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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
Study period:
2004-06-15 to 2004-07-10
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report date:
2005

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
BI 1356 BS /CD 605 XX
IUPAC Name:
BI 1356 BS /CD 605 XX
Test material form:
solid: crystalline
Details on test material:
- Physical state: brown - crystalline powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Biological Laboratory Service of Boehringer Ingelheim Pharma GmbH&Co. KG
- Age at study initiation: approx. 4 - 6- months
- Weight at study initiation: 3.6 kg (day of application)
- Housing: individually in solid wire cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: pretest period 5 to 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +-2°C
- Humidity (%): 45 - 80%
- Air changes (per hr): approx. 10 per hr
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: demineralized water
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g test item
Duration of treatment / exposure:
3 min; 1 h; 4 h (one animal)
4 h (two animals)
Observation period:
immediately after the end of exposure, as well as 1 h, 24 h, 48 h and 72 h thereafter
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm², dorsal skin of the rabbit
- Type of wrap if used: occluded by muslin tissue and fixed by a non-skin-irritating plaster

REMOVAL OF TEST SUBSTANCE
- Washing (if done): demineralized water after exposure

SCORING SYSTEM: according to OECD Guideline 404

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1 h, 24 h, 48 h, 72 h
Score:
0
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1 h, 24 h, 48 h, 72 h
Score:
0
Irritant / corrosive response data:
In summary, BI 1356 BS/CD 605 XX had no irritating or corrosive effect on rabbit skin subsequent to dermal application.
Other effects:
no

Any other information on results incl. tables

The exact amount of the paste (test item mixed with demineralized water) applied to the single skin sites of the individual rabbits is shown in Table 1:

Table 1: Acute dermal irritation/corrosion study in rabbits – Amount of paste applied to individual skin sites

Animal number

Skin area

Amount of test item applied as paste (mg)

151

1

579

2

539

3

563

251

3

587

252

3

586

The exact amount of the paste (item mixed with demineralized water) applied to the single skin sites of the individual rabbits, was close to the expected 0.5 g per site.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
No macroscopic signs of irritation or corrosion and no signs of systemic side effects or of skin alterations beyond the area of exposure were observed. Thus, the test item is not classified.