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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 619-383-6 | CAS number: 98967-40-9
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- two-generation reproductive toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 June 1988 to 1 November 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 83-4 (Reproduction and Fertility Effects)
- GLP compliance:
- yes
- Limit test:
- yes
Test material
- Reference substance name:
- N-(2,6-difluorophenyl)-5-methyl-[1,2,4]triazolo[1,5-a]pyrimidine-2-sulfonamide
- EC Number:
- 619-383-6
- Cas Number:
- 98967-40-9
- Molecular formula:
- C12H9F2N5O2S
- IUPAC Name:
- N-(2,6-difluorophenyl)-5-methyl-[1,2,4]triazolo[1,5-a]pyrimidine-2-sulfonamide
- Reference substance name:
- N-(2',6'-difluorophenyl)-5-methyl[1,2,4]triazolo[1,5-a]pyrimidine-2-sulfonamide
- IUPAC Name:
- N-(2',6'-difluorophenyl)-5-methyl[1,2,4]triazolo[1,5-a]pyrimidine-2-sulfonamide
- Details on test material:
- - Name of test material (as cited in study report): XRD-498
- Molecular weight:253.3 Daltons
- Physical state:White, very fine crystals
- Analytical purity:99.7%
- Purity test date: 10 January 1989
- Lot/batch No.: AGR 240043
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: rodent chow
- Details on mating procedure:
- - M/F ratio per cage:1:1
- Length of cohabitation: 7 days
- Proof of pregnancy: vaginal plug and sperm in vaginal smear considered day 1 of pregnancy
- After 7 days of unsuccessful pairing replacement of first male by another male with proven fertility.
- Further matings after two unsuccessful attempts: a third 7-day cohabitation period was used for females as necessary
- After successful mating each pregnant female was caged (how): singly in stainless steel cages with wire mesh floors - Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- F0 generation was dosed for for 10 weeks.
F1 adults were dosed for 12 weeks. - Frequency of treatment:
- Daily
- Details on study schedule:
- - F1 parental animals not mated until 12 weeks after selected from the F1 litters.
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0 - control
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
100 mg/kg body weight/day
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
500 mg/kg body weight/day
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
1000 mg/kg body weight/day
Basis:
actual ingested
- No. of animals per sex per dose:
- 30 animals per sex per dose group
- Control animals:
- yes
Results and discussion
Results: P0 (first parental generation)
Effect levels (P0)
- Dose descriptor:
- NOEL
- Effect level:
- 1 000 other: mg/kg bw/day (actual ingested)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: see 'Remark'
- Remarks on result:
- other: Generation: F0, F1a, F1b, F2 (migrated information)
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
The F1a pups, which served as parental generation for the F2 animals, matured and successfully produced litters with no evidence of treatment-related effects.
Applicant's summary and conclusion
- Conclusions:
- Based on the results of this study, the no-observable-effect-level for reproductive effects was 1000 mg/kg bw/day. No paternal or maternal toxicity was demonstrated at any dose level tested including the high dose level of 1000 mg/kg bw/day.
- Executive summary:
Fischer-344 rats were fed XRD-498 at dose levels of 0, 100, 500, or 1000 mg/kg bw/day in the diet. Following 10 weeks of exposure, the F0 rats were mated to produce F1a and F1b litters. At weaning, 30 F1a pups/sex/dose level were randomly selected to become the F1 adults. After 12 weeks of exposure to XRD-498, the F1 adults were mated to produce the F2 litters. Reproductive performance and neonatal survival and development were evaluated to assess the reproductive effects of treatment. Body weights, body weight gains, feed consumption, clinical observations, kidney weights, and gross pathologic and results of histopathologic examinations were evaluated for evidence of toxicity. Reproductive performance of the F0 and F1 adult rats was not affected by XRD-498 treatment. No effects attributable to XRD-498 treatment were found in the growth and development of the F1a, F1b, and F2 pups. The F1a pups, which served as parental generation for the F2 animals, matured and successfully produced litters with no evidence of treatment-related effects. No parental toxicity was demonstrated in the F0 or F1 adult rats, even at the high dose level of 1000 mg/kg bw/day. Based on the results of this study, the no-observable-effect-level for reproductive effects was 1000 mg/kg bw/day (limit test). No paternal or maternal toxicity was observed at any dose level tested.
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.