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EC number: 939-689-6 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
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- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
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- Water solubility
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- Endpoint summary
- Stability
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- 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
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- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
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- 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:
- 1 980
- Report date:
- 1980
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:
- Reaction mass of bis(2-hydroxyethanaminium) sulfite and 2-(methylamino)ethanol - oxosulfane oxide (1:1)
- IUPAC Name:
- Reaction mass of bis(2-hydroxyethanaminium) sulfite and 2-(methylamino)ethanol - oxosulfane oxide (1:1)
- Details on test material:
- - Name of test material: Kauramin-Härter CE 5196 flüssig; N-Methyläthanolammonium(-hydrogen) sulfit + Äthanolammonium(-hydrogen) sulfit in Wasser (German)
- Physical state: liquid
- Composition of test material, percentage of components: N-Methylethanolamine: 21 %, Ethanolamine: 24.6 %, Sulfur dioxide: 35 %, Water: 19.4 %
- Other: pH-neutral mixture
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- No data
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: intact abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: approximately 1 mL (not indicated in the report; standard volume used in the BASF test) - Duration of treatment / exposure:
- 5 minutes, 2 hours
20 hours - Observation period:
- 8 days
- Number of animals:
- 2 rabbits (5 minutes, 2 hours)
3 rabbits (20 hours) - Details on study design:
- TEST SITE
- Area of exposure: back (2.5 cm × 2.5 cm)
SCORING SYSTEM:
BASF scheme
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- (20-hour exposure)
- Basis:
- mean
- Remarks:
- (animal #1)
- Time point:
- other: 24/72 hours
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: superficial necrosis after 8 days; tested on intact skin
- Irritation parameter:
- erythema score
- Remarks:
- (20-hour exposure)
- Basis:
- mean
- Remarks:
- (animal #2)
- Time point:
- other: 24/72 hours
- Score:
- 2.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: scaling after 8 days; tested on intact skin
- Irritation parameter:
- erythema score
- Remarks:
- (20-hour exposure)
- Basis:
- mean
- Remarks:
- (animal #3)
- Time point:
- other: 24/72 hours
- Score:
- 3.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: scaling after 8 days; tested on intact skin
- Irritation parameter:
- edema score
- Remarks:
- (20-hour exposure)
- Basis:
- mean
- Remarks:
- (animal #1)
- Time point:
- other: 24/72 hours
- Score:
- 2.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: tested on intact skin
- Irritation parameter:
- edema score
- Remarks:
- (20-hour exposure)
- Basis:
- mean
- Remarks:
- (animal #2)
- Time point:
- other: 24/72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: tested on intact skin
- Irritation parameter:
- edema score
- Remarks:
- (20-hour exposure)
- Basis:
- mean
- Remarks:
- (animal #3)
- Time point:
- other: 24/72 hours
- Score:
- 2.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: tested on intact skin
- Irritant / corrosive response data:
- Test on intact skin, 20-hour application (key information):
The key results are summarised in the irritation/corrosion results table (see above).
The mean erythema score (24/72 hours) was ≥ 2.5 in 3/3 rabbits. Findings were not fully reversibe in 3/3 rabbits within the observation period of 8 days. At the end of the observation period, superficial necrosis, which in contrast to full thickness necrosis represents an indicator for strong irritancy, was noted in 1/3 rabbits and scaling was observed in 2/3 rabbits.
The mean edema score (24/72 hours) was 2.5 in 2/3 rabbits. Findings were not fully reversible in 1/3 rabbits.
Test on abraded (scarified skin), 20-hour application (supporting information):
The mean erythema score (24/72 hours) was 4 in 3/3 rabbits. Necroses indicative of strong irritancy were seen at the 24- and 72-hour readings and at the end of the 8-day observation period in all rabbits.
The mean edema score (24/72 hours) was ≥ 2.5 in 3/3 rabbits. The findings were not reversible within 8 days.
Short-term test (supporting information):
No findings were noted in 2/2 rabbits (24/48 hours) following exposure for 5 min. Exposure for 2 hours resulted in a mean erythema score of 0.5 and no edema in one rabbit, and in a mean erythema score of 2 and a mean edema score of 0.5 in the remaining rabbit. These findings were fully reversible within 8 days.
- Other effects:
- None
Any other information on results incl. tables
A primary irritation score of 5.8 was calculated (under consideration of the test results for intact plus abraded skin). The test item was considered to be a moderate irritant based on this score.
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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