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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: scientifically acceptable study report

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Principles of method if other than guideline:
according to Fed. Reg. 38, No. 187, § 1500.41, 1973
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Potassium N,N-dimethylglycinate
EC Number:
241-629-2
EC Name:
Potassium N,N-dimethylglycinate
Cas Number:
17647-86-8
Molecular formula:
C4H8NO2.K
IUPAC Name:
potassium 2-(dimethylamino)acetate

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
The animals were offered a standardized animal laboratory diet

Test system

Type of coverage:
occlusive
Preparation of test site:
other: intact and abraded skin
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin served as control
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
24 hours
Observation period:
8 days
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm

REMOVAL OF TEST SUBSTANCE
The substance was not washed off after application

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24, 72 h
Score:
1.5
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: Skin scales formation after 72 h to the end of the observation periode (8 days)
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: Skin scales formation after 72 h to the end of the observation periode (8 days)
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Skin scales formation at the end of the observation periode (8 days)
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
other: 24, 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Skin scales formation after 72 h to the end of the observation periode (8 days)
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
other: 24, 72 h
Score:
2.5
Max. score:
4
Reversibility:
fully reversible within: within 8 days
Remarks on result:
other: Skin scales formation after 72 h to the end of the observation periode (8 days)
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
other: 24, 72 h
Score:
1.5
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: Skin scales formation after 72 h to the end of the observation periode (8 days)
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24, 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24, 72 h
Score:
1.5
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24, 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
animal #4
Time point:
other: 24, 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #5
Time point:
other: 24, 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
animal #6
Time point:
other: 24, 72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 72 h
Score:
3.75
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: abraded skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 72 h
Score:
1.85
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: abraded skin
Irritant / corrosive response data:
All animals showed slight erythema after treatment. Four out of six animals developed slight edema. After 8 days (intact skin) all animals showed scaling of the skin but no erythema or edema.
Other effects:
The skin findings were pathologically confirmed.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU