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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 203-571-6 | CAS number: 108-31-6
- 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
Carcinogenicity
Administrative data
Description of key information
Maleic anhydride has low concern for carcinogenicity
Key value for chemical safety assessment
Justification for classification or non-classification
According to Directive 67/548/EEC, no classification is proposed for this substance based on the tests results.
Additional information
An oral feeding carcinogenicity study has been conducted for maleic anhydride and another one for maleic acid. Both studies are likely to reflect the toxicity of maleic acid since maleic anhydride is rapidly hydrolyzed to maleic acid in the body, particularly by the oral route of exposure.
Maleic anhydride
Maleic anhydride Male and female rats were exposed to 0, 10, 32, or 100 mg/kg/day maleic anhydride in feed, seven days a week for two years. There was only marginal toxicity, which was evidenced by small (<6%), but dose-related, decrease in body weights of male rats fed 32 and 100 mg/kg/day compared to the controls. The female rats fed 32 and 100 mg/kg/day also had reduced body weights, but the reductions were smaller and of shorter duration than those observed in males. Food consumption was also slightly reduced during limited periods during the study for animals in the mid- and high- dose groups. There were no increases in tumor incidence that were considered related to maleic anhydride exposure. There was an unusually high incidence of uterine adenocarcinomas in this study. These lesions were present in similar numbers in control and treated animals (23/86 and 20/82, respectively). The report stated that “Uterine adenocarcinomas is not a common spontaneous lesion in this strain of rats,” although no historical control data was provided. It is unclear why the incidence of uterine adenocarcinomas was high in this particular study both in the controls and the treated animals. But, it does not appear to be related to exposure to maleic anhydride. The authors speculated that this may have been related to altered hormonal status caused by the continuous light exposure since there were problems with the animal room lighting control system which resulted in exposure to continuous light for an unknown period.
Maleic acid
In a two-year chronic feeding study, Osborne-Mendel rats were fed 0, 0.5, 1.0, or 1.5% (0, 5000, 10000 and 15000 ppm) maleic acid in their diets for two years. These concentrations can be approximated to correspond with doses of (0, 250, 500 and 750 mg/kg/day) assuming a 0.4 kg rat eats 20g food/day. Concentrations of 1.0 and 1.5% maleic acid retarded the growth rate of rats and all concentrations of maleic acid increased mortality rate. However, no treatment-related increase in tumors was reported (Fitzhugh and Nelson, 1947).
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.