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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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline with restrictions (method shortly described; LD50 expressed in mL/kg instead of mg/kg; animals not fasted before exposure).
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- method shortly described; LD50 expressed in mL/kg instead of mg/kg; animals not fasted before exposure.
- GLP compliance:
- no
- Remarks:
- GLP was not mandatory at the time of the study
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Germany.
- Weight at study initiation: 160-180 g.
- Housing: animal were housed in groups of 5 animals per cage. - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- Observation period: 14 days.
- Doses:
- Doses: 1.0, 1.5, 1.8, 2.0, and 3.1 mL/kg (1150, 1750, 2070, 2300, 3565 mg/kg bw).
- No. of animals per sex per dose:
- 10
- Control animals:
- other: not necessary
- Statistics:
- The calculation of the LD50 was performed according to Fink and Hund, Arzneim.-Forsh 15, 1965, 624.
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 1 909 mg/kg bw
- 95% CL:
- 1 644 - 2 116
- Remarks on result:
- other: rat
- Mortality:
- Mortality occurred at doses of 1750 mg/kg bw and higher concentrations.
- Clinical signs:
- other: Toxic symptoms: reduction of general conditions.
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- Based on the study results and according to EU classification criteria, the test substance is classified as Acute Tox. 4, according to the CLP regulation.
- Executive summary:
Bayer (1977)
In an acute oral toxicity 10 non-fasted male rats were administered with 1150, 1750, 2070, 2300, 3565 mg/kg bw dimethyl maleate with a method similar to OECD guideline 401 with acceptable deviations (method shortly described; LD50 expressed in mL/kg instead of mg/kg; animals not fasted before exposure).
The animals were observed for 14 days after administration.
Mortality occurred at doses of 1750 mg/kg bw and higher concentrations. Reduction of general conditions was observed. The acute oral LD50 was calculated to be 1909 mg/kg bw.
Based on the study results and according to EU classification criteria, the test substance is classified as Acute Tox. 4, according to the EU-CLP regulation.
Reference
LD 50= 1.66 mL/kg. The density of dimethyl maleate is 1.15 g/cm³ at 20 °C. Therefore LD50 expressed in mg/kg is calculated to be 1909 mg/kg.
Table 1. Acute oral toxicity results
Dosis mg/kg b.w |
Time of death |
Toxicological Results Dead animals/ Aanimals with symptoms/Animals used |
1150 |
- |
0/0/10 |
1750 |
2 -5d |
3/10/10 |
2070 |
2 -7d |
7/10/10 |
2300 |
2 -4d |
8/10/10 |
3565 |
4h -2d |
10/10/10 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 909 mg/kg bw
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study with restrictions (analytical purity not reported; occlusive dressing instead of porous dressing).
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- analytical purity not reported, occlusive dressing instead of porous dressing.
- Principles of method if other than guideline:
- This study was conducted using the method of Noaks and Sanderson (1969). British Journal of Industrial Medicine 26:59-64.
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Age at study initiation: 9-12 weeks old.
- Weight at study initiation: 235-288 g (males); 179-230 g (female). - Type of coverage:
- occlusive
- Vehicle:
- not specified
- Details on dermal exposure:
- 5/rats/sex/group received a single application of 500 or 2000 mg MAD/kg body weight on their shaved backs (area approx. 20 cm²), and this was covered with an occlusive dressing for 24 hours. The rats were observed for 14 days after application, and systemic and local effects were recorded.
- Duration of exposure:
- 24 hours
- Doses:
- 500 or 2000 mg of dimethyl maleate/kg body weight.
- No. of animals per sex per dose:
- 5/sex/ group
- Control animals:
- no
- Details on study design:
- Details on study design
- Duration of observation period following administration: 14 days.
- Examinations performed: systemic and local effects were recorded. - Statistics:
- no data
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: rat
- Mortality:
- No deaths occurred after application of 500 or 2000 mg dimethyl maleate/kg body weight.
- Clinical signs:
- other: No systemic effects occurred after application of 500 or 2000 mg dimethyl maleate/kg body weight. Local erythema followed by necrosis could be observed in the treated skin in both groups.
- Interpretation of results:
- GHS criteria not met
- Executive summary:
Heimann (1991)
Acute dermal toxicity study was conducted according to OECD guideline 402 with acceptable restrictions (analytical purity not reported, occlusive dressing instead of porous dressing).
5 rats/sex/group received a single application of 500 or 2000 mg dimethyl maleate/kg body weight on their shaved backs (area approx. 20 cm²), and this was covered with an occlusive dressing for 24 hours. The rats were observed for 14 days after application, and systemic and local effects were recorded.
No deaths and no systemic effects occurred after application of 500 or 2000 mg dimethyl maleate/kg body weight. Therefore, the LD50 was concluded to be greater than 2000 mg/dimethyl maleate body weight. Local erythema and followed by necrosis could be observed on the treated skin in both groups.
Based on the study results and according to EU and EU-CLP classification criteria, the test substance is not to be classified.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- > 2 000 mg/kg bw
Additional information
Justification for classification or non-classification
Acute oral toxicity:
The acute oral LD50 was calculated to be 1909 mg/kg bw. Based on the study results, the test substance is classified as Acute Tox. 4, according to the EU-CLP regulation.
Acute dermal toxicity:
The LD50 was concluded to be greater than 2000 mg/kg bw. Based on the study results and according to EU-CLP classification criteria, the test substance is not to be classified.
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