Registration Dossier
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EC number: 941-496-7 | 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

Exposure related observations in humans: other data
Administrative data
- Endpoint:
- exposure-related observations in humans: other data
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Falling short of highest standards concerning aspects of protocol or reporting. Acceptable literature publication.
Data source
Reference
- Reference Type:
- publication
- Title:
- Biomonitoring of workers exposed to 4,4'- methylenedianiline or 4,4'- methylenediphenylmethane diisocyanate
- Author:
- Schütze D, Sepai O, Lewalter J, Miksche L, Henschler D & Sabbioni G
- Year:
- 1 995
- Bibliographic source:
- Carcinogenesis 16: 573-582
Materials and methods
- Type of study / information:
- Type of experience: Human
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Type:
- Constituent
- Details on test material:
- 4,4'-Methylenediphenyl diisocyanate, MDI, no more data.
Results and discussion
Any other information on results incl. tables
In 3/27 cases the MDI level was greater than the detection limit of 3 micrograms/m3. The concentrations were 19, 30 and 11 micrograms MDI/m3.
In 16/26 workers the haemoglobin adduct levels of 4,4'-methylenedianiline (MDA) and N'-acetyl-4,4'-methylenedianiline (AcMDA) were below the detection limits of 20 fmol and 100 fmol, respectively. The detection limits corresponded to 60 and 330 fmol/g Hb, respectively. In the other 10 workers 57-219 fmol MDA/g Hb was present.
After the base treatment of urine, MDA was found in 22/23 cases, and at 20-139 pmol/l. AcMDA was found in 18/23 cases, and at 83-3000 pmol/l. After acid treatment the MDA found in 22/23 cases was 0.66-10.18 nmol/l.
In workers, most of whom were exposed to <20 micrograms MDA/m3, the Hb MDA levels were at 64-895 (2614) fmol/g Hb, and the Hb AcMDA was 299-4214 fmol/g Hb. After acid hydrolysis the urinary MDA was 0.4-40(188) nmol/l.
Applicant's summary and conclusion
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