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EC number: 210-848-5 | CAS number: 624-48-6
- 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
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- short-term repeated dose toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test procedure in accordance with national standard methods with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 410 (Repeated Dose Dermal Toxicity: 21/28-Day Study)
- Deviations:
- not specified
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Dimethyl maleate
- EC Number:
- 210-848-5
- EC Name:
- Dimethyl maleate
- Cas Number:
- 624-48-6
- Molecular formula:
- C6H8O4
- IUPAC Name:
- dimethyl (Z)-but-2-enedioate
- Test material form:
- other: liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 9-11 weeks
- Weight at study initiation: 216-238 g (males), 183-215 g (females)
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data
IN-LIFE DATES: no data
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- olive oil
- Details on exposure:
- TEST SITE
- Area of exposure: ca. 10 % of the body surface
- Type of wrap if used: occlusive
- Time intervals for shavings or clipplings: no data
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 ml/kg bw
- Constant volume used: yes - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- no data
- Duration of treatment / exposure:
- 6 hours daily
- Frequency of treatment:
- 5 days/week, 20 applications
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 60, 170, 500 mg/kg bw
Basis:
nominal per unit body weight
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- according to OECD guideline 410, adopted May 1981
- Positive control:
- not appropriate
Examinations
- Observations and examinations performed and frequency:
- according to OECD guideline 410, adopted May 1981
- Sacrifice and pathology:
- according to OECD guideline 410, adopted May 1981
- Other examinations:
- according to OECD guideline 410, adopted May 1981
- Statistics:
- no data
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Dermal irritation:
- effects observed, treatment-related
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- CLINICAL SIGNS AND MORTALITY:
No compound-related mortality and systematic clinical symptoms. Clear, dose-related local effects, ranging from slight erythema and scaling in the lowest dose group up to severe erythema, slight to moderate oedema and scaling and slight to severe necrosis in the highest dose group
BODY WEIGHT AND WEIGHT GAIN:
Significantly reduced body weight gain only in male rats of the middle and high-dose groups
FOOD CONSUMPTION
Significantly reduced feed consumption only in male rats of the middle and high-dose groups
HAEMATOLOGY
slight leucocytosis (increase of about 56%), accompanied by a slight increase of neutrophilic granulocytes (factor 2) and a decrease (27%) of lymphocytes in rats of the high-dose group.
CLINICAL CHEMISTRY
35% depletion of oxidized hepatic glutathione (GSSG) and a corresponding 37% decrease in the total hepatic glutathione (reduced glutathione and GSSG) level in the high dose group
URINALYSIS
No treatment-related changes.
ORGAN WEIGHTS
Absolute and relative organ weights of the liver, kidneys, heart, brain and adrenal glands were not significantly affected
GROSS PATHOLOGY
Clear, dose-related local effects, ranging from slight erythema and scaling in the lowest dose group up to severe erythema, slightto-
moderate oedema and scaling and slight to severe necrosis in the highest dose group
HISTOPATHOLOGY: NON-NEOPLASTIC
The histopathological examination did not reveal any treatment-related changes in the liver and kidney. In correlation with the macroscopic findings, some rats in the middle-dose group showed minimal to slight dermatitis, acanthosis and hyperkeratosis. Moderate dermatitis and moderate-to-marked necrosis were detected in all rats in the high-dose group.
Effect levels
- Dose descriptor:
- NOEL
- Effect level:
- 60 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: haematology; clinical chemistry; gross pathology; histopathology;
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The NOEL,dermal,rat,28days was 60 mg/kg body weight.
- Executive summary:
The test substance was applied to the shaved backs of 4 groups of 5 male and 5 female Wistar rats each on 6 hours per day on 5 days/week for a study period of 4 weeks. Investigations performed were in accordance with the OECD guideline 410.
No compound-related mortality and systemic clinical symptoms occurred. Clear, dose-related local effects, ranging from slight erythema and scaling in the lowest dose group up to severe erythema, slight to moderate oedema and scaling and slight to severe necrosis in the highest dose group, were observed. Significantly reduced feed consumption and body weight gain occurred only in male rats of the middle and high-dose groups.
The haematological investigation revealed slight leucocytosis (increase of about 56%), accompanied by a slight increase of neutrophilic granulocytes (factor 2) and a decrease (27%) of lymphocytes in rats of the high-dose group. The main effects of the clinical chemistry analysis were a 35% depletion of oxidized hepatic glutathione (GSSG) and a corresponding 37% decrease in the total hepatic glutathione (reduced glutathione and GSSG) level in the high dose group. Some variations in the haematological and clinicochemical parameters (thromboplastin, partial thromboplastin time, electrolytes, glucose, urea, transferases) of the high-dose group were observed, but they were considered to be of no major toxicological relevance.
Urinalysis did not reveal any treatment-related changes.
Absolute and relative organ weights of the liver, kidneys, heart, brain and adrenal glands were not significantly affected by treatment with the test substance.
The histopathological examination did not reveal any treatment-related changes in the liver and kidney. In correlation with the macroscopic findings, some rats in the middle-dose group showed minimal to slight dermatitis, acanthosis and hyperkeratosis. Moderate dermatitis and moderate-to-marked necrosis were detected in all rats in the high-dose group.
The systemic no-effect level was 60 mg/kg body weight.
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