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EC number: 220-971-6 | CAS number: 2950-43-8
- 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
Endpoint summary
Administrative data
Description of key information
Skin
EpiDerm in-vitro test: corrosive (BASF AG, 2003)
Corrositex in vitro test: corrosive (BASF SE, 2015)
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation / corrosion
- Remarks:
- in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Species:
- other: in vitro
- Strain:
- other: in vitro
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- up to 4 hours or until break through
- Observation period:
- Test substance: 3 min to 4 hours until break through
Negative control: 60 min
Positive control: continuosly until break through - Details on study design:
- 4 tests were performed for the test item, one test for the positive, negative and the color (blank) control. The experimental design of this study consisted of a qualification screen with the CDS (to determine if a color change can be detected) and a categorization screen (to categorize weak acids/bases and strong acids/bases), which were performed as a pretest, and a definitive Corrositex® assay.
The Corrositex® assay was evaluated on the basis of the color change of the CDS. The time that a color change was observed was recorded manually and the breakthrough times of the four replicates was used to determine the corrosive potential of the test substance. For the qualification screen, 100 mg of the test substance was added to the CDS screening tube. If the test substance failed to produce a color change in the CDS within one minute, the test substance could not be analyzed in this system, and no further testing was required.
In addition, one vial was used for the PC, NC and for the color (blank) control, each. A membrane disc coated with the biobarrier matrix was placed into one vial containing the CDS and 500 mg of the undiluted test substance was added onto the membrane disc. An electronic time clock was started with the application. The vial was observed for three minutes for any change in the CDS.
If no color change was observed within three minutes, the remaining membranes were treated with the test substance. An electronic time clock was started with each application. The vials were observed continuously for the first ten minutes. Thereafter the vials were observed for approximately ten minutes around the time points relevant for evaluation or until breakthrough of the test substance occurred. The elapsed time between test-substance application and the first change in the indicator solution (i.e. barrier penetration) was recorded.
The categorization screen was used to assess the appropriate scoring scale for the test substance. he categorization screen was performed by adding 100 mg of test substance to each tube A and B. Each tube was mixed and the resulting color observed. If required, 2 drops of the "confirm" reagent were added to tube B, the tube mixed, and the resulting color observed. The categorization kit and color chart provided by InVitro International were used to determine the category. The test substance was scored as category 1 (high acid/alkaline reserve) or category 2 (low acid/alkaline reserve)
Reference
Breakthrough times of the test substance and the PC and NC
Test substance |
Break Through Time[min:s] |
||||
Vial 1 |
Vial 2 |
Vial 3 |
Vial 4 |
Mean |
|
03/0169-3 |
5:18 |
5:19 |
4:51 |
4:18 |
4:57 |
Controls: |
|
||||
PC: Sodium hydroxide, solid |
10:44 |
- |
- |
- |
- |
NC: 10% citric acid |
NB |
- |
- |
- |
- |
NB = no breakthrough within maximum observation period (60 min)
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
There are valid in vitro data available for the assessment of the skin irritation/corrosion potential of hydroxylamine-O-sulphonic acid available.
Skin
The potential of Hydroxylamine-O-sulphonic acid to cause dermal corrosion was assessed by a single topical application of 500 mg of the test substance to the Corrositex® Biobarrier Membrane (Corrositex® assay). The Corrositex® Biobarrier Membrane is the test system consisting of a reconstituted collagen matrix. The assay is based on the time that is required for the test substance to penetrate through the Corrositex® Biobarrier Membrane and produce a change in the Chemical Detection System (CDS). The qualification screen demonstrated that the test substance is able to react with the CDS and produce a visible color change. Therefore the membrane barrier test method was determined to be suitable for the evaluation of the corrosive potential of the test substance. A timescale category test was carried out to distinguish between weak and strong acids or bases. The test substance was assigned to timescale category 1 (having a high acid/alkaline reserve).
In the main test four Corrositex® Biobarrier Membranes were treated with the undiluted test substance. Based on the observed results and applying the evaluation criteria it was concluded, that Hydroxylamine-O-sulphonic acid shows a corrosive potential in the Corrositex® - Skin Corrosion Test under the test conditions chosen. The mean breakthrough time determined in the in vitro membrane barrier test was 4 minutes and 57 seconds. The breakthrough time indicates that the test substance has an intermediate corrosive potential and should be assigned to UN GHS skin corrosivity subcategories 1B or UN Transport Packing Group II as specified in OECD TG 435 (adopted 19 July 2006) (BASF SE, 2015).
The potential of hydroxylamin-O-sulphonic acid to cause dermal corrosion was assessed by a single topical application of 25 µl bulk volume (corresponding to about 15 mg) of the test substance to a reconstructed three dimensional human epidermis model (EpiDermTM). Two EpiDermTM tissue samples were incubated with the test substance for 3 minutes and 1 hour, each. Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure using a colorimetric test. The reduction of mitochondrial dehydrogenase activity, measured by reduced formazan production after incubation with a tetrazolium salt (MTT) was chosen as suitable endpoint. The formazan production of the test substance treated epidermal tissues is compared to that of negative control tissues. The quotient of both values indicates the relative tissue viability. The EpiDerm skin corrosivity test showed the following results: The test substance is not able to directly reduce MTT. Viability of the test substance treated tissues determined after an exposure period of 3 minutes was 80 %. Viability of the test substance treated tissues determined after an exposure period of 1 hour was 9 %. Based on the observed results and applying the evaluation criteria it was concluded, that hydroxylamin-O-sulphonic acidshows a corrosive potential in the EpiDermTM skin corrosivity test under the test conditions chosen. The test method does not yet allow for the differentiation of severity of the effect. The results however indicate moderate corrosivity (BASF AG, 2003).
Justification for selection of skin irritation / corrosion endpoint:
GLP-conform guideline study. Estimated Klimisch Rating: 1
Justification for selection of eye irritation endpoint:
No study necessary since the test substance is classified as corrosive to the skin.
Effects on skin irritation/corrosion: corrosive
Justification for classification or non-classification
Based on the results for skin irritation (corrosive), the test substance is classified for skin irritation/corrosion as follows:
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008 (CLP). As a result the test substance is considered to be classified for skin or eye irritation under Regulation (EC) No 1272/2008, as amended for the sixth time in Regulation (EC) No 605/2014, as follows:
Cat. 1B, H314, causes severe skin burns and eye damage; Cat. 1, H318, causes serious eye damage.
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