Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 208-761-2 | CAS number: 540-92-1
- 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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Sodium 2-hydroxypropane-2-sulphonate
- EC Number:
- 208-761-2
- EC Name:
- Sodium 2-hydroxypropane-2-sulphonate
- Cas Number:
- 540-92-1
- Molecular formula:
- C3H8O4S.Na
- IUPAC Name:
- sodium 2-hydroxypropane-2-sulphonate
- Details on test material:
- - Name of test substance: Natrium-2-hydroxypropan-2-sulfonat
- CAS No.: 540-92-1
- Batch No.: 13./14.01.2001
- Date of manufacturing: Jan. 13/14, 2001
- Physical state/appearance: Liquid/colorless-clear
- Degree of purity/content: The degree of purity of the test substance was found to be 13 g/100 g. The content of water was found to be 87.2 g/100 g.
- Homogeneity: The test substance was homogeneous by visual inspection.
- Stability: The stability of the test substance has not been determined by reanalysis, because the study and the characterization were performed in the same time period.
- Storage conditions: Room temperature, exclusion of oxygen (storage under nitrogen)
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan-Winkelmann GmbH, Borchen, FRG
- Age at study initiation: About 8 months
- Weight at study initiation: 3.80 - 3.92 kg
- Housing: Single housing in wire mesh cages with grating, floor area 3000 cm²
- Diet: Kliba-Labordiät, Provimi Kliba SA, Kaiseraugst, Switzerland (about 130 g/animal per day)
- Water: Tap water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin of same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 ml
- Concentration: undiluted - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: Upper third of the back or flanks, area of 2.5 cm x 2.5 cm
- Type of wrap if used: The test substance was covered with a test patch (Idealbinde, Pfälzische Verbandstoff-Fabrik, Kaiserslautern) and Fixomull stretch (adhesive fleece; Beiersdorf AG)
REMOVAL OF TEST SUBSTANCE
- Washing: with Lutrol and Lutrol/water (1:1).
- Time after start of exposure: 4 hours
SCORING SYSTEM: according to OECD guideline
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- Slight erythema (grade 1) was observed in all animals on the day of application and persisted only in 1 animal up to day 1. No edema was noted. The cutaneous reactions were reversible in all animals within 48 hours after removal of the patch at latest. Mean scores over 24, 48 and 72 hours for each animal were 0.3, 0.0 and 0.0 for erythema and 0.0, 0.0 and 0.0 for edema.
Any other information on results incl. tables
Individual cutaneous examinations and mean values:
Readings |
Animal |
Exposure period: 4 h |
|
Erythema |
Edema |
||
1 h |
01 |
1 |
0 |
02 |
1 |
0 |
|
03 |
1 |
0 |
|
24 h |
01 |
1 |
0 |
02 |
0 |
0 |
|
03 |
0 |
0 |
|
48 h |
01 |
0 |
0 |
02 |
0 |
0 |
|
03 |
0 |
0 |
|
72 h |
01 |
0 |
0 |
02 |
0 |
0 |
|
03 |
0 |
0 |
|
Mean (24, 48, 72 h) |
01 |
0.3 |
0.0 |
02 |
0.0 |
0.0 |
|
03 |
0.0 |
0.0 |
|
Mean (24, 48, 72 h) |
|
0.1 |
0.0 |
Applicant's summary and conclusion
- Conclusions:
- Natrium-2-hydroxypropan-2-sulfonat does not give indication of an irritant property to the skin under the test conditions chosen.
- Executive summary:
The potential of Natrium-2-hydroxypropan-2-sulfonat to cause acute dermal irritation or corrosion was assessed by a single topical application of 0.5 ml of the test substance to the intact skin of 3 White New Zealand rabbits for 4 hours under semiocclusive dressing. After removal of the patch the application area was washed off. The cutaneous reactions were assessed approximately 1, 24, 48 and 72 hours after removal of the patch. Slight erythema was observed in all animals on the day of application. No edema was observed. The cutaneous reactions were reversible in all animals within 48 hours after removal of the patch at latest.
The average score (24 to 72 hours) for irritation was calculated to be 0.1 for erythema and 0.0 for edema. Considering the described cutaneous reactions as well as the average score for irritation, Natrium-2-hydroxypropan-2-sulfonat does not give indication of an irritant property to the skin under the test conditions chosen.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.