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EC number: 203-743-0 | CAS number: 110-17-8
- 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:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- no
- Remarks:
- GLP was not yet legally implemented when the study was conducted.
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study report from 1989 available.
Test material
- Reference substance name:
- Fumaric acid
- EC Number:
- 203-743-0
- EC Name:
- Fumaric acid
- Cas Number:
- 110-17-8
- Molecular formula:
- C4H4O4
- IUPAC Name:
- but-2-enedioic acid
- Details on test material:
- - Physical state: Solid
- Analytical purity: >99.6%
- Lot/batch No.: Month average March 1989
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Bor: DHPW
- Sex:
- female
- Details on test animals and environmental conditions:
- One to five animals were kept in type IV Makrolon cages for an acclimation period of 5-8 days. Average weight of animals was 400 g. G4 general diet for guinea pigs and water were provided ad libitum. Room temperature was 20 °C with 60 % relative humidity. There were 15 air exchanges per hour with a 12 hr light-dark rhythm.
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- corn oil
- Concentration / amount:
- Induction, intradermal: 0.5%
Induction, epicutaneous: 25% test material - Day(s)/duration:
- 7
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- Challenge: 25 %
- Day(s)/duration:
- 2
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 19 animals per dose
- Details on study design:
- A total of six intracutaneous injections were made in the right and left shoulder area of animals: a mixture of Freunds Complete Adjuvant and water, 0.5 % test material in corn oil, and 0.5 % test material in a mixture of FCA and corn oil. A patch test was carried out a week later. Twenty-four hours prior to the patch test, the shoulder region was shaved and 10 % SDS prepared in vaseline was massaged into the skin to provoke a mild skin irritation. Filter paper was coated with 25 % test material in corn oil, applied to the injection region and covered with an adhesive bandage. The patch was secured for 48 hrs with an elastic bandage.
Two weeks later, a filter paper patch coated with 25% test substance in corn oil was applied to the left flank of animals and covered with an adhesive bandage. An elastic bandage was used to secure the patch for 24 hours. A patch containing only corn oil was applied to the right flank of animals. - Challenge controls:
- A total of six intracutaneous injections were made in the right and left shoulder area of animals: A mixture of Freunds Complete Adjuvant and water, corn oil, and a mixture of FCA and corn oil. A patch test was carried out a week later. Filter paper was coated with corn oil, applied to the injection region and covered with an adhesive bandage. The patch was secured for 48 h with an elastic bandage. Two weeks later, a filter paper patch coated with 25 % test substance in corn oil was applied to the left flank of animals and covered with an adhesive bandage. An elastic bandage was used to secure the patch for 24 hours. A patch containing only corn oil was applied to the right flank of animals.
- Positive control substance(s):
- not required
Results and discussion
- Positive control results:
- None - not necessary according to guideline.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 45
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Group:
- positive control
- Remarks on result:
- not measured/tested
Any other information on results incl. tables
Local reactions during experiment
After intracutaneous injection: All injection sites treated with FCA showed intense redness and swelling, as well as necrosis, in both control and treated animals. Mild redness and swelling was also seen in control animals treated with corn oil. Twenty-four hours after patch removal, all injection sites treated with FCA were crusted and scabby.
After patch test of 48 h duration: Intense inflammation, at times bloody, was seen in control and test animals treated with FCA and demineralised water. 24 hours after patch removal: all injections sites treated with FCA were crusted and scabby.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Conclusions:
- This study supports the conclusion that fumaric acid is not a skin sensitiser.
- Executive summary:
Fumaric acid shows no sensitisation effect on the skin of female guinea pigs according to the Magnusson-Kligman maximization test.
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