Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1991-06-17 to 1991-08-01
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
- 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 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
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
- Details on test material:
- - Name of test material (as cited in study report): maleic anhydride
- Physical state: white, chrystalline solid
- Storage condition of test material: stored at room temperature (approximately 22°C)
Constituent 1
- Specific details on test material used for the study:
- Maleic anhydride was received June 11, 1991. The test article was a white, crystalline solid and was stored at room temperature.
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: the test article was administered undiluted. Individual doses of the test article were weighed onto aluminum foil to facllltate dosing
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Johnson Rabbit Ranch, Wilkinson, IN
- Age at study initiation: 2-3 months
- Weight at study initiation: 1.84 to 2.81 kg
- Housing: individually in stainless steel cages measuring 61.0 x 45.5 x 41.0 cm
- Diet: 150 g of Purina Lab Rabbit Chow HF #5326 per rabbit per day
- Water: reverse osmosis-purified water, ad libitum
- Acclimation period: approximately 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23
- Humidity (%): 54
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 g of the undiluted test item - Duration of treatment / exposure:
- 0.1 g of the undiluted test article was placed in the everted lower lid of tte right eye of each rabbit. The lids of all treated eyes were held closed for approximately two seconds following test article administration. The other eye was left untreated.
- Observation period (in vivo):
- 1, 24 and 48 hours following test article administration (according to the study protocol, treated eyes were to be examined a minimum of 72 hours after dosing. However, due to signs of severe ocular irritation, the study was terminated following the 48 hour examination.)
- Duration of post- treatment incubation (in vitro):
- n.a.
- Number of animals or in vitro replicates:
- three animals per sex
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing
SCORING SYSTEM: According to OECD testing guideline 405 (Draize).
TOOL USED TO ASSESS SCORE: fluorescein and ultraviolet light (after the 1 hr scoring)
OTHER:
- All rabbits were observed daily for mortalIty and morbidity.
- The rabbits were weighed immediately prior to dosing.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 3.8
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 3.8
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Remarks:
- The study was terminated at day 2 due to severe effects/corrosion.
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Remarks:
- The study was terminated at day 2 due to severe effects/corrosion.
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Remarks:
- The study was terminated at day 2 due to severe effects/corrosion.
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Remarks:
- The study was terminated at day 2 due to severe effects/corrosion.
- Irritant / corrosive response data:
- The maximum eye irritation score was 106.7 (out of 110) 48 hours after administration of the test item. For detailed results please refer to Table 1 in box "Any other information on results incl. tables".
- Other effects:
- No deaths occurred during the study.However, two rabbits were vocal immediately following test article administration and signs of ocular irritation were severe. Therefore, out of concern for the animals' pain and discomfort, the study was terminated following the 48-hour examination.
One animal also developed corneal bulging, an ocular lesion not addressed by the Draize and OECD criteria.
Any other information on results incl. tables
Table 1: Summary of eye irritation score
Cornea | Iris | Conjunctiva | Sex | |||||
Animal | Reading | Opacity | Area involved | Redness | Chemosis | Discharge | ||
1 | 1 hrs | 4 | 4 | 2 | 2 | 3 | 3 | M |
2 | 1 hrs | 4 | 4 | 2 | 2 | 3 | 2 | M |
3 | 1 hrs | 4 | 4 | 2 | 2 | 4 | 3 | M |
4 | 1 hrs | 4 | 4 | 2 | 2 | 4 | 2 | F |
5 | 1 hrs | 4 | 4 | 2 | 2 | 3 | 3 | F |
6 | 1 hrs | 4 | 4 | 2 | 2 | 4 | 3 | F |
1 | 24 hrs | 4 | 4 | 2 | 2 | 4 | 3 | M |
2 | 24 hrs | 4 | 4 | 2 | 2 | 4 | 3 | M |
3 | 24 hrs | 4 | 4 | 2 | 2 | 4 | 3 | M |
4 | 24 hrs | 4 | 4 | 2 | 2 | 4 | 3 | F |
5 | 24 hrs | 3 | 4 | 2 | 2 | 4 | 3 | F |
6 | 24 hrs | 4 | 4 | 2 | 2 | 4 | 3 | F |
1 | 48 hrs | 4 | 4 | 2 | 3 | 4 | 3 | M |
2 | 48 hrs | 4 | 4 | 2 | 3 | 4 | 3 | M |
3 | 48 hrs | 4 | 4 | 2 | 3 | 4 | 3 | M |
4 | 48 hrs | 4 | 4 | 2 | 3 | 4 | 3 | F |
5 | 48 hrs | 3 | 4 | 2 | 3 | 4 | 3 | F |
6 | 48 hrs | 4 | 4 | 2 | 3 | 4 | 3 | F |
Table 2: Total eye irritation score
Total irritation score (according to Draize) | ||
Animal | Reading | Score |
1 | 1 hr | 106 |
2 | 1 hr | 104 |
3 | 1 hr | 108 |
4 | 1 hr | 106 |
5 | 1 hr | 106 |
6 | 1 hr | 108 |
1 | 24 hrs | 103 |
2 | 24 hrs | 108 |
3 | 24 hrs | 108 |
4 | 24 hrs | 108 |
5 | 24 hrs | 88 |
6 | 24 hrs | 108 |
1 | 48 hrs | 110 |
2 | 48 hrs | 110 |
3 | 48 hrs | 110 |
4 | 48 hrs | 110 |
5 | 48 hrs | 90 |
6 | 48 hrs | 110 |
mean | 1 hr | 106.3 |
mean | 24 hrs | 104.7 |
mean | 48 hrs | 106.7 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- In this study under the given conditions the test item showed severe effects on rabbit eyes
- Executive summary:
In a primary eye irritation study, maleic anhydride was administered undiluted at a dose of 0.1 g to the right eye of each of six New Zealand albino rabbits, with the left eye serving as an untreated control. The treated eye of each rabbit was scored for irritation at 1, 24- and 48-hours following test article administration. The control eye was used for comparison. According to the study protocol, treated eyes were to be examined a minimum of 72 hours after dosing. However, due to signs of severe ocular irritation, the study was terminated following the 48-hour examination. Irritation was scored according to OECD guideline 405 and to the criteria of Draize.
No deaths occurred during the study. However, two rabbits were vocal immediately following test article administration and signs of ocular irritation were severe. Therefore, out of concern for the animals' pain and discomfort, the study was terminated following the 48-hour examination. The maximum eye irritation score was 106.7 (out of a maximum of 110). The mean conjunctival erythema scores at 24 and 48 hours were 2.0 and 3.0, respectively. The mean conjunctival chemosis scores at 24 and 48 hours were 4.0 and 4.0, respectively. The corneal opacity scores at 24 and 48 hours were 3.8 and 3.8, respectively. The iridial lesions scores at 24 and 48 hours were 2.0 and 2.0, respectively.
In this study, maleic anhydride showed severe effects on rabbit eyes. Thus, based on the severity of the effects, the test item must be considered as eye damaging. In accordance with ATP13 to CLP Regulation 1272/2008 classification as Eye Dam. 1, H318 is warranted.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.