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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
Endpoint summary
Administrative data
Description of key information
No positive reactions were noted in the Guniea Pig Skin Sensitisation for the test substance
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- In Vivo Study was conducted prior to the availability of the LLNA or other in-vitro test methods
- Qualifier:
- according to guideline
- Guideline:
- other: Conducted in compliance with EEC Methods for the determination of toxicity. Annex. of Directive 92/69/EEC, Part B, Method B.6.
- Version / remarks:
- Skin sensitisation method used was the guinea-pig maximisation test described by MAGNUSSON, B, And KLIGMAN, A.M. (1970) Aliergic Contact Dermatitis in the Guinea-pig: identification of contact allergens„ Thormis, C,C.. Springfield, Illinois, I A
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study was conducted prior to the ammendments to Annex VII and the availability of the LLNA
- Specific details on test material used for the study:
- Off White Powder, 95% purity
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- The guinea-pigs were housed in groups of five in suspended metal cages with wire mesh floors. A vitamin C enriched guinea-pig diet (Harlan Teldad 9600 FD2 SQC) and drinking water were provided ad libitum. Hay was given weekly. Thee batch of diet used for the study was anal ysed for nutrients, possible contaminants or microorganisms, likely to be present in the diet,and which, if in excess, may have had an undesirable effect on the test system. Animal room temperature wa.s controlled within the range 17,0 to 28,5 °C and relative humidity within
the range 39 to 67%. These environmental parameters were recorded daily. Air exchange was maintained at approximately 15 air changes per hour and lighting was controlled by means of a time switch to give 12 hours of artificial light (0700 - 1900 hours) in each 24 hours period. Each animal was identified by ear tattoo number. Animal were observed daily for signs of ill health or toxicity, Body weight of each guinea pig in the main study was recorded on Day 1 and on the last day of observations to the challenge applications. - Route:
- intradermal
- Vehicle:
- other: 5% Acetone in Alembicol D
- Concentration / amount:
- 1) Freund's complete adjuvant was diluted with an equal volume of water for irrigation
2) 5% w/v in 5% acetone in Alembicol D.
3) 5% w/v in a 30 :50 mixture of Freund's complete adjuvant and 5% acetone in Alembicol D. - Day(s)/duration:
- 7
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, open
- Vehicle:
- other: acetone
- Concentration / amount:
- 70%
- Day(s)/duration:
- 48 hours
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: acetone
- Concentration / amount:
- 70% w/v and 35% w/v
- Day(s)/duration:
- 24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 10 animals per treated dose and 5 animals for control
- Details on study design:
- Based on the results of the preliminary investigations, the following concentrations of UK-220,955 were selected:
- Induction iritradermal injection - 5% w/v in 5% acetone in Alembicol D
This was the maximum practical concentration for intradermal administration and caused irritation but did not adversely affect the animals.
- Induction topical application - 70% w/v in acetone
- Topical challenge - 70 and 35% w/v in acetone
From preliminary investigations 70% wlv in acetone was the maximum practical concentration and did not give rise to irritating effects. - Challenge controls:
- During the induction phase the control animals were treated similarly to the test animals with the exception that the test substance was omitted from the intradermal injections and topical application. The control were challenged topically as per the treated animals
- Positive control substance(s):
- yes
- Remarks:
- The sensitivity of the guinea.-pig strain used is checked periodically with known sensitisers hexyt cinnamic aldehyde (HCA). Benzocaine and 2-mercaptobenzothiazole
- Positive control results:
- All animals exposed to the HCA and the MBT showed positive responses.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 35%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 70%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 70
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 70% Acetone only
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 35% Acetone
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- 4-[2-Ethoxy-5-(4-methyl-1-piperazinylsulfonyl)benzamido]-1-3-propyl-1H-pyrazole-5-carboxamide did not produce evidence of skin sensitisation (delayed contact hypersensitivity) in any of the ten test animals.
- Executive summary:
This study was performed to assess the skin sensitisation potential of 4-[2-Ethoxy-5-(4-methyl-1-piperazinylsulfonyl)benzamido]-1-3-propyl-1H-pyrazole-5-carboxamide using the guinea-pig. The method followed was that described in: EEC Methods for the determination of toxicity, Annex of Directive 92/69/EEC Method B 6. Skin sensitisaiion. MAGNUSSON, B. and KLIGMAN_A.M. (1970). Based on the results of a preliminary study and in compliance with the guideline, the following dose levels were selected:
Intradennal injection 5 w/v in 5% A acetone in Alembieol D
Topical application: 70% w/v in acetone
Challenge application: 70 and 35% w/v in acetone
Ten test and five control guine.a.-pigs were used in this study. 4-[2-Ethoxy-5-(4-methyl-1-piperazinylsulfonyl)benzamido]-1-3-propyl-1H-pyrazole-5-carboxamidedid not produce evidence of skin sensitisation (delayed contact hypersensitivity) in any of the ten test animals.
4-[2-Ethoxy-5-(4-methyl-1-piperazinylsulfonyl)benzamido]-1-3-propyl-1H-pyrazole-5-carboxamide does not require classification or labelling accordance with GHS
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Justification for classification or non-classification
Substance did not produce evidence of skin sensitisation (delayed contact hypersensitivity) in any of the ten test animals therefore no classification for Skin Sensitisation is necessary
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