Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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: 244-169-0 | CAS number: 21049-70-7
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
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.
