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Diss Factsheets
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EC number: 401-300-8 | CAS number: 86168-95-8
- 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:
- 1985-03-19 to 1985-04-02
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD 402) performed under GLP-like quality controlled conditions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- adopted on 12 May 1981
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- Predating compulsory compliance to GLP, QA statement included
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Details on test material:
- - Physical state: solid
- Storage condition of test material: room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Rat, Tif:RAIf(SPF), F3-crosses of RII 1/Tif X RII 2/Tif
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY LTD. Tierfarm, 4334 Sisseln, Switzerland
- Age at study initiation: 7-8 weeks
- Weight at study initiation: 215 - 233 g
- Housing: conventional laboratory conditions. Animals were caged individually in Macrolon cages type 2 with standardized softwood bedding (Societe Parisienne des Sciures, Pantin).
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature: 22+3° C
- Humidity: 55±15%
- Air changes: 15 air changes/h
- Photoperiod: 12 hours light/day
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- other: Distilled water containing 0.5% carboxymethylcellulose and 0.1% polysorbate 80
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Back of the rat
- % coverage: 10 % of the body surface
- Type of wrap: gauze-lined semiocclusive dressing
REMOVAL OF TEST SUBSTANCE
- Washing: the skin was cleaned with lukewarm water
- Time after start of exposure: After an exposure period of 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg body weight
VEHICLE
- Amount(s) applied (volume or weight with unit): 4 mL/kg bw
- Concentration: 500 mg / mL
- Distilled water containing 0.5% carboxymethylcellulose and 0.1% polysorbate 80 (prepared by Pharmaceuticals Division, Ciba-Geigy Ltd.).
Pretreatment: Approximately 24 hours before treatment, an area on the back of the rat of at least 10% of the body surface was shaved with an electric clipper.
Administration: The required amount of the test substance was evenly dispersed on the skin. It was covered with a gauze-lined semiocclusive dressing, which was fastened around the trunk with an adhesive elastic bandage. After an exposure period of 24 hours the dressing was removed and the skin was cleaned with lukewarm water. Thereafter the reaction of the skin was appraised repeatedly. - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- Observation Period: 14 days
Mortality: daily, a.m. and p.m., a.m. on weekends
Signs and Symptoms: daily
Body weight: on days 1, 7, and 14
Necropsies: The animals were submitted to a gross necropsy at the end of the observation period. - Statistics:
- From the body weights, the group means and their standard deviations were calculated.
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred
- Clinical signs:
- other: Dyspnea, ruffled fur, and abnormal body positions were seen, being common symptoms in acute dermal tests. Additionally, diarrhea was observed on day 1 after application. The animals recovered within 13 days.
- Gross pathology:
- No deviations from normal morphology were found.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information
- Conclusions:
- The dermal LD50 in the rat was determined at greater than 2000 mg/kg body weight
- Executive summary:
In a dermal acute toxicity study according to OECD guideline 402, five male and five female rats were treated semiocclusively with the test article in distilled water containing 0.5% carboxymethylcellulose and 0.1% polysorbate 80 for 24 hours and observed for 14 days. There were no deaths. Dyspnea, ruffled fur, and abnormal body positions were seen, being common symptoms in acute dermal tests. Additionally, diarrhea was observed on day 1 after application. The animals recovered within 13 days. All gained weight by day 14 of the study. No irritations were noted on any of the test sites. All animals appeared normal at necropsy. Under the conditions of this study, the LD50 is greater than 2000 mg/kg bw in male and female rats when topically applied.
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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