Tributylamine

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1984

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted 12 May 1981

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Tributylamine

EC Number:

203-058-7

EC Name:

Tributylamine

Cas Number:

102-82-9

Molecular formula:

C12H27N

IUPAC Name:

tributylamine

Test material form:

liquid

Details on test material:

- Name of test material (as cited in study report): Tri-n-butylamin
- purity: about 98.5%

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Gaukler, Offenbach/Main, Germany
- Age at study initiation: no data
- Weight at study initiation: male: 2.89 kg, mean weight females: 2.96 kg
- Housing: individually
- Diet: KLIBA 341 (Klingentalmühle AG, Kaiseraugst, Switzerland), ca. 130 g/animal/day
- Water: tap water, ca. 250 mL/animal/day
- Acclimation period: at least 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin of the same animals

Amount / concentration applied:

undiluted; 0.5 ml test substance

Duration of treatment / exposure:

4 h

Observation period:

8 days

Number of animals:

3 (1 male, 2 females)

Details on study design:

TEST SITE
- Area of exposure: upper third of the dorsal region or the flank
- Type of wrap if used: 4 layers of gauze and a porous-bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with lutrol and lutrol /water (1:1) after removing the exposure patch

SCORING SYSTEM:
according to Draize
Erythema:
0       no erythema
1       very slight erythema (barely perceptible)
2       well-defined erythema
3       moderate to serious erythema
4       severe erythema (beet redness) with slight eschar formation (injuries in depth)

Edema:
0       no edema
1       very slight edema (barely perceptible)
2       slight edema (edges of area well-defined by definite raising)
3       moderate edema (raised approx. 1 mm)
4       severe edema (raised more than 1 mm, extending beyond the area of exposure)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

:individual scores 1.3 / 2.7 / 2.7

Time point:

24/48/72 h

Score:

ca. 2.2

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Remarks on result:

other: scaling in 2 out of 3 animals at the end of the observation period

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

: individual scores 0.0 / 0.3 / 0.3

Time point:

24/48/72 h

Score:

ca. 0.2

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Any other information on results incl. tables

Reading Time	Animal No.	Erythema	Oedema
4 h	1	1	0
	2	2	1
	3	2	1
24 h	1	2	0
	2	3	1
	3	3	1
48 h	1	1	0
	2	2	0
	3	3	0
72 h	1	1	0
	2	3	0
	3	2	0
8 d	1*	0	0
	2*	2	0
	3	2	0

*Scaling

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

Under these test conditions there was irritation to the skin with the undiluted test substance.

Executive summary:

Three rabbits (one male, two females) were exposed dermally to single doses of 0.5 mL of undiluted test substance (purity about >=98.5%, test item was soaked into gauze patch (2.5 cm x 2.5 cm = 0.5 mL fluid) for 4 hours. The residual test item was wiped with lutrol and lutrol/water (1:1) and grading was performed according to Draize. Examinations for dermal reactions were carried out at 4, 24, 48, 72 hours, as well as 8 days following initiation of the exposure.

After 4-h exposure 3/3 animals showed well defined erythemas (overall 24 -48 -72 h mean score 2.2) and 2/3 animals slight edema (score 1 each) after 4 and 24 h, but not at later time points. Erythemas were still present after 8 d (2/3 animals, score 2 each). Two animals showed scaling at the end of the 8 d observation period (one animal with erythema and one animal without erythema, the second animal with erythema did not reveal scaling).

Based on the given results the test item was considered to be irritating to skin under the test conditions (BASF AG, 1985).