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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 876-151-9 | CAS number: 2292123-68-1
- 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: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 022
- Report date:
- 2022
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Version / remarks:
- September 07, 2009
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- traditional method
- Limit test:
- yes
Test material
- Reference substance name:
- N,N’-di[3-(p-toluene sulfonyl)oxy]phenyl urea
- EC Number:
- 876-151-9
- Cas Number:
- 2292123-68-1
- Molecular formula:
- C27H24N2O7S2
- IUPAC Name:
- N,N’-di[3-(p-toluene sulfonyl)oxy]phenyl urea
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- RccHan
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: In-house Laboratory
- Females nulliparous and non-pregnant: yes
- Rationale for use of males (if applicable): not specified
- Age at study initiation: 9 to 10 weeks
- Weight at study initiation: Male (min. 262.7g, max. 269.3g); Female (min. 181.3g, max. 191.2g)
- Fasting period before study: not applicable
- Housing: 3 rats/cage (polypropylene cages covered with stainless steel grip tops
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 23
- Humidity (%): 56 60 66
- Air changes (per hr): minimum 15
- Photoperiod (hrs dark / hrs light): 12 hours/12 hours
Administration / exposure
- Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Mass median aerodynamic diameter (MMAD):
- 3.17 µm
- Geometric standard deviation (GSD):
- 2.61
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: nose-only inhalation equipment
- Exposure chamber volume: 2.062 Litres
- Method of holding animals in test chamber:
- Source and rate of air (airflow): dynamic air flow rate of 523 to 524 air changes per hour, ensuring adequate oxygen content of at least 19%. Co2 level was less than 1%.
- System of generating particulates/aerosols: The test item was loaded in a cylindrical powder reservoir which was loaded onto the dust generation system positioned below the cylindrical brush. The transportation piston pushes the compacted mass at a given speed out of the reservoir and onto the rotating brush which carries it into the upper part of the dispersion head. The mass is blown out of the brush by a high velocity air stream and is carried off via the dust exit nozzle to the chamber. The air flow rate through the dust generator was maintained at approx. 18 litres per minute.
- Method of particle size determination: gravimetric analysis
- Temperature, humidity in air chamber: 21.2 to 22.4°C, 52.0 to 53.7%,
TEST ATMOSPHERE
- Brief description of analytical method and equipment used: gravimetric samples were collected and analysed to determine the chamber aerosol concentration. The concentration of the aerosol present in the chamber was determined gravimetrically twice during the 4 hour exposure period. Each sample was taken by drawing chamber atmosphere from the animal breathing zone at a set rate using a constant flow air sampling pump (0.8 LPM)
- Samples taken from breathing zone: yes - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- Gravimetric analysis
- Duration of exposure:
- 4 h
- Remarks on duration:
- As stated in the test guideline
- Concentrations:
- 1.819 mg/L air (Maximum Achievable Breathing Zone Concentration) equivalent to 34.052 mg/L air (nominal)
- No. of animals per sex per dose:
- 3 male/3 female per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All rats observed twice per day for morbidity and mortality, once per day for clinical signs. Body weights recorded at Day 0 and post-exposure Day 1, 3, 7 and 14
- Necropsy of survivors performed: yes
- Clinical signs including body weight
- Other examinations performed: gross pathology, external examination and the opening of the nasal passage, abdominal and thoracic cavities - Statistics:
- Not applicable.
Results and discussion
- Preliminary study:
- Conducted without animals to determine the maximum concentration of the test item which could be generated in the test system. Breathing zone concentration ca. 1.8 mg/L air. Same experimental conditions used for main study.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LC50 cut-off
- Effect level:
- > 1.819 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Remarks:
- No mortality was recorded at the highest concentration tested.
- Mortality:
- None.
- Clinical signs:
- other: None
- Body weight:
- A decrease in the mean body weight was observed on Day 1 whereas an increase in the mean body weight was observed on Day 3, 7 and 14 in both sexes when compared with the Day 0 mean body weight. See Table 1 below.
- Gross pathology:
- External: no abnormalities
Internal: no lesions
No treatment related effects.
Any other information on results incl. tables
Table 1: Individual and mean body weights (g) and body weight changes (%)
Maximum Achievable Breathing Zone Concentration (mg/L air) | Sex | Rat no. | Body weights (g) on Day | Percent body weight change on Day | |||||||
0 | 1 | 3 | 7 | 14 | 1 | 3 | 7 | 14 | |||
1.819 | Male | 1 | 265.8 | 263.1 | 279.1 | 302.9 | 330.0 | -1.0 | 5.0 | 14.0 | 24.2 |
2 | 262.7 | 260.4 | 275.2 | 294.3 | 320.2 | -0.9 | 4.8 | 12.0 | 21.9 | ||
3 | 269.3 | 267.8 | 280.8 | 300.2 | 330.4 | -0.6 | 4.3 | 11.5 | 22.7 | ||
Mean | 265.9 | 263.8 | 278.4 | 299.1 | 326.9 | -0.8 | 4.7 | 12.5 | 22.9 | ||
Standard Deviation | 3.3 | 3.7 | 2.9 | 4.4 | 5.8 | 0.2 | 0.4 | 1.3 | 1.2 | ||
Female | 4 | 181.5 | 180.1 | 190.7 | 198.0 | 211.3 | -0.8 | 5.1 | 9.1 | 16.4 | |
5 | 181.3 | 180.2 | 184.5 | 195.5 | 213.1 | -0.6 | 1.8 | 7.8 | 17.5 | ||
6 | 191.2 | 189.2 | 200.8 | 208.8 | 219.9 | -1.0 | 5.0 | 9.2 | 15.0 | ||
Mean | 184.7 | 183.2 | 192.0 | 200.8 | 214.8 | -0.8 | 4.0 | 8.7 | 16.3 | ||
Standard Deviation | 5.7 | 5.2 | 8.2 | 7.1 | 4.5 | 0.2 | 1.9 | 0.8 | 1.3 |
Key: 0 = before exposure
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- The test item concentration was tested at the maximum achievable breathing zone concentration and no mortality was observed and hence no LC50 could be calculated.
- Conclusions:
- The 4 hour acute median lethal concentration (LC50) of the test item in male and female Wistar was found to be greater than the maximum achievable breathing zone concentration of 1.819 mg/L air.
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.