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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
Endpoint summary
Administrative data
Description of key information
The oral LD50 of 6,6’-di-tert-butyl-4,4’-diethyl-2,2’-methylenediphenol exceeds 2000 mg/kg body weight.
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:
- From July 21 to October 25, 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Japan Hino Rearing Center
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8 weeks old
- Weight at study initiation: 184.2 to 188.0 g (first dose group) and 186.2 to 194.6 g (second dose group)
- Fasting period before study: yes, approximately 17.5 hours starting on the day prior to administration and for approximately 4 hours after administration.
- Housing: Stainless steel wire-bottom cages were used
- Diet (e.g. ad libitum): ad libitum (MF, Lot number 10034, Oriental Yeast Co., Ltd.)
- Water (e.g. ad libitum): ad libitum (chlorinated Hita municipal tap water)
- Acclimation period: yes, at least 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23.0 to 24.5°C
- Humidity (%): 52.4 to 62.5 %
- Air changes (per hr): ventilation frequency of 10 to 15 times/hour
- Photoperiod (hrs dark / hrs light): light/dark cycle of 12-hour intervals (lights on at 7:00 and off at 19:00)
IN-LIFE DATES: From: July 27 to August 20, 2010 - Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 25.0 w/v% concentration. The "Homogeneity, stability, and concentration confirmation study on a test solution of 6,6’-di-tert-butyl-4,4’-diethyl-2,2’-methylenediphenol " (study code: X02-0238) conducted prior to the start of administration confirmed the homogeneity of the test solution of 0.0100 and 25.0 w/v% and the stability of the test solution when stored in a cool place using high speed liquid chromatography (HPLC).
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: the test substance did not dissolve in olive oil at a 25.0 w/v% concentration, but was evenly suspended.
- Lot/batch no. (if required): 050ORS
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
DOSAGE PREPARATION: The test solution was stored in a cool place and confirmed to be stable 2 days after preparation (stable for 15 days in the end), so the test solution was prepared the day before administration. The test substance was weighted accurately and suspended in a mortar while adding olive oil. Then, while adding olive oil, a constant volume was created and the test solution (suspension) thus prepared. The prepared test solution was place in a lidded plastic container and stored in a cold place (actual value 4 to 9°C).
CLASS METHOD
- Rationale for the selection of the starting dose: In a "Chromosomal aberration study of 6,6’-di-tert-butyl-4,4’-diethyl-2,2’-methylenediphenol using mammalian cultivated cells" conducted at the study facility (study code: K06-1358), the 50% maximal inhibitory concentration (IC50) was calculated to be at least 34 µg/ml. Based on a correlation equation of cytotoxicity IC50 and acute toxicity LD50 proposed by ICCVAM*, rodent LD50 was calculated to be 550 mg/kg. But because it was predicted that no deaths would occur even with a single dose of 2,000 mg/kg based on the above results, 2,000 mg/kg was selected as the initial dose (step 1). The dose for step 2 was selected in accordance with "OECD Test Guidelines 423".
*In Vitro Cytotoxicity Test Methods for Estimating Acute Oral Systemic Toxicity. NIH Publication No. 07-4518, November 2006. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 per group
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: General status was observed, including death. On the day of administration, all animals were observed immediately after administration, 5, 10, and 30 minutes and 1, 2, and 4 hours after administration. Detailed observations were collected, including the time of onset of symptoms. Furthermore, in the first dose group, symptoms were observed on the day of administration and up to 5 days after administration, so observations were taken in the afternoons during this period. Symptoms disappeared 6 days after administration, so a single observation was taken in the mornings between day 6 and day 14.
In the second dose group, symptoms were observed on the day of administration and up to 2 days after administration, so observations were taken in the afternoons during this period. Symptoms disappeared 3 days after administration, so single observations were taken in the mornings between day 3 and day 14.
The animals were weighed prior to administration and 1, 7, and 14 days after administration.
- Necropsy of survivors performed: yes, gross observations were taken and included the body surface, orifices, subcutis, intracranial cavity, thoracic cavity, abdominal cavity, and pelvic cavity. - Statistics:
- Not applicable
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 6,6’-di-tert-butyl-4,4’-diethyl-2,2’-methylenediphenol did not cause mortality at a dose level of 2000 mg/kg bw.
- Clinical signs:
- other: Reduced spontaneous movement appeared 2 hours after administration and was present in all 6 animals 4 hours after administration. Additionally, 5 animals had reduced respiratory frequency and 3 had incomplete eyelid opening. These symptoms disappeared in
- Gross pathology:
- No macroscopic observations were seen in animals dosed at 2000 mg/kg bw terminated on Day 14.
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- Under the conditions of this study, the acute oral LD50 value of the test item 6,6’-di-tert-butyl-4,4’-diethyl-2,2’-methylenediphenol was found to be above 2000 mg/kg bw in female Crl:CD(SD) rats.
- Executive summary:
The single-dose oral toxicity of 6,6’-di-tert-butyl-4,4’-diethyl-2,2’-methylenediphenol was studied according to the acute toxic class method (OECD 423 in Crl:CD(SD) rats. Two groups of 3 female Sprague-Dawley rats were treated with the test item at a dose level of 2000 mg/kg bw (Group 1 and Group 2).
A single oral treatment was carried out by gavage for each animal after an overnight food withdrawal. Food was made available again 4 hours after the treatment.The test item was formulated in olive oil at a concentration of 200 mg/mL at a dose volume of 10 mL/kg bw.
Initially, three females (Group 1) were treated at a dose level of 2000 mg/kg bw. As no mortality was observed, a confirmatory group (Group 2) was treated at the same dose level. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (day 14).
No mortality occurred. Clinical signs were reduced spontaneous movement, reduced respiratotry frequence, incomplete eyelid opening, loose stool, mucous stool, lower abdominal soiling, diarrhea, and reduced fecal volume. Although suppression of weight increase or reduction in weight was observed 1 day after administration, appropriate weight gain was observed 7 days and 14 days after administration. No abnormalities were found at macroscopic post mortem examination of the animals. The oral LD50 value of the test substance in Sprague-Dawley rats was established to exceed 2000 mg/kg body weight and therefore the substance is not classified for acute oral toxicity according to the EC/1272/2008 CLP criteria.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- GLP studies according to standard guidelines.
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 route:
An acute oral toxicity study according to OECD guideline 423 and under GLP conditions are available. The test substance was administered at 2000 mg/kg bw by oral gavage. Animals were observed for 14 days and necropsied. No mortality occurred. Clinical signs were reduced spontaneous movement, reduced respiratotry frequence, incomplete eyelid opening, loose stool, mucous stool, lower abdominal soiling, diarrhea, and reduced fecal volume. Although suppression of weight increase or reduction in weight was observed 1 day after administration, appropriate weight gain was observed 7 days and 14 days after administration. No abnormalities were found at macroscopic post mortem examination of the animals. The oral LD50 value of the test substance in Sprague-Dawley rats was established to exceed 2000 mg/kg body weight
Justification for classification or non-classification
The oral LD50 value of the test substance in Sprague-Dawley rats was established to exceed 2000 mg/kg body weight and therefore the substance is not classified for acute oral toxicity according to the EC/1272/2008 CLP criteria.
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