Registration Dossier
Registration Dossier
Diss Factsheets
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EC number: 700-674-2 | CAS number: -
- 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

Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Additional information
Effects on fertility - read-across with other MDI substances:
The toxicological database for inhaled MDI demonstrates consistently that toxicity is associated only with the portal of entry (respiratory tract), any other manifestations of toxicity are secondary to this. While no fertility studies are available for MDI, subchronic and chronic studies all show toxicity confined to the respiratory tract. Fertility studies with TDI and HDI show no effects on reproductive parameters, all effects are confined to the respiratory tract. Hence the databases for MDI, TDI and HDI all show that primary toxicity for diisocyanates is to the respiratory tract, other effects, such as fetotoxicity in developmental studies, are secondary to this. This relationship applies to TDI and HDI when tested in fertility studies in the rat and is considered to apply equally to MDI, i.e., if any effects were to be seen in a fertility study, these would occur only as a secondary effect of the toxicity to the respiratory system of the exposed rats. Protection against respiratory tract toxicity will protect against any secondary effects.
Using the weight of evidence, it is concluded that reproductive toxicity is not an endpoint of concern for MDI and additional toxicity testing is not necessary.
Short description of key information:
No fertility nor multigeneration studies are available for MDI. Data waiver is claimed
Effects on developmental toxicity
Description of key information
MDI is not a developmental toxicant.
Additional information
Developmental toxicity / teratogenicity - read-across with other MDI substances:
Based on the available data on polymeric MDI from the study by Gamer et al., 2000, the NOAEL for maternal and fetal toxicity is 4 mg/m3. This key study was conducted according to OECD Guideline 414 (Prenatal Developmental Toxicity Study and GLP with reliability 1). The NOAEL for development/teratogenicity is observed at 12 mg/m3 (Gamer et al., 2000). As the observed fetotoxic effects and adverse effects on the embryonic development are considered as minor signs of developmental toxicity and as these effects occur at the concentration inducing maternal toxicity, they are considered to be secondary to maternal toxicity. As a consequence, polymeric MDI is considered not to be a developmental toxicant.
Justification for classification or non-classification
According to CLP Regulation (EC) No.1272/2008 the non-classification of 4,4'-MDI (CAS No.101-68-8) was considered for the non-classification of MDI MT (CAS No.147993-65-5):
4,4'-MDI was not classified as a reproductive toxicant by DSD or GHS.
Additional information
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.

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