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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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25 April to 9 May 1984
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 12 May 1981
- GLP compliance:
- no
- Remarks:
- GLP was not yet legally implemented when the study was conducted.
Test material
- Reference substance name:
- Fumaric acid/Fumaril
- IUPAC Name:
- Fumaric acid/Fumaril
- Details on test material:
- - Physical state: Solid
- Analytical purity: 99.5%
- odour: odourless
- Name of test material (as cited in study report): fumaric acid
- Impurities (identity and concentrations): benzoic, maleic and phthalic acid <0.05%
- Composition of test material, percentage of components:
- Stability under test conditions:
- Storage condition of test material:
- Other: pH 2.1 at 4.9 g/L density 1.63 g/cm3
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: small white Russian
- Details on test animals or test system and environmental conditions:
- Male and female rabbits between 1.9 and 2.8 kg were housed in individual stainless steel cages and acclimated for 14 days. Rabbits received K4 single diet for rabbits (Ssniff Special Feed GmbH) and water ad libitum. Room temperature was 20 °C with 60 % relative humidity. Air was exchanged 15 times per hour and a 12 hr light-dark cycle was employed.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- other: paraffin oil
- Controls:
- not required
- Amount / concentration applied:
- 0.5 g test material wetted with paraffin oil
- Duration of treatment / exposure:
- 4 hrs
- Observation period:
- 1, 24, 48 and 72 hours as well as 5, 7, 8, 12 and 14 days
- Number of animals:
- 3 males and 3 females
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm² patch of skin
- Type of wrap if used: Linen cloth (2.5 × 2.5 cm) covered with a polyethylene foil (6 × 6 cm). The application site was secured with an elastic band.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Distilled water
SCORING SYSTEM:
Erythema and eschar formation:
No erythema...0
Very slight erythema (barely perceptible)...1
Well-defined erythema...2
Moderate to severe erythema...3
Severe erythema to slight eschar formation...4
Oedema formation:
No oedema...0
Very slight oedema...1
Slight oedema...2
Moderate oedema...3
Severe oedema...4
Reaction values for redness and swelling were calculated for 1, 24, 48 and 72 hours after patch removal. These absolute values were added together and divided by the number of assessment times (4) to determine the irritation index:
0–0.5 Not irritating
0.6–3.0 Mildly irritating
3.1–5.0 Moderately irritating
5.0–8.0 Highly irritating
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 72 hrs
- Score:
- 0.63
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 1.67
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- ca. 0.67
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0.33
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- ca. 0.33
- Max. score:
- 4
- Irritant / corrosive response data:
- The mean score over 24-72 hours for redness was calculated to be 0.72.
The mean score over 24-72 hours for swelling was calculated to be 0.11.
Neither score warrants classification for skin irritation.
Any other information on results incl. tables
Individual and average redness (R) and swelling (S) values
Animal number | 1 hr | 24 hr | 48 hr | 72 hr | ||||
R | S | R | S | R | S | R | S | |
1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
2 | 0 | 0 | 1 | 0 | 1 | 0 | 1 | 0 |
3 | 0 | 0 | *2 | 0 | *1 | 1 | *2 | 0 |
4 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 |
5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
6 | 0 | 0 | 0 | 0 | 1 | 0 | 2 | 1 |
Total | 0 | 0.5 | 0.83 | 1.17 | ||||
Average | 2.50/4 = 0.63 | |||||||
*Redness directly on the application surface |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- This study supports the conclusion that fumaric acid is a mild skin irritant that does not require classification for dermal irritation according to EU and GHS systems.
- Executive summary:
Dermal application of 0.5 g fumaric acid was mildly irritating to the skin of male and female rabbits. Fumaric acid did not elicit dermal reactions that would exceed the threshold for classification in accordance with EU criteria.
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