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EC number: 412-600-3 | CAS number: 152827-98-0
- 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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 September 2003 to 2 October 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 412-600-3
- EC Name:
- -
- Cas Number:
- 152827-98-0
- Molecular formula:
- C32H48ClN5O3
- IUPAC Name:
- tetradecyl 3-[(4-{6-tert-butyl-7-chloro-1H-pyrazolo[1,5-b][1,2,4]triazol-2-yl}phenyl)carbamoyl]propanoate
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): Butanoic acid, 4-[[4-[7-chloro-6-(1,1-dimethylethyl)-1H-pyrazolo[1,5-b][1,2,4]triazol-2-yl]phenyl]amino]-4-oxo-, tetradecyl ester
- HAEL Number: 2003-0090
- KAN: 632021-1
- CIN: 10084241
- SRID or Lot No.: DEV84241
- Physical state and appearance: brown powder
- Storage conditions of test material: at room temperature
- Purity determination: 96.5 weight percent
- Stability: stable
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: The male rats were 8 to 9 weeks of age and the female rats were 10 to 11 weeks of age.
- Weight at study initiation: The male rats weighed 250.90 to 278.64 grams and the female rats weighed 215.20 to 252.91 grams.
- Fasting period before study: Not reported
- Housing: Animals were housed in an Association for Assessment and Accreditation of Laboratory Animal Care International-accredited vivarium in accordance with the Guide for the Care and Use of Laboratory Animals (National Research Council, 1996). The rats were singly housed in suspended, stainless-steel, wire mesh cages. Cages and racks were washed once a week. Absorbent paper, used to collect excreta, was changed at least three times a week.
- Diet: Certified Rodent Diet (pelleted) was available ad libitum.
- Water: Water was available ad libitum through an automatic watering system. The source of the water was the local public water system.
- Acclimation period: The animals were isolated upon arrival and allowed to acclimate for a period of 5 days. Animals were judged to be healthy prior to testing.
ENVIRONMENTAL CONDITIONS
- Temperature: 21.4 - 23.8 °C
- Humidity: 41.3 - 60.7 %
- Photoperiod: A photoperiod of 12 hours of light was maintained.
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Not reported
- % coverage: Not reported
- Type of wrap if used: A fiber pad and an occlusive wrap to hold the test substance in place
REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the exposure period, any residual test substance was removed with running water.
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): The test substance, a solid, was administered at 2000 mg/kg moistened with water. - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- Five male and five female
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Body weights were measured on Days 0 (prior to treatment), 7, and 14. Animals were observed at least once during the exposure period, and once each day thereafter for the duration of the experiment. Observations included, but were not limited to, examination of the hair, skin, eyes, mucous membranes, motor activity, feces, urine, respiratory system, circulatory system, autonomic nervous system, central nervous system, and behavior patterns.
- Necropsy of survivors performed: yes - Statistics:
- No statistical procedures were required during the study. No dose/mortality curve was constructed since graphs become statistically useful only with the use of large numbers of animals and dose groups.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed during the 14-day observation period for rats administered a dose of 2000 mg/kg of the test substance.
- Clinical signs:
- other: No abnormal clinical signs were observed.
- Gross pathology:
- No treatment-related changes were observed at necropsy, and no tissue was collected for microscopic examination.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified in accordance with EU criteria
- Conclusions:
- Under the conditions of the test, the acute dermal LD50 for the test substance was determined to be greater than 2000 mg/kg for male and female rats.
- Executive summary:
In a GLP compliant study conducted in line with OECD Guideline 402 and EU Method B.3, the acute toxicity of butanoic acid, 4-[[4-[7-chloro-6-(1,1-dimethylethyl)-3H-pyrazolo[1,5-b][1,2,4]triazol-2-yl]phenyl]amino]-4-oxo, tetradecyl ester to rats was investigated.
Male and female rats were administered a single limit dose of 2000 mg/kg of the test substance topically. The test substance was administered moistened with water. No abnormal clinical signs were noted at any time during the 14-day observation period. No mortality was observed, and all animals gained weight. No treatment-related changes were observed at necropsy, and no tissues were collected for histological examination.
The acute dermal LD50 for this test substance was greater than 2000 mg/kg for male and female rats and requires no toxicity classification in line with current EU requirements.
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