Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15 January - 31 January, 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Conducted prior to GLP, and the availabilty of OECD guidelines. No information on the purity of the test sample, limited information on the animals and the conditions of the testing (such as no information on temperature and humidity) but adequate for the purposes of hazard classification
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 401 (Acute Oral Toxicity)
- 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:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Sprague Dawley, Madison, WI
- Age at study initiation: No data
- Weight at study initiation: 221 - 261 g (males) 208 - 215 g (females)
- Fasting period before study: No data
- Housing: No data
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: 26 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data
IN-LIFE DATES: From: 19/12/1978 To: 31/1/1979
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: No data
- Amount of vehicle (if gavage): No data
- Justification for choice of vehicle: No data
- Lot/batch no. (if required): No data
- Purity: No data
MAXIMUM DOSE VOLUME APPLIED: No data
DOSAGE PREPARATION (if unusual): No data - Doses:
- 0.34, 0.50, 0.73, 1.07, 2.31, 5.0 g/kg
- No. of animals per sex per dose:
- 8 rats/sex/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Weight was measured at study initiation, day 7 and study termination
Pharmacotoxic signs were observed at hours 1, 2, 5 and daily thereafter.
- Necropsy of survivors performed: yes - Statistics:
- No further data
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 850 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 700 - 1 130
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 530 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 380 - 660
- Mortality:
- No animals died in the 0.34 dosage group
1 male and 6 females died in the 0.5 dosage group
3 males and 6 females died in the 0.73 dosage group
6 males and all females died in the 1.07 dosage group
All animals died in the 2.31 dosage group
All animals died in the 5.0 dosage group - Clinical signs:
- other: 0.34 dosage group: all animals appeared normal with no clinical signs 0.5 dosage group - 5.0 dosage group: Animals showed a range of symptoms including diarrhea, hypoactivity, ataxia, decrease limb tone, bradypnea, piloerection, absence of grasping reflex
- Gross pathology:
- No significant visible lesions were observed
- Other findings:
- No further data
Any other information on results incl. tables
No further data
Applicant's summary and conclusion
- Interpretation of results:
- Toxicity Category IV
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The oral LD50 was found to be 0.85 g/kg in males and 0.53 g/kg in females. Therefore it is classified as Category 4, signal word warning, hazard statement H302: Harmful if swallowed.
- Executive summary:
The test substance Busan 11-M1 was administered to 8 rats/sex/dose male and female Sprague-Dawley rats in dosages administered at 0.34, 0.50, 0.73, 1.07, 2.31, 5.0 g/kg. The test animals were observed for 14 days following administration. Under the conditions of this study, the oral LD50 of the test substance was determined to be 0.85 g/kg in males and 0.53 g/kg in females . Based on this result, Busan 11-M1 is classified as Category 4, signal word warning, hazard statement H302: Harmful if swallowed in accordance with Regulation EC No. 1272/2008.
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.