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Diss Factsheets
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EC number: 919-006-8 | 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: oral
Some information in this page has been claimed confidential.
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1985/07/11-1985/07/31
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: According to OECD 423 guideline. GLP
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 1985/07/11-1985/07/31
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: According to OECD 423 guideline. GLP
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- yes
- Remarks:
- only one dose tested
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Sex: Males (10); Females (10)
- Weight at study initiation: Males (130-135 g), Females (110-115 g)
- Housing: individual
- Acclimation period: 6d - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- A single dose of BP83HF (5 ml/kg; converted to 4.15 g/kg) was administered by oral gavage. An additional group of 5 males and 5 females were sham - dosed and acted as controls.
- Doses:
- 5 ml/kg (converted to 4.15 g/kg)
- No. of animals per sex per dose:
- Male (10), Female (10); total animals (20)
- Control animals:
- yes
- Details on study design:
- The acute oral toxicity of BP83HF was investigated in a group of 5 male and 5 female CD rats of the Sprague - Dawley strain. Each animal received a single oral dose of 5 ml/kg (converted to 4.15 g/kg) administered by gavage. An additional group of 5 males and 5 females were 'sham - dosed and acted as controls. The condition of all animals was observed over a 14 day period following dosing.
- Statistics:
- Differences between treated and control group mean values for bodyweight gains were analyzed by Student t-test. When individual variance ratios were significant (P < 0.05), Cochran's approximation was applied (Snedecor and Cochran, 1973) .
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 4 150 mg/kg bw
- Remarks on result:
- other: (converted from 5 mL/kg bw) no mortality noted
- Mortality:
- No mortality was observed in any of the animals treated with 5 ml/kg (converted to 4.15 g/kg) of BP83HF.
- Clinical signs:
- other: Transient staining of the urogenital region with test material was observed in all test rats within 24 hours of dosing. Slight flaking of the skin on the feet of these, first noted on Day 7, resolved in most animals prior to termination. During days 0-2,
- Gross pathology:
- Macroscopic post mortem examination of all animals killed at termination (Day 14) revealed no findings considered to be related to treatment. Although a haemorrhagic focus was seen in the fore-stomach of a female dosed with the test material, this lesion was minimal and was considered to be incidental to treatment with the test material.
- Interpretation of results:
- other: Not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 for BP83HF following oral gavage was >5 ml/kg (converted to 4.15 g/kg). Classification as an oral toxicant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
- Executive summary:
The acute toxicity of BP83HF was evaluated in rats via oral gavage at a dose of 5 ml/kg bw(converted to 4.15 g/kg). Observations were made as to the nature, onset, severity, and duration of toxicological signs once per day for a total of 14 days. All animals survived the entire observational period and displayed a low incidence of clinical symptoms. The animals displayed little or no abnormalities. The LD50 for BP83HF following oral gavage was >5 ml/kg (converted to 4.15 g/kg). Classification as an oral toxicant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- yes
- Remarks:
- only one dose tested
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Sex: Males (10); Females (10)
- Weight at study initiation: Males (130-135 g), Females (110-115 g)
- Housing: individual
- Acclimation period: 6d
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- A single dose of BP83HF (5 ml/kg; converted to 4.15 g/kg) was administered by oral gavage. An additional group of 5 males and 5 females were sham - dosed and acted as controls.
- Doses:
- 5 ml/kg (converted to 4.15 g/kg)
- No. of animals per sex per dose:
- Male (10), Female (10); total animals (20)
- Control animals:
- yes
- Details on study design:
- The acute oral toxicity of BP83HF was investigated in a group of 5 male and 5 female CD rats of the Sprague - Dawley strain. Each animal received a single oral dose of 5 ml/kg (converted to 4.15 g/kg) administered by gavage. An additional group of 5 males and 5 females were 'sham - dosed and acted as controls. The condition of all animals was observed over a 14 day period following dosing.
- Statistics:
- Differences between treated and control group mean values for bodyweight gains were analyzed by Student t-test. When individual variance ratios were significant (P < 0.05), Cochran's approximation was applied (Snedecor and Cochran, 1973) .
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 4 150 mg/kg bw
- Remarks on result:
- other: (converted from 5 mL/kg bw) no mortality noted
- Mortality:
- No mortality was observed in any of the animals treated with 5 ml/kg (converted to 4.15 g/kg) of BP83HF.
- Clinical signs:
- other: Transient staining of the urogenital region with test material was observed in all test rats within 24 hours of dosing. Slight flaking of the skin on the feet of these, first noted on Day 7, resolved in most animals prior to termination. During days 0-2,
- Gross pathology:
- Macroscopic post mortem examination of all animals killed at termination (Day 14) revealed no findings considered to be related to treatment. Although a haemorrhagic focus was seen in the fore-stomach of a female dosed with the test material, this lesion was minimal and was considered to be incidental to treatment with the test material.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 for BP83HF following oral gavage was >5 ml/kg (converted to 4.15 g/kg). Classification as an oral toxicant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
- Executive summary:
The acute toxicity of BP83HF was evaluated in rats via oral gavage at a dose of 5 ml/kg bw(converted to 4.15 g/kg). Observations were made as to the nature, onset, severity, and duration of toxicological signs once per day for a total of 14 days. All animals survived the entire observational period and displayed a low incidence of clinical symptoms. The animals displayed little or no abnormalities. The LD50 for BP83HF following oral gavage was >5 ml/kg (converted to 4.15 g/kg). Classification as an oral toxicant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
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.
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