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EC number: 237-222-4 | CAS number: 13701-59-2
- 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:
- 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Conducted prior to GLP, and the availability of OECD guidelines. No information on the purity of the test sample. No information on temperature and humidity) Test was conducted on abraded skin. No information on the size of test site. Animals were immobilised while it is not a recommended method.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Principles of method if other than guideline:
- Acute dermal toxicity in the rabbit (abraded skin)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Busan 11-M1
- IUPAC Name:
- Busan 11-M1
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): BUSAN 11-1M
- Substance type: No data
- Physical state: No data
- Analytical purity: No data
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: No data
- Isomers composition: No data
- Purity test date: No data
- Lot/batch No.: 47601
- Expiration date of the lot/batch: No data
- Stability under test conditions: No data
- Storage condition of test material: No data
- Other: No data
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:
- Age at study initiation: approximately 14 weeks
- Weight at study initiation: 2-3 kg
- Fasting period before study: No data
- Housing: Individually, in screen bottom cages
- Diet (e.g. ad libitum): continuous access to commercial laboratory feed
- Water (e.g. ad libitum): continuous access to water
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): air conditioned
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data
IN-LIFE DATES: From: No data To: No data
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- other: moistened with physiological saline
- Details on dermal exposure:
- TEST SITE
- Area of exposure: No data
- % coverage: 100%
- Type of wrap if used: rubber sleeve closely fastened for 24 hours
- Test site abraded
REMOVAL OF TEST SUBSTANCE
- Washing (if done): None
- Time after start of exposure:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): No data
- Constant volume or concentration used: No data
- For solids, paste formed: moistened with physiological saline
VEHICLE
- Amount(s) applied (volume or weight with unit): No data - Duration of exposure:
- 24 hours
- Doses:
- 2 g/kg
- No. of animals per sex per dose:
- 5/sex/dose
- Control animals:
- not specified
- Details on study design:
- - Animals were imobilized during exposure.
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were made hourly for 5 hours after treatment initiation and twice daily for the remainder of the observation period.
- Necropsy of survivors performed: yes - Statistics:
- No further data
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: One female died on day 2
- Mortality:
- One female died on day 2
- Clinical signs:
- other: None observed and no signs of skin irritiation.
- Gross pathology:
- The liver of one male had white areas, possible tapeworm migration scars. No visible lesions were found in any of the other male test animals.
The liver of one female was slightly pale with a nodule inguinal region (1.5 cm diameter) and another had tapeworm cysts in omentum and white area on liver, probably tapeworm migration scars. No other visible lesions were found in any of the other female animals. - Other findings:
- No further data
Any other information on results incl. tables
No further data
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The dermal LD50 was found to be >2.0 g/kg body weight. Therefore it does not warrant classification of acute dermal toxicity according to current EU legislation.
- Executive summary:
In a study conducted by Thompson (1979) the test substance, Busan 11-M1, was tested for its ability to cause acute dermal toxicity when applied to male and female New Zealand White albino rabbits. The exposure site on each test animal was shaved and abraded prior to application of the test material and the test substance moistened with physiological saline was applied. A rubber sleeve wrap was applied to the test site and remained in place for the 24 hours exposure period. During this exposure period, the test animals were immobilised. Following exposure, the test animals were placed in cages for the 14 day observation period. Under the conditions of this study, the dermal LD50 of Busan 11-M1, was determined to be >2.0 g/kg bw, equivalent to 2000 mg/kg bw. Based on this result, the test substance does not warrant classification for acute dermal toxicity in accordance with Regulation EC No. 1272/2008.
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