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EC number: 203-571-6 | CAS number: 108-31-6
- 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
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- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
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- Endpoint summary
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- 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
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- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
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- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
- Reference Type:
- review article or handbook
- Title:
- Maleic Anhydride and Maleic Acid, SIDS Initial Assessment Report For SIAM 18
- Author:
- OECD SIDS
- Year:
- 2 004
- Bibliographic source:
- OECD SIDS Initial Assessment Report For SIAM 18, Paris, France, 20-23 April 2004
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- New Zealand White rabbits were used to determine the skin irritation potential of maleic anhydride. Test substance (0.5 g) was applied to two intact skin locations on the backs of six rabbits for four hours.
- GLP compliance:
- no
Test material
- Reference substance name:
- Maleic anhydride
- EC Number:
- 203-571-6
- EC Name:
- Maleic anhydride
- Cas Number:
- 108-31-6
- Molecular formula:
- C4H2O3
- IUPAC Name:
- 2,5-dihydrofuran-2,5-dione
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material (as cited in study report): Maleic anhydride
- Physical state: white solid
Constituent 1
- Specific details on test material used for the study:
- The maleic anhydride used in this study was supplied by the Chevron Chemical Company, Petrochemical Division, Industrial Chemicals, San Francisco, California. It was a white solid which was ground to a fine powder with a mortar and pestle.
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Sex: male New Zealand White rabbits
- Housing: individually housed in wire-bottom cages
- Diet: daily ration of a commercial laboratory feed (approximately 4 oz)
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 g
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- Irritation was scored at 4, 24, 48, 72 hours and after 7 days.
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: the test material powder was applied to each of two separate intact sites on each rabbit.
- Type of wrap if used: After application of the material the sites were covered with a gauze patch which was secured by adhesive tape. The trunk of each animal was loosely wrapped in a plastic sheet. Paper' towels were wrapped around the plastic sheet to prevent tearing. A collar was placed on each animal to protect the wrappings during the exposure period.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
- 4, 24, 48, 72 hours and at 7 days
SCORING SYSTEM:
- Method of calculation: Draize scoring system (please refer to box " Any other information on materials and methods incl. tables")
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- (site 1)
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- (site 2)
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- (site 1)
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- (site 2)
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- (site 1)
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- (site 2)
- Time point:
- 24/48/72 h
- Score:
- 3.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Remarks:
- (site 1)
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Remarks:
- (site 2)
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Remarks:
- (site 1)
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Remarks:
- (site 1)
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Remarks:
- (site 2)
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- (site 1)
- Time point:
- 24/48/72 h
- Score:
- 3.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- (site 2)
- Time point:
- 24/48/72 h
- Score:
- 3.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- (site 1)
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- (site 2)
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- (site 1)
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- (site 2)
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Remarks:
- (site 1)
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Remarks:
- (site 2)
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Remarks:
- (site 1)
- Time point:
- 24/48/72 h
- Score:
- 3.66
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Remarks:
- (site 2)
- Time point:
- 24/48/72 h
- Score:
- 3.66
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Remarks:
- (site 1)
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Remarks:
- (site 2)
- Time point:
- 24/48/72 h
- Score:
- 3.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritant / corrosive response data:
- Severe skin irritation was present in both treated areas of all rabbits for the entire 7-day observation period. For detailed results please refer to table 1 in box " Any other information on results incl. tables".
- Other effects:
- The pathological findings exhibit that eschar formation with epidermal regeneration was present in all of the sections. One section (not further specified) had an area of granulation tissue down to the muscle with some regeneration of epidermal tissue over the area.
Any other information on results incl. tables
Table 1: The skin corrrosion potential of maleic anhydride
Exposition: | 4 h occlusive | ||||
Site 1 | Site 2 | ||||
Animal | Reading | Erythema | Edema | Erythema | Edema |
1 | 4 h | 4 | 3 | 4 | 3 |
2 | 4 h | 4 | 4 | 4 | 4 |
3 | 4 h | 4 | 4 | 4 | 2 |
4 | 4 h | 4 | 4 | 4 | 4 |
5 | 4 h | 2 | 1 | 2 | 4 |
6 | 4 h | 4 | 2 | 4 | 2 |
1 | 24 h | 4 | 4 | 4 | 4 |
2 | 24 h | 4 | 4 | 4 | 4 |
3 | 24 h | 4 | 4 | 2 | 2 |
4 | 24 h | 4 | 4 | 4 | 4 |
5 | 24 h | 4 | 4 | 4 | 4 |
6 | 24 h | 4 | 4 | 4 | 4 |
1 | 48 h | 4 | 3 | 4 | 3 |
2 | 48 h | 4 | 4 | 4 | 4 |
3 | 48 h | 4 | 4 | 4 | 2 |
4 | 48 h | 4 | 4 | 4 | 4 |
5 | 48 h | 4 | 4 | 4 | 4 |
6 | 48 h | 4 | 4 | 4 | 4 |
1 | 72 h | 4 | 3 | 4 | 3 |
2 | 72 h | 4 | 4 | 4 | 4 |
3 | 72 h | 4 | 4 | 4 | 2 |
4 | 72 h | 4 | 4 | 4 | 4 |
5 | 72 h | 4 | 3 | 4 | 3 |
6 | 72 h | 4 | 4 | 4 | 2 |
1 | 7 d | 4 | 2 | 4 | 2 |
2 | 7 d | 4 | 4 | 4 | 4 |
3 | 7 d | 4 | 4 | 4 | 2 |
4 | 7 d | 4 | 4 | 4 | 4 |
5 | 7 d | 4 | 2 | 4 | 2 |
6 | 7 d | 4 | 4 | 4 | 4 |
At 24 hours, the mean Draize scores for erythema and edema for site 1 (site 2) were 4.0 (3.7) and 4.0 (3.7), respectively. At 48 hours, the mean scores for erythema and edema were 4.0 (4.0) and 3.8 (3.5), respectively. At 72 hours, the mean erythema and edema scores were 4.0 (4.0) and 3.7 (3.0), respectively. At 7 days, the mean erythema and edema scores were 4.0 (4.0) and 3.3 (3.0), respectively.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (corrosive) based on GHS criteria
- Conclusions:
- In this study under the given conditions the test item showed corrosive effects. The test item is therefore classified as corrosive and in accordance with annex 6 of CLP regulation 1272/2008 classification as Skin Corr. 1B, H314 is warranted.
- Executive summary:
In a primary dermal irritation study 6 male New Zealand white rabbits were dermally exposed to 0.5 mg of the test item maleic anhydride for 4 hours to two intact skin locations on the back under occlusive conditions. Irritation was scored at 4, 24, 48, and 72 hours and at 7 days after in accordance to Draize. Severe skin irritation was present in both treated areas of most rabbits for the entire 7-day observation period. Eschar formation with epidermal regeneration was present in all of the sections. One section (not further specified) had an area of granulation tissue down to the muscle with some regeneration of epidermal tissue over the area.
Based on the results, the test item is considered as corrosive and in accordance with ATP13 to CLP regulation 1272/2008 classification as Skin Corr. 1B, H314 is warranted.
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