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EC number: 911-418-6 | CAS number: 55965-84-9
- 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:
- sub-chronic toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 413 (Subchronic Inhalation Toxicity: 90-Day Study)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Test material form:
- other: Yellow liquid
- Details on test material:
- - Name of test material (as cited in study report): Kathon™ 886 MMPA Process
- Physical state: Yellow liquid
- Stability under test conditions: Stable at room temperature
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Rohm and Haas, Batch No. SW 82/0169
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
- Stability under test conditions: Stable at room temperature
- Solubility and stability of the test substance in the solvent/vehicle: Soluble and stable
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: No
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Dilution in water
OTHER SPECIFICS: Purity of test material was 14% (11% of CMIT and 3% of MIT).
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD(SD)BR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River-Kingston, Stone Ridge, New York, USA.
- Age at study initiation: Approximately 6 weeks old.
- Weight at study initiation: 135-169 g for males and 117 to 147 g for females.
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Mass median aerodynamic diameter (MMAD):
- 1.3 µm
- Geometric standard deviation (GSD):
- 1.9
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: 2000-L stainless steel and glass chamber
- System of generating particulates/aerosols: all glass Laskin-type nebulizer
TEST ATMOSPHERE
- Brief description of analytical method used: pairs of impingers collected both the vapor and aerosol phases.
VEHICLE (if applicable)
- Concentration of test material in vehicle: 0.34, 1.15 and 2.64 mg a.i./m3 - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The Kathon™ 886 concentrations were determined by sampling the chamber atmosphere using pairs of impingers which collected both the vapor and aerosol phases of Kathon™ 886.
- Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- 5 days per week, 6 hours per day
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0.34 mg/m³ air
- Remarks:
- Based on a.i. concentration
- Dose / conc.:
- 1.15 mg/m³ air
- Remarks:
- Based on a.i. concentration
- Dose / conc.:
- 2.64 mg/m³ air
- Remarks:
- Based on a.i. concentration
- No. of animals per sex per dose:
- 16
- Control animals:
- yes
Examinations
- Observations and examinations performed and frequency:
- DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Daily. Before, during and after each exposure.
BODY WEIGHT: Yes
- Time schedule for examinations: Weekly
FOOD CONSUMPTION:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No
WATER CONSUMPTION: No
OPHTHALMOSCOPIC EXAMINATION: Yes
- Time schedule for examinations: Prior to study start and during the last week of exposure.
- Dose groups that were examined: All groups.
HAEMATOLOGY: Yes
- Time schedule for collection of blood: At 13 week necropsy.
- Anaesthetic used for blood collection: Yes (identity) / No / No data
- How many animals: 16/sex/group
- Parameters checked in table [No.?] were examined.
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: At 13 week necropsy.
- How many animals: 16/sex/group
- Parameters checked in table [No.?] were examined.
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No
OTHER: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes (see table)
HISTOPATHOLOGY: Yes (see table) - Other examinations:
- None
- Statistics:
- Body weight, body weight gain, clinical chemistry, hemaglobin and hematocrit were inspected for normality and homogeneity of variance by residual plots and then analyzed with a two-way ANOVA. If a significant p < 0.05 treatment group by sex effect were observed, group means were compared utilizing Dunnett’s t-test.
Hematology and differentials were inspected for normality and homogeneity of variance by stem leaf, boxplot and normal probability plots. If the ANOVA assumptions were satisfied, then the statistical analysis described above for the continuous data was utilized. When ANOVA assumptions were not satisfied, chi-square and Jonckheere tests were applied.
Pathology incidences were compared by Fischer’s Exact Test.
For all comparisons, the null hypothesis was rejected at a probability of 0.05 or less.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- rhinitis
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- rhinitis
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- decreased body weight gains
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Decreased serum protein
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- Decreased spleen weights
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- eosinophilic droplets in the anterior respiratory mucosa of the nasal turbinates and slight rhinitis in the lining of the anterior portion of the nasal cavity
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not examined
- Details on results:
- CLINICAL SIGNS AND MORTALITY
Rats exposed to 2.64 mg/m3 exhibited signs resulting from exposure consistent with those produced by a sensory irritant (chromorhinorrhea, rhinorrhea, eye squint, bradypnea, dyspnea).
BODY WEIGHT AND WEIGHT GAIN
Decreased body weight gains at 2.64 mg/m3.
CLINICAL CHEMISTRY
Decreased serum protein in females at 2.64 mg/m3.
ORGAN WEIGHTS
Decreased male spleen weights at 2.64 mg/m3.
HISTOPATHOLOGY: NON-NEOPLASTIC
Slight to moderate incidences of eosinophilic droplets in the anterior respiratory mucosa of the nasal turbinates and slight rhinitis in the lining of the anterior portion of the nasal cavity were observed in the 2.64 mg/m3 treated animals. All the histopathologic changes were very minor, potentially reversible, and generally reflective of minimal tissue responses to a very mild, low-grade respiratory irritant. No adverse effects were seen on the histopathology of any tissues/organs distant from the site of dosing.
Effect levels
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 0.34 mg/m³ air (analytical)
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- histopathology: non-neoplastic
- Dose descriptor:
- LOAEL
- Effect level:
- 1.15 mg/m³ air (analytical)
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- other: overall effects clinical signs; gross pathology
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- NO(A)EL = 0.34 mg a.i./m3 (0.00034 mg/L). There were no systemic effects in this study. LOEL = 1.15 mg a.i./m3based on slight, treatment-related rhinitis. Rats at the highest dose (2.64 mg/m3) exhibited very mild, low grade respiratory irritation. No adverse effects on the histopathology of any tissues/organs distant from the site of dosing.
- Executive summary:
OECD 413, subchronic inhalation toxicity, 90-day study with analytical confirmation of concentrations of Kathon™886.
LOEL = 1.15 mg a.i./m3based on slight, treatment-related rhinitis. There were no systemic effects in this study. Rats at the highest dose (2.64 mg/m3) exhibited very mild, low grade respiratory irritation. No adverse effects on the histopathology of any tissues/organs distant from the site of dosing.
NO(A)EL = 0.34 mg a.i./m3 (0.00034 mg/L).
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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