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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:
2006-01-17 to 2006-02-13
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
GLP study following OECD guidelines without any deviation.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report Date:
2006

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
impurity
Type:
impurity
Type:
impurity
Type:
impurity
Type:
impurity
Type:
impurity
Type:
impurity
Type:
impurity
Test material form:
liquid
Details on test material:
Batch No.: 049807
Purity: 67.2% (sum of the three main constituents)
Name of test material (as cited in study report): TERPINEOL MULTICONSTITUENT
Physical state: colourless liquid
Storage conditions: +2°C to +8°C, under nitrogen and protected from light
Expiry date: 30 November 2017

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Elevage de Gerome, Linxe, France
- Weight at study initiation: between 2.23 kg and 3.08 kg
- Housing: kept in individual box installed in conventional air conditioned
- Acclimation period: 5 days
- Diet (e.g. ad libitum): supplied from UAR 112, Villemoisson s/Orge, France, ad libitum
- Water (e.g. ad libitum): tap water from public distribution system, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): between 17 and 22
- Humidity (%): between 30 and 49
- Air changes (per hr): at least 10 cycles
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 2006-01-17 To: 2006-02 13

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: shorn by electric clippers
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): undiluted
Duration of treatment / exposure:
4 h
Observation period:
14 days
Number of animals:
3 females
Details on study design:
TEST SITE
- Type of wrap if used: strip of surgical adhesive tape
- Area of exposure: approximately 6 cm²

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 4 h
- Washing (if done): residual product is removed, if necessary, using a swab soaked in distilled water or a suitable solvent

SCORING SYSTEM:
Erythema and Eschar formation
0....No erythema
1....Very slight erythema
2....Well definite erythema
3....Moderate to severe erythema
4....Severe erythema (beef redness) with eschars formation preventing grading of erythema
Oedema
0......No oedema
1......Very slight oedema
2......Slight oedema (contour clearly defined)
3......Moderate oedema (raised approx. 1mm)
4......Severe oedema (raised more than 1 mm, and extended beyond the area of exposure)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: day 5
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
2.7
Max. score:
4
Reversibility:
fully reversible within: day 5
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
2.7
Max. score:
4
Reversibility:
fully reversible within: day 5
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: day 5
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: day 5
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: day 5
Irritant / corrosive response data:
Application of the test substance Terpineol multiconstituent, was associated with a moderate erythema and a slight oedema 24 h after application. The reactions were totally reversible by the 6th day of the test. Skin recovered a normal aspect between the 11th and 14th day of the test.
Other effects:
Skin reactions such as dryness, slight dryness, scab, roughness/loss of lightness were observed from D2 to D12

Any other information on results incl. tables

Table 1: Individual and average scores after 4-hour exposure

OBSERVATIONS

INDIVIDUAL DATA

TOTAL OF INDIVIDUAL DATA

Skin reactions

Observation time

Animal n°

Weight (kg)

Animal n°

Weight (kg)

Animal n°

Weight (kg)

A 7158

Start : 2.64

A7181

Start : 2.23

A7182

Start : 2.43

End : 3.08

End : 2.52

End : 2.88

Erythema and eschar

24 h

48 h

72 h

3

3

3

9

3

3

3

9

3

2

2

7

Total

9                           8 

8

Mean

3.0                        2.7

2.7

Oedema

24 h

2

2

2

6

48 h

2

2

2

6

72 h

2

1

1

4

Total

6

5

5

 

Mean

2.0

1.7

1.7

 

Table 2: Individual skin reactions

OBSERVATIONS

INDIVIDUAL DATA

Skin reactions

Observation time

Animal n°

Weight (kg)

Animal n°

Weight (kg)

Animal n°

Weight (kg)

A 7158

Start : 2.64

A7181

Start : 2.23

A7182

Start : 2.43

End : 3.08

End : 2.52

End : 2.88

Erythema and eschar

1 h

2

2

2

24 h

3

3

3

48 h

3

3

3

72 h

3

2

2

Day 4

3

2

2

Day 5

0

0

0

Day 6

0

0

0

Day 7

0

0

0

Day 8

0

0

0

Day 9

0

0

0

Day 10

0

0

0

Oedema formation

1 h

2

2

2

24 h

2

2

2

48 h

2

2

2

72 h

2

1

1

Day 4

2

1

1

Day 5

0

0

0

Day 6

0

0

0

Day 7

0

0

0

Day 8

0

0

0

Day 9

0

0

0

Day 10

0

0

0

Applicant's summary and conclusion

Interpretation of results:
irritating
Conclusions:
Terpineol multiconstituent should be classified as irritating to skin, in category 2 according to CLP regulation (EC) No 1272/2008.
Executive summary:

A dermal irritation study was conducted according to OECD guideline 404 in compliance with GLP. Three healthy adult New Zealand white rabbits were exposed to 0.5 mL/rabbit of Terpineol multiconstituent on clipped skin of the dorsal area for 4 hours in semi-occlusive conditions. Skin reactions were observed at 1, 24, 48 and 72 h after removal of the substance until day 10. 1 hour after patch removal there was moderate erythema with slight oedema in all animals. Mean individual scores for 24, 48 and 72 h observation time points were 3, 2.7 and 2.7 for erythma and 2, 1.7 and 1.7 for oedema. The reactions were reversible within 5 days for all animals. The skin recovered a normal aspect between the 11th and the 14th day of the test.

Terpineol multiconstituent should be classified as irritant category 2 according to CLP Regulation (EC) No 1272/2008.