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EC number: 218-529-2 | CAS number: 2173-57-1
- 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
Acute oral toxicity (study similar to OECD TG 401): LD50 > 5000 mg/kg bw.
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 10
- Control animals:
- no
- Details on study design:
- - Observations: mortality, clinical signs
- Necropsy of survivors performed: yes - Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 3 out of 10 animals died. One animal on day 1 and two on day 2.
- Clinical signs:
- Clinical signs observed included diarrhea, lethargy, ptosis and piloerection.
- Gross pathology:
- Upon necrosy the following results were revealed: 5/10 animals were normal; 1/10 animals were cannibalized; red exudate in the nose/mouth in 1/10 animals; yellow exudate in the nose/mouth in 1/10 animals; yellow anogenital exudate in 2/10 animals; red areas in the intestines in 2/10 animals; bloated intestines in 1/10 animals; red areas in the stomach in 1/10 animals; dark liver in 3/10 animals; mottled liver in 1/10 animals; dark lungs in 2/10 animals; dark kidney in 3/10 animals.
- Interpretation of results:
- other: Not classified
- Remarks:
- According to Regulation (EC) No. 1272/2008 and its updates
- Conclusions:
- The acute oral toxicity test showed an LD50 > 5000 mg/kg bw
- Executive summary:
In a pre-GLP acute toxicity study similar to OECD 401, 10 rats were orally exposed to 5000 mg/kg bw test substance. 3 out of 10 animals died. Clinical signs observed included diarrhea, lethargy, ptosis and piloerection. Upon necropsy the following results were revealed: 5/10 animals were normal; 1/10 animals were cannibalized; red exudate in the nose/mouth in 1/10 animals; yellow exudate in the nose/mouth in 1/10 animals; yellow anogenital exudate in 2/10 animals; red areas in the intestines in 2/10 animals; bloated intestines in 1/10 animals; red areas in the stomach in 1/10 animals; dark liver in 3/10 animals; mottled liver in 1/10 animals; dark lungs in 2/10 animals; dark kidney in 3/10 animals. Under the conditions of the test the acute oral LD50 was determined to be >5000 mg/kg bw in rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The acute oral toxicity result is of sufficient quality and adequate for this dossier.
Additional information
Acute oral toxicity: In a pre-GLP acute toxicity study similar to OECD 401, 10 rats were orally exposed to 5000 mg/kg bw test substance. 3 out of 10 animals died. Clinical signs observed included diarrhea, lethargy, ptosis and piloerection. Upon necropsy the following results were revealed: 5/10 animals were normal; 1/10 animals were cannibalized; red exudate in the nose/mouth in 1/10 animals; yellow exudate in the nose/mouth in 1/10 animals; yellow anogenital exudate in 2/10 animals; red areas in the intestines in 2/10 animals; bloated intestines in 1/10 animals; red areas in the stomach in 1/10 animals; dark liver in 3/10 animals; mottled liver in 1/10 animals; dark lungs in 2/10 animals; dark kidney in 3/10 animals. Under the conditions of the test the acute oral LD50 was determined to be >5000 mg/kg bw in rats.
In a supporting study (Jenner, 1964), which presents similar results as above, five Osborne-Mendel rats per sex per dose were exposed to the test substance via oral gavage. A wet posterior, coma within 1 h after exposure, rough fur and black, soft stool were observed. The LD50 was determined to be 5930 (4750 – 7420) mg/kg bw.
Acute dermal toxicity: Additional information is available from a pre-GLP acute toxicity study (Moreno, 1978) similar to OECD 402. which does not impact the C&L. A short summary is presented below. In this study 10 rabbits were dermally exposed to 5000 mg/kg bw test substance. Animals were observed for mortality and/or systemic effects. Skin irritation was recorded and gross necropsy was carried out on all animals. A limited dose of 5000 mg/kg bw was used. Clinical signs observed included ptosis in 1/10 animals on day 1. Skin irritation effects included slight redness observed in 6/10 animals, moderate redness in 3/10 animals and slight edema in 4/10 animals. Upon necropsy the following results were revealed: 7/10 animal were normal; dark areas in the lungs in 1/10 animals; dark kidney in 2/10 animals. No animals died. The acute dermal LD50 was determined to be >5000 mg/kg bw. This result does not have an impact on the classification.
Justification for classification or non-classification
Based on the available information classification and labelling for acute oral toxicity is not warranted in accordance with EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008 and its amendments.
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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