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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
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- 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 GLP, analytical purity not reported, only few information on animal environmental conditions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- no GLP, analytical purity not reported, only few information on animal environmental conditions.
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- other: Albino
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hacking & Churchill Ltd., Huntingdon, UK.
- Housing: animals were housed in standard conventional single cages.
- Diet (e.g. ad libitum): Standard diet ( “Ssniff K4” Versuchstierdiäten GmbH, Soest/Westfalen) ad libitum.
- Water (e.g. ad libitum): ad libitum.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25 °C.
- Humidity (%): 40-60%.
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light. - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The untreated skin area served as control.
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 3
- Details on study design:
- The day before the application of the test substance the flank skin of each animal was shaved with an electric hair clipper on both sides on an area of about 6x6 cm.
For the treatment of each animal, 0.5 mL of the undiluted test substance was applied to a gauze patch (2.5 x 2.5 cm²).
The patch was then placed on the flanks of the animal and secured with an elastic, air permeable adhesive bandage.
After 4 hours the bandages were removed, and the exposed skin was washed with water. - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- No sign of irritation or corrosion was found on the application site right after the exposure, and during and at the end of observation time.
- Interpretation of results:
- GHS criteria not met
- Executive summary:
Suberg (1985)
In a primary dermal irritation study, the skin irritation/corrosion potential of dimethyl maleate was tested according to OECD guideline 404 with acceptable restrictions (no GLP, analytical purity not reported, only few information on animal environmental conditions). The shaved flank of 3 male New Zealand White rabbits was exposed to 0.5 mL dimethyl maleate for 4 hours under semiocclusive conditions. The rabbits were observed up to 14 days. Skin reactions were assessed using the Draize scheme approx. 1, 24, 48 and 72 hours after removal of the test substance. No sign of irritation or corrosion was found on the application site right after the exposure, and during and at the end of observation time. Based on the study results, the dimethyl maleate was assessed as not irritating according to EU classification criteria.
Reference
Table 1. The individual skin reactions are collected in the following table.
Animal number | 1 hours |
24 hours |
48 hours |
72 hours |
7 days |
14 days |
||||||
Erythema | Edema | Erythema | Edema | Erythema | Edema | Erythema | Edema | Erythema | Edema | Erythema | Edema | |
7 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
8 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
10 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- 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 GLP, analytical purity not reported, only few information on animal environmental conditions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- no GLP, analytical purity not reported, only few information on animal environmental conditions.
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hacking& Churchill Ltd., Huntingdon, UK.
- Housing: single housing in standard conventional cages.
- Diet (e.g. ad libitum): Standard diet ( “Ssniff K4” Versuchstierdiäten GmbH, Soest/Westfalen) ad libitum.
- Water (e.g. ad libitum): ad libitum.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25 °C.
- Humidity (%): 40-60%.
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light. - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye served as control
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 7 d
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- After application, the eye lids were held together for approximately 1 second.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with NaCl phisiological solution.
- Time after start of exposure: 24 hours after application.
SCORING SYSTEM: Draize.
TOOL USED TO ASSESS SCORE: fluorescein. - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 1.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritant / corrosive response data:
- All animals showed slight corneal opacity after application, slight iritis, partially scaled pupil, as well as slight redness and swelling of the conjunctiva with lacrimation. 7 days after application none of the mentioned symptoms were observed anymore and no change from the normal physiological findings was recorded in the eyes.
- Interpretation of results:
- Category 2B (mildly irritating to eyes) based on GHS criteria
- Conclusions:
- Based on the study results, dimethyl maleate is is classified as Category 2B (mildly irritating to eyes) according to UN-GHS regulation and classificed as Category 2 according to EU-CLP.
- Executive summary:
Suberg (1985)
In an eye irritation study, 0.1 mL of undiluted dimethyl maleate was instilled into the conjunctival sac of one eye of three male New Zealand White rabbits. Animals were observed for 7 days. Irritation was scored according to the method of Draize. All animals showed slight corneal opacity after application, slight iritis, partially scaled pupil, as well as slight redness and swelling of the conjunctiva with lacrimation. 7 days after application none of the mentioned symptoms were observed anymore and no change from the normal physiological findings was recorded in the eyes. Based on the study results, dimethyl maleate is is classified as Category 2B (mildly irritating to eyes) according to UN-GHS regulation and classificed as Category 2 according to EU-CLP.
Reference
Table 1: Results of eye irritation test
Conjunctiva |
|||||
Rabbit No./ sex |
Scoring [h] |
Cornea |
Iris |
Redness |
Chemosis |
42/male |
1 | 2 | 1 | 2 | 3 |
24 | 2 | 1 | 3 | 2 | |
48 | 2 | 0 | 2 | 1 | |
72 | 1 | 0 | 1 | 0 | |
168 | 0 | 0 | 0 | 0 | |
Mean (24, 48, 72 h) |
1.7 | 0.3 | 2 | 1 | |
43/male |
1 | 1 | 1 | 2 | 2 |
24 | 1 | 1 | 3 | 1 | |
48 | 1 | 0 | 1 | 1 | |
72 | 1 | 0 | 1 | 0 | |
168 | 0 | 0 | 0 | 0 | |
Mean (24, 48, 72 h) |
1 |
0.3 |
1.7 | 0.7 | |
44/male |
1 | 1 | 1 | 2 | 2 |
24 | 1 | 0 | 2 | 1 | |
48 | 1 | 0 | 1 | 1 | |
72 | 1 | 0 | 1 | 0 | |
168 | 0 | 0 | 0 | 0 | |
Mean (24, 48, 72 h) |
1 | 0 | 1.3 | 0.7 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
Justification for classification or non-classification
Skin irritation:
According to the OECD TG404 (1985) study resulst, dimethyl maleate is not classified according to EU-CLP.
Eye irritation:
According to the OECD TG 405 study results, dimethyl maleate is classified as Category 2B (mildly irritating to eyes) according to UN-GHS regulation and classificed as Category 2 according to EU-CLP.
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