Tripropylamine

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:

other: Acceptable well-documented report which meets basic scientific principles (72 hour reading time point is missing).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Method: BASF-Test: Two animals were treated for 1, 5, 15 min or 20 h using occlusive conditions. An application site of 2.5x2.5 cm was covered with the liquid test substance. After the application time the skin was washed with Lutrol (conc.) and Lutrol/water (1:1). The animals were observed for 8 days and skin changes were recorded daily. The report describes findings after 24 and 48 hours and at the end of the observation period (8 days).

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Tripropylamine

EC Number:

203-047-7

EC Name:

Tripropylamine

Cas Number:

102-69-2

Molecular formula:

C9H21N

IUPAC Name:

tripropylamine

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): Tri-n-propylamine
- Physical state: liquid
- Analytical purity: >= 98 %

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 3.0 and 3.15 kg

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin sites of the same animal served as control

Duration of treatment / exposure:

1, 5, 15 min and 20 h

Observation period:

24 h, 48 h, 8 days

Number of animals:

2

Details on study design:

TEST SITE
- Area of exposure: back: 2.5 x 2.5 cm

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with Lutrol (conc.) and Lutrol/water (1:1)
- Time after start of exposure: after the exposure time: 1, 5, 15 min

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

20 h exposure

Basis:

mean

Time point:

other: 24, 48 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 8 days

Remarks on result:

other: 72 hour reading point missing, leathery necrosis after 8 days

Results 2

Irritation parameter:

edema score

Remarks:

20 h exposure

Basis:

mean

Time point:

other: 24, 48 h

Score:

2.5

Max. score:

4

Reversibility:

fully reversible within: 8 days

Irritant / corrosive response data:

Exposure to the substance for 15 minutes resulted in one animal in a leathery necrosis which was not reversible within 8 days. A 20-hour exposure resulted in both tested animals in leathery necrosis which was not reversible within 8 days.

Any other information on results incl. tables

Detailed results:

			Duration of treatment
Animal	Reading after		1 min	5 min	15 min	20 hours
1	24 hours	Erythema	1	1	4	2
		Edema	0	1	2	2
		other	Spotted	-		Partly grey necrosis
	48 hours	Erythema	0	1	2	2
		Edema	0	1	1	2
		other		spotted		Partly necrosis
	8 days	Erythema	0	0	0	0
		Edema	0	0	0	0
		other		Slight scaling	marked scaling (parchmenty)	Leathery necrosis, surrounding: slight scaling
2	24 hours	Erythema	1	2	3	2
		Edema	1	2	2	3
		Other				Grey soft necrosis
	48 hours	Erythema	1	2	2	2
		Edema	0	2	1	3
		Other	spotted			Partly parchmenty necrosis
	8 days	Erythema	0	0	0	0
		Edema	0	0	0	0
		Other	scaling	marked scaling (parchmenty)	Leathery necrosis	Comprehensive leathery necrosis

Applicant's summary and conclusion

Interpretation of results:

corrosive

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Exposure of skin of rabbits to tripropylamine for 15 minutes resulted in necrosis which was not reversible within 8 days.

Executive summary:

The skin irritation potential of tripropylamine was determined in a test according to an internal BASF method. Two animals (Vienna White rabbits) were treated with the test substance for 1, 5, 15 min or 20 h using occlusive conditions. An application site of 2.5 x 2.5 cm was covered with the liquid test substance. After the application time the skin was washed with Lutrol (conc.) and Lutrol/water (1:1). The animals were observed for 8 days and skin changes were recorded daily. The report describes findings after 24 and 48 hours and at the end of the observation period (8 days). The 1 -min and 5 -min exposure of the animal skin to tripropylamine resulted in skin reactions which were fully reversible within 8 days. Exposure to the substance for 15 minutes resulted in one animal in a leathery necrosis which was not reversible within 8 days. A 20-hour exposure resulted in both tested animals in leathery necrosis which was not reversible within 8 days.