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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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 16 May to 18 June 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- 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
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: Epidermal cells from adult donors
- Justification for test system used:
- One of the validated in vitro skin irritation tests is the EPISKIN test, which is recommended in international guidelines (e.g. OECD and EC).
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: Episkin Small Model
- Tissue batch number: 12-EKIN-024
- Surface: 0.38 cm^2
- Expiration date: 18 June 2012
CHECK FOR REDUCTION OF MTT BY TEST SUBSTANCE
- The MTT reducing capability of the test substance was investigated by mixing approximately 10 mg of the test substance with 2 mL of 0.3 mg/mL MTT solution in duplicate. A control of 10 μL of distilled water, mixed with 2 mL of 0.3 mg/mL MTT solution was also included in duplicate.
CHECK FOR COLOR INTERFERENCE OF MTT BY TEST SUBSTANCE
- The test substance was evaluated for its colour or ability to become coloured in contact with water (simulating a tissue humid environment). Evaluation was achieved by mixing 10.1 mg of the test substance with 91 μL of distilled water in a transparent container to give 10 mg/90 μL. 100 μL of distilled water was included as a control. The solution was mixed for 15 minutes on a shaker. At the end of the shaking period the colour of the solution was assessed by eye.
CHECK FOR PH
An estimate of the pH of the test substance as a 10% suspension in distilled water was determined using pH indicator paper and recorded.
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: at room temperature
- Temperature of post-treatment incubation (if applicable): 42 ± 1 hour at 37 ± 2°C in a humidified atmosphere of 5% CO2 in air + 3 hours ± 5 minutes with MTT .
REMOVAL OF TEST MATERIAL AND CONTROLS
- Volume and number of washing steps: each tissue was rinsed with 25 mL sterile Dulbeccos Phosphate Buffered Saline (DPBS) to remove residual test substance
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT :
- MTT concentration: 0.3 mg/mL
- Incubation time: 3 hours ± 5 minutes at 37 ± 2°C
- Wavelength of OD measurements: 540 nm
VIABILITY MEASUREMENTS PREPARATION
AFTER all the tissues had been punched, the tissues (epidermis and collagen matrix) were vortexed with 500 μL of acidic isopropanol (0.04 N HCl final concentration).
The tissues were extracted by storing at 2-8 ºC, protected from light, for 48 - 70 hours. After formazan extraction, duplicate 200 μL aliquots of the extractant from each micro tube were pipetted into the wells of flat-bottomed 96-well plates. The extractant was mixed by vortexing prior to taking the aliquots. The absorbance was read at 540 nm, with six wells containing acidified isopropanol (0.04 N HCl final concentration) as a blank.
NUMBER OF REPLICATE TISSUES: triplicate tissues with the test item, negative and positive control.
PREDICTION MODEL / DECISION CRITERIA
If the mean tissue viability was equal to or less than 50% of the negative control value, the sample was classed as Irritant R38 (EU classification) or Category 2 (GHS classification).
ACCEPTANCE CRITERIA:
The OD from the negative control tissue in the MTT assay is an indicator of tissue viability after the shipping and storage procedure and under the specific conditions of the assay. The mean absorbance of the triplicate negative control values should be ≥0.6 and ≤1.5. The Standard Deviation (SD) value of the % viability should be <18.
The OD of the positive control is an indicator of the sensitivity of the tissues. The mean viability should be ≤40% of the negative control and the SD <18. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount applied: 10 ± 2 mg (spread over the surface of the tissue using a curved spatula)
- The tissues were wetted with 5 μL of distilled water prior to application of the test material. - Duration of treatment / exposure:
- 15 ± 0.5 minutes
- Duration of post-treatment incubation (if applicable):
- 42 hour ± 1 hours ; + 3 hours ± 5 minutes with MTT
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Mean of 3 experiments
- Value:
- 91.7
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- Negative control
The mean absorbance of the triplicate negative control values was 0.917 which was between the minimum and maximum values of 0.6 and 1.5. The standard deviation (SD) of the % viability was 5.9 which was below the maximum value of 18.
Positive control
The percentage mean viability of the positive control was 10.9 ± 2.9 of the negative control. These were below the maximum acceptance values of 40% viability and SD of 18.
Results of individual reports are reported in "any other information"
Any other information on results incl. tables
The results of the assay are summarised in the table below.
Sample |
Tissue viability as percentage of mean OD negative control |
Prediction MTT endpoint |
|||
Replicate Tissues |
Mean ± SD |
||||
a |
b |
c |
|||
Negative control |
99.2 |
106.3 |
94.6 |
100.0 ± 5.9 |
Not applicable |
Positive control |
12.9 |
12.3 |
7.6 |
10.9 ± 2.9 |
Irritant |
Test substance |
96.8 |
92.0 |
86.3 |
91.7 ± 5.3 |
Not-irritant |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an in vitro skin irritation test, performed according to OECD guideline 439 and in accordance with GLP principles, BMI showed to be a non-irritant (tissue viability of 91.7± 5.3%). Therefore, the substance was predicted as non-irritant to the skin.
- Executive summary:
In an in vitro skin irritation test, performed according to OECD guideline 439 and in accordance with GLP principles. The influence of BMI on the viability of human skin was tested. Ca. 10 mg of test substance was applied directly on top of 0.38 cm2cultured skin. After 15 minutes, the substance was removed and cells were cultured for 42 hours. BMI showed to be a non-irritant (mean tissue viability of 91.7%). Therefore, the substance does not need to be classified according to regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments).
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.
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