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Diss Factsheets
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EC number: 940-268-4 | 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
Endpoint summary
Administrative data
Description of key information
Oral: The acute oral median lethal dose (LD50) of the test material in the rat was greater than 5000 mg/kg bodyweight.
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
- Study period:
- 1977-03-14 to 1977-04-04
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: US Federal Hazardous Substances Labelling Act
- Deviations:
- not applicable
- Principles of method if other than guideline:
- A group of 30 albino male and female rats, fasted for 24-hours were assigned to various dose levels at random. The product was placed in a glass syringe and introduced into the stomach through the oesophagus using a stainless steel catheter.
Animals on the same dose were placed in a common cage with free access to food and water. The animals were observed daily for a two week period. No post mortem, or histopathology examinations were performed. - GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No information provided on test animals
Animals housed in common cage after dosing. (5 per cage)
Free access to food and water. - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- The product was placed in a glass syringe and introduced into the stomach through the oesophagus using a stainless steel catheter.
- Doses:
- 2.0, 4.0, 8.0, 16.0, 32.0 and 64.0 cc/kg (64 cc/kg corresponds to a dose of 5000 mg/kg)
- No. of animals per sex per dose:
- 5 per dose (random assignment)
- Control animals:
- no
- Details on study design:
- Animals fasted for 24 hours prior to dosing.
The animals were observed daily for a two week period for clinical signs and mortalities.
No post mortem, or histopathology examinations were performed. - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths during the study period.
- Clinical signs:
- other: Unkempt coats were noted for 4-6 hours after intubation at 2.00 cc/kg. Slight nasal haemorrhage accompanied unkempt coats at the 4.0 cc/kg dosage At 8.0 cc/kg nasal haemorrhage and wetness around the posterior was evident. Normalcy prevailed by the third
- Gross pathology:
- Not performed.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral median lethal dose (LD50) of the test material in the rat was greater than 5000 mg/kg bodyweight.
- Executive summary:
Introduction
The study was performed to assess the acute oral toxicity of the test material following oral administration in the rat. The method was performed in accordance with the US Federal Hazardous Substances Labelling Act prior to GLP.
Method
A group of 30 albino male and female rats, fasted for 24-hours were assigned one of the following dose levels at random;.2.0, 4.0, 8.0, 16.0, 32.0 and 64.0 cc/kg (64 cc/kg corresponds to a dose of 5000 mg/kg) The product was placed in a glass syringe and introduced into the stomach through the oesophagus using a stainless steel catheter. Animals on the same dose were placed in a common cage with free access to food and water. The animals were observed daily for a two week period. No post mortem, or histopathology examinations were performed.
Results
There were no deaths. Signs of toxicity noted during the study for all dose levels were unkempt coat and nasal haemorrhage. The animals dosed at 32.0 cc/kg and 64.0 cc/kg exhibited lethargy, nasal haemorrhage, diarrhoea and wet, oily coats. Alopecia commenced on day 6. Weight loss was evident in these animals.
The acute oral median lethal dose (LD50) of the test material in the rat was greater than 5000 mg/kg bodyweight.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Oral
The key study on the read-across substance EC 255 -485 -3 was performed in accordance with the US Federal Hazardous Substances Labelling Act prior to GLP.
A group of 30 albino male and female rats, fasted for 24-hours were assigned one of the following dose levels at random;.2.0, 4.0, 8.0, 16.0, 32.0 and 64.0 cc/kg (64 cc/kg corresponds to a dose of 5000 mg/kg) The product was placed in a glass syringe and introduced into the stomach through the oesophagus using a stainless steel catheter. Animals on the same dose were placed in a common cage with free access to food and water. The animals were observed daily for a two week period. No post mortem, or histopathology examinations were performed.
There were no deaths. Signs of toxicity noted during the study for all dose levels were unkempt coat and nasal haemorrhage. The animals dosed at 32.0 cc/kg and 64.0 cc/kg exhibited lethargy, nasal haemorrhage, diarrhoea and wet, oily coats. Alopecia commenced on day 6. Weight loss was evident in these animals.
The acute oral median lethal dose (LD50) of the test material in the rat was greater than 5000 mg/kg bodyweight.
The justification for read-across is attached in Section 13 of the IUCLID dossier.
Justification for classification or non-classification
Oral: The acute oral median lethal dose (LD50) of the test material in the rat was greater than 5000 mg/kg bodyweight. In the absence of an LD50 value below the threshold level for classification, the substance is not classified for acute toxicity.
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