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Description of key information

The experimental results on the four studies on vetiveryl acetate sourced from different companies, indicates that vetiveryl acetate is a skin sensitiser.

The EC3 results at 25% are very consistent with a low to moderate frequency (EC3 = 9.27%, EC3 = 10.89%, EC3 = 13.3% and EC3 = 13.11%).

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:
supporting study
Study period:
2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
GLP compliance:
yes
Type of study:
mouse local lymph node assay (LLNA)
Specific details on test material used for the study:
Acetyver 230451
Batch 0000203938
Room Temperature
Light yellow colour
Certificate of analysis
Species:
mouse
Strain:
CBA:J
Sex:
female
Details on test animals and environmental conditions:
Groups of 5 CBA/J female mice were treated.
Age Range: 11-12 weeks old.
Body weight range: 18-25 grams on Day 1.

Housed 5 mice per cage.
12 hour light/dark.
Room temperature 21-28'C.
Animals climatised for 8 days prior to the first dose.

Harlan Teklad certified rodent Chow 7012C as libitum.
Tap water ad libitum.
Vehicle:
other: Diethyl phthalate/ethanol, ratio 3:1.
Concentration:
1, 2.5, 5, 10, 25%
No. of animals per dose:
5 per dose
Details on study design:
Groups of 5 female mice were treated on the dorsal surface of both ears once per day for 3 days with the test substance or the vehicle.
On day 6, the mice were injected, i.v. with 20 uCi of 3H-thymidine in sterile saline.
Five hours later the mice were euthanised and the draining auricular lymph nodes were removed.
The lymph node cells wereprecipitated with 5% trichloroacetic acid and the pellets counted in a scintillation counter to determine incorporation of the 3H-thymidine.
Statistics:
The EC3 was calculated using the following formula:
EC3 = c+ [(3-d) / (b-d)] (a-c)
Positive control results:
NA
Key result
Parameter:
SI
Value:
1.67
Variability:
Not given
Test group / Remarks:
1% - Negative
Key result
Parameter:
SI
Value:
1.9
Variability:
Not given
Test group / Remarks:
2.5% - Negative
Key result
Parameter:
SI
Value:
2.53
Variability:
Not given
Test group / Remarks:
5% - Negative
Key result
Parameter:
SI
Value:
3.33
Variability:
Not given.
Test group / Remarks:
10% - Positive induction
Key result
Parameter:
SI
Value:
10.09
Variability:
Not given
Test group / Remarks:
25% - Positive induction
Interpretation of results:
Category 1B (indication of skin sensitising potential) based on GHS criteria
Conclusions:
A stimulation index greater than or equal to 3 is regarded as a positive response.
Therefore, based on the criteria of the study, treatment at 10% and 25% (v/v) did result in a stimulation index of greater than 3 and hence is considered to skin sensitising activity.
Executive summary:

The EC3 was calculated to be 9.27%

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
GLP compliance:
yes
Type of study:
mouse local lymph node assay (LLNA)
Specific details on test material used for the study:
Identification: Acet Vetivenyl E 112 Extra
Batch: 9000669418
Storage conditions: Room Temperature
Physical description: Yellow liquid
Expiration date: 16 Dec 2008
Species:
mouse
Strain:
CBA:J
Sex:
female
Details on test animals and environmental conditions:
Groups of 5 CBA/J female mice were treated.
Age Range: 11-12 weeks old.
Body weight range: 18-25 grams on Day 1.

Housed 5 mice per cage.
12 hour light/dark.
Room temperature 22-28'C.
Animals climatised for 8 days prior to the first dose.

Harlan Teklad certified rodent Chow 7012C as libitum.
Tap water ad libitum.
Vehicle:
other: Diethyl phthalate/ethanol, ratio 3:1.
Concentration:
1, 2.5, 5, 10, 25%
No. of animals per dose:
5 per dose
Details on study design:
Groups of 5 female mice were treated on the dorsal surface of both ears once per day for 3 days with the test substance or the vehicle.
On day 6, the mice were injected, i.v. with 20 uCi of 3H-thymidine in sterile saline.
Five hours later the mice were euthanised and the draining auricular lymph nodes were removed.
The lymph node cells wereprecipitated with 5% trichloroacetic acid and the pellets counted in a scintillation counter to determine incorporation of the 3H-thymidine.
Statistics:
The EC3 was calculated using the following formula:
EC3 = c+ [(3-d) / (b-d)] (a-c)
Positive control results:
NA
Key result
Parameter:
SI
Value:
1.59
Variability:
Not given
Test group / Remarks:
1% - Negative
Key result
Parameter:
SI
Value:
0.88
Variability:
Not given
Test group / Remarks:
2.5% - Negative
Key result
Parameter:
SI
Value:
2
Variability:
Not given
Test group / Remarks:
5% - Negative
Key result
Parameter:
SI
Value:
2.18
Variability:
Not given.
Test group / Remarks:
10% - Negative
Key result
Parameter:
SI
Value:
15.93
Variability:
Not given
Test group / Remarks:
25% - Positive induction
Interpretation of results:
Category 1B (indication of skin sensitising potential) based on GHS criteria
Conclusions:
A stimulation index greater than or equal to 3 is regarded as a positive response.
Therefore, based on the criteria of the study, treatment at 25% (v/v) did result in a stimulation index of greater than 3 and hence is considered to skin sensitising activity.
Executive summary:

The EC3 was calculated to be 10.89%

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
GLP compliance:
yes
Type of study:
mouse local lymph node assay (LLNA)
Specific details on test material used for the study:
Vetiveryl Acetate EX Haiti Clos Ha
Batch: B
Room Temperature
Light yellow liquid
Certificate of analysis
Species:
mouse
Strain:
CBA:J
Sex:
female
Details on test animals and environmental conditions:
Groups of 5 CBA/J female mice were treated.
Age Range: 11-12 weeks old.
Body weight range: 18-25 grams on Day 1.

Housed 5 mice per cage.
12 hour light/dark.
Room temperature 22-28'C.
Animals climatised for 8 days prior to the first dose.

Harlan Teklad certified rodent Chow 7012C as libitum.
Tap water ad libitum.
Vehicle:
other: Diethyl phthalate/ethanol, ratio 3:1.
Concentration:
1, 2.5, 5, 10, 25%
No. of animals per dose:
5 per dose
Details on study design:
Groups of 5 female mice were treated on the dorsal surface of both ears once per day for 3 days with the test substance or the vehicle.
On day 6, the mice were injected, i.v. with 20 uCi of 3H-thymidine in sterile saline.
Five hours later the mice were euthanised and the draining auricular lymph nodes were removed.
The lymph node cells were precipitated with 5% trichloroacetic acid and the pellets counted in a scintillation counter to determine incorporation of the 3H-thymidine.
Statistics:
The EC3 was calculated using the following formula:
EC3 = c+ [(3-d) / (b-d)] (a-c)
Positive control results:
NA
Key result
Parameter:
SI
Value:
1.15
Variability:
Not given
Test group / Remarks:
1% - Negative
Key result
Parameter:
SI
Value:
1.49
Variability:
Not given
Test group / Remarks:
2.5% - Negative
Key result
Parameter:
SI
Value:
2.29
Variability:
Not given
Test group / Remarks:
5% - Negative
Key result
Parameter:
SI
Value:
2.23
Variability:
Not given.
Test group / Remarks:
10% - Negative
Key result
Parameter:
SI
Value:
5.73
Variability:
Not given
Test group / Remarks:
25% - Positive induction
Interpretation of results:
Category 1B (indication of skin sensitising potential) based on GHS criteria
Conclusions:
A stimulation index greater than or equal to 3 is regarded as a positive response.
Therefore, based on the criteria of the study, treatment at 25% (v/v) did result in a stimulation index of greater than 3 and hence is considered to skin sensitising activity.
Executive summary:

The EC3 was calculated to be 13.3%

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
GLP compliance:
yes
Type of study:
mouse local lymph node assay (LLNA)
Specific details on test material used for the study:
ROB HB = Vetiveryl Acetate
Batch: 1590849
Refrigerated (0.5 - 8 °C)
Yellow liquid

Species:
mouse
Strain:
CBA:J
Sex:
female
Details on test animals and environmental conditions:
Groups of 5 CBA/J female mice were treated.
Age Range: 11-12 weeks old.
Body weight range: 18-25 grams on Day 1.

Housed 5 mice per cage.
12 hour light/dark.
Room temperature 23-28'C.
Animals climatised for 8 days prior to the first dose.

Harlan Teklad certified rodent Chow 7012C as libitum.
Tap water ad libitum.
Vehicle:
other: Diethyl phthalate/ethanol, ratio 3:1.
Concentration:
1, 2.5, 5, 10, 25%
No. of animals per dose:
5 per dose
Details on study design:
Groups of 5 female mice were treated on the dorsal surface of both ears once per day for 3 days with the test substance or the vehicle.
On day 6, the mice were injected, i.v. with 20 uCi of 3H-thymidine in sterile saline.
Five hours later the mice were euthanised and the draining auricular lymph nodes were removed.
The lymph node cells were precipitated with 5% trichloroacetic acid and the pellets counted in a scintillation counter to determine incorporation of the 3H-thymidine.
Statistics:
The EC3 was calculated using the following formula:
EC3 = c+ [(3-d) / (b-d)] (a-c)
Positive control results:
NA
Key result
Parameter:
SI
Value:
0.85
Variability:
Not given
Test group / Remarks:
1% - Negative
Key result
Parameter:
SI
Value:
0.93
Variability:
Not given
Test group / Remarks:
2.5% - Negative
Key result
Parameter:
SI
Value:
1.52
Variability:
Not given
Test group / Remarks:
10% - Negative
Key result
Parameter:
SI
Value:
1.12
Variability:
Not given.
Test group / Remarks:
10% - Negative
Key result
Parameter:
SI
Value:
10.18
Variability:
Not given
Test group / Remarks:
25% - Positive induction
Interpretation of results:
Category 1B (indication of skin sensitising potential) based on GHS criteria
Conclusions:
A stimulation index greater than or equal to 3 is regarded as a positive response.
Therefore, based on the criteria of the study, treatment at 25% (v/v) did result in a stimulation index of greater than 3 and hence is considered to skin sensitising activity.
Executive summary:

The EC3 was calculated to be 13.11%

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)

Justification for classification or non-classification