Registration Dossier

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: Comparable to guideline study. Irreversible skin damage was observed following 4-hr exposure in 2/2 animals, therefore the short observation period (8 days) is in line with the provisions of OECD TG 404.

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
no 72 h reading
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-(2-aminoethylamino)ethanol
EC Number:
203-867-5
EC Name:
2-(2-aminoethylamino)ethanol
Cas Number:
111-41-1
Molecular formula:
C4H12N2O
IUPAC Name:
2-[(2-aminoethyl)amino]ethan-1-ol
Details on test material:
AEEA (substance 77/715), degree of purity 99 %

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: M. GAUCKLER, 6050 Offenbach, Germany
- Weight at study initiation: mean bw was 3.0 kg
- Diet: Ssniff K standard diet, Intermast GmbH Soest, Germany, ad libitum:
- Water: tap water ad libitum

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount applied : 0.5 mL of the neat test substance was applied to the intact dorsal skin, clipped 24 h before treatment
- Concentration: undiluted
Duration of treatment / exposure:
1 hour (4 animals), 4 hours (2 animals)
Observation period:
8 days
Number of animals:
6 male and female rabbits
Details on study design:
TEST SITE
- Area of exposure: 4 cm²
- coverage: 100 %
- Type of wrap if used: rubberbacked linen cloth


REMOVAL OF TEST SUBSTANCE
- Washing: At the end of the exposure period excess AEEA was removed and the skin was rinsed with lutrol or a mixiture of water/lutrol (1:1) and dried  with pulp
- Skin reactions were examined and scored immediately after patch removal, and 1, 2, and 8 days thereafter


SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
(4 h exposure)
Basis:
animal #1
Time point:
other: 4, 24, 48 hours
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks:
necrosis developed after 4 hours and was not reversible within 8 days
Remarks on result:
other: 4 h exposure
Irritation parameter:
erythema score
Remarks:
(4 h exposure)
Basis:
animal #2
Time point:
other: 4, 24, 48 hours
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks:
necrosis developed after 8 days
Remarks on result:
other: 4 h exposure
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 4, 24, 48 hours
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks:
necrosis develpoed in both animals
Remarks on result:
other: 4 h exposure
Irritation parameter:
edema score
Remarks:
(4 h exposure)
Basis:
animal #1
Time point:
other: 4, 24, 48 hours
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: 4 h exposure
Irritation parameter:
edema score
Remarks:
(4 h exposure)
Basis:
animal #2
Time point:
other: 4, 24, 48 hours
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: 4 h exposure
Irritation parameter:
edema score
Remarks:
(4 h exposure)
Basis:
mean
Time point:
other: 4, 24, 48 hours
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: 4 h exposure
Irritation parameter:
erythema score
Remarks:
(1 h exposure)
Basis:
animal #1
Time point:
other: 1, 24, 48 hours
Score:
3.67
Max. score:
4
Reversibility:
not reversible
Remarks:
necrosis developed within 1 day
Remarks on result:
other: 1 h exposure
Irritation parameter:
erythema score
Remarks:
(1 h exposure)
Basis:
animal #2
Time point:
other: 1, 24, 48 hours
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: 1 h exposure
Irritation parameter:
erythema score
Remarks:
(1 h exposure)
Basis:
animal #3
Time point:
other: 1, 24, 48 hours
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 days, scales developed within 8 days
Remarks on result:
other: 1 h exposure
Irritation parameter:
erythema score
Remarks:
(1 h exposure)
Basis:
animal #4
Time point:
other: 1, 24, 48 hours
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 1 day
Remarks on result:
other: 1 h exposure
Irritation parameter:
erythema score
Remarks:
(1 h exposure)
Basis:
mean
Time point:
other: 1, 24, 48 hours
Score:
2.09
Max. score:
4
Remarks on result:
other: 1 h exposure
Irritation parameter:
edema score
Remarks:
(1 h exposure)
Basis:
animal #1
Time point:
other: 1, 24, 48 hours
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: 1 h exposure
Irritation parameter:
edema score
Remarks:
(1 h exposure)
Basis:
animal #2
Time point:
other: 1, 24, 48 hours
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: 1 h exposure
Irritation parameter:
edema score
Remarks:
(1 h exposure)
Basis:
animal #3
Time point:
other: 1, 24, 48 hours
Score:
1.33
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: 1 h exposure
Irritation parameter:
edema score
Remarks:
(1 h exposure)
Basis:
animal #4
Time point:
other: 1, 24, 48 hours
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 1 day
Remarks on result:
other: 1 h exposure
Irritation parameter:
edema score
Remarks:
(1 h exposure)
Basis:
mean
Time point:
other: 1, 24, 48 hours
Score:
1.33
Max. score:
4
Remarks on result:
other: 1 h exposure

Any other information on results incl. tables

Necroses (full thickness) were confirmed by pathological examination of the skin after terminal sacrifice.
No signs of systemic toxicity were noted following either treatment.

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information
Executive summary:

In a dermal irritation study (BASF AG, Department of Toxicology, 1979) six Vienna White rabbits were dermally exposed to undiluted AEEA. The test site (intact dorsal skin) was covered with an occlusive dressing for 1 or 4 hours. Rabbits then were observed for 8 days. Irritations regarding erythema, edema and necrosis were scored and converted into the presently used numerical grading system according to the OECD system. AEEA exhibited a corrosive potential in this study, since the development of necrosis, which were not reversible within 8 days, were noted in both the 1-hour exposure group (1/4 animals) and the 4-hours exposure group (1/2 animals).

 

Mean scores 1-hour exposure (4 animals):

Erythema:        2.09 of max. 4

Edema:            1.33 of max. 4

 

Mean scores 4-hour exposure (2 animals):

Erythema:        3.00 of max. 4

Edema:           2.00 of max. 4