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EC number: 226-798-2 | CAS number: 5470-11-1
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific standards.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 969
- Report date:
- 1969
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Before OECD guideline 404 was established, skin irritation was tested using an internal BASF method. White Vienna rabbits were used. Usually, 2 animals were treated for 1, 5, 15 min and 20 h using occlusive conditions. An application site of 2.5 cm x 2.5 cm was covered with the liquid test substance. In addition, skin tissue from the ear was tested by wrapping the ear. These results from the ear, however, would not be taken into account for evaluation as they do not represent testing of the dorsal/lateral flank of the back. After the application time, the skin was washed with water which sometimes contained a mild detergent. The animals were observed for 8 days. Skin reaction was recorded after 1 h, 24 h, 48 h, 72 h, 96 h and after 7 and 8 days.
Differences as compared to OECD TG 404: application time: 1, 5, 15 min and 20 h (OECD: 4 h); 2 animals used (OECD: 1-3); observation period 8 days (OECD: 14); skin changes recorded on working days; dose ~1 ml (OECD: 0.5 ml), additionally testing of the ear (not recomm. by the OECD TG), application under occlusive conditions (OECD: semi-occlusive) - GLP compliance:
- no
- Remarks:
- ; GLP was not compulsory at the time the study was conducted.
Test material
- Reference substance name:
- Bis(hydroxylammonium) sulphate
- EC Number:
- 233-118-8
- EC Name:
- Bis(hydroxylammonium) sulphate
- Cas Number:
- 10039-54-0
- Molecular formula:
- H3NO.1/2H2O4S
- IUPAC Name:
- bis(hydroxyammonium) sulfate
- Details on test material:
- - Name of test material (as cited in study report): Hydroxylammoniumsulfat
- Physical state: solid
- Analytical purity: pure grade
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: male 3.32 kg, female 2.86 kg
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- other: the untreated sites of the same animal served as control.
- Amount / concentration applied:
- The test substance (ca. 2 g), moistured with water and mixed to a paste (concentration: 80 %), was applied to a 2.5 cm x 2.5 cm patch
- Duration of treatment / exposure:
- 1, 5, 15 min, 20 hours
- Observation period:
- The animals were observed following exposure for 8 days on working days. Skin changes were recorded after removal of the bandage after 1 hour as well as after 24 h, 48 h, and on day 6 and 8.
- Number of animals:
- 4 animals (2 animals were used for the 20 h treatments and 2 animals were used for th 1 min, 5 min and 15 min treatments).
- Details on study design:
- The test substance, moistured with water and mixed to a paste, was applied to a 2.5 cm x 2.5 cm patch (~2 g) and placed on the clipped and intact skin of four white Vienna rabbits for 1 min, 5 min, 15 min and 20 h under occlusive conditions.
The right and the left flank of each animal was clipped and the test material was administered on both sites (on the left and on the right site each and each application was scored separately).
The test substance was removed on both sites by washing once. Skin reactions were recorded after 1 h, 24 h, 48 h, and on day 6 and 8. The application time used for assessment was 20 hours, the test material was applied on dorsal skin. The corresponding reading time points used for assessment were 24 and 48 hours after application. Dermal reactions were classified using a BASF-scoring system, which is convertible into the current OECD Draize scheme. For the evaluation, the BASF scores given in the raw data were converted to Draize scores.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24-48 h
- Score:
- 2.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: exposure time: 20 h; scale was seen on day 6
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24-48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: exposure time: 20 h; scale was seen on day 6
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24-48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- other: exposure time: 20 h
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24-48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- other: exposure time: 20 h
- Irritation parameter:
- erythema score
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable because of methodological limitations
- Remarks:
- 72-h reading time point was not determined
- Irritation parameter:
- edema score
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable because of methodological limitations
- Remarks:
- 72-h reading time point was not determined
- Irritant / corrosive response data:
- Under the experimental conditions chosen, the mean scores for erythema after an application time of 20 hours under occlusive conditions were for animal 1 (male) 2.5; for animal 2 (female) 2.0, regarding the readings after 24 h and 48 h. No edema was observed in any animal. Scaling was observed on day 6. The effects observed were fully reversible at the end of the observation period on day 8.
In addition, readings were performed in two further animals after exposure times of 1, 5 and 15 min resulting in no effects after 1 and 5 min and a slight erythema (scored 1) after 15 min in both animals.
Applicant's summary and conclusion
- Interpretation of results:
- other: Category 2 based on CLP/EU GHS criteria, according to Regulation (EC) No 1272/2008
- Conclusions:
- CLP: Skin Irrit, Cat.2, corresponding to the harmonized classification according to Annex VI of CLP Regulation
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