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Diss Factsheets
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EC number: 201-816-1 | CAS number: 88-27-7
- 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://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Similar to OECD guideline 402. Non-GLP study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- (Limit test requires five animals/sex. However, in the study five abraded rabbits and five intact rabbits were used)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 2,6-di-tert-butyl-α-dimethylamino-p-cresol
- EC Number:
- 201-816-1
- EC Name:
- 2,6-di-tert-butyl-α-dimethylamino-p-cresol
- Cas Number:
- 88-27-7
- Molecular formula:
- C17H29NO
- IUPAC Name:
- 2,6-di-tert-butyl-4-[(dimethylamino)methyl]phenol
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Antioxidant 703
- Substance type: pale yellow powder
- Physical state: solid
- Lot/batch No.: 964-76
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: no data reported
- Age at study initiation: no data reported
- Weight at study initiation: 2.937 +/- 0.332 kg
- Housing: no data reported
- Diet (e.g. ad libitum): no data reported
- Water (e.g. ad libitum): no data reported
ENVIRONMENTAL CONDITIONS: no data reported
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- not specified
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Upper back
- % coverage: Not reported
- Type of wrap if used: rabbits were wrapped with an impervious band
REMOVAL OF TEST SUBSTANCE
- Washing: After removal of the wrapping, the compound residue was gently flushed off.
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 4000 mg/kg - Duration of exposure:
- 24 hours
- Doses:
- 4000 mg/kg
- No. of animals per sex per dose:
- 10 rabbits
- 5 rabbits Abraded
- 5 rabbits Intact - Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: At 24 hours after removal of the wrapping and daily for 14 days
- Necropsy of survivors performed: yes - A macroscopic examination of the viscera was conducted on all rabbits survival at day 14.
- Other examinations performed: Body weights were recorded at Day 0, 3, 7, 10 and 14
Results and discussion
- Preliminary study:
- Range finding study:
Six rabbits were prepared for dosing by clipping the fur from the upper back and dermally applying equivalent doses of 1000 mg, 2000 mg or 4000 mg/kg body weight , two rabbits per dose . The rabbits were wrapped with an impervious band which was left in place for 24 hours. Observations for mortality were made for 72 hours
Effect levels
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 4 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- > 50% of the animals tested survived
- Gross pathology:
- Macroscopic examination of the viscera revealed no treatment related observations.
- Other findings:
- Daily observation:
- Three of the 10 rabbits died during the first 48 hours. All of these animals were treated on abraded skin. A fourth rabbit died on day 9. This was the only death observed in an animal with intact skin.
- Three rabbits showed slight erythema at the treatment site at 24 hours. No other dermal or behavioral reactions were noted.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Rabbits were exposed during 24 hours to the test item according to test procedure in accordance with generally accepted scientific standards. The test substance was applied to 5 test animals with abraded skin and 5 test animals with intact skin. 3 of the animals with abraded skin died within the first 48 h indicating that test substance absorption was higher and faster when the skin was damaged. One animal with intact skin died on day 9. As the overall mortality was 40%, the LC50 is considered to be higher than 4000 mg/kg bw. Therefore, a classification for acute dermal toxicity according to Regulation 1272/2008/EC and amendments and Directive 67/548/EEC and amendments is not warranted following the study results.
- Executive summary:
Ten rabbits were exposed to a limit dose of 4000 mg/kg bw to the test item under occlusive conditions for 24 h. The dose was chosen after a preliminary dose range finding study. In 5 animals the skin was abraded. The observation period was 14 days. Four of 10 animals died during the study (3 with abraded skin and one with intact skin). The LD50 was therefore > 4000 mg/kg bw. No signs of systemic toxicity and only slight erythema in three animals after 24h only. The results of this study show that the substance should not be classified for acute dermal toxicity following Regulation 1272/2008/EC and amendments and Directive 67/548/EEC and amendments.
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