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EC number: 259-766-1 | CAS number: 55699-10-0
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant guideline study, available as unpublished report
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Qualifier:
- according to guideline
- Guideline:
- other: Japan MAFF Testing guideline of 12 Nosan No. 8147
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- 4-tert-butyl-3-hydroxy-2,6-xylylacetonitrile
- EC Number:
- 259-766-1
- EC Name:
- 4-tert-butyl-3-hydroxy-2,6-xylylacetonitrile
- Cas Number:
- 55699-10-0
- Molecular formula:
- C14H19NO
- IUPAC Name:
- 2-(4-tert-butyl-3-hydroxy-2,6-dimethylphenyl)acetonitrile
- Details on test material:
- - Name of the test substance used in the study report: 4-tert-Butyl-3-hydroxy-2,6-xylylacetonitrile
- Physical state: white powder
- Storage: ambient temperature, and away from light
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Janvier supplier, 53940 Le Genest-St-Isle, France
- Age at study initiation: about 7 weeks
- Weight at study initiation: 210.1 - 230.5 kg
- Fasting period before study: overnight
- Housing: 3 animals per cage, 31 x 46 x 19 cm polypropylene cages with stainless steel lid; bedding composed of wood shavings delivered dust-free and sterilized (gamma-radiation) supplied by SICSA (94142 Alfortville France)
- Diet: pelleted from (A04-10) deliverd sterilezed to gamma-radiations by SAFE (89290 Augy, France)
- Water: tap water in polypropylene bottles
- Acclimation period: at least 5 days
- Nulliparous and non-pregnant females were used
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Air changes (per hr): about 10
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Justification for choice of vehicle: The test substance (powder), was administered suspended in corn oil, vehicle chosen after performing previous tests of solubility.
DOSE PREPARATION
The preparation (at 150 mg/mL concentration) was homogenized manually with a spatula. The preparation obtained was looking like a pale yellow homogenous thick liquid. The preparation (at 200 mg/mL concentration) was homogenized using a pestle in a mortar. The preparation obtained was looking like a pale yellow homogenous suspension. Both preparations were put under magnetic stirring during treatments. The preparations of the test substance were performed few minutes before treatment the day of the study D1 in sufficient quantity for the necessities of the study.
MAXIMUM DOSE VOLUME APPLIED: 2 mL/kg for the 300 mg/kg dosage and to 10 mL/kg for the 2000 mg/kg dosage - Doses:
- 300 and 2000 mg/kg
- No. of animals per sex per dose:
- 6 females per dose
- Control animals:
- no
- Details on study design:
- - Experimental chronology: According to the test substance nature, the experiment started (1st step) on 3 female animals receiving a pre-defined dosage (300 mg/kg) of test substance. After this 1st step, according to the methodology described in the OECD guideline 423, the study was performed using a stepwise procedure, on 3 other animals receiving the test substance at the dose level of 300 mg/kg of body weight, under the same conditions as the animals from the step 1 and on 6 other animals receiving the test substance at the dose level of 2000 mg/kg of body weight (steps 3 and 4).
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were regularly observed the day of administration (immediately, during the 30 minutes following gavage, 1h, 2h, 3h and 4h after administration) then at least once a day for 14 days at least. The animals were regularly weighed on D-1 the day before administration then on D1 just before administration of the test substance and on D4, D8 and D15 i.e. 3, 7 and 14 days after administration.
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed in animals exposed to 300 or 2000 mg/kg.
- Clinical signs:
- other: - No clinical signs were observed in all animals exposed to 300 mg/kg. - Some clinical signs were observed during the first 4 hours following the treatment (first a piloerection and a reduced motor activity were observed in all the animals receiving 2000
- Gross pathology:
- No organ or tissue lesion macroscopically visible was found during the post mortem examination performed in all the animals 14 days after treatment with the 300 mg/kg and 2000 mg/kg dose levels.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of this study the oral LD50 in Sprague-Dawley rats is above 2000 mg/kg bw.
- Executive summary:
In an OECD 423 guideline study performed in compliance with GLP, the test substance was administered to six female Sprague-Dawley rats per dose by oral gavage. Rats were exposed to 300 or 2000 mg/kg bw After an observation period of 14 days surviving animals were necropsied. No mortality was observed in all exposed animals. No significant toxicity signs were observed in the animals receiving the 300 mg/kg dosage. Some toxicity signs were observed during the first 4 hours in rats treated with 2000 mg/kg bw (first piloerection and a reduced motor activity were observed in all animals; these symptoms were then associated to porphyrin deposits around the muzzle and hollow flanks). These signs totally disappeared after two days. No organ or macroscopically visible tissue lesion were found during the post mortem examination. The LD50 was determined to be above 2000 mg/kg bw.
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