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Toxicological information

Skin irritation / corrosion

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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:
1980
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

Constituent 1
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

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