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Diss Factsheets
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EC number: 419-370-3 | CAS number: 84632-66-6
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1994-12-20 to 1995-01-03
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- adopted February 24, 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- 92/69/EEC, 31-Jul-1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.1100 (Acute Dermal Toxicity)
- Version / remarks:
- Revised as of July 01, 1991
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Testing Methods for New Chemical Substances according to the Revised Japanese Chemical Substance Law (March 31, 1987).
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd., Wölferstrasse 4, 4414 Füllinsdorf / Switzerland
- Age at study initiation: males: 8 weeks, females: 11 weeks
- Weight at study initiation: males: 223.5 - 239.7 g, females: 197.0 - 219.4 g
- Fasting period before study: no
- Housing: During acclimatization in groups of five per sex in Makrolon type-4 cages with autoclaved standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz). During treatment and observation individually in Makrolon type-3 cages with autoclaved standard softwood bedding.
- Diet: Pelleted standard Kliba 343, Batch no. 82/94 rat maintenance diet ("Kliba", Klingentalmuehle AG, CH-4303 Kaiseraugst) available ad libitum.
- Water: Community tap water from Füllinsdorf, available ad libitum.
- Acclimation period: One week under laboratory conditions, after health examination.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-20.5
- Humidity (%): 46-62
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 1994-12-13 To: 1995-01-03
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- other: corn oil
- Details on dermal exposure:
- TEST SITE
- Area of exposure: back
- % coverage: 10 % of the total body surface
- Type of wrap if used: semi-occlusive dressing: The dressing was wrapped around the abdomen and fixed with an elastic adhesive bandage.
REMOVAL OF TEST SUBSTANCE
- Washing: Twenty-four hours after the application the dressing was removed and the skin was washed with lukewarm tap water and dried with disposable paper towels.
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied: 500 mg/mL
- Constant volume or concentration used: yes
VEHICLE
- Amount(s) applied: 4.0 mL/kg bw - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 male and 5 female animals
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality / Viability: Four times during test day 1 and daily for surviving animals during days 2-15.
Body Weights: On test days 1 (pre-administration), 8 and 15 for surviving animals.
Clinical Signs: Each animal was examined for changes in behaviour and appearance (with special emphasis on the application area, except for the time when the semi-occlusive dressing was in place) four times during day 1, and once daily during days 2-15. All abnormalities were recorded.
- Necropsy of survivors performed: yes
At the end of the observation period all animals were anesthetized by intraperitoneal injection of NARCOREN (Rhone Merieux GmbH, D -88471 Laupheim, Germany) at a dose of at least 2.0 mL/kg bw (equivalent to at least 320 mg/kg sodium pentobarbitone/kg bw) and sacrificed by exsanguination. The animals were examined macroscopically and all abnormalities recorded. - Statistics:
- No statistical assessment was performed due to lack of mortality.
Results and discussion
- Preliminary study:
- No preliminary study
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths as a result of treatment with the test article.
- Clinical signs:
- other: Clinical signs of systemic toxicity were observed in one female and local effects of the test article on the skin at the application site (red skin, back) were observed in all animals during the observation period. Discoloration of the skin at the applica
- Gross pathology:
- No organ abnormalities were observed at necropsy.
- Other findings:
- None
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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