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Diss Factsheets
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EC number: 205-516-1 | CAS number: 141-97-9
- 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:
- 1975
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Principles of method if other than guideline:
- The study was performed before GLP- and OECD-testing guidelines were available and in force.
A group of approximately 70 albino male and female rats, fasted for twenty-four hours were employed to establish an LD50 range for each product under test. Young adult rats which had not been used for previous test purposes were assigned to various dose levels at random. Both sexes were equally distributed. Body weight of the rats were 200-300 grams at the beginning of the study. Animals on the same dosage level were then placed in a common cage with free access to food and water. The animals were observed daily for a two week period.
No postmortem, or histopathology examinations were performed in this particular study. - GLP compliance:
- no
- Remarks:
- GLP-guidelines not yet in force at date of the study
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Test material form:
- other: non-viscous clear liquid
- Details on test material:
- - Physical state: Colourless liquid
Constituent 1
- Specific details on test material used for the study:
- no data
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Fasted albino rats were used in this study.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- The product under test was placed in a glass syringe and introduced through the esophagus into the stomach with a stainless steel catheter.
- Doses:
- 7 dose groups (males & females) with dosages of:
- 0 mg/kg (control)
- 2000 mk/kg
- 4000 mg/kg
- 6400 mg/kg
- 8000 mg/kg
- 10000 mg/kg
- 12600 mg/kg
- 16000 mg/kg - No. of animals per sex per dose:
- Five animals per sex and dose
- Control animals:
- yes
- Details on study design:
- no data
- Statistics:
- no data
Results and discussion
- Preliminary study:
- No preliminary test performed.
Effect levelsopen allclose all
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 12 300 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 10 300 - 14 800
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 10 800 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 9 300 - 12 500
- Mortality:
- No mortality was observed up to dose concentrations of 6400 mg/kg in males and up to 8000 mg/kg. Animals were found dead at 8000 mg/kg and above in males and at 10000 mg/kg and above in females. Details are given in the table below.
- Clinical signs:
- other: MALES: Males dosed at 2.0 g/kg and 4.0 g/kg exhibited moderate diarrhea for 2-3 days following intubation. Lethargy and moderate to severe diarrhea were noted at 6.4 g/kg and 8.0 g/kg. Rapid erratic respiration, lethargy, severe diarrhea, ruffled and unke
- Gross pathology:
- No postmortem, or histopathology examinations were performed in this particular study.
- Other findings:
- none
Any other information on results incl. tables
Mortality:
Dose Level (mg/kg) |
No. of deaths (males) |
Number of deaths (females) |
2000 |
0 |
0 |
4000 |
0 |
0 |
6400 |
0 |
Not tested |
8000 |
1 (day 2) |
0 |
10000 |
1 (day 1) |
2 (day 1 and 2) |
12600 |
2 (day 1 and day 2) |
4 (3 on day 1 and 1 on day 2) |
16000 |
5 (day 1) |
5 (day 1) |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral toxicity on Albino rats was determined to be 12300 mg/kg for males and 10800 mg/kg for females.
- Executive summary:
A study was carried out equivalent or similar to EU Method B.1 and OECD Guideline 401 (Acute Oral Toxicity). 6 groups of 10 rats (5 male, 5 female) were treated by gavage with doses from 2000 up to 16000 mg/kg.Males and females dosed at 2.0 g/kg and 4.0 g/kg exhibited moderate diarrhea for 2-3 days following intubation. Lethargy and moderate to severe diarrhea were noted at 6.4 g/kg (only males tested) and 8.0 g/kg (both sexes). Rapid erratic respiration, lethargy, severe diarrhea, ruffled and unkempt coats were evident at the 10.0 g/kg and 12.6 g/kg dosage levels in both sexes. Death animals were observed at dose levels of 6400 mg/kg and above; for details refer to the above mentioned table. At 16000 mg/kg, the animals succumbed within 30 minutes after forced feeding. The LD50 was determined to be 12300 mg/kg for females and 10800 mg/kg for males.
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.
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