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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:
April 1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP-guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1981
Deviations:
yes
Remarks:
occlusive coverage; no further observations after 72 h to establish reversibility
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): N-Butylchlorid
- Storage condition of test material: at 5°C (+/- 2°C)

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harald Schriever, Kaninchenfarm, Bremervörde, Germany
- Weight at study initiation: 2.4 - 2.8 kg
- Housing: individually (cages: 40 cm x 45 cm x 50 cm)
- Diet: ad libitum
- Water: ad libitum tap water; analysed regularly
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 2
- Humidity (%): 50 -85
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: March, 21th 1989 To:

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: skin areas without test substance
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL is directly applied to skin
- Concentration (if solution): undiluted (pH 6.5)
Duration of treatment / exposure:
4 hours
Observation period:
30 - 60 min, 24 h, 48 h and 72 h
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: left scarified and shaved dorsal area and right shaved (but not scarified) dorsal area of the trunk; the sacrified area was not taken into account for assessment of skin irritation potential
- % coverage: 2.5 x 2.5 cm
- Type of wrap if used: "Kosmoplast" and "Elastoplast" (breathable) patches and additional wrapping of the trunk with "Stülpa"

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with tepid water
- Time after start of exposure: 4 hours

SCORING SYSTEM: according to guideline (Draize scores)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: average over 24 h/48 h/72 h
Score:
1.67
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: average over 24 h/48 h/72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: average over 24 h/48 h/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
other: average over 24 h/48 h/72 h
Score:
1.67
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
other: average over 24 h/48 h/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
other: average over 24 h/48 h/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: average over 24 h/48 h/72 h
Score:
1.67
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: average over 24 h/48 h/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: average over 24 h/48 h/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #4
Time point:
other: average over 24 h/48 h/72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
edema score
Basis:
animal #5
Time point:
other: average over 24 h/48 h/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #6
Time point:
other: average over 24 h/48 h/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable

Any other information on results incl. tables

Erythema formation scores (max. score 4) for each animal at the time points 24, 48 and 72 hours after patch removal

Animal No.

24 hours

48 hours

72 hours

Mean value from gradings at 24, 48 and 72 hours

test substance

control

test substance

control

test substance

control

Test substance

1

2

0

2

0

1

0

1.67

2

1

0

1

0

1

0

1

3

1

0

1

0

0

0

0.67

4

2

0

2

0

1

0

1.67

5

1

0

1

0

0

0

0.67

6

0

0

0

0

0

0

0

Oedema formation scores (max. score 4) for each animal at the time points 24, 48 and 72 hours after patch removal

Animal No.

24 hours

48 hours

72 hours

Mean value from gradings at 24, 48 and 72 hours

test substance

control

test substance

control

test substance

control

Test substance

1

2

0

2

0

1

0

1.67

2

0

0

0

0

0

0

0

3

0

0

0

0

0

0

0

4

1

0

1

0

1

0

1

5

0

0

0

0

0

0

0

6

0

0

0

0

0

0

0

 

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS