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EC number: 700-740-0 | CAS number: 1103234-56-5
- 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:
- Nov-Dec 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: done under GLP condition and acc. to OECD guideline no. 404
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2,6-difluoro-3-(propane-1-sulfonamido)benzoic acid
- EC Number:
- 700-740-0
- Cas Number:
- 1103234-56-5
- Molecular formula:
- C10H11F2NO4S
- IUPAC Name:
- 2,6-difluoro-3-(propane-1-sulfonamido)benzoic acid
- Details on test material:
- -Substance type: organic
-Physical state: white powder
-Storage condition of test material: at room temerature, protected from light
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
-Source: Charles River Laboratories France, L'Arbresle Cedex, France
-Age at study initiation: 11 weeks (male)
15-17 weeks (females)
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped with electric clippers
- Vehicle:
- other: PEG 300
- Controls:
- no
- Amount / concentration applied:
- 0.5 g of test substance moistened with 0.5 mL PEG 300 and applied to the skin
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- Test Item Administration
The test item was administered at 0.5 g/animal, the dose specified in the test guidelines for a
solid test item.
Four days before treatment, the left flank was clipped with an electric clipper, exposing an area
of approximately 100 cm2 (10 cm x 10 cm). The skin of the animals was examined one day
before treatment, and regrown fur of all animals was clipped again.
Animals with overt signs of skin injury or marked irritation which may have interfered with the
interpretation of the results were not used in the test.
On the day oftreatment, 0.5 g ofSAC-Sulfonamidsaure moistened with 0.5 mL
PEG 300 was placed on a surgical gauze patch (ea. 2.5 cm x 2.5 cm) held in contact with the skin
by means of an adhesive hypoallergenic aerated semi-occlusive dressing and a restrainer
bandage wrapped around the abdomen.
The duration of treatment was 4 hours. Then the dressing was removed and the skin was flushed
with lukewarm tap water to clean the application site.
As it was suspected that the test item might produce irritancy, a single animal (one female) was
treated first. As neither a corrosive effect nor a severe irritant effect was observed after the 4-
hour exposure, the test was completed using the two remaining animals for an exposure period of
four hours.
Rationale: The application form and dose were used to detect a possible irritating potential of the
test item applied.
Observations
Viability I Mortality:
Clinical Signs (systemic):
Body Weights:
Skin Reactions:
No necropsy was performed on the animals sacrificed at termination of observation.
All rabbits were sacrificed by an intravenous injection of pentobarbitone into the ear vein at a
dose of at least 1 mL/kg body weight and discarded.
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1,24,48 and 72 hours
- Score:
- 0
- Irritant / corrosive response data:
- none
- Other effects:
- none
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on these results SAC-Sulfonamidsäure does not have to be classified and has no obligatory labelling requirements for skin irritation acc to the : GHS and EU CLP regulations
- Executive summary:
The primary skin irritation potential of SAC-Sulfonamidsaure was investigated according to OECD test guideline No. 404 and Commission Regulation (EC) No. 440/2008. The test item was applied by topical semi-occlusive application of 0.5 g to the intact left flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the dressing.
The mean score was calculated across 3 scoring times (24, 48 and 72 hours after patch removal) for each animal for erythema/eschar grades and for oedema grades, separately. The test item did not elicit any skin reactions at the application site of any animal at any of the observation times (all scores 0). The individual mean score for erythema/eschar and oedema for each of the three animals was therefore 0.
Based upon the referred classification criteria (Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008), SAC-Sulfonamidsaure is not classified with respect to skin irritation.
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