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Diss Factsheets
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EC number: 416-730-1 | 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
- Study period:
- June 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
Test material
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Appearance: Yellow powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Lot/batch number of test material: KL384
- Expiration date of the lot/batch: not specified
- Purity test date: not specified
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature in the dark
- Stability under storage conditions: not specified
- Stability under test conditions: not specified
- Solubility and stability of the test substance in the solvent/dispersant/vehicle/test medium: not specified
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: suspended in distilled water
- Final dilution of a dissolved solid, stock liquid or gel: 71.43 % concentration in distilled water
FORM AS APPLIED IN THE TEST (if different from that of starting material): suspended in distilled water. The test substance was prepared on the day of dosing.
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Olac Ltd., Bicester, Oxon, England
- Age at study initiation: approximately 7 to 10 weeks
- Weight at study initiation: males: 240.8 g (mean); females: 226.2 g (mean)
- Fasting period before study: no
- Housing: one animal per cage
- Diet: standard laboratory rodent diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: 6 days
- Microbiological status when known: not specified
- Method of randomisation in assigning animals to test and control groups: not specified
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 24
- Humidity (%): 52
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: To: not specified
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorso-lumbar region
- % coverage: approximately 10% of the total body surface
- Type of wrap if used: The treated area (approximately 50 mm x 50 mm) was covered with gauze which was held in place with a non-irritative dressing encircled firmly around the trunk.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated area of skin was washed with warm (30° to 40°C) water and blotted dry with absorbent paper.
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.0 g/kg bodyweight
- Constant volume or concentration used: yes
- For solids, paste formed: not specified. The suspended test substance was applied by spreading it evenly over the prepared skin. - Duration of exposure:
- 24 h
- Doses:
- 2 g/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed soon after dosing and at frequent intervals for the remainder of Day 1 (a period of three hours). On subsequent days animals were observed once in the morning and again at the end of the experimental day. Local dermal irritation at the treatment site was assessed daily. Individual bodyweights were recorded on Days 1 (prior to dosing), 8 and 15.
- Necropsy of survivors performed: All animals were killed on Day 15 by cervical dislocation and were subjected to a macroscopic examination which consisted of opening the abdominal and thoracic cavities. The macroscopic appearance of all examined tissues was recorded.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: no mortality and no signs of specific toxicity observed
- Mortality:
- none
- Clinical signs:
- There were no signs of systemic reaction to treatment.
- Body weight:
- - A slightly low bodyweight gain was recorded for one male and one female on Day 8 and in three males on Day 15. All other rats achieved the anticipated bodyweight gains throughout the study.
- Gross pathology:
- No macroscopic abnormalities were observed.
- Other findings:
- Sites of application of the test substance showed no irritation or other dermal changes. However, a residual yellow staining was evident in a number of animals during the study clearing in all instances by Day 15.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute lethal dermal dose to rats was found to be greater than 2.0 g/kg bodyweight.
- Executive summary:
A group of ten rats (five males and five females) was given a single dermal application of the test substance, at a maximum practical concentration of 71.43% w/v in distilled water, and at a dose level of 2.0 g/kg bodyweight. All animals were killed and examined macroscopically on Day 15, the end of the observation period. There were no deaths and no signs of systemic reaction to treatment. Sites of application of the test item showed no irritation or other dermal changes. However, a residual yellow staining was evident in a number of animals during the clearing in all instances by Day 15. A slightly low bodyweight gain was recorded for one male and one female on Day 8 and in three males on Day 15. All other rats achieved the anticipated bodyweight gains throughout the study. No abnormalities were recorded at the macroscopic examination on Day 15.
The acute lethal dermal dose to rats was found to be greater than 2.0 g/kg bodyweight.
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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