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Diss Factsheets
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EC number: 203-742-5 | CAS number: 110-16-7
- 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
- Endpoint:
- carcinogenicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions. Reliability adopted from OECD SIDS Draft.
Data source
Referenceopen allclose all
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 1 983
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 983
- Reference Type:
- secondary source
- Title:
- A 6-month multispecies inhalation study with maleic anhydride
- Author:
- Short, R.D., Johannsen, F.R., Ulrich, C.
- Year:
- 1 988
- Bibliographic source:
- Appl. Toxicol. 10: 517-524; cited in OECD SIDS Draft for CAS. Nos. 108-31-8/ 110-16-7, 2005
- Reference Type:
- secondary source
- Title:
- Chronic Dietary Administration of Maleic Anhydride
- Author:
- Preach, M.
- Year:
- 1 983
- Bibliographic source:
- cited in: EPA: Health and environmental effects profile for maleic anhydride, 06/1986
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 451 (Carcinogenicity Studies)
- Deviations:
- not applicable
- Remarks:
- due to missing details in the OECD SIDS
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Automatically generated during migration to IUCLID 6, no data available
- IUPAC Name:
- Automatically generated during migration to IUCLID 6, no data available
- Details on test material:
- - Name of test material (as cited in study report): Maleic anhydride
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The analysis of the diet for maleic anhydride was conducted 2 to 4 years after completion of the in-life phase of the study. A sample of each diet was removed, refrigerated or frozen for future chemical determination of the concentration of maleic anhydride. The GC-MS measurements were (on average of random samples) 69-75% of the expected for male and female diets, respectively.
- Duration of treatment / exposure:
- 2 years
- Frequency of treatment:
- 7 days/week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 10, 32, 100 mg/kg/day
Basis:
nominal conc.
- No. of animals per sex per dose:
- 126
- Control animals:
- yes, concurrent no treatment
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: No data
DETAILED CLINICAL OBSERVATIONS: Yes
BODY WEIGHT: Yes
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption : Yes
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data
OPHTHALMOSCOPIC EXAMINATION: Yes
HAEMATOLOGY: Yes
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: 5 animals of each sex from the control and each test group at 6 and 12 months and on approximately 20 animals from each group at 18 and 24 months.
CLINICAL CHEMISTRY: Yes
- Animals fasted: No data
- How many animals: 5 animals of each sex from the control and each test group at 6 and 12 months and on approximately 20 animals from each group at 18 and 24 months.
URINALYSIS: Yes
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data
NEUROBEHAVIOURAL EXAMINATION: No data
- Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes
Results and discussion
Results of examinations
- Details on results:
- CLINICAL SIGNS AND MORTALITY: no data
BODY WEIGHT AND WEIGHT GAIN: 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 AND COMPOUND INTAKE (if feeding study): slightly reduced during limited periods during the study for animals in the mid- and high-dose groups.
FOOD EFFICIENCY: no data
OPHTHALMOSCOPIC EXAMINATION: no data
HAEMATOLOGY: no data
CLINICAL CHEMISTRY: no data
URINALYSIS: no data
ORGAN WEIGHTS: no data
GROSS PATHOLOGY: no data
HISTOPATHOLOGY: NON-NEOPLASTIC: no data
HISTOPATHOLOGY: NEOPLASTIC: No increases in tumor incidence that were considered related to maleic anhydride exposure. There was an unusally high incidence of uterine adenocarcinomas in this study. The tumors were present in similar numbers in both the 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 rat,” although no historical control data was provided. The authors speculated that this may have been related to altered hormonal status caused by the continuous light exposure.
Effect levels
open allclose all
- Dose descriptor:
- NOEL
- Effect level:
- >= 100 other: mg/kg/day
- Sex:
- male/female
- Basis for effect level:
- other: overall effects
- Remarks on result:
- other: Effect type: carcinogenicity (migrated information)
- Dose descriptor:
- NOEL
- Effect level:
- 10 mg/kg bw/day
- Sex:
- male/female
- Basis for effect level:
- other: reduced body weight (& food consumption)
- Remarks on result:
- other: Effect type: toxicity (migrated information)
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.