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EC number: 217-420-7 | CAS number: 1843-03-4
- 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:
- Not specified
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non standard study design but data are adequate to draw conclusion on toxicity.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 963
- Report date:
- 1963
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Not specified
- GLP compliance:
- not specified
- Test type:
- other: Not specified
- Limit test:
- yes
Test material
- Reference substance name:
- 4,4',4''-(1-methylpropanyl-3-ylidene)tris[6-tert-butyl-m-cresol]
- EC Number:
- 217-420-7
- EC Name:
- 4,4',4''-(1-methylpropanyl-3-ylidene)tris[6-tert-butyl-m-cresol]
- Cas Number:
- 1843-03-4
- Molecular formula:
- C37H52O3
- IUPAC Name:
- 4-[4,4-bis(5-tert-butyl-4-hydroxy-2-methylphenyl)butan-2-yl]-2-tert-butyl-5-methylphenol
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Name of material: Topanol CA
Uses of material and estimated scale of production: To be used as a thermal stabiliser in polypropylene (up to 1.0% w/w in virgin polymer). 11,000 tons p.a. of stabilised polymer are expected to be manufactured, hence up to 110 tons p.a. of Topanol CA could be expected to be used.
In the present state of knowledge Topanol CA is by far the best agent for stability in this product (“Propathene”).
Physical state: fine powder
Colour: nearly white
Odour: faintly “organic”
Particle size: very small
Stability: stable
Solubility in water, acids, alkalis, vegetable and mineral oils and organic solvents: soluble in some organic solvents, polymers, etc.
Constituent 1
Test animals
- Species:
- other: rat, guinea pig, dog
- Strain:
- other: albino rats, no data for guinea pig, beagle dog
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- no data
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- other: maize oil, polyethylene glycol, beef suet
- Details on oral exposure:
- Rats
A single dose of 5 g/kg given dissolved in polyethylene glycol 300 to two groups of 5 male and 5 female albino rats. To investigate the influence of the solvent on the toxicity of Topanol CA, corresponding doses with either polyethylene glycol 300 or maize oil as solvent were given to groups of 3 female rats. Dose levels of 1 g/kg and 5 g/kg were used. In feeding trials preliminary to a 90-day study, groups of 5 male and 5 female rats were fed at concentrations of 5%, 1% and 0.2% w/w in the diet incorporated by dissolving an appropriate quantity of Topanol CA in maize oil.
Guinea pigs
In two groups of 5 male and 5 female guinea pigs receiving a single oral dose of 5 g/kg.
Dogs
A beagle bitch was given a dose of 2 g/kg as a 25% solution in polyethylene glycol. To a second bitch, the Topanol CA was given dissolved in beef suet, and the animal consumed an amount of food equivalent to a dose of approx. 3 g/kg. - Doses:
- Rats
Dose levels of 1 g/kg and 5 g/kg were used. In feeding trials preliminary to a 90-day study, concentrations of 5%, 1% and 0.2% w/w in the diet incorporated by dissolving an appropriate quantity of Topanol CA in maize oil.
Guinea pigs
Single oral dose of 5 g/kg.
Dogs
2 g/kg as a 25% solution in polyethylene glycol. Substance dissolved in beef suet, and the animal consumed an amount of food equivalent to a dose of approx. 3 g/kg. - No. of animals per sex per dose:
- Rats
Two groups of 5 male and 5 female albino rats
To investigate the influence of the solvent on the toxicity3 female rats
In feeding trials preliminary to a 90-day study, groups of 5 male and 5 female rats
Guinea pigs
Two groups of 5 male and 5 female guinea pigs
Dogs
two beagle bitches - Control animals:
- not specified
- Details on study design:
- Rats
A single dose of 5 g/kg given dissolved in polyethylene glycol 300 to two groups of 5 male and 5 female albino rats. To investigate the influence of the solvent on the toxicity of Topanol CA, corresponding doses with either polyethylene glycol 300 or maize oil as solvent were given to groups of 3 female rats. Dose levels of 1 g/kg and 5 g/kg were used.
In feeding trials preliminary to a 90-day study, groups of 5 male and 5 female rats were fed at concentrations of 5%, 1% and 0.2% w/w in the diet incorporated by dissolving an appropriate quantity of Topanol CA in maize oil.
Guinea pigs
In two groups of 5 male and 5 female guinea pigs receiving a single oral dose of 5 g/kg.
Dogs
A beagle bitch given a dose of 2 g/kg as a 25% solution in polyethylene glycol. To a second bitch, the Topanol CA was given dissolved in beef suet, and the animal consumed an amount of food equivalent to a dose of approx. 3 g/kg. - Statistics:
- no data
Results and discussion
- Preliminary study:
- no data
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: rats
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Guinea pigs
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 3 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Dog
- Mortality:
- Rats
A single dose of 5 g/kg given dissolved in polyethylene glycol 300 to two groups of 5 male and 5 female albino rats caused no deaths.
To investigate the influence of the solvent on the toxicity of Topanol CA, corresponding doses with either polyethylene glycol 300 or maize oil as solvent were given to groups of 3 female rats. Dose levels of 1 g/kg and 5 g/kg were used. In the groups receiving 5 g/kg both showed signs of gastro-intestinal irritation within a few hours, the group given the Topanol CA in maize oil being much more severely affected. The group receiving Topanol CA in polyethylene glycol recovered completely in 24 hours. In the maize oil group one animal died at this interval after administration.
In feeding trials preliminary to a 90-day study, groups of 5 male and 5 female rats were fed at concentrations of 5%, 1% and 0.2% w/w in the diet incorporated by dissolving an appropriate quantity of Topanol CA in maize oil. In the 5% group the first animal died after 3 days and all of the remaining animals were dead within a week. A similar course of events was found in the animals fed at 1% and 7/10 animals died within the week.
Guinea Pigs
No deaths
Dogs
No deaths - Clinical signs:
- other: Rats: A single dose of 5 g/kg dissolved in polyethylene glycol made the animals look in poor condition for some hours after administration. After 24 hours the animals had returned to normal and remained fit during the subsequent 10-day observation period.
- Gross pathology:
- Rats: In a group of rats given daily oral doses of 1 g/kg in polyethylene glycol for 10 consecutive days nothing abnormal was found on blood examination at the end of the period. No pathological changes were found at post mortem apart from quantities of white solid material in the gut lumen. Histopathological examination of tissue from the liver, kidney, lungs, pancreas, adrenals and representative portions of the alimentary tract revealed no abnormality.
In feeding trials preliminary to a 90-day study, post mortem showed inflammatory changes and haemorrhage were found in the mucosa of the stomach and small intestine, the adrenals were enlarged and patches of haemorrhage were found in the cortex on section. A similar course of events was found in the animals fed at 1% and 7/10 animals died within the week.
Guinea pigs: In two groups of 5 male and 5 female guinea pigs receiving a single oral dose of 5 g/kg, nothing abnormal was found at post mortem examination 10 days later and apart from some glycogen deficiency in the liver of 2 female animals, no pathological changes were found in tissue from the lungs, liver, kidney, pancreas, adrenals or representative portions of the gastro-intestinal tract.
Dogs: no data - Other findings:
- With large doses, the appearance of the faeces suggests that much of a single dos remains unabsorbed in the gut. When given in a fatty solvent (maize oil) Topanol CA has an irritant effect on the gastro-intentinal tract but the toxicity of single doses is not greatly increased.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance is not acutely toxic in all three species examined (rat, guinea pig, dog).
- Executive summary:
The test substance was assessed by acute exposure in a combined study with three species, albino rat, guinea pig and beagle dog. With large doses, the appearance of the faeces suggests that much of a single dose remains unabsorbed in the gut. When given in a fatty solvent (maize oil) the substance has an irritant effect on the gastro-intentinal tract but the toxicity of single doses is not greatly increased.
No deaths occured due to acute exposure and the substance is considered non-toxic, with LD50 >5000 mg/kg in rats, >5000 mg/kg in guinea pigs and >3000 mg/kg in beagle dogs.
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