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EC number: 251-964-6 | CAS number: 34364-26-6
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- No details on test material were included, and details about gavage volume and environmental conditions of the animals were not stated. Study conducted under GLP but no certificate was included. Further, the age of the animals was not stated.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 1981-05-12
- GLP compliance:
- yes
- Remarks:
- certificate not included
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- Bismuth(3+) neodecanoate
- EC Number:
- 251-964-6
- EC Name:
- Bismuth(3+) neodecanoate
- Cas Number:
- 34364-26-6
- Molecular formula:
- C10H19O2.xBi
- IUPAC Name:
- tris[(3,3,5,5-tetramethylhexanoyl)oxy]bismuthine
- Details on test material:
- - Density: 1.13- 1.14 mg/ml
Constituent 1
- Specific details on test material used for the study:
- Composition statement Cos Cat 83 is attached
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc., Wilmington, MA
- Housing: animals were individually housed in wire mesh bottom cages in environment-controlled rooms and provided food and water ad libitum
- Acclimation period: at least 5 days
- Weight at study initiation: males: 255.0-317.2 g; females: 213.6- 252.4 g
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- undiluted
- Details on oral exposure:
- CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: dose levels based on results of dose range findinge study - Doses:
- 1000, 1368, 1871, 2559, 3500, 4787 mg/kg bw
- No. of animals per sex per dose:
- 5 animals/sex/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: trial test: 8 days, main study: 15 days
- Frequency of observations and weighing: animals were observed frequently on the day of dosing and twice daily thereafter, body weights were recorded initially, on days 8 and 15 or at death
- Necropsy of survivors performed: yes, all animals that dies during the study and those sacrificed at termination were subjected to a gross necropsy and abnormalities were noted - Statistics:
- Miller-Tainter Determination of LD50
Results and discussion
- Preliminary study:
- A trial test with 10 animals/dose and a dose range finding study with 2 animals/dose were conducted to determine dose levels for the main study. Male and female Sprague Dawley rats (5 animals/dose) were dosed with 5 g/kg bw of bismuth neodecanoate. All animals died during the first four days of observation. A second study was conducted to define the dose levels for the main study. One male and one female rat were dosed with 500, 889, 1581, 2812 and 5000 mg/kg bw and observed for 8 days. Both animals in the high dose groups (2812 and 5000 mg/kg bw) died after 2 days. All animals in the other treatment groups survived. No details about clinical signs and necropsy are stated.
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 3 030 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 2 437 - <= 3 624
- Mortality:
- Main study
Males:
3/5 animals died in the 3500 mg/kg bw group
5/5 animals died in the 4787 mg/kg bw group
Females
2/5 animals died in the 1871 mg/kg bw group
2/5 animals died in the 2559 mg/kg bw group
5/5 animals died in the 3500 mg/kg bw group
3/5 animals died in the 4787 mg/kg bw group - Clinical signs:
- Trial Test:
5g/kg bw
Decreased activity observed in 4/5 males and all females
Ataxia observed in all males and females
Salivation observed in 1/5 males
Lacrimation observed in 1/5 females
Death observed in all animals
Main study
1000 mg/kg
Ataxia observed in 4/5 males and all females
Decreased activity observed in 1/5 males and 3/5 females
1368 mg/kg
Decreased activity observed in 2/5 males and 4/5 females
Ataxia observed in 4/5 males and all females
Salivation observed in 1/5 males
Lacrimation observed in 1/5 females
Wet-abdomen observed in 2/5 females
1871 mg/kg
Decreased activity observed in 3/5 males and 3/5 females
Ataxia observed in 4/5 males and 4/5 females
Gaspring observed in 1/5 males
Wet-abdomen observed in 1/5 females
Lacrimation observed in 1/5 males and 3/5 females
Diarrhea observed in 1/5 females
Deaths observed in 2/5 females
2559 mg/kg bw
Decreased activity observed in 4/5 males and 5/5 females
Ataxia observed in 3/5 males and 3/5 females
Wet-abdomen observed in 1/5 females
Lacrimation observed in 1/5 males and 3/5 females
Diarrhea observed in 4/5 males
Deaths observed in 2/5 females
3500 mg/kg bw
Decreased activity observed in 5/5 males and 5/5 females
Ataxia observed in 3/5 males and 2/5 females
Salivation observed in 1/5 females and 1/5 males
Wet-abdomen observed in 2/5 females
Lacrimation observed in 1/5 males and 4/5 females
Diarrhea observed in 1/5 males
Deaths observed in 3/5 males and 5/5 females
4787 mg/kg bw
Decreased activity observed in 5/5 males and 5/5 females
Ataxia observed in 5/5 males and 5/5 females
Salivation observed in 1/5 females and 1/5 males
Wet-abdomen observed in 4/5 females
Lacrimation observed in 4/5 females
Diarrhea observed in 1/5 females
Deaths observed in 5/5 males and 3/5 females - Body weight:
- Males
Trial Test
5 g/kg bw
339 ± 16.3 g (day1)
Main study
1000 mg/kg bw
Day 1: 266.8 ± 9.1 g; day 8: 330.8 ± 13.4 g; day 15: 376.0 ± 15.7 g
1368 mg/kg bw
Day 1: 262.0 ± 15.7 g; day 8: 328.4 ± 18.9 g; day 15: 376.8 ± 23.3 g
1871 mg/kg bw
Day 1: 261.4 ± 10.0 g; day 8: 313.4 ± 20.4 g; day 15: 358.8 ± 28.7 g
2559 mg/kg bw
Day 1: 255.4 ± 12.1 g; day 8: 307.2 ± 16.0 g; day 15: 354.8 ± 15.8 g
3500 mg/kg bw
Day 1: 255.0 ± 10.9 g; day 8: 307.5 g; day 15: 363.0 g
4787 mg/kg bw
Day 1: 317.2 ± 14.3 g
Females
Trial Test
5 g/kg bw
236.8 ± 3.6 g (day1)
Main study
1000 mg/kg bw
Day 1: 213.6 ± 15.5 g; day 8: 239.0 ± 16.2 g; day 15: 250.2 ± 20.0 g
1368 mg/kg bw
Day 1: 227.8 ± 8.3 g; day 8: 251.4 ± 16.3 g; day 15: 261.2 ± 15.6 g
1871 mg/kg bw
Day 1: 219.4 ± 16.7 g; day 8: 252.7 ± 32.9 g; day 15: 260.0 ± 38.2 g
2559 mg/kg bw
Day 1: 218.4 ± 8.1 g; day 8: 246.7 ± 12.0 g; day 15: 258.0 ± 11.1 g
3500 mg/kg bw
Day 1: 231.8 ± 8.2 g
4787 mg/kg bw
Day 1: 252.4 ± 19.5 g; day 8: 260.0 g; day 15: 264.0 g - Gross pathology:
- Trial Test 5 g/kg bw
No noteworthy findings in males and females, except in one female: bladder contains blood-like liquid
Main study
No noteworthy findings in males and females of the dose groups 1000, 1368, 1871, 2559 and 3500 mg/kg bw
No noteworthy findings in males and females of the 4787 mg/kg group, except in one female: intestine contains blood-like liquid
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 for male rats was calculated to be 3294 mg/kg bw; the LD50 for female rats was calculated to be 2612 mg/kg bw. The combined LD50 was calculated to be 3030 mg/kg bw.
- Executive summary:
Sprague Dawley rats were exposed to Bismuth neodecanoate in an acute oral toxicity study. A trial test with 10 animals/dose and a dose range finding study with 2 animals/dose were conducted to determine dose levels for the main study. Male and female Sprague Dawley rats (5 animals/dose) were dosed with 5 g/kg bw of bismuth neodecanoate. All animals died during the first four days of observation. A second study was conducted to define the dose levels for the main study. One male and one female rat were dosed with 500, 889, 1581, 2812 and 5000 mg/kg bw and observed for 8 days. Both animals in the high dose groups (2812 and 5000 mg/kg bw) died after 2 days. All animals in the other treatment groups survived. No details about clinical signs and necropsy are stated.
Based on these results the main study was conducted with 1000, 1368, 1871, 2559, 3500 and 4787 mg/kg bw bismuth neodecanoate and 5 males and 5 females per dose group. All animals were observed for 14 days and clinical signs were recorded twice daily. Body weight was recorded at day 1, 8 and 15. At the end of the observation period a necropsy of all animals was conducted.
Ataxia, decreased activity, salivation, lacrimation as well as a wet abdomen, diarrhea and death were observed with increasing dose. 3/5 males in the 3500 mg/kg bw group and 5/5 males in the 4787 mg/kg died prematurely, 2/5 females in the 1871 mg/kg bw, 2/5 females in the 2559 mg/kg bw, 5/5 females in the 3500 mg/kg bw and 3/5 females in the 4787 mg/kg bw group died prematurely.
Based on these findings the LD50 for male rats was calculated to be 3294 mg/kg bw; the LD50 for female rats was calculated to be 2612 mg/kg bw. The combined LD50 was calculated to be 3030 mg/kg bw.
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