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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
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:
2-hydroxyethylammonium chloride
EC Number:
217-900-6
EC Name:
2-hydroxyethylammonium chloride
Cas Number:
2002-24-6
IUPAC Name:
2-hydroxyethanaminium chloride
Details on test material:
- Name of test material: Härter 421 flüssig; Äthanolaminhydrochlorid 45 % (German)
- Physical state: liquid

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 and abraded
Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
5 minutes, 2 hours
20 hours
Observation period:
8 days
Number of animals:
2 rabbits (5 minutes, 2 hours)
6 rabbits (20 hours)
Details on study design:
TEST SITE
- Area of exposure: back (2.5 cm x 2.5 cm)

REMOVAL OF TEST SUBSTANCE
- Washing: yes
- Time after start of exposure: 24 hours

SCORING SYSTEM
OECD Draize scores.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
(20-hour exposure)
Basis:
mean
Remarks:
(animal #1)
Time point:
other: 24/48/72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: tested on intact skin
Irritation parameter:
erythema score
Remarks:
(20-hour exposure)
Basis:
mean
Remarks:
(animal #2)
Time point:
other: 24/48/72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: tested on intact skin
Irritation parameter:
erythema score
Remarks:
(20-hour exposure)
Basis:
mean
Remarks:
(animal #3)
Time point:
other: 24/48/72 hours
Score:
1.5
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: tested on intact skin
Irritation parameter:
erythema score
Remarks:
(20-hour exposure)
Basis:
mean
Remarks:
(animal #4)
Time point:
other: 24/48/72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: tested on intact skin
Irritation parameter:
erythema score
Remarks:
(20-hour exposure)
Basis:
mean
Remarks:
(animal #5)
Time point:
other: 24/48/72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: tested on intact skin
Irritation parameter:
erythema score
Remarks:
(20-hour exposure)
Basis:
mean
Remarks:
(animal #6)
Time point:
other: 24/48/72 hours
Score:
2
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 #1)
Time point:
other: 24/48/72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: tested on intact skin
Irritation parameter:
edema score
Remarks:
(20-hour exposure)
Basis:
mean
Remarks:
(animal #2)
Time point:
other: 24/48/72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: tested on intact skin
Irritation parameter:
edema score
Remarks:
(20-hour exposure)
Basis:
mean
Remarks:
(animal #3)
Time point:
other: 24/48/72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: tested on intact skin
Irritation parameter:
edema score
Remarks:
(20-hour exposure)
Basis:
mean
Remarks:
animal #4
Time point:
other: 24/48/72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: tested on intact skin
Irritation parameter:
edema score
Remarks:
(20-hour exposure)
Basis:
mean
Remarks:
(animal #5)
Time point:
other: 24/48/72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: tested on intact skin
Irritation parameter:
edema score
Remarks:
(20-hour exposure)
Basis:
mean
Remarks:
(animal #6)
Time point:
other: 24/48/72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
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 (24/48/72 hours) for the 6 rabbits ranged from 1 to 2. Findings were fully reversibe in 5/6 rabbits within 72 hours and in 1/6 rabbits within the observation period of 8 days.
The mean edema score (24/48/72 hours) for the 6 rabbits was 1. Findings were fully reversible within 72 hours.

Test on abraded (scarified) skin, 20- or 24-hour application (supporting information):
The mean erythema score (24/48/72 hours) for the 6 rabbits was 2.8. The erythema seen in all animals were not reversible within the 8-day observation period. On day 8, necroses indicative of strong irritancy were seen in 4/6 rabbits and scaling was noted in the 2 remaining rabbits.
The mean edema score (24/48/72 hours) for the 6 rabbits was 2.0. Edema were fully reversible in 5/6 rabbits within 8 days, while the edema score for the remaining rabbit was 2 on day 8.

Short-term test (supporting information):
No findings were noted in 2/2 rabbits (24/48 hours and 8 days) following exposure for 5 min. Exposure for 2 hours resulted in a mean erythema score of 0.5 (score 1 at 24 hours, score 0 at 48 hours) and no edema in both rabbits. The findings were fully reversible within 48 hours.
Other effects:
Macroscopic examination revelaed yellow discolouration of fat tissue in one rabbit and the presence of parasites in the liver of another rabbit. The local clinical findings noted during the in-life period (necrosis, scaling) were confirmed for all animals.

Any other information on results incl. tables

A primary irritation score of 3.53 was calculated (under consideration of the test results for intact plus abraded skin). The test substance was considered to be a moderate 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