Registration Dossier

Administrative data

Description of key information

Weight of evidence: The skin sensitization potential of the main constituents are available from experimental data:

Terpinolene: Patch test on humans (Woeber K, 1969). Terpinolene was found not to be a sensitizer for human skin.

Terpinolene: Maximization test on 24 volunteers (Opdyke DLJ, 1976). The material was tested on humans at a concentration of 20 % in petrolatum and produced no sensitization reactions.

Camphene: Patch test on humans (Woeber K, 1969). Camphene was found not to be a sensitizer for human skin.

Camphene: Maximization test on 25 volunteers (Opdyke DLJ, 1975). The material was tested on humans at a concentration of 4 % in petrolatum and produced no sensitization reactions.

D-Limonene: Test method similar to OECD Guideline 429 (Warbrick EV, 2001). The calculated EC3-value was found to be 68.5%, and thus, classified as skin sensitizer 1B according to the CLP Regulation (EC) no. 1272/2008.

Alpha terpinene: Maximization test on 25 volunteers (Opdyke DLJ, 1976). The material was tested on humans at a concentration of 5 % in petrolatum and produced no sensitization reactions.

Alpha terpinene: Test method similar to OECD Guideline 429 (Rudbäck J, 2012). The results demonstrated that alpha terpinene is able to auto-oxidise rapidly on exposure to air and to acquire strong skin sensitising potential, with an EC3 of approximately 1%.

Alpha terpinene: Test method similar to OECD Guideline 429 (Bergstrom MA, 2006). Alpha terpinene was shown to be sensitizer of moderate potency with the EC3 value of 0.65 M (8.9 % w/v). The SI was greater than 3 at the concentrations of 10, 15 and 25 %. According to the CLP Regulation (EC) no. 1272/2008, the substance is classified as skin sensitizer 1B.

Alpha pinene: Patch test on humans (Woeber K, 1969). Alpha pinene was found not to be a sensitizer for human skin.

Alpha pinene: Maximization test on 25 volunteers (Opdyke DLJ, 1978). The material was tested on humans at a concentration of 10 % in petrolatum and produced no sensitization reactions.

Based on the experimental data available on the components of the substance and, since content of those classified as skin sensitizers 1B is higher than 1%, it is determined that the substance is classified as skin sensitizer 1B, H317 according to the CLP Regulation (EC) no. 1272/2008.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
yes
Remarks:
Lack of data on test animals and housing conditions.
GLP compliance:
not specified
Type of study:
mouse local lymph node assay (LLNA)
Species:
mouse
Strain:
not specified
Sex:
not specified
Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
0 (vehicle), 1, 5 10, 15 and 25% w/v
No. of animals per dose:
three females
Details on study design:
MAIN STUDY

ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: murine local lymph node assay.
- Criteria used to consider a positive response:
Test materials that at one or more concentrations gave rise to an stimulation index (SI) greater than 3 were considered to be sensitizers in the LLNA.
The sensitizing potency of the test compound was classified according to the following: <0.1, extreme; ≥0.1-<1, strong; ≥1- <10, moderate; and ≥10-<100, weak ((ECETOC (2003), Kimber et al. (2003)).
Positive control substance(s):
other: The results of this study were compared with the prohaptenic cinnamic alcohol and its reactive metabolite cinnamic aldehyde.
Statistics:
Results were expressed as mean dpm/lymph node for each experimental group and as stimulation index (SI), i.e., test group/control group ratio.
EC3 values were calculated by linear interpolation (Basketter et al. (1999)) and used to determine the sensitizing potency of the test substance.

Positive control results:
Prohaptenic cinnamic alcohol and its reactive metabolite cinnamic aldehyde gave EC3 values of 1.5 (20.1%) and 0.10 M (1.3%), respectively (Elahi et al. (2004)).
Key result
Parameter:
SI
Value:
1.1
Test group / Remarks:
1 % w/v
Key result
Parameter:
SI
Value:
1.5
Test group / Remarks:
5 % w/v
Key result
Parameter:
SI
Value:
3.4
Test group / Remarks:
10 % w/v
Key result
Parameter:
SI
Value:
8.9
Test group / Remarks:
15 % w/v
Key result
Parameter:
SI
Value:
23
Test group / Remarks:
25% w/v
Key result
Parameter:
EC3
Value:
8.9
Remarks on result:
other: EC3= estimated concentration to induce a Stimulation index of 3

Table 1. LLNA results for alpha terpinene

Alpha terpinene and test concentrations

(% w/v)

[3H]thymidine

incorporation

(dpm/lymph node)

SI

 

EC3 value of  

Alpha terpinene and test concentrations

(% w/v)

sensitizing potency

% w/v

M

0

755

 

8.9

0.65

moderate

1

848

1.1

5

1153

1.5

10

2595

3.4

15

6740

8.9

25

17176

23

Interpretation of results:
other: Category 1B (CLP Regulation EC no. 1272/2008)
Conclusions:
Based on the results of this study, alpha terpinene was shown to be sensitizer of moderate potency with the EC3 value of 0.65 M (8.9 % w/v). The SI was greater than 3 at the concentrations of 10, 15 and 25 %.
Executive summary:

The murine LLNA assay was used in this study to assess the sensitizing potency of alpha terpinene which was tested at concentrations of 0 (acetone/olive oil, 4:1 v/v), 1, 5, 10, 15 and 25 (% w/v) using mice in groups of three. The results were expressed as mean dpm/lymph node for each experimental group and as stimulation index (SI), i.e., test group/control group ratio. Test material that at one or more concentrations gave rise to an SI greater than 3 were considered to be sensitizers in the LLNA. The results of this study were compared with the prohaptenic cinnamic alcohol and its reactive metabolite cinnamic aldehyde, which have EC3 values of 1.5 (20.1%) and 0.10 M (1.3%), respectively. The results demonstrated that the SI was greater than 3 at the concentrations of 10, 15 and 25 % of alpha terpinene. Based on these results, alpha terpinene was shown to be a sensitizer of moderate potency with EC3 value of 0.65 M (8.9 % w/v).

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Remarks:
maximization test
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Qualifier:
no guideline available
Principles of method if other than guideline:
A maximization test (Kligman, 1966; Kligman & Epstein, 1975) was carried out on 25 volunteers.
No more data was provided on the method.
GLP compliance:
no
Type of study:
other: maximization test
Justification for non-LLNA method:
Data suitable for a weight of evidence approach.
Species:
other: human
Strain:
other: Not applicable
Sex:
not specified
Reading:
1st reading
Group:
test group
Dose level:
4 % in petrolatum
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Group:
negative control
Remarks on result:
other: No data
Reading:
1st reading
Group:
positive control
Remarks on result:
other: No data

The material was tested at a concentration of 4 % in petrolatum and produced no sensitization reactions.

Interpretation of results:
other: Not classified (CLP Regulation EC no. 1272/2008)
Conclusions:
The material was tested on humans at a concentration of 4 % in petrolatum and produced no sensitization reactions.
Executive summary:

A maximization test was carried out on 25 volunteers. The material was tested at a concentration of 4 % in petrolatum and produced no sensitization reactions.

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Remarks:
maximization test
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Qualifier:
no guideline available
Principles of method if other than guideline:
A maximization test (Kligman, 1966; Kligman & Epstein, 1975) was carried out on 25 volunteers.
No more data was provided on the method.
GLP compliance:
no
Type of study:
other: maximization test
Justification for non-LLNA method:
Data suitable for a weight of evidence approach.
Species:
other: human
Strain:
other: Not applicable
Sex:
not specified
Reading:
1st reading
Group:
test group
Dose level:
5 % in petrolatum
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Group:
negative control
Remarks on result:
other: No data
Reading:
1st reading
Group:
positive control
Remarks on result:
other: No data

The material was tested at a concentration of 5 % in petrolatum and produced no sensitization reactions.

Interpretation of results:
other: Not classified (CLP Regulation EC no. 1272/2008)
Conclusions:
The material was tested on humans at a concentration of 5 % in petrolatum and produced no sensitization reactions.
Executive summary:

A maximization test was carried out on 25 volunteers. The material was tested at a concentration of 5 % in petrolatum and produced no sensitization reactions.

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Remarks:
maximization test
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Qualifier:
no guideline available
Principles of method if other than guideline:
-Principle of test: A maximization test (Kligman, 1966; Kligman & Epstein, 1975) was carried out on 24 volunteers.
GLP compliance:
no
Type of study:
other: maximization test
Justification for non-LLNA method:
Data suitable for a weight of evidence approach.
Species:
other: human
Strain:
other: Not applicable
Sex:
not specified
Reading:
1st reading
Group:
test group
Dose level:
20% in petrolatum
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Group:
negative control
Remarks on result:
other: No data
Reading:
1st reading
Group:
positive control
Remarks on result:
other: No data

The material was tested at a concentration of 20 % in petrolatum and produced no sensitization reactions.

Interpretation of results:
other: Not classified (CLP Regulation EC no. 1272/2008)
Conclusions:
The material was tested on humans at a concentration of 20 % in petrolatum and produced no sensitization reactions.
Executive summary:

A maximization test was carried out on 24 volunteers. The material was tested at a concentration of 20 % in petrolatum and produced no sensitization reactions.

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Remarks:
maximization test
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Qualifier:
no guideline available
Principles of method if other than guideline:
A maximization test (Kligman, 1966; Kligman & Epstein, 1975) was carried out on 25 volunteers.
No more data was provided on the method.
GLP compliance:
no
Type of study:
other: maximization test
Justification for non-LLNA method:
Data suitable for a weight of evidence approach.
Species:
other: human
Strain:
other: Not applicable
Sex:
not specified
Key result
Reading:
1st reading
Group:
test group
Dose level:
10 % in petrolatum
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Group:
negative control
Remarks on result:
other: No data
Reading:
1st reading
Group:
positive control
Remarks on result:
other: No data

The material was tested at a concentration of 10 % in petrolatum and produced no sensitization reactions.

Interpretation of results:
other: Not classified (CLP Regulation EC no. 1272/2008)
Conclusions:
The material was tested on humans at a concentration of 10% in petrolatum and produced no sensitization reactions.
Executive summary:

A maximization test was carried out on 25 volunteers. The material was tested at a concentration of 10% in petrolatum and produced no sensitization reactions.

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
GLP compliance:
not specified
Remarks:
No information is provided on the report.
Type of study:
mouse local lymph node assay (LLNA)
Species:
mouse
Strain:
CBA/Ca
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Scanbur or NOVA SCB/Charles River (Sollentuna, Sweden or Germany, respectively)
- Age at study initiation: around 8 weeks
Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
0 (vehicle), 0.1, 1, 5 10 and 25% w/v (3 weeks air exposure assay)
0 (vehicle), 1, 5 10, 15 and 30% w/v (7 weeks air exposure assay)
No. of animals per dose:
three females
Details on study design:
MAIN STUDY
Groups of female CBA/Ca mice (n = 3) received 25 µL of the test compound dissolved in vehicle (acetone/olive oil 4:1, v/v), on the dorsum of the ears daily for 3 consecutive days. Control animals were treated with a vehicle alone.

All mice were injected intravenously 5 days after the first treatment, with 250 µL of phosphate-buffered saline (PBS) containing 20 µCi of [3H]thymidine. After 5 h, the draining auricular lymph nodes were excised and pooled for each group, and single cell suspensions of lymph node cells were prepared. The relative thymidine incorporation was measured by ß-scintillation counting. Results were expressed as mean dpm/lymph node for each experimental group and as a stimulation index (SI), i.e., test group/control group ratio.

ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: murine local lymph node assay.
- Criteria used to consider a positive response:
Test materials that at one or more concentrations gave rise to an stimulation index (SI) greater than 3 were considered to be sensitizers in the LLNA.
The sensitizing potency of the test compound was classified according to the following: <0.1, extreme; ≥0.1-<1, strong; ≥1- <10, moderate; and ≥10-<100, weak ((ECETOC (2003), Kimber et al. (2003)).

Positive control substance(s):
other: The results of this study were compared with the prohaptenic cinnamic alcohol and its reactive metabolite cinnamic aldehyde.
Statistics:
Results were expressed as mean dpm/lymph node for each experimental group and as stimulation index (SI), i.e., test group/control group ratio.
EC3 values were calculated by linear interpolation (Basketter et al. (1999)) and used to determine the sensitizing potency of the test substance.

Parameter:
SI
Value:
0.8
Test group / Remarks:
0.1 (%w/v)
Remarks on result:
other: 3 week air exposure assay
Parameter:
SI
Value:
3.2
Test group / Remarks:
1 (% w/v)
Remarks on result:
other: 3 week air exposure assay
Parameter:
SI
Value:
13
Test group / Remarks:
5 (% w/v)
Remarks on result:
other: 3 week air exposure assay
Parameter:
EC3
Value:
0.9
Remarks on result:
other: 3 week air exposure assay
Parameter:
SI
Value:
3
Test group / Remarks:
1 (% w/v)
Remarks on result:
other: 7 week air exposure assay
Parameter:
SI
Value:
10
Test group / Remarks:
5 (% w/v)
Remarks on result:
other: 7 week air exposure assay
Parameter:
SI
Value:
13
Test group / Remarks:
10 (% w/v)
Remarks on result:
other: 7 week air exposure assay
Parameter:
EC3
Value:
1
Remarks on result:
other: 7 week air exposure assay

Table 1. LLNA Responses for 3-week air-exposed alpha terpinene

air-exposed alpha terpinene(% w/v)

[3H]thymidine

incorporation

(dpm/lymph node)

SI

 

EC3 value ofair-exposed alpha terpinene(% w/v)

sensitizing potency

% w/v

M

Control

1075

 

0.9

 

 

strong

0.1

857

0.8

1

3380

3.2

5

14168

13

10

18399

17

25

13365

12

Table 2. LLNA Responses for 7-week air-exposed alpha terpinene

air-exposed alpha terpinene(% w/v)

[3H]thymidine

incorporation

(dpm/lymph node)

SI

 

EC3 value ofair-exposed alpha terpinene(% w/v)

sensitizing potency

% w/v

M

Control

1290

 

1

 

 

strong

1

3900

3.0

5

13074

10

10

16781

13

15

10593

8.2

25

12074

9.4

Interpretation of results:
study cannot be used for classification
Conclusions:
The results demonstrated that alpha terpinene is able to auto-oxidise rapidly on exposure to air and to acquire strong skin sensitising potential, with an EC3 of approximately 1%.


Executive summary:

The murine LLNA assay was used in this study to assess the sensitizing potency of air exposed alpha terpinene and its oxidation products. A sample of pure alpha terpinene was air-exposed (3 week and 7 weeks) at room temperature and under a daylight lamp lit for 12 h a day. The oxidation mixture was stirred four times daily for 1 h. Samples were taken on a regular basis and analysed using LC/UV or LC/MS/MS for quantification of alpha terpinene and its major oxidation products. It was shown, that the concentration of alpha terpinene decreased rapidly when exposed to air at room temperature. The concentration of alpha terpinene decreased to 53% after 10 days and 21% after 24 days, and after 66 days, alpha terpinene was not detected in the oxidation mixture (method limit of detection 0.2%). Groups of female CBA/Ca mice (n = 3) received 25 µL of the test compound dissolved in vehicle (acetone/olive oil 4:1, v/v), on the dorsum of the ears daily for 3 consecutive days. Control animals were treated with a vehicle alone. All mice were injected intravenously 5 days after the first treatment, with 250 µL of phosphate-buffered saline (PBS) containing 20 µCi of [3H]thymidine. After 5 h, the draining auricular lymph nodes were excised and pooled for each group, and single cell suspensions of lymph node cells were prepared. The relative thymidine incorporation was measured by ß-scintillation counting. Results were expressed as mean dpm/lymph node for each experimental group and as stimulation index (SI), i.e., test group/control group ratio. The results of the study showed that alpha terpinene is able to auto-oxidise rapidly on exposure to air, and to acquire strong skin sensitising potential, with an EC3 of approximately 1%. The following EC3 values were afforded for air exposed alpha terpinene: three weeks oxidized alpha terpinene: 0.9% w/v (content of pure alpha terpinene: ca. 20%); seven weeks oxidized alpha terpinene: 1.0% w/v (content of pure alpha terpinene: ca. 2%).

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
2001
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
yes
Remarks:
no data on physicochemical properties of test substance; no data on individual weights, housing conditions of test animals; no information on time course of onset and signs of toxicity
GLP compliance:
not specified
Type of study:
mouse local lymph node assay (LLNA)
Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Seralab, Oxon, UK
- Age at study initiation: 8-12 weeks
- Housing: four/cage on flushing metal racks
- Diet: SDS PCD pelleted diet; Special Diets Services, Witham, UK; ad libitum
- Water: ad libitum

Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
0 (vehicle), 25, 50 and 100% v/v
No. of animals per dose:
Four females
Details on study design:
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Local lymph node assay (Kimber and Basketter, 1992)
- Criteria used to consider a positive response: Stimulation index (SI) ≥ 3 (Kimber and Basketter, 1992).

TREATMENT PREPARATION AND ADMINISTRATION:
Groups of mice received 25 µL of various concentrations of limonene in vehicle, or vehicle alone, on the dorsum of both ears daily for 3 consecutive days. Five days following the initiation of treatment, all mice were injected intravenously with 250 µL of 20 µCi 3H-TdR in PBS. Five hours later draining auricular lymph nodes were excised and a single cell suspension prepared. The incorporation of 3H-TdR was measured by β-scintillation counter (dpm/node and stimulation index [SI]) (Kimber and Basketter, 1992).

The estimated concentration of chemical required to induce a stimulation index of 3 relative to concurrent vehicle-treated controls (EC3 value) was derived by linear interpolation by method as explained by Basketter et al. (1999).

The EC3 value was calculated by interpolating between two points on the SI axis, one immediately above, and the other immediately below, the SI value of three. The vehicle-treated control value (SI=1) cannot be used for the latter. Where the data points falling immediately above and below the SI value of three have the co-ordinates (a,b) and (c,d), respectively, then the EC3 value may be calculated using the following equation (Basketter et al., 1999): EC3=c + [3−d) / (b−d)] × (a−c).
Statistics:
None
Key result
Parameter:
SI
Value:
1
Test group / Remarks:
0 % v/v
Key result
Parameter:
SI
Value:
1.84
Test group / Remarks:
25 % v/v
Key result
Parameter:
SI
Value:
2.44
Test group / Remarks:
50 % v/v
Key result
Parameter:
SI
Value:
3.95
Test group / Remarks:
100 % v/v
Key result
Parameter:
EC3
Value:
68.5
Remarks on result:
other: EC3= estimated concentration to induce a Stimulation index of 3

Table 1: Local lymph node assay responses to limonene

Exposure Concentration (% v/v)

dpm/node

Stimulation index (SI)

EC3 (%)

0

476

1

68.5

25

877

1.84

50

1164

2.44

100

1882

3.95

Interpretation of results:
other: Category 1B (CLP Regulation EC no. 1272/2008)
Conclusions:
The calculated EC3-value for d-limonene was found to be 68.5%. Under these test conditions, d-limonene was found to be sensitising and should be clasified as skin sensitiser 1B according to the criteria of the CLP Regulation (EC) N° (1272-2008).
Executive summary:

In a skin sensitization study conducted following a method similar to OECD guidelines 429, four groups of CBA/Ca strain female mice (4/concentration) were exposed topically on the dorsum of both ears to 25 µL of vehicle (acetone/olive oil, 4:1 v/v), 25, 50 and 100% v/v of d-limonene daily for 3 consecutive days. Five days following initiation of exposure all mice were injected 250 µL of phosphate buffered saline (PBS) containing 20 µCi of [3H] methyl thymidine (3H-TdR). The animals were then sacrificed after 5 hours and suspension of lymph node cells was prepared from auricular lymph nodes. The incorporation of 3H-TdR was measured by β-scintillation counting as disintegrations per minute (dpm) per node for each experimental group. A Stimulation index of 3 or greater was considered to be indicative of a potential to cause contact sensitization. D-limonene at exposure concentration of 0 (vehicle), 25, 50 and 100% v/v resulted in 476, 877, 1164 and 1882 dpm/node and stimulation index of 1, 1.84, 2.44 and 3.95, respectively. The calculated EC3-value for d-limonene was found to be 68.5%. Under these test conditions, d-limonene was found to be sensitising and should be clasified as skin sensitiser 1B according to the CLP Regulation (EC) N° (1272-2008).

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Qualifier:
no guideline followed
Principles of method if other than guideline:
A Patch-Test was performed on humans for stuying the sensitizing properties of 17 terpenes and related compounds present in essential oils.
No more data provided on the method.
GLP compliance:
no
Type of study:
patch test
Justification for non-LLNA method:
Data suitable for a weight of evidence approach.
Species:
other: human
Strain:
other: Not applicable
Sex:
not specified
Route:
other: No data
Vehicle:
other: No data
Concentration / amount:
no data
Route:
other: No data
Vehicle:
other: No data
Concentration / amount:
No data
No. of animals per dose:
No data
Positive control substance(s):
not specified
Key result
Reading:
1st reading
Group:
test group
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Group:
negative control
Remarks on result:
other: No data
Reading:
1st reading
Group:
positive control
Remarks on result:
other: No data

alpha pinene was found not to be a sensitizer for human skin.

Interpretation of results:
other: Not classified (CLP Regulation EC no. 1272/2008)
Conclusions:
Alpha pinene was found not to be a sensitizer for human skin.
Executive summary:

A Patch-Test was performed on humans for stuying the sensitizing properties of 17 terpenes and related compounds present in essential oils. Alpha pinene was found not to be a sensitizer for human skin.

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Qualifier:
no guideline followed
Principles of method if other than guideline:
A Patch-Test was performed on humans for stuying the sensitizing properties of 17 terpenes and related compounds present in essential oils.
No more data provided on the method.
GLP compliance:
no
Type of study:
patch test
Justification for non-LLNA method:
Data suitable for a weight of evidence approach.
Species:
other: human
Strain:
other: Not applicable
Sex:
not specified
Route:
other: No data
Vehicle:
other: No data
Concentration / amount:
no data
Route:
other: No data
Vehicle:
other: No data
Concentration / amount:
No data
No. of animals per dose:
No data
Positive control substance(s):
not specified
Reading:
1st reading
Group:
test group
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Group:
negative control
Remarks on result:
other: No data
Reading:
1st reading
Group:
positive control
Remarks on result:
other: No data

Camphene was found not to be a sensitizer for human skin.

Interpretation of results:
other: Not classified (CLP Regulation EC no. 1272/2008)
Conclusions:
Camphene was found not to be a sensitizer for human skin.
Executive summary:

A Patch-Test was performed on humans for stuying the sensitizing properties of 17 terpenes and related compounds present in essential oils. Camphene was found not to be a sensitizer for human skin.

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Qualifier:
no guideline followed
Principles of method if other than guideline:
-Principle of test: A Patch-Test was performed on humans for stuying the sensitizing properties of 17 terpenes and related compounds present in essential oils. No more data provided on the method.
GLP compliance:
no
Type of study:
patch test
Justification for non-LLNA method:
Data suitable for a weight of evidence approach.
Species:
other: human
Strain:
other: Not applicable
Sex:
not specified
Route:
other: No data
Vehicle:
other: No data
Concentration / amount:
no data
Route:
other: No data
Vehicle:
other: No data
Concentration / amount:
No data
No. of animals per dose:
No data
Positive control substance(s):
not specified
Reading:
1st reading
Group:
test group
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Group:
negative control
Remarks on result:
other: no data
Reading:
1st reading
Group:
positive control
Remarks on result:
other: No data

Terpinolene was found not to be a sensitizer for human skin.

Interpretation of results:
other: Not classified (CLP Regulation EC no. 1272/2008)
Conclusions:
Terpinolene was found not to be a sensitizer for human skin.
Executive summary:

A Patch-Test was performed on humans for stuying the sensitizing properties of 17 terpenes and related compounds present in essential oils. Terpinolene was found not to be a sensitizer for human skin.

Endpoint:
skin sensitisation: in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
In accordance with column 2 of REACH Annex VII, the study does not need to be conducted since in vivo studies on sensitisation are available.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available data, the substance needs to be classified for skin sensitization cat. 1B according to CLP Regulation no. 1272/2008.