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Diss Factsheets
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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
Dermal absorption
Administrative data
- Endpoint:
- dermal absorption in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 417
- Deviations:
- no
- GLP compliance:
- no
Test material
- Test material form:
- other: Amber Liquid
- Details on test material:
- - Name of test material (as cited in study report): Kathon™ 886
- Physical state: Amber 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. 395.0201B, 395.0207, 555.0101 and 555.0201
RADIOLABELLING INFORMATION (if applicable)
- Radiochemical purity: 96.7-98.4 %
- Specific activity: 10.47 mCi/mg (395.0201B and 395.0207), 38.40 µCi/mg (555.0101) and 49.55 µCi/mg (555.0201)
- Locations of the label: 4, 5
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Not described
- Stability under test conditions: Stable
- 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: Dissolution in water
- Preliminary purification step (if any): No
- Final dilution of a dissolved solid, stock liquid or gel: 2.5 to 4000 ppm a.i.
FORM AS APPLIED IN THE TEST (if different from that of starting material)
Liquid
OTHER SPECIFICS: Purity of test material was as follows:
Batch No. 395.0201B, 14 % active substance (3 parts of 14C-CMIT and 1 part of MIT)
Batch No. 395.0201B, 14 % active substance (3 parts of 14C-CMIT and 1 part of MIT)
Batch No. 395.0207, 1.5 % active substance (1.2 % of 14C-CMIT and 0.3 % of MIT)
Batch No. 555.0101, 14.6 % active substance (11 % of 14C-CMIT and 3.6 % of MIT)
Batch No. 555.0201, 14.5 % active substance (11 % of CMIT and 3.5 % of 14C-MIT) - Radiolabelling:
- yes
Test animals
- Species:
- rat
- Strain:
- other: Albino, Sprague-Dawley and Crl:CD
- Sex:
- male
- 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: 1-3 months old
- Weight at study initiation: Not reported
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- not specified
- Duration of exposure:
- 6h, 24h or 4 days with one daily application
- Doses:
- - Nominal doses: 2.5 to 4000 ppm a.i.
- Dose volume: 0.2 mL - No. of animals per group:
- 3-5
- Control animals:
- no
- Details on study design:
- APPLICATION OF DOSE: Single or repeated dose
REMOVAL OF TEST SUBSTANCE
- Washing procedures and type of cleansing agent: Not described
- Time after start of exposure: After 6 or 24 hours
ANALYSIS
- Method type(s) for identification: HPLC, Liquid scintillation counting
Results and discussion
- Signs and symptoms of toxicity:
- yes
- Remarks:
- Mortality
- Dermal irritation:
- not specified
- Absorption in different matrices:
- - Skin wash: 6-11% (single 24h dermal application), 0.3-3% (single 6h dermal application), 1-11% (repeated dermal applications during 4 days)
- Skin test site: 39-62% (single 24h dermal application), 54-73% (single 6h dermal application), 26-41% (repeated dermal applications during 4 days)
- Blood
Single 24h dermal application: 14C-Concentration in whole blood 24 hours after dermal application was non-linear with respect to dose level (i.e., a 2-fold increase in dose from 1000 to 2000 ppm a.i. resulted in a 30-fold increase in 14C-concentration)
Single 6h dermal application: Whole blood 14C-concentrations were greater than the corresponding plasma 14C-concentrations. 14C derived from 14C-CMIT peaked within 1 hour, decreased over the initial 24 hours after dosing, and then remained relatively constant at low levels for the remainder of the 7 days. 14C derived from 14C-MIT peaked within 48 hours and then decreased gradually for the remainder of the 7 days.
Repeated dermal applications during 4 days:
- Urine: 5-10% (single 24h dermal application), <23% (single 6h dermal application), 11-19% (repeated dermal applications during 4 days)
- Faeces: Negligible (single 24h dermal application), <35% (single 6h dermal application), <2% (repeated dermal applications during 4 days) - Total recovery:
- - Total recovery: >=60%
- Recovery of applied dose acceptable: Yes
- Quantification of values below LOD or LOQ: No
Percutaneous absorptionopen allclose all
- Key result
- Time point:
- 24 h
- Dose:
- 4000 to 500 ppm a.i.
- Parameter:
- percentage
- Absorption:
- >= 27 %
- Key result
- Time point:
- 6 h
- Dose:
- 2.5 ppm a.i.
- Parameter:
- percentage
- Absorption:
- 38 %
- Remarks on result:
- other: 14C-CMIT; Determined after 7 days
- Key result
- Time point:
- 6 h
- Dose:
- 25 ppm a.i.
- Parameter:
- percentage
- Absorption:
- 27 %
- Remarks on result:
- other: 14C-CMIT; Determined after 7 days
- Key result
- Time point:
- 6 h
- Dose:
- 2.5 ppm a.i.
- Parameter:
- percentage
- Absorption:
- 43 %
- Remarks on result:
- other: 14C-MIT; Determined after 7 days
- Key result
- Time point:
- 6 h
- Dose:
- 25 ppm a.i.
- Parameter:
- percentage
- Absorption:
- 26 %
- Remarks on result:
- other: 14C-MIT; Determined after 7 days
- Key result
- Time point:
- 4 d
- Dose:
- 500 or 1000 ppm a.i.
- Parameter:
- percentage
- Absorption:
- >= 48 %
- Remarks on result:
- other: One daily application
Applicant's summary and conclusion
- Conclusions:
- A significant fraction of dermally administered 14C-Kathon™ biocide-derived 14C-label was recovered in the application site skin, and was thus not readily systemically bioavailable. Peak whole blood 14C -concentrations were disproportionately higher after high dermal dose applications than after lower dermal dose applications indicating nonlinear kinetics. Whole blood 14C -concentrations were greater than the corresponding plasma 14C -concentrations following dermal administration.
- Executive summary:
Five toxicokinetic and metabolism studies have been conducted in rats with Kathon™ biocide for regulatory and risk assessment purposes. Kathon™ biocide labelled alternatively on the CMIT and on the MIT part was used. The collective results of these five studies fulfills the requirements for an OECD 417 Toxicokinetic study and have been enclosed in 1997 in the overall report presented here.
A significant fraction of dermally administered14C-Kathon™biocide-derived14C-label was recovered in the application site skin, and was thus not readily systemically bioavailable. Peak whole blood14C -concentrations were disproportionately higher after high dermal dose applications than after lower dermal dose applications indicating nonlinear kinetics. Whole blood14C -concentrations were greater than the corresponding plasma14C -concentrations following dermal administration.
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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