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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:
09. Sept. 1986 - 15. Sept. 1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable study report, which meets basic scientific priniciples

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Tetrabutan (dest.)
- Physical state: liquid
- Isomers composition: C16-(branched), C20-(branched) and C24-(branched)-alkanes

Test animals

Species:
rabbit
Strain:
other: Kleine weiße Russen, Chbb-SPF
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach
- Weight at study initiation: 2.1 - 2.3 kg
- Housing: single housing
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 14 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1 °C
- Humidity (%): 60 ± 5 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 cm3
Duration of treatment / exposure:
Exposure: 4 hours
Observation period:
1, 24, 48, 72 hours, and 6 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: gauze and polyethylene foil


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


SCORING SYSTEM: according to OECD 404

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
probability of weak irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
probability of mild irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
probability of weak irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hrs
Score:
0.67
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24,48 and 72 hrs
Score:
0
Max. score:
4

Any other information on results incl. tables

 

Animals

1h

24h

48h

72h

6 days

 

 

 

Eryth.

Edem.

Eryth.

Edem.

Eryth.

Edem.

Eryth.

Edem.

Eryth.

Edem.

1

18701

male

2

1

1

0

0

0

0

0

0

0

2

18883

male

2

1

2

1

1

0

x1

0

0

0

3

18895

male

2

2

1

0

1

0

0

0

0

0

 

 

 

 

 

 

 

 

 

 

 

 

 

Mean

 

3.33

1.67

0.67

0.33

0

Irritation index (72h)

1.5

 

Eryth.: Erythema

Edem.:Edema

x:        blotched

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the described test conditions, only slightly irritating effects were recorded early after application, which were reversible. However, the observations did not meet GHS criteria and according to Regulation (EC) 1272/2008 the data are conclusive but not sufficient for classification.
Executive summary:

In an acute skin irritation /corrosion study 0.5 cm3 of Tetrabutan (dest.) was applied onto the shaved skin of 3 rabbits (Kleine weiße Russen, ChBB-SPF, Dr. Karl Thomae GmbH, Biberach). Exposure was occlusive for 4 hours. Animals were then observed for 6 days. Irritation was scored by the Draize scheme, according guideline OECD 404, after 1 h, 24h, 48h, 72h, and 6 days.

During the observation period all animals showed erythema (score 2) and edema (score 1 or 2) at 1 hour after exposure. Symptoms decreased over time and were complete reversible after 6 days.