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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:
other: Meets generally accepted scientific standards, well documented and acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1964
Report date:
1964

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
Method: BASF-Test: Animals were treated for 1, 5, 15 min and 20 hours using occlusive conditions. An application site of 2.5x2.5 cm was covered with the liquid test substance. After the application time (1, 5 and 15 min) the skin was washed with Lutrol (50%). The animals were observed for 8 days and skin changes were recorded daily. The report describes findings after 24 hours and at the end of the observation period (8 days). For a final evaluation, the findings after 48 h and 72 h from the raw data were taken into account.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
1-(dimethylamino)propan-2-ol
EC Number:
203-556-4
EC Name:
1-(dimethylamino)propan-2-ol
Cas Number:
108-16-7
Molecular formula:
C5H13NO
IUPAC Name:
1-(dimethylamino)propan-2-ol
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: ca. 2.32 kg

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): ca. 0.5 g
Duration of treatment / exposure:
1, 5 and 15 minutes and 20 hours
Observation period:
8 days
Number of animals:
2 per exposure duration
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm

REMOVAL OF TEST SUBSTANCE
Washing might have been done with Lutrol and Lutrol/Water (50%/50%) at the end of the treatment (1, 5 and 15 minutes, 20 hours)

SCORING SYSTEM:
Similar to the one described in OECD 404 guideline

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
1 min exposure
Basis:
mean
Time point:
other: 24 h - 8 d
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: redness and scaling
Irritation parameter:
erythema score
Remarks:
5 min exposure
Basis:
mean
Time point:
other: 24 h - 8 d
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: redness, necrosis and scaling
Irritation parameter:
erythema score
Remarks:
15 min exposure
Basis:
mean
Time point:
other: 24 h - 8 d
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: redness and severe necrosis
Irritation parameter:
erythema score
Remarks:
20 h exposure
Basis:
mean
Time point:
other: 24 h - 8 d
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: redness and severe necrosis
Irritation parameter:
edema score
Remarks:
1, 5, 15 min exposure
Basis:
mean
Time point:
other: 24 h - 8 d
Score:
0
Max. score:
4
Irritation parameter:
edema score
Remarks:
20 h exposure
Basis:
mean
Time point:
other: 24 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritant / corrosive response data:
Full thickness necrosis of the skin was observed in animals when exposed to the test substance for 20 hours under occlusive conditions. In addition full thickness necrosis was observed in rabbits at the end of the observation period (8 days) when exposed to the test substance for 5 or 15 minutes under occlusive conditions. Exposure for 1 minute did not lead to necrosis.

Applicant's summary and conclusion

Interpretation of results:
corrosive