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EC number: 240-183-6 | CAS number: 16040-69-0
- 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
Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Well documented study; however the tested material was a mixture and is therefore not equivalent to submission substance identity.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 412 (Subacute Inhalation Toxicity: 28-Day Study)
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Imron paint & Desmodur N-100 (mixture of various compounds, including CAS No 1328-53-6 in unspecified quantity)
- IUPAC Name:
- Imron paint & Desmodur N-100 (mixture of various compounds, including CAS No 1328-53-6 in unspecified quantity)
- Details on test material:
- - Name of test material (as cited in study report): Mixture (Imron Paint Formulated with and without Desmodur N-100)
- Analytical purity and composition: no data given
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories, New York
- Age at study initiation: 8 weeks
- Weight at study initiation: 207 - 253 g
- Housing: 2 animals per cage
- Diet: Purina Certified Rodent Chow (R) #5002, ad libitum, except during exposure
- Water: ad libitum
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature: 20-25 °C
- Humidity: 36-60 %
- Photoperiod: 12 hrs dark / 12 hrs light
Administration / exposure
- Route of administration:
- inhalation
- Type of inhalation exposure:
- nose only
- Vehicle:
- other: unchanged (no vehicle)
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- A gravimetric analyses was used to monitor total particulate. A gas chromatographic method and a liquid chromatographic method were also used to quantify specific ingredients of the mixture.
- Duration of treatment / exposure:
- 2 weeks
- Frequency of treatment:
- 6 hours/day, 5 days/week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 0.01, 0.03, 0.1 mg/l (0, 9.7, 30, 96 mg/m3)
Basis:
nominal conc.
- No. of animals per sex per dose:
- 10 animals per dose.
- Control animals:
- other: air only
- Details on study design:
- Test animals (10 per exposure group) were exposed to Imron Paint Formulated with Desmodur N-100 or clean air (control group). One additional group of 10 rats was exposed to Imron Paint Formulated without Desmodur N-100.
5 rats were sacrificed after the 10th exposure, and the remaining 5 rats were sacrificed on day 14 of the recovery for gross and histopathology examinations.
Post-exposure period: 5 rats/group were killed immediately and 5 rats/group were allowed to recover for 14 days post exposure
Examinations
- Observations and examinations performed and frequency:
- Mean body weights ofthe rats of the test group were compared to controls during exposure and recovery period.
Blood and urine samples were collected for clinical analysis. - Sacrifice and pathology:
- At the end of the exposure period 5 rats per group were killed for pathologic examination. Remaining rats were observed tor 14 days post exposure, and were given the same clinical and pathological examinations.
Organs and tissues were collected for pathology (heart, lungs, nasalcavities, mesenteric lymph node, trachea, liver, pancreas, esophagus, stomach, intestine, kidneys, urinary bladder, bone marrow, spleen, thymus, thyroid, testes, epididymides, adrenal glands, brain and eyes).
Results and discussion
Results of examinations
- Details on results:
- No differences to the control were observed in mean body weights for exposed rats throughout the study. Rats in all exposure groups were stained green by the test materials after exposures. In addition, rats exposed to 0.03 or 0.1 mg/l of test mixture with or 0.1 mg/l test mixture without Desmodur N-100 had lung noise after each exposure.
Clinical chemical analyses after 10 exposures revealed decreased serum alkaline phosphatase activities in rats exposed to 0.1 mg/l test mixture with or without Desmodur N-100. This change was absent after 14 days recovery. No other adverse clinical chemical or hematologic changes were observed in any group.
Pathologic examination revealed dose-dependent accumulations of paint-containing alveolar macrophages in the lungs of all exposed rats both after 10 exposures and after 14 days recovery. In addition, at concentrations greater 0.1 mg/l, the mediastinal lymph nodes and/or lungs were stained green. No significant inflammatory lesions were observed in the lungs of rats exposed to test mixture containing Desmodur N-100 at any exposure concentration. In contrast, rats exposed to 0.1 mg/l of test mixture without Desmodur N-100 had elevated lung weights and multiple foci of subacute inflammation in the lungs at both sacrifices, and granulomatous inflammation in the mediastinal lymph nodes after 14 days recovery.
No significant adverse effects were observed in rats exposed to 0.1 mg/l of test mixture containing Desmodur N-100. The 0.1 mg/l level is considered a no-effect concentration under the conditions of this test. Test mixture without Desmodur N-100 caused more severe effects than with Desmodur N-100.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 9.7 mg/m³ air (nominal)
- Sex:
- male
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
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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