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EC number: 208-208-5 | CAS number: 515-74-2
- 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:
- From 09 May 1995 to 16 May 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline and EU method. GLP study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Sodium sulphanilate
- EC Number:
- 208-208-5
- EC Name:
- Sodium sulphanilate
- Cas Number:
- 515-74-2
- Molecular formula:
- C6H7NO3S.Na
- IUPAC Name:
- sodium 4-aminobenzenesulfonate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Physical state: white powder
- Analytical purity: 91.5%
- Lot/batch No.: 868 TO
- Storage condition of test material: room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Interfauna UK Ltd., Wyton, Huntingdon, England
- Weight at study initiation: 3.9-4.3 kg
- Housing: The rabbits were individually housed in stainless steel cages with flat rod bases or plastic cages with perforated bases, under standardized conventional conditions.
- Diet (e.g. ad libitum): Standard diet "Ssniff K4", approx. 100-120 g per animal/day; once per day in the morning.
- Water (e.g. ad libitum): Tap water; ad libitum.
- Acclimation period: Approximately one week.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 ºC (higher when ambient temperature over 24 ºC)
- Humidity (%): 50-70%
- Air changes (per hr): 12-15 times per hour
- Photoperiod (hrs dark / hrs light): 12 hours, artificial illumination from 6 a.m. to 6 p.m.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: the test substance was moistened with deionized water
- Controls:
- other: no control animals (the contralateral skin area not treated with test substance served as control)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg of the pulverized test substance. - Duration of treatment / exposure:
- Four hours
- Observation period:
- 1, 24, 48 and 72 hours and 7 days
- Number of animals:
- Three animals
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: A patch was placed on the exposed area and held in place with a semiocclusive dressing.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The exposed skin areas were carefully washed with water without altering the existing response or the integrity of the epidermis.
- Time after start of exposure: Four hours.
SCORING SYSTEM:
Erythema and Eschar Formation
No erythema 0
Very slight erythema (barely perceptible) 1
Well defined erythema 2
Moderate to severe erythema 3
Severe erythema (R) to slight eschar formation (S) 4R or 4S
Edema Formation
No edema 0
Very slight edema (barely perceptible) 1
Slight edema (edges of area well defined by definite raising) 2
Moderate edema (raised approximately 1 mm) 3
Severe edema (raised more than 1 mm and extending beyond area of exposure) 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24-72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24-72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24-72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24-72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24-72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24-72 h
- Score:
- 0
Any other information on results incl. tables
Table 1: Dermal irritation scores
Erythema |
Oedema |
|||||
Animal No |
1 |
2 |
3 |
1 |
2 |
3 |
after 24 h |
0 |
0 |
0 |
0 |
0 |
0 |
after 48 h |
0 |
0 |
0 |
0 |
0 |
0 |
after 72 h |
0 |
0 |
0 |
0 |
0 |
0 |
Mean score 24 – 72 h |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The results of the exposure of the test substance to the skin indicate that the test substance may be regarded as not irritating to the skin.
- Executive summary:
The acute skin irritation/corrosion study was performed according to the OECD Guideline No. 404 and EU Method B.4. The test item in the amount of 0.5 g was applied only once to the shaved skin of three animals. The exposure lasted four hours. Detailed clinical observations of the treated skin were performed 1, 24, 48 and 72 hours and 7 days after the end of the exposure. The results of the exposure of the test substance to the skin indicate that the test substance may be regarded as not irritating to the skin.
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