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EC number: 201-814-0 | CAS number: 88-24-4
- 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
Specific investigations: other studies
Administrative data
- Endpoint:
- specific investigations: other studies
- Remarks:
- anticoagulant properties
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- 1954
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Non GLP study which meets basic scientific methods however details on used method and results are not provided in the report.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 954
- Report date:
- 1954
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- GLP compliance:
- no
- Type of method:
- in vivo
- Endpoint addressed:
- other: Influence of dietary Vitamin K on prothrobin time
Test material
- Reference substance name:
- 6,6'-di-tert-butyl-4,4'-diethyl-2,2'-methylenediphenol
- EC Number:
- 201-814-0
- EC Name:
- 6,6'-di-tert-butyl-4,4'-diethyl-2,2'-methylenediphenol
- Cas Number:
- 88-24-4
- Molecular formula:
- C25H36O2
- IUPAC Name:
- 2-tert-butyl-6-[(3-tert-butyl-5-ethyl-2-hydroxyphenyl)methyl]-4-ethylphenol
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: albino rats
- Sex:
- male
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 42 days (animals receiving diet with Vitamin K)
23 days (animals receiving diet without Vitamin K) - Frequency of treatment:
- daily
- No. of animals per sex per dose:
- 10 male animals per treatment
- Control animals:
- yes, plain diet
- Details on study design:
- A group of 30 young, male, albino rats was maintained for 2 weeks on a synthetic diet containing 50 ppm menadione as the sole source of vitamin K. Concurrently a group of 30 males was fed the identical diet with the exception that all menadione was omitted. There was no significant difference in either food intake or weight gain between the two groups over this initial period. At the end of this period, the groups were further subdivided:
1. Vitamine K present
A. 10 animals, Controls: no change in diet
B. 10 animals, 1% Antioxidant 425 added to diet
C. 10 animals, 1% Antioxidant 2246 added to diet (results not further discussed here)
1. Vitamine K omitted
A. 10 animals, Controls: no change in diet
B. 10 animals, 1% Antioxidant 425 added to diet
C. 10 animals, 1% Antioxidant 2246 added to diet (results not further discussed here)
Results and discussion
- Details on results:
- Addition of 1% Antioxidant 425 to the diet in the presence of VItamin K caused a reduction in food consumption and growth rate in comparison to the corresponding controls. In addition, the animals appeared hyper-irritable and exhibited rapid respiration and diarrhea of 1 to 2 weeks duration. None of the animals of this sub-group died; 2 were sacrificed after 22 days feeding and the remainder after 42 feeding. Gross autopsy revealed mild gastrointestinal irritation in 2 cases, and hyperemic kidneys in about half of the group. However, no evidence of bleeding was observed. Prothrombin times and hematocrit values were within normal limits and comparable to those of the controls.
Addition of 1% Antioxidant 425 to the diet in absence of vitamin K resulted in a marked recution of food intake and growth rate. During the second week of feeding of the antioxidant, dyspnea, irritability and diarrhea developed among the animals, and one death occurred on the 9th day. Subsequently, depression, paleness of the ears and tail, and blood about the anal region were observed. Additional deaths occurred; 2 on the 18th day, 1 on the 19th day and 1 on the 21st day. The survivors were sacrificed after 22 to 23 days feeding. Autopsy of the animals sacrificed disclosed vascular congestion of the brain, with small blood clots in the transverse and sagittal sinuses in one case; hemorrhagic arreas about testes, epidimides, and surrounding fatty tissue; clotted blood in the peritoneal cavity; and subcutaneous hemorrhage about the front and hind limbs and in the neck region. Prothrombin times were prolonged in all of the 5 rats sacrificed. In the case of the 3 animals in which hematocrits were obtained, the values were within normal limits.
Applicant's summary and conclusion
- Conclusions:
- Based on the results of this study it was concluded that Antioxidant 425 does not possess anticoagulant properties.
- Executive summary:
Male albino rats were maintained on a synthetic diet containing menadione at a concentration of 50 ppm as the sole source of Vitamin K. The addition of Antioxidant 425 to this diet at a concentration of 1 % (equivalent to approx. 0.63 gm/kg/day) over a period of 42 days resulted in a significant reduction in food intake and weight gain. However, prothrombin times and hematocrit values were not affected. There were no deaths, and no gross evidence of hemorrhagic tendencies. All animals were sacrificed at termination of the period of feeding, and gross autopsy revealed no evidence of internal bleeding. When vitamin K was omitted in the diet, the prothrombin times in the group that received 1% Antioxidant 425 in the diet for 23 days, was prolonged in all animals. Based on the results of this study it was concluded that Antioxidant 425 does not possess anticoagulant properties.
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