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EC number: 237-163-4 | CAS number: 13676-54-5
- 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:
- 14 August 2012 - 07 September 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- April 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- May 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Version / remarks:
- August 1998
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Agriculture, Forestry and Fisheries, Test Data for Registration of Agricultural Chemicals, Eye Irritation (2-1-5), 12 Nohsan No. 8147, Agricultural Production Bureau, November 24, 2000
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1,1'-(methylenedi-p-phenylene)bismaleimide
- EC Number:
- 237-163-4
- EC Name:
- 1,1'-(methylenedi-p-phenylene)bismaleimide
- Cas Number:
- 13676-54-5
- Molecular formula:
- C21H14N2O4
- IUPAC Name:
- 1-(4-{[4-(2,5-dioxo-2,5-dihydro-1H-pyrrol-1-yl)phenyl]methyl}phenyl)-2,5-dihydro-1H-pyrrole-2,5-dione
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): BMI (1,1’-(methylenedi-p-phenylene)bismaleimide)
- Substance type: Organic
- Physical state: Light yellow or light brown powder
- Storage condition of test material: Room temperature
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 31 or 39 weeks
- Weight at study initiation: 3.69 to 4.46 kg
- Housing: Each animal was housed individually in a plastic cage with perforated floors
- Diet (e.g. ad libitum): standard laboratory rabbit diet per day
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 11 or 17 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16- 20
- Humidity (%): 40 to 70
- Photoperiod (hrs dark / hrs light): 12 hrs dark/ 12 hrs light
Test system
- Vehicle:
- not specified
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- After instillation of the test substance the eyelids of each animal were gently held together for one second before releasing
- Observation period (in vivo):
- 1, 24,48, 72 and 8 days after instillation
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Eyes were flushed with saline for animal #1 24 hours after instillation, Eyes were flushed with saline for animal #2 24 hours and 48 hours after instillation. Eyes were not flushed for animal #3
SCORING SYSTEM: Kay and Calandra and EC (Regulation 1272/2008) and GHS classification
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- Animal #1;#2;#3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: n/a
- Remarks on result:
- other: The scores are calculated at approximately 24, 48 and 72 hours after administration, separately for each animal
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- Animal #1;#2;#3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: n/a
- Remarks on result:
- other: The scores are calculated at approximately 24, 48 and 72 hours after administration, separately for each animal
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: The scores are calculated at approximately 24, 48 and 72 hours after administration, separately for each animal
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: The scores are calculated at approximately 24, 48 and 72 hours after administration, separately for each animal
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: The scores are calculated at approximately 24, 48 and 72 hours after administration, separately for each animal
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: The scores are calculated at approximately 24, 48 and 72 hours after administration, separately for each animal
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: The scores are calculated at approximately 24, 48 and 72 hours after administration, separately for each animal
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: n/a
- Remarks on result:
- other: The scores are calculated at approximately 24, 48 and 72 hours after administration, separately for each animal
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- An in vivo eye irritation test was performed in new zealand white rabbits. Based on the results, BMI does not have to be classified for eye irritation or serious eye damage according to Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments).
- Executive summary:
An in vivo eye irritation test was performed in new zealand white rabbits according to internationally accepted guidelines and in accordance with GLP principles. Following a instillation dose of 0.1 mL,
slight chemosis, slight to moderate discharge, and injection of the conjunctival blood vessels were noted in 1 or more animals, all clinical signs were reversed to normal within 8 days in all test animals.
Based on the results, BMI does not have to be classified for eye irritation or serious eye damage according to Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments).
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