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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 911-915-8 | 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1967
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1967
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- not specified
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- not specified
- Test type:
- other: Acute Oral Toxicity
- Limit test:
- no
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material:
- Expiration date of the lot/batch:
- Purity test date:
RADIOLABELLING INFORMATION (if applicable)
- Radiochemical purity:
- Specific activity:
- Locations of the label:
- Expiration date of radiochemical substance:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
- Stability under test conditions:
- Solubility and stability of the test substance in the solvent/vehicle:
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium:
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing:
- Preliminary purification step (if any):
- Final dilution of a dissolved solid, stock liquid or gel:
- Final preparation of a solid:
FORM AS APPLIED IN THE TEST (if different from that of starting material)
OTHER SPECIFICS: - Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- no data
- Route of administration:
- oral: unspecified
- Vehicle:
- other: distilled water
- Details on oral exposure:
- no data
- Doses:
- 500, 625, 750 or 1000 mg/kg bw (as base) in a dose volume of 20 mL/kg bw distilled water.
- No. of animals per sex per dose:
- Ten animals per dose were tested.
- Control animals:
- yes
- Details on study design:
- The animals were dosed orally at 500, 625, 750 or 1000 mg/kg bw (as base) in a dose volume of 10 mL/kg bw distilled water. Controls received distilled water at 20 mL/kg bw.
In general, the rats were observed for seven consecutive days for death and the LD50 with 95% Fieller Confidence Limits was calculated. Due to the death of 750 mg/kg bw dose the study was continued two additional days. No additional animals died during that period. - Statistics:
- no data
- Preliminary study:
- not applicable
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 608 mg/kg bw
- 95% CL:
- >= 337 - <= 777
- Mortality:
- Dose (mg/kg bw) Dead/Tested
500 4/10
625 4/10
750 7/10
1000 9/10 - Clinical signs:
- other: no data
- Gross pathology:
- no data
- Other findings:
- no data
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The LD50 with 95% Fieller Confidence Limits was determined to be 608 (337 – 777) mg/kg bw.
- Executive summary:
Female Charles River rats, weighing between 100 and 155 g, were used in this study.
The animals were dosed orally at 500, 625, 750 or 1000 mg/kg bw (as base) in a dose volume of 10 mL/kg bw distilled water. Controls received distilled water at 20 mL/kg bw.
Ten animals per dose were tested. In general, the rats were observed for seven consecutive days for death and the LD50 with 95% Fieller Confidence Limits was calculated. Due to the death of 750 mg/kg bw dose the study was continued two additional days. No additional animals died during that period.
Mortality
Dose Dead/Tested
500 mg/kg bw, 4/10
625 mg/kg bw, 4/10
750 mg/kg bw, 7/10
1000 mg/kg bw, 9/10
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 969
- Report date:
- 1969
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- not specified
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- not specified
- Test type:
- other: Acute Oral Toxicity
- Limit test:
- no
Test material
Test animals
- Species:
- mouse
- Strain:
- CF-1
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- no data
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- other: distilled water
- Details on oral exposure:
- not applicable
- Doses:
- 500, 625, 750, 1000, 1250, 1750 mg/kg bw (as base) in a dose volume of 10 or 30 mL/kg bw distilled water.
The 500 - 1000 mg/kg bw doses were given at 10 mL/kg bw. As the data was insufficient to calculate an LD50, additional higher doses were tested. A 30 mL/kg bw was used for these higher doses. Controls received distilled water at 20 and 30 mL/kg bw. - No. of animals per sex per dose:
- Ten animals per dose
- Control animals:
- yes
- Details on study design:
- 500, 625, 750, 1000, 1250, 1750 mg/kg bw (as base) in a dose volume of 10 or or 30 mL/kg bw distilled water. The 500 - 1000 mg/kg bw doses were given at 10 mL/kg bw. As the data was insufficient to calculate an LD50, additional higher doses were tested. A 30 mL/kg bw was used for these higher doses. Controls received distilled water at 20 and 30 mL/kg bw.
The mice were observed for seven consecutive days for death and the LD50 with 95% Fieller Confidence Limits was calculated. - Statistics:
- NA
Results and discussion
- Preliminary study:
- not applicable
Effect levels
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 929 mg/kg bw
- 95% CL:
- >= 760 - <= 1 141
- Mortality:
- Dose (mg/kg bw) Dead/Tested
500 2/10
625 0/10
750 2/10
1000 5/10
1250 8/10
1500 10/10
1750 9/10
Resulting LD50 with 95% Fieller Confidence Limits (CL): 929 (760 - 1141) mg/kg - Clinical signs:
- other: no data
- Gross pathology:
- no data
- Other findings:
- not applicable
Any other information on results incl. tables
Mortality
Dose Dead/Tested
500 mg/kg bw, 2/10
625 mg/kg bw, 0/10
750 mg/kg bw, 2/10
1000 mg/kg bw, 5/10
1250 mg/kg bw, 8/10
1500 mg/kg bw, 10/10
1750 mg/kg bw, 9/10
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The LD50 with 95% Fieller Confidence Limits was determined to be 929 (760 – 1141) mg/kg bw.
- Executive summary:
Male Carworth Farms CF-1S mice, weighing between 18 and 26 g were dosed orally at 500, 625, 750, 1000, 1250, 1500 or 1750 mg/kg bw (as base) in a dose volume of 10 or 30 mL/kg bw distilled water. The 500 - 1000 mg/kg bw doses were given at 10 mL/kg bw. As the data was insufficient to calculate an LD50, additional higher doses were tested. A 30 mL/kg bw was used for these higher doses. Controls received distilled water at 10 and 30 mL/kg bw.
Ten animals per dose were tested. The mice were observed for seven consecutive days and the LD50 with 95% Fieller Confidence Limits were calculated. The LD50 with 95% Fieller Confidence Limits in CF-1S mice was determined to be 929 (760 – 1141) mg/kg bw.
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.