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EC number: 806-543-7 | CAS number: 215917-77-4
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- 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:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- yes
- Remarks:
- : Deviations from the maximum level of daily mean relative humidity occured. HCD did not indicate an effect of these deviations.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- yes
- Remarks:
- : Deviations from the maximum level of daily mean relative humidity occured. HCD did not indicate an effect of these deviations.
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 1-(2-benzenesulfonamidophenyl)-3-phenylurea
- EC Number:
- 806-543-7
- Cas Number:
- 215917-77-4
- Molecular formula:
- C19H17N3O3S
- IUPAC Name:
- 1-(2-benzenesulfonamidophenyl)-3-phenylurea
- Test material form:
- solid: particulate/powder
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: Young adult animals (approx. 10 weeks old)
- Weight at study initiation: variation was within ± 20% of the sex mean.
- Housing: Group housed
- Diet (e.g. ad libitum):ad libitum to pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany)
- Water (e.g. ad libitum):Free access to tap water
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C):18 to 24°C
- Humidity (%):40 to 70%
- Air changes (per hr):approximately 10 room air changes/hour
- Photoperiod (hrs dark / hrs light):12-hour light/12-hour dark cycle.
IN-LIFE DATES: From: 2014-07-16 To: 2014-18-04
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- 0, 10, 25 and 50 % (test substance w/w)
- No. of animals per dose:
- 5
- Details on study design:
- RANGE FINDING TESTS:
- Two test substance concentrations were tested; a 25% and 50% concentration. The highest concentration was the maximum concentration as required in the test guidelines (50% for solids).
- Irritation: No irritation and no signs of systemic toxicity were observed in any of the animals examined.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 (1 per day)
- Exposure period: Days 1-3
- Test groups: 2,3,4
- Control group: 1
- Site: Dorsal surface of both ears (25 uL/ear)
- Frequency of applications: Once per day (Each ear) at approximately the same time each day
- Concentrations: 0, 10, 25 or 50% (test substance w/w)
- Exision of the nodes was undertaken on Day 6.
Each animal was injected via the tail vein with 0.25 mL of sterile phosphate buffered saline (PBS) (Merck, Darmstadt, Germany) containing 20 μCi of
3H-methyl thymidine (PerkinElmer Life and Analytical Sciences, Boston, MA, US). After approximately 5 hours animals were killed and the nodes
excised. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- The SI values calculated for the substance concentrations 5, 10 and 25% were 1.2, 1.4 and 4.7 respectively. An EC3 value of 17.3% was calculated
using linear interpolation. The calculated EC3 value was found to be in the acceptable range of 4.8 and 19.5%.
Based on the results, it was concluded that the Local Lymph Node Assay as performed at WIL Research Europe is an appropriate model for testing
for contact hypersensitivity.
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 1.3
- Remarks on result:
- other: The SI values calculated for the substance concentrations of 10 %
- Key result
- Parameter:
- SI
- Value:
- 1
- Remarks on result:
- other:
- Remarks:
- The SI values calculated for the substance concentration of 25 %
- Key result
- Parameter:
- SI
- Value:
- 1.4
- Remarks on result:
- other:
- Remarks:
- The SI values calculated for the substance concentration of 50 %
- Key result
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: 0%: 387 ± 55 10%: 521 ± 117 25%: 368 ± 56 50%: 541 ± 54
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on these results, the test substance would not be regarded as a skin sensitizer according to the recommendations made in the test guidelines.
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