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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 700-368-9 | CAS number: 328-90-5
- 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:
- screening for reproductive / developmental toxicity
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because a pre-natal developmental toxicity study is available
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
According to column 2 of REACH Annex VIII, the study does not need to be conducted if a pre-natal developmental study is available.
Cross-reference
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
- Endpoint:
- developmental toxicity
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH (see 'Attached justification')
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The analogue substance shares the same functional groups with the target and has a similar molecular weight, and comparable values for the relevant molecular properties.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
- Source: Triflusal.
- Target: TFMSA, see 'test item'.
3. ANALOGUE APPROACH JUSTIFICATION
Please find Reporting Format in 'Attached justification'.
4. DATA MATRIX
Please find Data Matrix included in 'Attached justification'. - Reason / purpose for cross-reference:
- read-across source
- GLP compliance:
- not specified
- Limit test:
- no
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 24.9 - < 49.8 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- gross pathology
- Remarks on result:
- other: read-across from supporting substance (structural analogue or surrogate)
- Key result
- Abnormalities:
- no effects observed
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 49.8 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no significant effects were observed.
- Remarks on result:
- other: read-across from supporting substance (structural analogue or surrogate)
- Key result
- Abnormalities:
- no effects observed
- Key result
- Developmental effects observed:
- no
- Conclusions:
- Based on the available data for the read-across approach, the target substance has a NOAEL (maternal toxicity) ≥ 24.9 mg/kg bw/day and a NOAEL (developmental) ≥ 49.8 mg/kg bw/day in rabbits.
- Executive summary:
Read-across from supporting substance (structural analogue or surrogate): A prenatal developmental toxicity test was conducted for the analogue substance Triflusal, according to OECD 414, under GLP contidions. The test item was administered daily by oral gavage to 16 pregnant female chinchilla rabbits per group at doses of 0 (vehicle control), 15, 30, or 60 mg/kg bw/day in bi-distilled water with 4% CMC from the 6th day to the 18th of pregnancy. The animls were observed daily for sings of toxicity from day 0 to day 28th of gestation, when they were sacrificed and the fetuses were removed from the uterus, weighed individually, examined for gross external abnormalities, sacrificed, and prepared for internal examination. This included external, visceral and skeletal examinations. Gross macroscopic examination of maternal animals was performed on all internal organs, with emphasis on the uterus, uterine contents, position of fetuses in the uterus and number of corpora lutea. Regarding maternal toxicity, the administration of the test item was associated with the death of 2 animals, body weight loss on the initiation of dosing and an increased incidence of macroscopic changes indicative of gastric irritation at 60 mg/kg bw/day and with reduced food consumption during the first 5 days of dosing at 30 and 60 mg/kg bw/day. Regarding developmental toxicity, there was no indication of an adverse effect of treatment with the test item on any of the maternal reproduction parameters or any of the fetal parameters up to and including the highest dose examined. For the analogue substance, the NOAEL (developmental) in rabbits was determined to be greater than 60 mg/kg bw/day; whereas the NOAEL (maternal toxicity) was found to be between 30 and 60 mg/kg bw/day. Based on the available data for the read-across approach, the target substance has a NOAEL (maternal toxicity) ≥ 24.9 mg/kg bw/day and a NOAEL (developmental) ≥ 49.8 mg/kg bw/day in rabbits.
The results of the read-across approach from the experimental data obtained for the supporting substance are expressed as the estimated toxicity based on molecular weights. No other adaptation is necessary.
Data source
Materials and methods
Results and discussion
Applicant's summary and conclusion
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.