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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 688-332-8 | CAS number: 199119-58-9
- 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
Immunotoxicity
Administrative data
Description of key information
The test substance did not cause immunotoxic effects in a reliable subacute oral study.
Key value for chemical safety assessment
Effect on immunotoxicity: via oral route
Link to relevant study records
- Endpoint:
- immunotoxicity: short-term oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 17 October 2011 - 25 January 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPPTS 870.7800
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- female
- Route of administration:
- oral: feed
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- Continuous
- Dose / conc.:
- 4 000 ppm
- Dose / conc.:
- 1 250 ppm
- Dose / conc.:
- 400 ppm
- No. of animals per sex per dose:
- 20
- Control animals:
- yes
- Conclusions:
- Trifloxysulfuron sodium administered ad libitum in the diet for up to 28 consecutive days to female B6C3F1 mice at dose levels of 400, 1250, and 4000 ppm resulted in a no-observed-effect-level (NOEL) for both the AFC assay (humoral immune response) and the NKC assay (innate immune response) of 4000 ppm (equivalent to 1066.6 mg/kg of body weight/day), the highest dose level evaluated.
- Executive summary:
The test substance, trifloxysulfuron sodium (hereafter referred to as trifloxysulfuron), was offered ad libitum in the diet for up to 28 consecutive days to female B6C3F1 mice in Groups 2, 3, and 4 at dietary concentrations of 400, 1250, and 4000 ppm, respectively.
Ten mice/group (Subset A) were used for the splenic Antibody-Forming Cell (AFC) assay and 10 mice/group (Subset B) were used for the Natural Killer Cell (NKC) assay. Mice in the AFC positive control group (Group 5A) were administered the positive control substance, cyclophosphamide (CPS), via intraperitoneal injection (50 mg/kg/day) once daily for 4 consecutive days (study days 24 through 27). All AFC group mice (Groups 1A-5A) were immunized with an intravenous injection of sheep red blood cells (sRBC) on study day 24.
Mice in the NKC positive control group (Group 6B) were administered the positive control substance, anti asialo GM1, via a single intravenous injection (0.2 mL/animal) on study day 27, approximately 24 hours prior to the scheduled necropsy. The concurrent control groups (Groups 1A and 1B) and the positive control groups (Groups 5A and 6B) were offered the basal diet on a comparable regimen to the trifloxysulfuron-treated groups. All animals were euthanized on study day 28.All animals were observed twice daily for mortality and moribundity. Clinical examinations were performed once daily for all animals. Detailed physical examinations were performed approximately weekly, and on the day of the scheduled necropsy. Individual body weights and food consumption were recorded approximately twice weekly. Complete necropsies were conducted on all animals. The liver, mesenteric lymph node, Peyer’s patches, spleen, and thymus were collected from all AFC- and NKC-designated animals at the scheduled necropsy, and the liver and spleen were weighed. In addition, the thymus was weighed from all NKC-designated animals. Spleens were placed in Earle’s Balanced Salt Solution (EBSS)/HEPES buffer and shipped to ImmunoTox®, Inc. After arrival at ImmunoTox®, Inc., spleen cell suspensions were prepared, spleen cell counts were performed, and the number of specific IgM antibody forming cells directed towards the sRBC antigen were determined for the AFC-designated animals to measure the humoral immune response using the splenic AFC assay. In addition, ImmunoTox®, Inc., personnel prepared the spleens from the NKC-designated animals to measure innate immunity using the NKC assay.
Mean achieved test substance consumption in the 0, 400, 1250, and 4000 ppm groups were 0.0, 94.8, 324.4, and 1066.6 mg/kg of body weight/day, respectively, over the entire 28-day study.
All animals survived to the scheduled necropsy. There were no trifloxysulfuron-related clinical observations, macroscopic findings, or effects on body weights, food consumption, or organ weights. There were no trifloxysulfuron-related effects on spleen cell numbers.
Trifloxysulfuron did not significantly suppress the humoral immune response when evaluated as either specific activity (AFC/106 spleen cells) or as total activity (AFC/spleen) of splenic IgM to the T-cell dependent antigen sRBC, and there were no trifloxysulfuron-related effects on NKC functional activity.
For the AFC positive control group, CPS, statistically significantly lower spleen weight, spleen cell numbers, specific activity, and total spleen activity of IgM antibody-forming cells were noted when compared to the vehicle control group. These effects were consistent with the known immunosuppressant effects of CPS and validated the functionality of the assay.
For the NKC positive control group, anti asialo GM1, statistically significantly lower
NKC activity at all effector:target ratios, except for the 6.25:1 effector:target ratio, were noted when compared to the vehicle control group. This effect was consistent with the known effects of anti asialo GM1 on NKC activity, which validated the functionality of the NKC assay.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 066.6 mg/kg bw/day
- Study duration:
- subacute
- Species:
- mouse
Effect on immunotoxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Effect on immunotoxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
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.