take place. Some absorption may also take place via the skin.
Once absorbed, the substance would be distributed in the serum and urine is the significant route of excretion. There is evidence to suggest that the test substance may be metabolised, however no studies have been conducted to identify metabolites. - Executive summary:
The available information suggests that the substance is readily available via the oral route; however absorption via the skin is also possible. This is supported by the physicochemical properties of the substance. Once absorbed, the substance would result in distribution in the serum. Urinary excretion is considered to be the significant route for the substance.
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.