Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 639-263-7 | CAS number: 200575-15-1
- 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:
- 30 July- 1 August 1997
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- yes
- Remarks:
- An upper temperature range of 28 oC occurred for a brief period (approximatelv 24 hours) during the study. This deviation was not considered to have affected the integrity or validity of the study.
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- 4-[2-Ethoxy-5-(4-methyl-1-piperazinylsulfonyl)benzamido]-1-3-propyl-1H-pyrazole-5-carboxamide
- EC Number:
- 639-263-7
- Cas Number:
- 200575-15-1
- Molecular formula:
- C22H32N6O5S
- IUPAC Name:
- 4-[2-Ethoxy-5-(4-methyl-1-piperazinylsulfonyl)benzamido]-1-3-propyl-1H-pyrazole-5-carboxamide
- Test material form:
- solid: particulate/powder
1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch No.of test material: 92,480/N/9/1
- Expiration date of the batch: Not supplied
- Purity test date: 95 %
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room Temperature
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- UK-220.955 was formulated at a maximum practical concentration of 62.5% w/v in 1% aqueous methylcellulose and administered at a volume of 3.2 ml/kg body-weight.
-The test substance was prepared on the day of dosing.
-The absorption of the test substance was not determined.
-The concentration, homogeneity and stability of the test substance in the vehicle was not evaluated.
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan O.K.. Ltd.. Bicester, Oxon. England.
- Male/Female
- Age at study initiation: seven to ten weeks of age prior to dosing
- Weight at study initiation: 215 to 242g
- Housing: Housed individually in metal cages with wire mesh floors
- Diet: Special Diet Services RMI (13) SQC expanded pellet) ad libitum
- Water: ad libitum
- Acclimation period: minimum of five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-28 (°C)
- Humidity (%): 45-62%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): I 2 hours of artificial light (0700 - 1900 hours) in each 24-hour period
IN-LIFE DATES: Day 0 to Day 15
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- methylcellulose
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorso-lumbar region, approximately 50 mm x 50 mm
- Type of wrap if used: 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.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the 24 hours exposure period the dressings was carefully removed and the treated area of the skin was washed with warm water (30o to 40oC) and the treated area was blotted dry with absorbent paper.
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 3.2 ml/kg
- Concentration (if solution): 62.5 % w/v in 1 % aqueous methylcellulose
- Constant volume or concentration used: yes
VEHICLE
- Concentration (if solution): 1 % aqueous methylcellulose - Duration of exposure:
- 24 hrs
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5/sex/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observed soon after dosing and at frequent intervals on Day 1. Subsequently, animals were observed once in the morning and again at the end of the experimental day (with the exception of Day 15- morning only). Bodyweights were recorded on Days 1 (prior to dosing), 8 and 15.
- Necropsy of survivors performed: All animals were killed on day 15 and all were subjected to a macroscopic examination
- Other examinations performed: mortality, clinical signs, dermal responses, body weight,macroscopic examination
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- discriminating dose
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths following a single dermal application of 2000 mg/kg UK-220.955 to a group of ten rats (5/sex/dose)
- Clinical signs:
- other: No systemic response was observed in any animal throughout the study.
- Gross pathology:
- Macroscopic examination of animals killed on Day 15 revealed no abnormalities.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- The acute lethal dermal dose to rats of UK-220, 955 was demonstrated to be greater than 2000 mg/kg bodyweight.
- Executive summary:
A study was preformed to assess the acute dermal toxicity of UK-220 955 to the rat. The method followed was that described in EEC Methods for the determination of toxicity. Annex to Directive 92/69/EEC (OJ No. L383A. 29.12.92), Part B, Method B.3. Acute toxicity (dermal).
A group of ten rats (five males and five females) received a single dose by topical application of the test substance, formulated at a maximum practical concentration of 62.5 % w/v in 1 % aqueous methylcellulose and administered at a dose level of 2000 mg/kg bodyweight. All animals were killed and examined macroscopically on Day 15, the end of the observation period.
There were no signs of systemic reaction to treatment observed throughout the study.
Transient well-defined dermal irritation (Grade 1 or 2 erythema with up to Grade 3 oedema) was evident in four females following removal of the dressings (Day 2) and resolving in all instances by Day 4. No dermal response to treatment was observed in the remaining six animals throughout the study.
All rats were considered to have achieved satifactory bodyweight gains throughout the study.
Macroscopic examination of animals killed on Day 15 revealed no abnormalities.
The acute lethal dermal dose to rats of UK-220,955 was demonstrated to be greater than 2000 mg/kg bodyweight.
UK-220, 955 will not require labelling in accordance with GHS
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.