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EC number: 617-298-9 | CAS number: 82097-50-5
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25 Jun 2012 to 30 Jun 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 202
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Version / remarks:
- 1998
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 2008
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-(2-chloroethoxy)-N-[(4-methoxy-6-methyl-1,3,5-triazin-2-yl)carbamoyl]benzene-1-sulfonamide
- EC Number:
- 617-298-9
- Cas Number:
- 82097-50-5
- Molecular formula:
- C14H16ClN5O5S
- IUPAC Name:
- 2-(2-chloroethoxy)-N-[(4-methoxy-6-methyl-1,3,5-triazin-2-yl)carbamoyl]benzene-1-sulfonamide
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Sex: Male
- Age at study initiation: ~10 weeks
- Weight at study initiation: 2817-2941 g
- Housing: Animals were housed individually in AAALAC approved metal wire rabbit cages. Cages are of an open wire structure and cages are placed together to allow some social interaction with rabbit(s) in adjoining cages.
- Diet: UNI diet for rabbits. Ad libitum
- Water: Tap water. Ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20.1-24 °C
- Humidity: 50-83 %
- Air changes: 15-20 air exchanges/hour
- Photoperiod: 12/12 hours light/dark
IN-LIFE DATES: From: 25 June 2012 to 30 June 2012
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Remarks:
- The test item was moistened with the smallest of water sufficient to ensure good skin contact
- Controls:
- no
- Amount / concentration applied:
- 0.5 g (per animal)
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: An area of 10 x 10 cm on the back and flanks of the rabbits was clipped with an electric clipper 24 hours before the treatment.
- Type of wrap if used: A surgical gauze pad (ca. 2.5 x 2.5 cm) was applied to the intact skin of the clipped area and was kept in contact with the skin by a patch with a surrounding adhesive hypoallergenic plaster. The entire trunk of the animals was than wrapped with plastic wrap held in place with an elastic stocking.
REMOVAL OF TEST SUBSTANCE
- Washing: The dressing was then removed and the skin was flushed with lukewarm tap water to clean the application site.
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
- 1, 24, 48 72 hours after the end of exposure
SCORING SYSTEM:
- Method of calculation: The skin reaction was assessed according to the numerical scoring system listed in the Commission Directive 2004/73/EC, April 29, 2004 which was based on the Draize scoring system. For criteria, see 'Any other information on materials and methods incl. tables'.
OTHER OBSERVATIONS
- Clinical signs, including viability/mortality, were recorded daily from the day of application of the animals to the termination of the test.
- Body weights were recorded on the day of application and the end of the observation period.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 8
- Irritant / corrosive response data:
- The primary irritation index was 0.00 (out of a maximum score of 8.0). No corrosive effects were noted on the treated skin of any animal at any of the observation intervals.
- Other effects:
- No clinical signs were observed in the animals during the study and no mortality occurred.
The body weights of all rabbits were considered to be within the normal range of variability
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The application of the test item did not result in any signs of skin irritation.
According to the Draize classification criteria the test item is considered to be “Not- Irritant” to rabbit skin. - Executive summary:
In an OECD TG 404 dermal irritation study performed under GLP, young adult New Zealand white rabbits (3 males) were exposed to 0.5 g the test item, applied to the intact shaved flank under a semi-occlusive dressing for 4 hours. Skin reactions were scored at 1, 4, 24, 48 and 72 hours after removal of the dressings for erythema and oedema. In addition, the Primary Irritation Index (PII) was calculated.
There were no signs of dermal irritation and the primary irritation index was calculated to be 0.00.
No local dermal signs were observed in the treated animals throughout the study and the 24/48/72h average scores were 0 for both erythema and oedema. There were no clinical signs of systemic toxicity and no mortalities. The body weights of all rabbits were considered to be within the normal range of variability. The study was terminated after the 72 hour observation period.
According to the Draize classification criteria the test item is considered to be “not-irritant” to rabbit skin.
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