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Diss Factsheets
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EC number: 700-161-3 | CAS number: -
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- 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:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes
- Test type:
- other: Single-dose acute dermal
- Limit test:
- yes
Test material
- Details on test material:
- - Purity: not reported as such
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Sprague-Dawley derived, albino
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: Approximately 9-10 weeks
- Weight at study initiation: Range of 279 – 308 grams for males; range of 215 – 231 grams for females.
- Fasting period before study: Not reported
- Housing: One per cage in suspended stainless steel caging with mesh floors.
- Diet (e.g. ad libitum): Rodent chow.
- Water (e.g. ad libitum): Filtered tap water, ad libitum, by an automatic water dispensing system.
- Acclimation period: 14 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23°C
- Humidity (%): 60-69%
- Air changes (per hr): Not reported.
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Dorsal area and trunk.
- % coverage: 2 inches x 3 inches, approximately 10% of the body surface.
- Type of wrap if used: 2-inch x 3-inch, 4-ply gauze pad. The gauze pad and entire trunk of each animal were then wrapped with 3-inch Durapore tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Test sites were gently cleansed.
- Time after start of exposure: After 24 hours of exposure to the test substance.
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5000 mg/kg of body weight of the test substance.
- Constant volume or concentration used: yes - Duration of exposure:
- Animals were exposed to the test substance for 24 hours. Animals were observed for 14 days.
- Doses:
- 5000 mg/kg body weight
- No. of animals per sex per dose:
- 5 animals per sex
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Body Weights – Individual body weights were recorded prior to test substance application, initial, and on Days 7 and 14.
Clinical Observations – Animals were observed for mortality, signs of gross toxicity, and behavioral changes, one hour and 5 hours after application and at least once daily thereafter for 14 days.
- Necropsy of survivors performed: Yes.
- Other examinations performed: Pathology examination, Gross – Tissues and organs of the thoracic and abdominal cavities were examined. - Statistics:
- No.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- No mortalities occurred. All animals survived exposure to the test substance.
- Clinical signs:
- Clinical observation of ano-genital staining for 2 male rats from Days 1 through 3. No other clinical observations were noted. There were no other signs of gross toxicity, dermal irritation, adverse pharmacologic effects, or abnormal behavior.
- Body weight:
- One male lost body weight through Day 7. All other animals gained weight over the entire 14-day study.
- Gross pathology:
- No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14-day observation period.
- Other findings:
- None.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- LD50 (rats) > 5000 mg/kg
- Executive summary:
An acute dermal toxicity test was conducted with rats to determine the potential for the test substance to produce toxicity from a single topical application. Five thousand milligrams of the test substance per kilogram of body weight was applied to the skin of 10 healthy rats for 24 hours. The animals were observed for mortality, signs of gross toxicity, and behavioral changes one and 5 hours post-dosing and at least once daily for 14 days. Body weights were recorded prior to application and again on Days 7 and 14 (termination). Necropsies were performed on all animals at terminal sacrifice.
All animals survived exposure to the test substance. Apart from ano-genital staining noted for 2 males from Days 1 through 3, there were no other signs of gross toxicity, dermal irritation, adverse pharmacologic effects, or abnormal behavior. Although one male lost body weight through Day 7, all animals gained weight over the entire 14-day study. No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14-day observation period.
Under the conditions of this study, the single dose acute dermal LD50of the test substance is greater than 5000 mg/kg of body weight in male and female rats.
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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