Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

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:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted 12 May 1981
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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

Resultsopen allclose all
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
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).