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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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 31 October 1990 - 14 December 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study was conducted in 1991 before the Local Lymph Node Assay was widely available. The GPMT was a standard and accepted method at the time at which the study was conducted. On the basis that pre-existing data are available for the skin sensitisation endpoint an additional test (LLNA) is not considered scientifically justified.
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): MB-3000, N,N'-(4,4'-diphenylenemethylene) bismaleimide
- Physical state: Pale yellow powder
- Lot/batch No.: CX-1074
- Storage condition of test material: Room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 8 - 12 weeks old
- Weight at study initiation: 300 - 376g
- Housing: Animals were housed in groups of up to three in solid-floor polypropylene cages furnished with softwood shavings.
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: At least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 23°C
- Humidity (%): 46 - 67%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark
IN-LIFE DATES: From: 31 October 1990 To: 14 December 1990
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- arachis oil
- Concentration / amount:
- Induction: 0.1% (w/v) in arachis oil or a 1:1 suspension of Freund's Complete Adjuvant plus arachis oil by injection; 50% (w/v) by topical application.
Challenge: 10% (w/v) in arachis oil.
A negative control group was also assessed, which recieved untreated arachis oil and a suspension of arachis oil and Freunds Complete Adjuvant during the induction phase.
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- arachis oil
- Concentration / amount:
- Induction: 0.1% (w/v) in arachis oil or a 1:1 suspension of Freund's Complete Adjuvant plus arachis oil by injection; 50% (w/v) by topical application.
Challenge: 10% (w/v) in arachis oil.
A negative control group was also assessed, which recieved untreated arachis oil and a suspension of arachis oil and Freunds Complete Adjuvant during the induction phase.
- No. of animals per dose:
- 20 animals in the test group; 10 animals in the control group.
- Details on study design:
- RANGE FINDING TESTS:
Injections made with 5%, 1%, 0.5%, and 0.1% (w/v); injection sites were assessed for local necrosis, ulceration, or signs of toxicity, and the highest concentration which caused none of these was used for the intradermal stage of the induction process.
48-hour topical applications were made on two guinea pigs (intradermally injected with Freund's Complete Adjuvant 7 days earlier); applications of 50%, 25%, 10%, and 5% (w/w) test material in arachis oil were made; the highest concentration which only caused mild to moderate irritation was selected at the concentration to be used.
50%, 25%, 10%, and 5%(w/v) preparations of the test material in arachis oil were applied occlusively to the flanks of two guinea pigs for a period of 24 hours. The guinea pigs tested had been treated identically to the control animals of the main study up to day 14.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (1 series of injections, and 1 topical application)
- Exposure period: The topical application was made one week after the injections. The topical application (occlusive dressing) lasted for 48 hours.
- Test groups: intradermal injections: Three injections (0.1 mL); (i) Freunds Complete Adjuvant and water, 1:1; (ii) 0.1% (w/v) suspension of test material in arachis oil; (iii) 0.1% suspension of test material in a 1:1 preparation of Freunds Complete Adjuvant and arachis oil. Topical application: 0.2 - 0.3 mL application of a 50% (w/w) suspension of test material in arachis oil.
- Control group: As above, but without tet material in each case.
- Site: Shoulder
- Frequency of applications: One single series of injections, followed by a single topical application 7 days later.
- Duration: Topical application was kept in place for 48 hours.
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Day 21
- Exposure period: 24 hours
- Site: Flank
- Concentrations: 10% (w/v) in arachis oil.
- Evaluation (hr after challenge): 24, 48, and 72 hours after removal of occlusive dressing.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10% (w/w)
- No. with + reactions:
- 9
- Total no. in group:
- 20
- Clinical observations:
- Incidents of well-defined oedema noted.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10% (w/w)
- No. with + reactions:
- 12
- Total no. in group:
- 20
- Clinical observations:
- Incidents of well-defined oedema and desquamation noted.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Group:
- positive control
- Remarks on result:
- not measured/tested
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- The test material produced a 60% sensitisation rate and was classified as a moderate sensitiser to guinea pig skin.
- Executive summary:
A Guinea-pig maximisation test was performed as described in OECD test guideline 406, consisting of an intradermal (0.1% (w/v)) and epidermal induction and an epicutaneous challenge at day 21. The dermal response following 24 hr after the challenge to 10% of chemical resulted in clinical effects (edema) in 45% of test animals. The dermal response following 48 hr after the challenge to 10% (w/v) of chemical resulted in clinical effects (edema and desquamation) for 60% of test animals.
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