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EC number: 911-254-5 | 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010-01-26 to 2010-02-10
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Meets the requirements of GLP. There are no deviations from the recommended guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- Reaction mass of 2-tert-butyl-4,6-dimethylphenol and 4-tert-butyl-2,5-dimethylphenol
- EC Number:
- 911-254-5
- Molecular formula:
- Not applicable - Multiconstituent substance
- IUPAC Name:
- Reaction mass of 2-tert-butyl-4,6-dimethylphenol and 4-tert-butyl-2,5-dimethylphenol
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Sprague Dawley rats (SPF Caw) originated from Elevage JANVIER (53940 Le Genest St Isle - France)
- Age at study initiation: 8 or 9 weeks old
- Weight at study initiation: 184 g and 232 g
- Fasting period before study: food was removed at D-1 and then redistributed 4 hours after the test item administration
- Housing: housed by group of three in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid. Each cage contains sawdust bedding which was changed at least 2 times a week.
- Diet: foodstuff (M20-SDS) was supplied freely. Food was removed at D-l and then redistributed 4 hours after the test item administration.
- Water (e.g. ad libitum): tap-water from public distribution system was supplied freely. Microbiological and chemical analyses of the water were carried out once every six months by the IPL, Santé, Environnement Durables - Atlantique.
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%):30 to 70%
- Air changes (per hr): approximately fifteen changes per hour
- Photoperiod (hrs dark / hrs light): twelve hours continuous light (07.00 to 19.00) and twelve hours darkness
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- Group treated with 300 mg/kg (step 1 and 2):
VEHICLE
- Concentration in vehicle: 300 mg/kg
- Amount of vehicle (if gavage): 1.79 mL
MAXIMUM DOSE VOLUME APPLIED: 2.1 mL/kg body weight
Group treated with 2000 mg/kg (step 3):
NO VEHICLE
- Concentration: 2000 mg/kg
MAXIMUM DOSE VOLUME APPLIED: 2.1 mL/kg body weight - Doses:
- 300 mg/kg bw and 2000 mg/kg bw
- No. of animals per sex per dose:
- 300 mg/kg bw: 6 females
2000 mg/kg bw: 3 females - Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Systematic examinations (list of symptoms, recorded as "present" or "absent" ) were carried out to identify any behavioural or toxic effects on the major physiological functions every day for 14 days or until the death of the animal.
The animals were weighed on day DO (just before administering the test item) then on D2, D7, and D14. Weight changes were calculated and recorded.
- Necropsy of survivors performed: yes, macroscopic observations were entered on individual autopsy sheets
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the study at 300 mg/kg body weight.
It was noted the death of the three animals treated at 2000 mg/kg body weight, one at 29 hours 45 minutes post-dose and the two others at about 48 hours post-dose. - Clinical signs:
- other: No clinical signs related to the administration of the test item were observed at the 300 mg/kg bw group. The mortalities at the 2000 mg/kg bw group were preceded by a decrease in spontaneous activity (313) and in rightiug reflex (113) and by a bradypnea
- Gross pathology:
- The macroscopical examination of the animals at the end of the study revealed a white thickness of the forestomach in three animals (3/6).
The macroscopical examination of the dead animals revealed a red thinning (2/3) or a red coloration (1/3) of the forestomach, associated or not with black spots on the forestomach (1/3) and a thinning of the corpus (2/3), associated or not with black spots on the corpus (1/3).
Applicant's summary and conclusion
- Interpretation of results:
- other: Category 4 (CLP Regulation EC no. 1272/2008)
- Conclusions:
- The LD50 of the test item is higher than 300 mg/kg body weight and lower than 2000 mg/kg body weight by oral route in the rat.
- Executive summary:
The test item was administered to a group of 6 female Sprague Dawley rats at the single dose of 300 mg/kg body weight and to a group of 3 female Sprague Dawley rats at the single dose of 2000 mg/kg body weight. The experimental protocol was established according to the official method as defined in the O.E.C.D. guideline N° 423 and the test method B.lter of the Council regulation N°440/2008. No mortality occurred during the study at 300 mg/kg body weight. No clinical signs related to the administration of the test item were observed. The body weight evolution of the animals remained normal throughout the study. The macroscopical examination of the animals at the end of the study revealed a white thickness of the forestomach in three animals (3/6). It was noted the death of the three animals treated at 2000 mg/kg body weight, one at 29 hours 45 minutes post-dose and the two others at about 48 hours post-dose. The mortalities were preceded by a decrease in spontaneous activity (3/3) and in righting reflex (1/3) and by a bradypnea (3/3), a partial ptosis (3/3), and a staggering gait (3/3) on the first day of the study. At 24 hours post-dose, it was noted a decrease in spontaneous activity (3/3), in body temperature (1/3) and in muscle tone (3/3), an absence of Preyer's reflex (3/3) and of righting reflex (2/3), a bradypnea (3/3), a partial ptosis (2/3), mydriasis (2/3),anincreased lachrymation (3/3) and a piloerection (3/3). The macroscopical examination of the dead animals revealed a red thinning (2/3) or a red coloration (1/3) of the forestomach, associated or not with black spots on the forestomach (1/3) and a thinning of the corpus (2/3), associated or not with black spots on the corpus (1/3). In conclusion, the LD50 of the test item is higher than 300 mg/kg body weight and lower than 2000 mg/kg body weight by oral route in the rat. In accordance with the OECD guideline n°423, the LD50 cut-off of the test item may be considered as 500 mg/kg body weight by oral route in the rat.
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