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EC number: 606-396-7 | CAS number: 198904-86-8
- 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:
- 10 november 1999 to 23rd November 1999
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- tert-butyl 2-{(2S,3S)-3-[(tert-butoxycarbonyl)amino]-2-hydroxy-4-phenylbutyl}-2-[4-(pyridin-2-yl)benzyl]hydrazinecarboxylate
- EC Number:
- 606-396-7
- Cas Number:
- 198904-86-8
- Molecular formula:
- C32H42N4O5
- IUPAC Name:
- tert-butyl 2-{(2S,3S)-3-[(tert-butoxycarbonyl)amino]-2-hydroxy-4-phenylbutyl}-2-[4-(pyridin-2-yl)benzyl]hydrazinecarboxylate
- Test material form:
- solid
- Details on test material:
- - Appearance: Off-white powder
- Storage condition of test material: At room temperature protected from light
Constituent 1
- Specific details on test material used for the study:
- Off White Powder, Purity 99.15%
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Animals in the main study were in the weight range of 210 to 254 g and approximately eight to eleven weeks of age prior to dosing (Day I). All the rats were acclimatised to the experimental environment for a minimum period of six days prior to the start of the study.
The rats were allocated without conscious bias to cages within the treatment group. They were housed individually in metal cages (RS Biotech Sub-Dividable Rodent Cages - polished stainless steel (20cm high x 39cm wide x 39cm long) until Day 6 when they were returned to group housing. The cages were fitted wit grid floors to ensure rapid removal of waste material to undertrays. The cages were suspended in mobile stainless steel racks
A standard laboratory rodent diet (Special Diet Services RMl(E) SQC expanded pellet) and drinking water were provided ad libitum. The batch(es) of diet used for the study was analysed for certain nutrients, possible contaminants and micro-organisms. Results of routine physical and chemical examination of drinking water, as conducted by the supplier, are made available to Huntingdon Life Sciences Limited as quarterly summaries
Thermostatic controls were set to maintain a temperature of22 ± 3 °C. Relative humidity was not fully controlled but was anticipated to be in the range 30 - 70%. Temperature and humidity were recorded continuously using a seven day recorder. Actual measurement of these parameters revealed that animal room temperature was in the range 20.5 to 21.5°C and relative humidity was in the range 28 - 54%. Permanent daily recordings of these parameters were made and these are archived with other Departmental raw data. Lighting was controlled by means of a time switch to provide 12 hours of artificial light (0600 - 1800 hours GMT) in each 24-hour period.
Each animal was identified by cage number and ear punching. Each cage was identified by a coloured label displaying the dose level, study schedule number, animal mark and the initials of the Study Director and Home Office licensee
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- methylcellulose
- Details on dermal exposure:
- One day prior to treatment, hair was removed from the dorso-lumbar region of each rat with electric clippers taking care to avoid damaging the skin, exposing an area equivalent to approximately 10% of the total body surface area.
The test substance was applied by spreading it evenly over the prepared skin. The treatment area (approximately 50 mm x 50 mm) was covered with porous gauze held in place with a non irritating dressing, and further covered by a waterproof dressing encircled firmly around the trunk of the animal.
Treatment in this manner was performed on Day 1 (day of dosing) of the study only.
At the end of the 24 hours exposure period the dressings were carefully removed and the treated area of skin was washed with warm water 30 to 40°C to remove any residual test substance. The treated area was blotted dry with absorbent paper. - Duration of exposure:
- 24 hrs expsoure
- Doses:
- 1 dose of 2000mg/kg
- No. of animals per sex per dose:
- 5 Male and 5 Female animals per dose
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations 0.5, 1, 2, and 4 hours after dosing, then once daily. Weighing was conducted on Day 0, 7, and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
BMS 233101-01 was formulated at a maximum practical concentration of 75% w/v in 1% w/v aqueous methy]cellulose and administered at a dose volume of 2.67 ml/kg bodyweight in order to achieve the desired dose concentration
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- no indication of skin irritation up to the relevant limit dose level
- Mortality:
- No mortality
- Clinical signs:
- other: No clinical sign effects detected
- Gross pathology:
- No macroscopic abnormalities
- Other findings:
- Dermal reactions characterised by slight erythema only were notable in one rat on Day 2 only. There was no dermal response seen in the remaining nine rats throughout the study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Acute letal dose was determined to be greater than 2000mg/kg,
- Executive summary:
A study was performed to assess the acute dermal toxicity of BMS 233101 to the rat.
A group often rats (five males and five females) received a single topical application of the test substance formulated at a maximum practical concentration in1%w/v aqueous methylcellulose and administered at a dosage of 2000mg/kg bodyweight
All animals were killed as scheduled at study termination (Day 15)and subjected to a macroscopic examination.
There was no clinical signs of reaction to treatment observed in any animal throughout the study.
Dermal reactions characterized by slight erythema only were notable in one rat on Day2 only. There was no dermal response seen in the remaining nine rats throughout the study. Minor bodyweight fluctuations were noted in the occasional animal, however, these were not considered to be of toxicological significance in light of the majority of animals achieving satisfactory weight gains.
No macroscopic abnormalities were observed for animals killed at study termination on Day15. The acute lethal dermal dose to rats of BMS 233101-01 was demonstrated to be greater than 2000mg/kg body weight.
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