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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
Endpoint summary
Administrative data
Description of key information
skin: not irritating
eye: not irritating
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- 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 - 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 - 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.
- 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.
Reference
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 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye 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
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan-Winkelmann GmbH, Borchen, FRG
- Age at study initiation: About 8 months
- Weight at study initiation: 3.86 - 3.99 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 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 ml
- Concentration: undiluted - Duration of treatment / exposure:
- The substance was washed out with tap water about 24 hours after application (before 24 hours reading).
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3 (2 females, 1 male)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: with tap water
- Time after start of exposure: 24 hours
SCORING SYSTEM: according to OECD gudeline - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- Slight conjunctival redness (grade 1) was observed in 1 animal only 24 hours after application. No other ocular findings were noted. The ocular reaction was reversible in the animal within 48 hours after application. Mean scores calculated for each animal over 24, 48 and 72 hours were 0.0, 0.0 and 0.0 for corneal opacity, iris lesions and chemosis and 0.0, 0.0 and 0.3 for redness of the conjunctiva.
- Conclusions:
- Natrium-2-hydroxypropan-2-sulfonat does not give indication of an irritant property to the eye under the test conditions chosen.
- Executive summary:
The potential of Natrium-2-hydroxypropan-2-sulfonat to cause damage to the conjunctiva, iris or cornea was assessed in 3 White New Zealand rabbits, subjected to a single ocular application of 0.1 ml of the test substance. About 24 hours after application the eye was rinsed with tap water. The ocular reactions were assessed approximately 1, 24, 48 and 72 hours after application. Slight conjunctival redness was observed in 1 animal only 24 hours after application. No other ocular findings were noted. The ocular reaction was reversible in the animal within 48 hours after application. The average score (24 to 72 hours) for irritation was calculated to be 0.0 for corneal opacity, iris and chemosis and 0.1 for conjunctival redness. Considering the described ocular reaction as well as the average score for irritation, Natrium-2-hydroxypropan-2-sulfonat does not give indication of an irritant property to the eye under the test conditions chosen.
Reference
Individual ocular examinations and mean values (24, 48, 72 hours):
Readings |
Animal |
Cornea |
Iris |
Conjunctiva |
|||
Opacity |
Area of cornea involved |
Redness |
Chemosis |
Discharge |
|||
1 h |
01 |
0 |
0 |
0 |
0 |
0 |
0 |
02 |
0 |
0 |
0 |
0 |
0 |
0 |
|
03 |
0 |
0 |
0 |
0 |
0 |
0 |
|
24 h |
01 |
0 |
0 |
0 |
0 |
0 |
0 |
02 |
0 |
0 |
0 |
0 |
0 |
0 |
|
03 |
0 |
0 |
0 |
1 |
0 |
0 |
|
48 h |
01 |
0 |
0 |
0 |
0 |
0 |
0 |
02 |
0 |
0 |
0 |
0 |
0 |
0 |
|
03 |
0 |
0 |
0 |
0 |
0 |
0 |
|
72 h |
01 |
0 |
0 |
0 |
0 |
0 |
0 |
02 |
0 |
0 |
0 |
0 |
0 |
0 |
|
03 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Mean |
01 |
0.0 |
|
0.0 |
0.0 |
0.0 |
|
02 |
0.0 |
|
0.0 |
0.0 |
0.0 |
|
|
03 |
0.0 |
|
0.0 |
0.3 |
0.0 |
|
|
Mean |
|
0.0 |
|
0.0 |
0.1 |
0.0 |
|
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
skin irritation:
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.
eye irritation:
The potential of Natrium-2-hydroxypropan-2-sulfonat to cause damage to the conjunctiva, iris or cornea was assessed in 3 White New Zealand rabbits, subjected to a single ocular application of 0.1 ml of the test substance. About 24 hours after application the eye was rinsed with tap water. The ocular reactions were assessed approximately 1, 24, 48 and 72 hours after application. Slight conjunctival redness was observed in 1 animal only 24 hours after application. No other ocular findings were noted. The ocular reaction was reversible in the animal within 48 hours after application. The average score (24 to 72 hours) for irritation was calculated to be 0.0 for corneal opacity, iris and chemosis and 0.1 for conjunctival redness. Considering the described ocular reaction as well as the average score for irritation, Natrium-2-hydroxypropan-2-sulfonat does not give indication of an irritant property to the eye under the test conditions chosen.
Justification for classification or non-classification
Based on the results, the test item is no subject to classification and labelling according to Regulation (EC) No 1272/2008 (CLP).
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.
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