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Diss Factsheets
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EC number: 431-870-3 | 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
Endpoint summary
Administrative data
Description of key information
BMS 217947 -01 was tested for acute oral toxicity on Sprague-Dawley male and female rats, according to EU Test Method B.1 bis (fixed dose procedure) and OECD Test Guideline 423. No deaths were observed on 3 male and 3 female rats at the 200 mg/kg bw dose, while all 3 female rats died at the dose level of 2000 mg/kg bw. Based on this, the oral LD50 for the substance was estimated to be 300 - 500 mg/kg bw. This is sufficient to classify the substance as acute toxic, categorty 4, according to CLP. No clinical signs or adverse effects were observed at the 200 mg/kg bw dose level.
A study was carried out on male and female Sprague-Dawley rats to determine the acute dermal (systemic) toxicity potential for substance BMS 217947 -01, according to EU Test Method B3, Part 3 of Directive 92/69/EEC and OECD Test Guideline No 402. None of the 5 male and 5 female rats died when exposed to doses of 200 mg/kg bw and 2000 mg/kg bw. Therefore, the LD50 value for dermal exposure is greater than 2000 mg/kg bw. As a result, the substance is not classified as acute dermal toxic.
A method devlopment trial was conducted on BMS 217947 -01 to determine the perforance of a OECD Guidelines for Testing of Chemicals, Section 4, Health Effects. No.436, "Acute Inhalation Toxicity - Acute Toxic Class Method. This study was conducted in order to develop and method for the generation of a suitable test atmosphere. Limitiations to generate a suitable test atmosphere were found and it was concluded that becasue of the intrinsic properties of substance it was not technically possible to determine the inhalation toxicity.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24 Nov. 1998 to 15 Dec. 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD method and GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Vehicle:
- other: Arachis oil BP.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- >= 300 - <= 500 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Male: 200 mg/kg bw; Number of animals: 3; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 3
Female: 200 mg/kg bw; Number of animals: 3; Number of deaths: 0 - Clinical signs:
- other: Signs of toxicity related to dose levels: Deaths were noted at a dose level of 2000mg/kg. There were no deaths at a dose level of 200mg/kg. Signs of toxicity noted at a dose level of 2000mg/kg were hunched posture, lethargy, ataxia decreased respira
- Gross pathology:
- Effects on organs:
Dose level 2000mg/kg = haemorrhagic lungs, dark liver, pale spleen, dark kidneys, pale appearance of the gastric mucosa and haemorrhage of the small intestine.
Dose level 200mg/kg = No abnormalities were detected. - Interpretation of results:
- Category 4 based on GHS criteria
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- LD 50 is estimated to be 300-500 mg/kg and classified as acute toxic class 4.
- Executive summary:
BMS 217947 -01 was tested for acute oral toxicity on Sprague-Dawley male and female rats, according to EU Test Method B.1 bis (fixed dose procedure) and OECD Test Guideline 423. No deaths were observed on 3 male and 3 female rats at the 200 mg/kg bw dose, while all 3 female rats died at the dose level of 2000 mg/kg bw. Based on this, the oral LD50 for the substance was estimated to be 300 - 500 mg/kg bw. This is sufficient to classify the substance as acute toxic, categorty 4, according to CLP.
No clinical signs or adverse effects were observed at the 200 mg/kg bw dose level.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 300 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Study period:
- 05 June 2015
- Data waiving:
- study technically not feasible
- Justification for data waiving:
- other:
- GLP compliance:
- no
Reference
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 27 July - 26 August 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: done under GLP and OECD method
- Qualifier:
- according to guideline
- Guideline:
- other: Directive 92/69/EEC, Method B3 Part 3;OECD Guideline No.402
- GLP compliance:
- yes
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Type of coverage:
- semiocclusive
- Vehicle:
- other: 1% methylcellulose.
- Duration of exposure:
- 24 h
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0 - Clinical signs:
- other: Signs of toxicity related to dose levels: No deaths occurred in any of the animals. A slight bodyweight loss was noted in two females on day 8 and day 15. One female gained no weight on day 8. No other systemic responses were observed in any animals.
- Gross pathology:
- Effects on organs:
No macroscopic abnormalities were observed for animals
killed at study termination on Day 15. - Other findings:
- Signs of toxicity (local):
Transient slight to well-defined irritation (erythema/oedema
Grade 1 or 2) was notable in four males and four females
following removal of dressings, resolving in all instances
by Day 5. No dermal response was evident in the remaining
two rats throughout the study. - Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute lethal dermal dose to rats was demonstrated to be greater than 2000mg/kg bodyweight
- Executive summary:
A study was carried out on male and female Sprague-Dawley rats to determine the acute dermal (systemic) toxicity potential for substance BMS 217947 -01, according to EU Test Method B3, Part 3 of Directive 92/69/EEC and OECD Test Guideline No 402. None of the 5 male and 5 female rats died when exposed to doses of 200 mg/kg bw and 2000 mg/kg bw. Therefore, the LD50 value for dermal exposure is greater than 2000 mg/kg bw. As a result, the substance is not classified as acute dermal toxic.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
Justification for classification or non-classification
The oral LD50 for the substance was estimated to be 300 - 500 mg/kg bw. This is sufficient to classify the substance as acute toxic, categorty 4, according to CLP.
The LD50 value for dermal exposure is greater than 2000 mg/kg bw. As a result, the substance is not classified as acute dermal toxic.
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