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Diss Factsheets
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EC number: 204-279-1 | CAS number: 118-82-1
- 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
![](https://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Direct observations: clinical cases, poisoning incidents and other
Administrative data
- Endpoint:
- direct observations: clinical cases, poisoning incidents and other
- Type of information:
- experimental study
- Adequacy of study:
- disregarded due to major methodological deficiencies
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Study is old (1973) and not conducted to regulatory guidelines or to GCP standards.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 973
- Report date:
- 1973
Materials and methods
- Study type:
- study with volunteers
- Endpoint addressed:
- other: Effect on blood lipid profile
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- In addition to human pharmacology, the purpose of this study was to obtain evidence of its efficiency in human volunteers and to monitor a number of serum constituents to detect any possible adverse response to compound administration.
- GLP compliance:
- no
Test material
- Reference substance name:
- 2,2',6,6'-tetra-tert-butyl-4,4'-methylenediphenol
- EC Number:
- 204-279-1
- EC Name:
- 2,2',6,6'-tetra-tert-butyl-4,4'-methylenediphenol
- Cas Number:
- 118-82-1
- Molecular formula:
- C29H44O2
- IUPAC Name:
- 2,6-di-tert-butyl-4-[(3,5-di-tert-butyl-4-hydroxyphenyl)methyl]phenol
- Test material form:
- not specified
Constituent 1
Method
- Type of population:
- other: Healthy volunteers
- Subjects:
- All volunteers included in this trial were male, ranging in age between 19 and 59 years. The presence of any clinical condition likely to alter interpretation of the results was eliminated by medical examination during the pre-experiment period. All volunteers were asked to continue with their normal dietary habits. Subjects were split into two groups at random.
- Ethical approval:
- not specified
- Route of exposure:
- oral
- Reason of exposure:
- intentional
- Exposure assessment:
- measured
- Details on exposure:
- The test compound was administered orally as two 500 mg containing gelatin capsules taken with breakfast and evening meal.
Results and discussion
- Clinical signs:
- No major toxicological manifestations have been detected when group mean results from a number of serum parameters are considered.
Any other information on results incl. tables
1. No major adverse toxicological manifestations have been detected when group mean results from a number of serum parameters are considered.
2. Evidence of raised serum glutamate-pyruvate transaminase (SGPT) activity has been obtained in a number of subjects during the period of test compound administration and again between 7 and 14 days of the recovery period.
3. Minor elevations in serum calcium have been observed during test and recovery periods.
4. Minor reductions in Haemoglobin were observed in some Volunteers during the period of test compound administration.
5. BRL 10901 lowered serum cholesterol by about 40 when Group 1 mean results were considered. Reduced and variable hypocholesterolaemic response was detected in Group 2 Volunteers. Poor response was obtained in subjects with hypertriglyceridaemia and high levels of VLDL.
6. In association with the hypocholesterolaemic response discrete reductions in serum phospholipids and inorganic phosphate were observed during the period when test compound was administered.
7. Results obtained after standard test meal indicate that BRL 10901 is effective in reducing the normal post-prandial elevation in serum Cholesterol, Triglycerides, Phospholipids and Inorganic phosphates.
8. Significant reductions in serum beta lipoproteins and less marked elevations in alpha lipoprotein fractions were observed in conjunction with changes in serum cholesterol and phospholipids.
Applicant's summary and conclusion
- Conclusions:
- No major toxicological manifestations have been detected when group mean results from a number of serum parameters are considered.
- Executive summary:
1. No major adverse toxicological manifestations have been detected when group mean results from a number of serum parameters are considered.
2. Evidence of raised serum glutamate-pyruvate transaminase (SGPT) activity has been obtained in a number of subjects during the period of test compound administration and again between 7 and 14 days of the recovery period.
3. Minor elevations in serum calcium have been observed during test and recovery periods.
4. Minor reductions in Haemoglobin were observed in some Volunteers during the period of test compound administration.
5. BRL 10901 lowered serum cholesterol by about 40 when Group 1 mean results were considered. Reduced and variable hypocholesterolaemic response was detected in Group 2 Volunteers. Poor response was obtained in subjects with hypertriglyceridaemia and high levels of VLDL.
6. In association with the hypocholesterolaemic response discrete reductions in serum phospholipids and inorganic phosphate were observed during the period when test compound was administered.
7. Results obtained after standard test meal indicate that BRL 10901 is effective in reducing the normal post-prandial elevation in serum Cholesterol, Triglycerides, Phospholipids and Inorganic phosphates.
8. Significant reductions in serum beta lipoproteins and less marked elevations in alpha lipoprotein fractions were observed in conjunction with changes in serum cholesterol and phospholipids.
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.
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