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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
- 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 (LLNA)
- 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
Reference
- Reference Type:
- publication
- Title:
- Characterization in mice of the immunological properties of five allergenic acid anhydrides
- Author:
- Dearman R.J. et al.
- Year:
- 2 000
- Bibliographic source:
- Journal of Applied Toxicology 20, 221-230
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- yes
- Remarks:
- (no positve controls, mice strain BALB/c used)
- GLP compliance:
- not specified
- Type of study:
- mouse local lymph node assay (LLNA)
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
- Analytical purity: 99%
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- Balb/c
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Seralab, Bicester, Oxfordshire, UK
- Age at study initiation: 6-12 weeks old
- Housing: 10 per cage (acclimation period), 4-5 per cage (during treatment)
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 2
- Humidity (%): 55 +/- 10
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 0, 0.1,0.25, 0.5, 1, 2.5% (w/v)
- No. of animals per dose:
- 4
- Details on study design:
- MAIN STUDY
Groups of mice (n= 4) were exposed topically on the dorsum of both ears to 25 µL of various concentrations of acid anhydrides or to vehicle (acetone:olive oil, AOO) alone, daily for three consecutive days. Five days after the initiation of exposure all mice were injected intravenously via the tail vein with 20 µCi of [3H] methyl thymidine in 250 µL of phosphate-buffered saline (PBS). Five hours later, mice were killed, and the draining auricular lymph nodes were excised and pooled for each experimental group. A single cell suspension of LNC was prepared by gentle mechanical disaggregation through 200-mesh stainless-steel gauze. Cells were washed twice with PBS and precipitated in 5% trichloroacetic acid (TCA) at 4 °C overnight. Pellets were then resuspended in 1 mL of 5% TCA and transferred to 10 mL of scintillation fluid. Incorporation of 3HTdR was measured by ß-scintillation counting as disintegrations per min (dpm) per node for each experimental group. In each case a stimulation index (SI) relative to the concurrent vehicle-treated control was derived. The estimated concentration of chemical required to induce SI= 3 relative to concurrent vehicle-treated controls i.e. the EC3 value was derived by linear interpolation.
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- EC3
- Value:
- 0.16
- Parameter:
- SI
- Value:
- 1.91
- Test group / Remarks:
- 0.1% w/v
- Parameter:
- SI
- Value:
- 4.86
- Test group / Remarks:
- 0.25 % w/v
- Parameter:
- SI
- Value:
- 6.32
- Test group / Remarks:
- 0.5% w/v
- Parameter:
- SI
- Value:
- 14
- Test group / Remarks:
- 1% w/v
- Parameter:
- SI
- Value:
- 15.98
- Test group / Remarks:
- 2.5% w/v
- Cellular proliferation data / Observations:
- For detailed results please refer to Table 1 in box "Any other information on results incl. tables".
Any other information on results incl. tables
Table 1: Local lymph node assay responses to maleic anhydride
Concentrations (% w/v) | DPM per node | SI |
0 | 245 | 1 |
0.1 | 467 | 1.91 |
0.25 | 1181 | 4.86 |
0.5 | 1548 | 6.32 |
1 | 3431 | 14 |
2.5 | 3915 | 15.98 |
5 | ND | |
10 | ND |
ND = not determined
Applicant's summary and conclusion
- Interpretation of results:
- Category 1A (indication of significant skin sensitising potential) based on GHS criteria
- Conclusions:
- In this study under the given conditions the EC3 was calculated to be 0.16% w/v = 0.016 M. Therefore, the test item in this test can be considered to be a skin sensitizer category 1A according to the CLP Regulation (EC) 1272/2008.
- Executive summary:
In a dermal sensitization study conducted equivalent to OECD Guideline 429 young adult Balb/c mice (4 females per dose) were treated with 0.1, 0.25, 0.5, 1 and 2.5% maleic anhydride in acetone/olive oil (4:1, v/v). Five days after the initiation of exposure all mice were injected intravenously via the tail vein with 20 µCi of [3H] methyl thymidine in 250 µL of phosphate-buffered saline (PBS). Five hours later, mice were killed, and the draining auricular lymph nodes were excised and pooled for each experimental group. Incorporation of 3HTdR was measured by ß-scintillation counting as disintegrations per min (dpm) per node. Furthermore, in each case a stimulation index (SI) was derived.
The stimulation indices (SI) were 1.91 (0.1%), 4.86 (0.25%), 6.32 (0.5%), 14.00 (1%) and 15.98 (2.5%). Based on the results, the extrapolated EC3 value was determined to be 0.16%. Thus, maleic anhydride must be considered as a dermal sensitizer and classification as Skin Sens 1A, H317 according to the criteria of the CLP Regulation (EC) 1272/2008 is warranted.
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