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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Experimental Toxicology and Ecology, BASF AG, Ludwigshafen, Germany

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Centre Lago S. A., 01540 Vonnas, France
- Age at study initiation: 6 - 7 months
- Weight at study initiation: 3.62 - 4.16 kg
- Housing: single
- Diet: Kliba-Labordiaet about 130 g/animal per day
- Water: tap water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipping of fur
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
1, 24, 48, 72 hours and on day 7, day 14
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: patch of 2.5 cm x 2.5 cm moisted with 0.5 ml undiluted test substance
- Type of wrap if used: The test substance was covered with a test patch (Idealbinde, Pfaelzische Verbandstoff-Fabrik, Kaiserslautern) and Fixomull® stretch (adhesive fleece), Beiersdorf AG

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with Lutrol and Lutrol/water (1:1)
- Time after start of exposure: 4 h

SCORING SYSTEM: according to guideline

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
3.1
Max. score:
4
Reversibility:
not fully reversible within: 14 d
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7d (2 animals); 14d (1 animal)

Any other information on results incl. tables

Individual cutaneous examination and mean values:

 

 

Exposure period: 4h

Animal

Erythema

Edema

Additional findings

0h

01

2

2

15, 16

02

2

2

15, 16

03

2

2

15, 16

1h

01

3

2

15, 16

02

3

2

15, 16

03

3

2

15, 16

24h

01

3

1

15, 16

02

3

1

15, 16

03

3

1

15, 16

48h

01

3

1

15, 16, 24

02

3

1

15, 16, 24

03

3

1

15, 16, 24

72h

01

3

1

15, 16, 24

02

3

1

15, 16, 24

03

4

1

15, 16, 24

7d

01

2

0

SS, 15, 18

02

3

1

SS, 15, 16, 18, 24

03

3

0

SS, 15, 18, 24

14d

01

2

0

S, 15, 24

02

1

0

S, 15

03

2

0

15

Mean

24-72h

01

3.0

1.0

 

02

3.0

1.0

 

03

3.3

1.0

 

Mean

 

3.1

1.0

 

15 = erythema extending beyond the area of exposure

16 = edema extending beyond the area of exposure

18 = severe scaling extending beyond the area of exposure

24 = petechiae

S = scaling

SS = severe scaling

Applicant's summary and conclusion