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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:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
2-amino-2-ethylpropanediol
EC Number:
204-101-2
EC Name:
2-amino-2-ethylpropanediol
Cas Number:
115-70-8
Molecular formula:
C5H13NO2
IUPAC Name:
2-amino-2-ethylpropanediol
Constituent 2
Reference substance name:
2-Amino-2-ethyl-1,3-propanediol
IUPAC Name:
2-Amino-2-ethyl-1,3-propanediol
Details on test material:
AEPD (P-1050)
Liquid
Specific details on test material used for the study:
- Lot No. NPP-41344
- Purity: 85.34%
- By-products
- Methanol: 1.48%
- Monomethyl amino butanol: 10.92%
- Water: 1.89%

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Animals purchased at least 1 week prior to study and allowed to acclimatise. Healthy animlas free of disease were selected for the study. 24 hours prior to test, animals examined for skin injury. Those with no injury were used in test. Animals were fed Purina Certified Rabbit Chow, ad libitum, certified free of contaminants by supplier. Animals were given tap water ad libitum. Water was tested to ensure levels of contaminants are equivalent to or less than recommended levels as per the primary drinking water regulations.

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
4 hours
Observation period:
up to 48 hours following treatment initiation
Number of animals:
6
Details on study design:
The skin corrosion test was carried out in six albino rabbits weighing 2.4 +/- c0.2 kg. The backs were shaved free of hair. A 0.5 m l of liquid t e s t material was applied on the back of each rabbit and the treated skin site was covered with a gauze and a "Dermicel" tape. The animal trunk was then loosely wrapped with an impervious rubberized cloth and a flexible stainless steel protective screen held in place by tape. Following a 4-hour exposure period, the patches were removed and the treated skin sites were gently cleaned. The sites were visually evaluated for erythema, edema, and tissue destruction at 4, 24, and 48 hours after exposure.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 4 hours
Score:
0
Max. score:
0
Reversibility:
other: no skin effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
0
Max. score:
0
Reversibility:
other: no skin effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
48 h
Score:
0
Max. score:
0
Reversibility:
other: no skin effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 4 hours
Score:
0
Max. score:
0
Reversibility:
other: no skin effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24 h
Score:
0
Max. score:
0
Reversibility:
other: no skin effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
48 h
Score:
0
Max. score:
0
Reversibility:
other: no skin effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 4 hours
Score:
0
Max. score:
0
Reversibility:
other: no skin effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
48 h
Score:
0
Max. score:
0
Reversibility:
other: no skin effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
other: 4 hours
Score:
0
Max. score:
0
Reversibility:
other: no skin effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24 h
Score:
0
Max. score:
0
Reversibility:
other: n skin effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
48 h
Score:
0
Max. score:
0
Reversibility:
other: no skin effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
other: 4 hours
Score:
0
Max. score:
0
Reversibility:
other: no skin effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24 h
Score:
0
Max. score:
0
Reversibility:
other: no skin effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
48 h
Score:
0
Max. score:
0
Reversibility:
other: no skin effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
other: 4 hours
Score:
0
Max. score:
0
Reversibility:
other: no skin effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24 h
Score:
0
Max. score:
0
Reversibility:
other: no skin effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
48 h
Score:
0
Max. score:
0
Reversibility:
other: no skin effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 4 hours
Score:
0
Max. score:
0
Reversibility:
other: no skin effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24 h
Score:
0
Max. score:
0
Reversibility:
other: no skin effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
48 h
Score:
0
Max. score:
0
Reversibility:
other: no skin effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 4 hours
Score:
0
Max. score:
0
Reversibility:
other: no skin effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24 h
Score:
0
Max. score:
0
Reversibility:
other: no skin effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
48 h
Score:
0
Max. score:
0
Reversibility:
other: no skin effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 4 hours
Score:
0
Max. score:
0
Reversibility:
other: no skin effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24 h
Score:
0
Max. score:
0
Reversibility:
other: no skin effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
48 h
Score:
0
Max. score:
0
Reversibility:
other: no skin effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
animal #4
Time point:
other: 4 hours
Score:
0
Max. score:
0
Reversibility:
other: no skin effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24 h
Score:
0
Max. score:
0
Reversibility:
other: no skin effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #4
Time point:
48 h
Score:
0
Max. score:
0
Reversibility:
other: no skin effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #4
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
animal #5
Time point:
other: 4 hours
Score:
0
Max. score:
0
Reversibility:
other: no skin effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24 h
Score:
0
Max. score:
0
Reversibility:
other: no skin effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #5
Time point:
48 h
Score:
0
Max. score:
0
Reversibility:
other: no skin effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #5
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
animal #6
Time point:
other: 4 hours
Score:
0
Max. score:
0
Reversibility:
other: no skin effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24 h
Score:
0
Max. score:
0
Reversibility:
other: no skin effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #6
Time point:
48 h
Score:
0
Max. score:
0
Reversibility:
other: no skin effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #6
Time point:
72 h
Remarks on result:
not measured/tested
Irritant / corrosive response data:
There was no erythema or edema in any of the rabbits at 4, 24, and 48 hours. The treated skin sites were normal and there was no tissue destruction. Nofurther recordings were made.

Any other information on results incl. tables

The liquid material applied easily on the skin. There was no erythema or edema in any of the rabbits at 4, 24, and 48 hours. The treated skin sites were normal and there was no tissue destruction.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
AEPD was tested for its skin corrosion and irritation potential in rabbits. It resulted in no skin damage; thus AEPD was found to be non-corrosive. There were also no signs of irritation and therefore it is not considered to be irritating.