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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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- No analytical purity reported; no positive control reported; method shortly described
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- No analytical purity reported; no positive control reported; method shortly described.
- Principles of method if other than guideline:
- The sensitizing potential of maleic acid dimethylester was tested on the skin of guinea pigs according to the maximization protocol developed by Magnusson and Kligman (1969).
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
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
- Details on test material:
- - Name of test material (as cited in study report): maleic acid dimethylester
- Analytical purity: not reported
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 276-328 g
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: ethanol
- Concentration / amount:
- A concentration of 1% maleic acid dimethylester in physiological saline solution (NaCl 0.9%) was used for the intradermal and dermal induction as well as for the dermal challenge.
Challengeopen allclose all
- Route:
- other: dermal challenge
- Vehicle:
- other: ethanol
- Concentration / amount:
- A concentration of 1% maleic acid dimethylester in physiological saline solution (NaCl 0.9%) was used for the intradermal and dermal induction as well as for the dermal challenge.
- No. of animals per dose:
- 10 treated , 5, controls.
- Details on study design:
- RANGE FINDING TESTS: The sensitization dose was chosen based on the results of a preliminary investigation where 100, 10 and 1% maleic acid dimethylester were tested. The applied volumes were 0.1 mL (intradermal) and 0.5 mL (dermal).
- Challenge controls:
- no data
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- During the entire observation period after the challenge treatment, positive reaction (erythema and oedema) occurred on the skin of the 10 guinea pigs treated with 1% maleic acid dimethylester.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1%. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: During the entire observation period after the challenge treatment, positive reaction (erythema and oedema) occurred on the skin of the 10 guinea pigs treated with 1% maleic acid dimethylester..
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- During the entire observation period after the challenge treatment, erythema occurred on the skin of the 10 animals and oedema occured on the skin of 8 guinea pigs treated with 1% maleic acid dimethylester.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 1%. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: During the entire observation period after the challenge treatment, erythema occurred on the skin of the 10 animals and oedema occured on the skin of 8 guinea pigs treated with 1% maleic acid dimethylester..
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Any other information on results incl. tables
Table 2. Sensitization scores of guinea pigs challenged* with 1% maleic acid dimethylester in 0.9% NaCl solution (with 1.5% ethanol).
Evaluation time (hr) | Effect | No. of guinea-pigs affected | |||||||||
48 | Control animals | 1 | 2 | 3 | 5 | ||||||
Erythema | 0 | 0 | 0 | 0 | |||||||
Oedema | 0 | 0 | 0 | 0 | |||||||
Treated animals | 11 | 12 | 13 | 14 | 15 | 16 | 17 | 18 | 19 | 20 | |
Erythema | 2 | 2 | 2 | 1 | 4 | 2 | 4 | 1 | 4 | 1 | |
Oedema | 1 | 1 | 2 | 1 | 2 | 2 | 1 | 1 | 2 | 1 | |
Open wound | x | ||||||||||
Scab formation | x | x | x | ||||||||
72 | Control animals | 1 | 2 | 3 | 5 | ||||||
Erythema | 0 | 0 | 0 | 0 | |||||||
Oedema | 0 | 0 | 0 | 0 | |||||||
Treated animals | 11 | 12 | 13 | 14 | 15 | 16 | 17 | 18 | 19 | 20 | |
Erythema | 1 |
2 |
2 |
1 |
4 |
3 |
4 |
1 |
4 |
1 |
|
Oedema | 1 |
1 |
2 |
0 |
2 |
2 |
1 |
1 |
2 |
0 |
|
Open wound | x |
x |
|||||||||
Scab formation | x |
x |
x |
x |
x |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Remarks:
- Skin Sens. 1 (CLP regulation).
- Executive summary:
Heimann (1991)
Dimethyl maleate was investigated for sensitization potential. A sensitization test was performed according to OECD guideline 406 (No analytical purity reported; no positive control reported; method shortly described).
15 female guinea pigs were used for the main study (10 treated, 5 controls). A concentration of 1% dimethyl maleate in physiological saline solution (NaCl 0.9%) was used for intradermal and dermal induction as well as for the dermal challenge. Ethanol served as a vehicle. The sensitization dose was chosen based on the results of a preliminary investigation where 100, 10, and 1% dimethyl maleate were tested. The applied volumes were 0.1 mL (intradermal) and 0.5 mL (dermal).
During the 48 h observation period after the challenge treatment, positive reaction (erythema and oedema) occurred on the skin of the 10 guinea pigs treated with 1% dimethyl maleate. Results of the maximization test in guinea pigs indicated a clear sensitizing potential of dimethyl maleate. During the 72h observation period after the challenge treatment, erythema and oedema occurred on the skin of the 10 and 8 guinea pigs respectively treated with 1% dimethyl maleate.
Based on the study results, the dimethyl maleate is skin sensitizers according to Category 1 for skin sensitization of the CLP Regulation.
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