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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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: well documented study, a reliability of 2 is assigned
Data source
Reference
- Reference Type:
- publication
- Title:
- Hypolipidemic activity of aliphatic dicarboxylic acids in rodents.
- Author:
- Izydore RA, Hall IH
- Year:
- 1 991
- Bibliographic source:
- Acta Pharm. Nord. 3 (3): 141-146
Materials and methods
- Principles of method if other than guideline:
- The hypolipidemic activity of maleic acid was investigated.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Maleic acid
- EC Number:
- 203-742-5
- EC Name:
- Maleic acid
- Cas Number:
- 110-16-7
- Molecular formula:
- C4H4O4
- IUPAC Name:
- but-2-enedioic acid
- Details on test material:
- Maleic acid, no data on purity
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- - Mean body weight 350 g
- Food and water were available ad libitium for animals in experiments. The animals were maintained in plastic cages in 12 h cycles of light and dark at 22°C.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 14 days
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
20 mg/kg/d
Basis:
actual ingested
- No. of animals per sex per dose:
- 6 males
- Control animals:
- yes
- Details on study design:
- Post-exposure period: none
Examinations
- Observations and examinations performed and frequency:
- Food consumption was determined daily for control rats and for those treated orally with compounds. Body weights were obtained during the experiments and expressed a percentage of the animals weight on day 0. After dosing for 14 days with compounds, selected organs were excised, trimmed of fat and weighed. On days 7 and 14, blood samples were taken and examined for serum lipids. After termination of administration, the liver, small intestine, aorta, and fecal materials (24 h collection) were removed, extracted and analyzed for tissue lipid levels (cholesterol, triglyceride, neutral lipids, and phospholipids) and protein levels; serum was examined for lipoprotein contents.
Results and discussion
Results of examinations
- Details on results:
- Body weight and food consumption
Food consumption of the treated rats was suppressed by 6% compared to controls, however, total body weight and organ weights were not altered significantly by drug treatment.
Clinical chemistry
Serum levels of free and total cholesterol were significantly decreased on days 7 and 14 (about half the control values); serum levels of triglycerides were also significantly decreased on days 7 and 14 (about three quarters of control values). Lipid content was significantly decreased in liver extract and significantly increased in fecal extract. In liver tissue, the levels of free and total cholesterol, triglyceride, and phospholipids were significantly decreased. In the small intestinal mucosa, levels of free and total cholesterol and phospholipids were significantly decreased. In aorta wall tissue, the level of free and total cholesterol was significantly decreased. In feces, levels of free and total cholesterol and triglyceride were significantly increased. The levels of neutral lipids were not significantly altered in any examined tissues. Protein content was significantly increased in tissue of the aorta wall and in feces. After 14 days of treatment, the serum levels of free and total cholesterol of the VLDL and LDL fraction were significantly decreased. HDL triglyceride content was significantly increased while the triglyderide content of the chylomicron fraction was significantly decreased. Neutral lipid content of serum was significantly decreased in chylomicron, VLDL, LDL, and HDL. Phospholipid levels were significantly increased in chylomicron and LDL fraction and significantly decreased in VLDL fraction. Chylomicron and VLDL protein content was significantly increased; LDL protein content was significantly decreased.
Effect levels
- Dose descriptor:
- LOAEL
- Effect level:
- 20 mg/kg bw/day (nominal)
- Sex:
- male
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
According to the authors, the findings showed that maleic acid was an effective hypolipidemic agent in rats.
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.
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