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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:
1978
Report date:
1978

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:
BASF-Test: Corrosion-Test (3 min and 1 hour exposure); 2 animals were treated for 3 minute and 2 other animals for 1 hour using occlusive conditions. An application site of 2 x 2 cm was covered with the liquid test substance (0.5 ml). After the application time, the skin was washed with lutrol (conc.) or Lutrol/water (1:1). The animals were observerd for 8 days and skin changes were recorded daily.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Dibutylamine
EC Number:
203-921-8
EC Name:
Dibutylamine
Cas Number:
111-92-2
Molecular formula:
C8H19N
IUPAC Name:
N-butylbutan-1-amine
Details on test material:
Di-n-butylamine

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Gaukler M., Offenbach, Germany
- Weight at study initiation: 1 hour-test: 3.2 kg (mean); 3 minute-test: 2.8 kg (mean)
- Diet: Sniff standard diet for rabbits and guinea pigs, supplied by INTERMAST GmbH, Soest, Germany, ad libitum
- Water ad libitum

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: Untreated skin site of the same animals served as control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml

Duration of treatment / exposure:
3 min, 1 hour
Observation period:
8 days
Number of animals:
1 male and 1 female
Details on study design:
TEST SITE
- Area of exposure: 2 x 2 cm
- Type of wrap if used: rubberized linen


REMOVAL OF TEST SUBSTANCE
- Washing (if done): the test substance was removed at the end of the exposure period with Lutrol and Lutrol/water (1:1)
- Time after start of exposure: 3 minutes, 1 hour

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
, 3 min exposure
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Remarks:
, 1 h expsoure
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Remarks:
, 3 min exposure
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
2
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
edema score
Remarks:
, 1 h exposure
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
2
Max. score:
2
Reversibility:
not reversible

Any other information on results incl. tables

Mean erythema score after 24 h, 48 h and 72 h (animal1/2):

 Exposure time  24 h  48 h  72 h mean
 3 min 4/4 4/4 4/4 4/4  
 1 h 4/4 4/4 4/4 4/4    

Mean edema score after after 24 h, 48 h and 72 h (animal1/2):

 Exposure time  24 h  48 h  72 h mean
 3 min 2/2 2/2 2/2 2/2    
 1 h 2/2 2/2 2/2 2/2    

The 3 min and 1 h exposure caused severe erythema and slight to moderate edema. After 24 h necrosis was observed. At the end of the observation period of 8 days leathery necrosis was observed. Leathery like necrosis is considered as a full thickness necrosis.

Applicant's summary and conclusion

Interpretation of results:
Category 1B (corrosive) based on GHS criteria
Conclusions:
3 min and 1 h exposure caused severe erythema and slight to moderate edema. After 24 h necrosis was observed. At the end of the observation period of 8 days leathery necrosis was observed. Leathery like necrosis is considered as a full thickness necrosis.
Executive summary:

In a skin irritation study, Vienna White rabbits were treated with the undiluted test substance. 2 animals were treated for 3 minutes and 2 other animals for 1 hour using occlusive conditions. An application site of 2 x 2 cm was covered with the liquid test substance (0.5 ml). After the application time, the skin was washed with lutrol (conc.) or Lutrol/water (1:1). The animals were observerd for 8 days and skin changes were recorded daily. 3 minutes as well as 1 hour of exposure caused severe erythema and slight to moderate edema. After 24 h necrosis was observed. At the end of the observation period of 8 days full thickness necrosis was observed.