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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:
Not reported
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Reliability 2 is assigned because it is a GLP compliant study conducted in compliance with OECD guideline 404 but observations were not followed until the reversibility of the effects (only 7 days).
Justification for type of information:
An in vivo study was conducted prior to the introduction of the regulatory requirement for an in vitro study

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:
No details on test animals and environmental conditions; no details on patch material; observations not followed until the reversibility of the effects (only until days 7)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

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 applied: 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:
1.89
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:
1.67
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
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:
2.33
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:
1.75
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:
1
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Test 3
Irritant / corrosive response data:
Test 1: One animal showed marked desquamation at the 7 day time interval. The other two animal showed desquamation at the 7 day time interval.
Test 2: One animal showed desquamation at the 7 day time interval. One other animal showed slight desquamation at the 7 day time interval.
Test 3: One animal showed minimal desquamation at the 7 day time interval. The other three other animals showed slight 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

0

1

1

1

1

1

Animal No. 2

 

Erythema

2

2

2

2

1

2

Oedema

1

2

2

2

1

2

Animal No. 3

 

Erythema

1

2

2

2

2

2

Oedema

2

2

2

2

1

2

 

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

3

3

3

3

1

3

Animal No. 2

 

Erythema

2

2

2

2

1

2

Oedema

2

2

2

2

1

2

Animal No. 3

 

Erythema

2

2

2

2

1

2

Oedema

2

2

2

2

1

2

Animal No. 4

 

Erythema

1

2

2

2

1

2

Oedema

0

2

2

2

1

2

 

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

1

2

2

2

1

2

Animal No. 2

 

Erythema

1

2

2

1

1

1.67

Oedema

1

2

1

0

0

1

Animal No. 3

 

Erythema

1

2

2

2

1

2

Oedema

1

1

1

0

0

0.67

Animal No. 4

 

Erythema

1

2

1

1

0

1.33

Oedema

0

1

0

0

0

0.33

Applicant's summary and conclusion

Interpretation of results:
other: Not irritating
Remarks:
in accordance with EU CLP (EC no. 1272/2008 and its updates)
Conclusions:
Terpinyl acetate alpha does not cause skin irritation in the primary dermal irritation studies (OECD TG 404).
Executive summary:

In three primary dermal irritation studies performed according to OECD TG 404 and in compliance with GLP, three or four albino rabbits were dermally exposed to 0.5 mL of undiluted alpha-Terpinyl Acetate 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 1.66, 2 and 2 for erythema score and 1, 2 and 2 for edema score. For the second test 2, 2, 2 and 2 for erythema score and 3, 2, 2 and 2 for edema score. For the third test the mean individual scores were 2, 1.67, 2 and 1.33 for erythema score and 2, 1, 0.67 and 0.33 for oedema score.

Under the test conditions Terpinyl acetate alpha is considered to be not irritating to the skin.