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Diss Factsheets
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EC number: 227-534-9 | CAS number: 5873-54-1
- 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
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Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- Hypothesis: Reactive NCO groups present on the substances of the MDI category polymerize in the acid environment of the stomach to form solid polyureas that are excreted via the feces without being absorbed. Consequently, oral exposure does not lead to local or systemic toxic effects.
Justification: All available oral toxicity data indicates consistent lack of toxicity within the data matrix. Further, since the formation of inert polyureas in the acids of the stomach is dependent on the presence of reactive NCO groups and all MDI substances acting via this common mechanism contain high levels of such groups, the mechanism of action justifies the claim of overall consistency within the matrix with high confidence.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test material
- Reference substance name:
- 2,4'-methylenediphenyldiisocyanate
- IUPAC Name:
- 2,4'-methylenediphenyldiisocyanate
Constituent 1
Results and discussion
Effect levels
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: Weight of evidence was performed on a sufficient representation of category and sub-category substances to demonstrate the lack of a trend in the data and to conclude a lack of acute oral toxicity across the substances of the MDI category.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No acute oral data exist for the target substance 2,4'-MDI. Accordingly, this endpoint is satisfied by a weight of evidence and read-across from valid acute oral toxicity studies on category substances that are considered the worst-case according to the hypothesized MoA. The study used (Bomhard, 1990) for read-across did not record mortality up to the limit dose of 2,000 mg/kg bw when rats were administered MDI mixed isomers. Both 2,4’-MDI and MDI mixed isomers are both member of the monomeric MDI subgroup.
Acute oral toxicity studies have been performed on a sufficient representation of category and sub-category substances (see table 1. attached background material) to demonstrate the lack of a trend in the data and to conclude a lack of acute oral toxicity across the substances of the MDI category. Based on the available study data all members of the MDI category are regarded as relatively non-toxic for the endpoint acute oral toxicity and are not classified according EU GHS 1272/2008 CLP. - Executive summary:
The available data indicate that all substances of the MDI category are of low toxicity by the oral route. Following acute oral exposure, the NCO groups present on the substances of the MDI category react with acids within the stomach leading to formation of an insoluble polymerized mass that is excreted in the feces without being absorbed. Acute oral toxicity studies performed on a sufficient representation of category substances define a lack of acute oral toxicity across the category.
The available acute oral toxicity studies are of high reliability and are sufficient for demonstrating the acute oral toxicity of the substances of the MDI category. Reliable chemical composition including NCO content is also available for all substances of the MDI category acting via this common mechanism and provides an adequate basis for predicting read-across between all of them.
All substances of the MDI category share similar chemical features namely that they a) all contain a significant amount of mMDI, and b) contain at least two NCO functional groups per molecule which is bound to an aromatic ring and this ring is connected to a second aromatic ring by a methylene group. It is the NCO value (driven by the bioaccessible groups on monomeric MDI and low molecular weight constituents (e.g. three-ring oligomer) which is responsible for chemical and physiological reactivity and subsequent toxicological profile. As reactive NCO groups are a common feature of all substances of the MDI category, it is predicted that these have a similar reactivity profile and a read across within the category is warranted (detailed information on the Mode of Action is available in Category Justification Document).
This low toxicity is consistent with the overall hypothesis: a) the bioaccessible reactive NCO group drives chemical and biological activity, and b) MDI substances are not systemically absorbed because the NCO groups present on them react with acids within the stomach leading to the formation of an insoluble polymerized mass that is excreted in the feces without being absorbed.
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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