Dibutylamine

Skin irritation / corrosion

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

Test material information

Constituent 1

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

Results

Results 1

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

Results 2

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

Results 3

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

Results 4

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.