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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
Study period:
1986
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:
1986
Report date:
1986

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
3-(dimethylamino)-N,N-dimethylpropionamide
EC Number:
241-304-5
EC Name:
3-(dimethylamino)-N,N-dimethylpropionamide
Cas Number:
17268-47-2
Molecular formula:
C7H16N2O
IUPAC Name:
3-(dimethylamino)-N,N-dimethylpropanamide
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
New Zealand White rabbits, weighing between 2.0 and 3.0 kg,
The animals are maintained on appropriate commercial diet and municipal water. Both are available ad libitum expect during periods of manipulation. Animal weights are recorded at 0 days (before dose), 7 days and 14 days (just prior sacrifice). At death or sacrifice, each animal is subjected to gross pathological evaluation.

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
0.5ml
Duration of treatment / exposure:
4 hours
Observation period:
14 days
Number of animals:
6
Details on study design:
Male or female New Zealand White rabbits are dosed with 0.5 ml (or 0.5 g for solids, moistened with water or other suitable vehicle). The dose is applied to the clipped, intact skin under a gauze patch and is loosely covered with impervious sheeting. Smaller amounts are given if 0.5 ml (or 0.5 g) is lethal. The test material is applied to each of 6 rabbits, which are restrained for the 4-hr contact period.

Excess sample is removed after contact. Skin reaction is scored, by the method of Draize, at one hour, one day, 2 days, 3 days, 7 days, and, depending on the local skin reaction, possibly 10 and 14 days after dosing.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
4
Max. score:
4
Reversibility:
not specified
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Score:
4
Max. score:
4
Reversibility:
not specified
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
3.2
Max. score:
4
Reversibility:
not specified
Irritation parameter:
erythema score
Basis:
mean
Time point:
14 d
Score:
0.3
Max. score:
1
Reversibility:
not specified
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
3.3
Max. score:
4
Reversibility:
not specified
Irritation parameter:
edema score
Basis:
mean
Time point:
48 h
Score:
3
Max. score:
3
Reversibility:
not specified
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
2.7
Max. score:
3
Reversibility:
not specified
Irritation parameter:
edema score
Basis:
mean
Time point:
21 d
Score:
1.2
Max. score:
2
Reversibility:
not specified

Applicant's summary and conclusion

Interpretation of results:
Category 1 (corrosive) based on GHS criteria
Conclusions:
Skin Irritation, Rabbit (4-hr occluded)
Severe erythema, moderate to severe edema, necrosis on 6 of 6 rabbits from 0.5 ml; ulceration, scabs also apparent; irritation persisted through 14 days. Corrosive to skin.