Vetiveria zizanioides, ext., acetylated

Endpoint summary

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

Reference

Reference 1

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%

Reference 2

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%

Reference 3

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%

Reference 4

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)