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EC number: 244-169-0 | CAS number: 21049-70-7
- 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: Acceptable non-GLP study, comparable to guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not applicable
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- Before OECD Guideline 404 was first adopted in 1981, skin irritation was tested using a BASF test.
The methods were based on Draize (Federal Register 38, No. 187, § 1500.41, p. 27019 (1973-09-27)). - GLP compliance:
- no
Test material
- Reference substance name:
- 2-(methylamino)ethanol, compound with sulphur dioxide
- EC Number:
- 244-169-0
- EC Name:
- 2-(methylamino)ethanol, compound with sulphur dioxide
- Cas Number:
- 21049-70-7
- Molecular formula:
- C3H9NO.xO2S
- IUPAC Name:
- (oxo-λ⁴-sulfanylidene)oxidane; 2-(methylamino)ethan-1-ol
- Details on test material:
- - Name of test material: Kauramin-Härter CE 5162 flüssig; N-Methyläthanolammonium(-hydrogen) sulfit in Wasser (German)
- Physical state: liquid
- Composition of test material, percentage of components: N-Methylethanolamine: 49.4 %, Sulfur dioxide: 29.5 %, Water: 21.1 %
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: albino (no further specification provided)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: adult (based on body weight)
- Weight at study initiation: 3-4 kg
- Housing: stainless steel cage without bedding material
- Diet: standard pelleted feed for rabbits, ad libitum
- Water: ad libitum
- Acclimation period: more than 3 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 1 °C
- Humidity: 55 ± 10 %
- Photoperiod: 12 hours dark / 12 hours light
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: intact and abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin served as negative control site
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 7 days
- Number of animals:
- 6 rabbits
- Details on study design:
- TEST SITE
- Area of exposure: on upper third of the back (2.5 × 2.5 cm²), intact skin: right side, abraded skin: left side
- Type of wrap if used: gauze (double layer) with elastic dressing, wrapped in PVC foil
SCORING SYSTEM:
Scoring was performed according to Draize (1959). The skin reactions were scored after 24 and 72 hours and after 7 days.
An irritation index was calculated by dividing the sum of the group mean scores for erythema and edema by the number of readings.
The derived irritation index was evaluated as follows:
Index intervals 0 -0.5: no irritant, 0.6 -3.0: weak irritant, 3.1 -5.0: moderate irritant, 5.1 -8.0: strong irritant.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- (24-hour exposure)
- Basis:
- mean
- Remarks:
- (animal #1)
- Time point:
- other: 24/72 hours
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: tested on intact skin
- Irritation parameter:
- erythema score
- Remarks:
- (24-hour exposure)
- Basis:
- mean
- Remarks:
- (animal #2)
- Time point:
- other: 24/72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: tested on intact skin
- Irritation parameter:
- erythema score
- Remarks:
- (24-hour exposure)
- Basis:
- mean
- Remarks:
- (animal #3)
- Time point:
- other: 24/72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: tested on intact skin
- Irritation parameter:
- erythema score
- Remarks:
- (24-hour exposure)
- Basis:
- mean
- Remarks:
- (animal #4)
- Time point:
- other: 24/72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: tested on intact skin
- Irritation parameter:
- erythema score
- Remarks:
- (24-hour exposure)
- Basis:
- mean
- Remarks:
- (animal #5)
- Time point:
- other: 24/72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: tested on intact skin
- Irritation parameter:
- erythema score
- Remarks:
- (24-hour exposure)
- Basis:
- mean
- Remarks:
- (animal #6)
- Time point:
- other: 24/72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: tested on intact skin
- Irritation parameter:
- edema score
- Remarks:
- (24-hour exposure)
- Basis:
- mean
- Remarks:
- (all animals)
- Time point:
- other: 24/72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: tested on intact skin
- Irritant / corrosive response data:
- Test on intact skin, 24-hour application (key information):
The key results are summarised in the irritation/corrosion results table (see above).
The mean erythema score was ≤ 1 in 6/6 rabbits. No erythema (24/72 hours) was seen in 2/6 rabbits. Findings were fully reversibe in the remaining 4/6 rabbits within the observation period of 7 days.
There were no edema (24/72 hours).
Test on abraded (scarified skin), 24-hour application (supporting information):
The mean erythema score (24/72 hours) was 1 in 1/6 rabbits and 1.5 in the remaining 5/6 rabbits. At the 72-hour reading, slightly hardened scarified skin was observed in 3/6 rabbits. After 7 days, there was sore at the application site of 4/6 rabbits.
No edema were seen in 2/6 rabbits (24/72 hours). The mean edema score (24/72 hours) was 0.5 and 1 in each 1/6 rabbits and 1.5 in the remaining 2/6 rabbits. - Other effects:
- At study termination, macroscopic examination of the application sites (intact and scarified skin) revealed no lesions of the hypodermal connective tissues and/or the subjacent musculature.
Any other information on results incl. tables
A primary irritation score of 1.38 was calculated (under consideration of the test results for intact plus abraded skin ). The test item was considered to be a weak irritant based on this score.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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