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EC number: 226-218-8 | CAS number: 5329-14-6
- 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:
- 26/11/09-05/12/09
- 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Sulphamidic acid
- EC Number:
- 226-218-8
- EC Name:
- Sulphamidic acid
- Cas Number:
- 5329-14-6
- Molecular formula:
- H3NO3S
- IUPAC Name:
- sulfamic acid
- Test material form:
- not specified
1
Test animals
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- ANIMALS
Species / Strain Rabbit / : Himalayan
Breeder : LPT Laboratory of Pharmacology and Toxicology GmbH & Co. KG, branch Löhndorf, 24601 Löhndorf/Post Wankendorf, Germany
Sex : Male animals
Number of animals : 3
Age (at dosing) : Approx. 7 - 9 months
Body weight
At dosing
Animal no. 1 : 2.6 kg
Animal no. 2 : 2.6 kg
Animal no. 3 : 2.6 kg
Termination of test
Animal no. 1 : 2.6 kg
Animal no. 2 : 2.7 kg
Animal no. 3 : 2.6 kg
Identification of animals : By tattooed number assigned by the Löhndorf breeding station.
Duration of study : At least 20 adaptation days, 1 test day and a follow-up period of 72 hours.
DIET
Commercial diet, ssniff® K-H V2333 (ssniff Spezialdiäten GmbH, 59494 Soest, Germany, The food was available ad libitum before and after the exposure period.
At regular intervals (at least twice a year), the food is analysed1 for contaminants by LUFA-ITL2.
DRINKING WATER
Drinking water was offered ad libitum before and after the exposure period. Samples of the drinking water are examined according to the 'Deutsche Trinkwasserverordnung 2001' [German Regulations on drinking water 2001] by the Wasserbeschaffungsverband Harburg, 21220 Seevetal, Germany, twice a year. In addition, drinking water samples taken at LPT are analysed by LUFA-ITL once a year for means of bacteriological investigations according to the 'Deutsche Trinkwas-serverordnung 2001, Anlage 1' [German Regulations on drinking water 2001, Addendum 1].
HOUSING
Before and after the 4-hour exposure period, the animals were kept singly in cages measuring 380 mm x 425 mm x 600 mm (manufacturer: Dipl. Ing. W. EHRET GmbH, 16352 Schönwalde, Germany) at a room temperature of 20°C ± 3°C (maximum range) and relative humidity of 30% - 70% (maximum range). Deviations from the maximum range caused for example during cleaning procedures are dealt with in SOPs. During the exposure period, the animals were kept singly in restrainers which allowed free movement of the head but prevented a complete body turn. The cages excluded irritation of the skin by excrements and urine. The rooms were lit (150 lux at approx. 1.5 m room height) and darkened on a 12-hour light/12-hour dark cycle.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- 500 mg/patch and animal
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- DOSE LEVEL AND ADMINISTRATION
Route of administration : Dermal application onto the shaved, intact dorsal skin.
Selection of route of administration : According to OECD guideline and most likely route of exposure.
Dose level : 500 mg/patch and animal (500 mg of the test item were mixed with 0.5 mL aqua ad iniectabilia3, 1000 mg of this paste were applied per animal (≈ 500 mg test item/animal))
Approximately 24 hours before the test, the fur was removed by closely clipping the dorsal area of the trunk of the animals. Care was taken to avoid abrading the skin.
Only animals with healthy intact skin were used.
A dose of 500 mg of the test item was applied to the test site (area: approx. 6 cm2).
The test item was applied to the test site and then covered with a gauze patch. The patch was held in contact with the skin with non-irritating tape for the duration of the exposure period. The surrounding untreated skin served as a control.
Exposure time was 4 hours. During the exposure the animals were kept in comfortable restrainers.
At the end of the exposure time no residual test item had to be removed.
Suspected corrosive / irritating test items:
Initial test
As there was no evidence that the test item will produce severe irritancy or corrosion, a single patch was applied to one animal for 4 hours.
Confirmatory test
As no corrosive or severe irritant effects were observed in the initial test, 2 further animals were employed 24 hours after start of the initial test.
Results and discussion
In vivo
Results
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- 3 rabbits were exposed for 4 hours to 500 mg Sulfamic Acid (100%)/patch (semi-occlusive conditions) showed following effects:
An erythema (grade 1) was observed in all animals 60 minutes after patch removal, in animal no. 2 until 24 hours after patch removal.
An oedema (grade 1) was observed in animal no. two 60 minutes after patch removal.
No systemic intolerance reactions.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- In a GLP guideline study conducted according to EC method B.4. and OECD guideline 404, sulfamic acid demonstrated only slight, transient effects on the skin of rabbits which were fully reversible after 48 hours. According to the criteria laid down in the Globally Harmonized System of Classification and Labelling of Chemicals, sulfamic acid is not considered to be irritating to skin.
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