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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:
No data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
no details on test animals and environmental conditions; no details on patch material; observations not followed until the reversibility of the effects (only 7 days)
Justification for type of information:
The in vivo test was performed before the REACH regulation came into force, requesting in vitro studies. This information is used for read across to Terpene hydrocarbon alcohols

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1995

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
. There is no certificate of analysis of the test substance; no details on test animals and environmental conditions; no details on patch material; and observations are not followed until the reversibility of the effects (only 7 days).
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Terpineol alpha
- Source: Givaudan-Roure

Test animals

Species:
rabbit
Strain:
other: albino

Test system

Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume with unit): 0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
7 days
Number of animals:
Test 1: 3
Test 2&3: 4
Details on study design:
SCORING SYSTEM: Draize scoring system
- tested in a multi-patch study

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
all animals
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Test 1
Irritation parameter:
edema score
Basis:
mean
Remarks:
all animals
Time point:
24/48/72 h
Score:
2.44
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Test 1
Irritation parameter:
erythema score
Basis:
mean
Remarks:
all animals
Time point:
24/48/72 h
Score:
2.17
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Test 2
Irritation parameter:
edema score
Basis:
mean
Remarks:
all animals
Time point:
24/48/72 h
Score:
2.58
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Test 2
Irritation parameter:
erythema score
Basis:
mean
Remarks:
all animals
Time point:
24/48/72 h
Score:
1.92
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Test 3
Irritation parameter:
edema score
Basis:
mean
Remarks:
all animals
Time point:
24/48/72 h
Score:
2.08
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Test 3
Irritant / corrosive response data:
Test 1: Two animals showed marked desquamation at the 7 day time interval. The other animal showed thickening and marked desquamation of the skin surface at the 7 day time interval.
Test 2: One animal showed slight desquamation at the 7 day time interval. The three other animals showed marked desquamation at the 7 day time interval.
Test 3: Two animals showed slight desquamation at the 7 day time interval. One animal showed slight desquamation at the 2, 3, and 7 day time interval. One animal showed marked desquamation at the 7 day time interval

Any other information on results incl. tables

 Test 1

 

1 hr

1 day

2 days

3 days

7 days

Mean (24, 48, 72 hrs)

Animal No. 1

Erythema

0

1

2

2

1

1.67

Oedema

1

2

2

2

1

2

Animal No. 2

 

Erythema

2

2

2

2

2

2

Oedema

2

3

2

2

1

2.33

Animal No. 3

 

Erythema

2

2

2

3

3

2.33

Oedema

2

3

3

3

3

3

 

Test 2

 

1 hr

1 day

2 days

3 days

7 days

Mean (24, 48, 72 hrs)

Animal No. 1

Erythema

2

2

2

2

2

2

Oedema

2

3

3

3

1

3

Animal No. 2

 

Erythema

2

2

3

3

2

2.67

Oedema

3

3

3

3

3

3

Animal No. 3

 

Erythema

2

2

2

2

2

2

Oedema

2

3

2

3

3

2.67

Animal No. 4

 

Erythema

1

2

2

2

1

2

Oedema

2

2

2

1

0

1.67

 

Test 3

 

1 hr

1 day

2 days

3 days

7 days

Mean (24, 48, 72 hrs)

Animal No. 1

Erythema

2

2

2

2

1

2

Oedema

2

3

3

2

0

2.67

Animal No. 2

 

Erythema

2

2

2

2

2

2

Oedema

2

2

2

2

2

2

Animal No. 3

 

Erythema

1

2

2

1

0

1.67

Oedema

0

1

1

0

0

0.67

Animal No. 4

 

Erythema

2

2

2

2

1

2

Oedema

1

3

3

3

1

3

Applicant's summary and conclusion

Interpretation of results:
other: Skin irritant Cat. 2
Remarks:
according to EU CLP (EC No. 1272/2008 and its amendments).
Conclusions:
Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals of the first test were 1.67, 2 and 2.33 for erythema score and 2, 2.33 and 3 for edema score. For the second test the mean individual scores were 2, 2.67, 2 and 2 for erythema score and 3, 3, 2.67 and 1.67 for edema score. For the third test the mean individual scores were 2, 2, 1.67 and 2 for erythema score and 2.67, 2, 0.67 and 3 for edema score. Under the test conditions the substance is considered to be irritating to the skin because the average oedema score exceeded 2.5 (CLP) and the effects were not fully reversible within the observation period of 7 days
Executive summary:

In three primary dermal irritation studies performed according to OECD guideline 404 and in compliance with GLP, three or four albino rabbits were dermally exposed to 0.5 mL of undiluted alpha-Terpineol under a semi-occlusive patch for 4 hours to intact skin of the flank. Animals were then observed for 7 days. Irritation was scored by the method of Draize at 1, 24, 48 and 72 hours and 7 days after exposure. Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals of the first test were 1.67, 2 and 2.33 for erythema score and 2, 2.33 and 3 for edema score. For the second test the mean individual scores were 2, 2.67, 2 and 2 for erythema score and 3, 3, 2.67 and 1.67 for edema score. For the third test the mean individual scores were 2, 2, 1.67 and 2 for erythema score and 2.67, 2, 0.67 and 3 for edema score. Under the test conditions the substance is considered to be irritating to the skin because the average oedema score exceeded 2.5 and the effects were not fully reversible within the observation period of 7 days.