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EC number: 701-276-1 | 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

Toxicity to reproduction
Administrative data
- Endpoint:
- toxicity to reproduction
- Remarks:
- other: Sub-chronic repeated dose toxicity test
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific standards, well documented and acceptable for assessment.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Acute, Subacute, and Subchronic Inhalation Toxicity Studies of Respirable Polymeric Methylene Diphenyl Diisocyanate (Polymeric MDI) Aerosol in Rats
- Author:
- Reuzel PGJ, Kuper CF, Feron VJ, Appelman LM and Löser E
- Year:
- 1 994
- Bibliographic source:
- Fundamental and applied toxicology 22, 186-194
Materials and methods
- Principles of method if other than guideline:
- Sub chronic repeated dose toxicity test including macroscopically and gross pathologically assessment of the reproductive organs and tissues.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 9016-87-9
- Cas Number:
- 9016-87-9
- IUPAC Name:
- 9016-87-9
- Reference substance name:
- Isocyanic acid, polymethylenepolyphenylene ester
- IUPAC Name:
- Isocyanic acid, polymethylenepolyphenylene ester
- Test material form:
- aerosol dispenser: not specified
- Remarks:
- migrated information: aerosol
- Details on test material:
- Polymeric methylene diphenyl diisocyanate (pMDI) was supplied by Bayer AG, Leverkusen. It is a viscous (200 ± 40 mP), dark brown liquid with the following composition and trace impurities (%, w/w) as specified by the supplier: -N=C=O (isocyanate) content, 30±2: monomeric MDI content,52 ± 3: hydrolysable chlorine, -< 0.3: total chlorine, -<0.8; chloro-benzene, -<0.015; phenyl isocyanate, -<0.005 ± 0.001 :and sediment content, -<0.01.
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- See section 7.5.2c Reuzel et al 1994 (rat, 90d)
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure (if applicable):
- whole body
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- See section 7.5.2c Reuzel et al 1994 (rat, 90d)
- Details on mating procedure:
- Not included in the test as this is a repeated dose test.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- See section 7.5.2c Reuzel et al 1994 (rat, 90d)
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- 6hr/day, 5 days/week
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0, 0.35, 1.4 or 7.2 mg respirable polymeric MDI/m3 for SC1
Basis:
analytical conc.
- Remarks:
- Doses / Concentrations:
0, 4.1, 8.4 or 12.3 mg respirable polymeric MDI/m3 for SC2
Basis:
analytical conc.
- No. of animals per sex per dose:
- 15
- Control animals:
- yes
- Details on study design:
- See section 7.5.2c Reuzel et al 1994 (rat, 90d)
Examinations
- Postmortem examinations (parental animals):
- Reproductive organs and tissues were macroscopically and gross pathologically assessed at the autopsy. A detailed histopathological assessment was performed of 10 rats/sex of the control group and 20 rats/sex of the high-concentration group at the end of the exposure (week 14) and of 10 rats/sex of the control and high-concentration group at the end of the posttreatment period (in week 18).
Histopathological assessment included e.g. adrenals, epididymides, mammary glands, seminal vesicles, testes and uterus. Neither gross examination at autopsy nor histopathological assessment revealed any treatment related systemic effects. The only treatment related effects were confined to the respiratory tract (increased relative lung weight ratios in the mid- and high concentration groups, histopathological and microscopic changes in all pMDI exposed groups).
Results and discussion
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
Neither gross examination at autopsy nor histopathological assessment revealed any treatment related systemic effects. The only treatment related effects were confined to the respiratory tract (increased relative lung weight ratios in the mid- and high concentration groups, histopathological and microscopic changes in all pMDI exposed groups).
Applicant's summary and conclusion
- Executive summary:
Reproductive organs and tissues were macroscopically and gross pathologically assessed at the autopsy. A detailed histopathological assessment was performed of 10 rats/sex of the control group and 20 rats/sex of the high-concentration group at the end of the exposure (week 14) and of 10 rats/sex of the control and high-concentration group at the end of the posttreatment period (in week 18).
Histopathological assessment included e.g. adrenals, epididymides, mammary glands, seminal vesicles, testes and uterus. Neither gross examination at autopsy nor histopathological assessment revealed any treatment related systemic effects. The only treatment related effects were confined to the respiratory tract (increased relative lung weight ratios in the mid- and high concentration groups, histopathological and microscopic changes in all pMDI exposed groups).
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