Vetiveria zizanioides ext., acetylated, Vetiveria Zizanoides Root Extract Acetylated, the inhalation toxicity of the fragrance ingredient

SOURCE_SUBDIR=sccs_o_285; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION ON the inhalation toxicity of the fragrance ingredient Acetylated Vetiver Oil – AVO (CAS No 84082-84-8, EC No 282-031-1); OPINION_NUMBER=SCCS/1663/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=unclear:Table 11 N: was compared to the | NOAEL sys | of 58.33 mg/ | kg bw derive | d | in SC | CS/1559/20 | 18.; EFFECT=Table 11 N: was compared to the | NOAEL sys | of 58.33 mg/ | kg bw derive | d | in SC | CS/1559/20 | 18.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"84082-84-8","citation":"","dose":"","duration":"","effect":"Table 11 N: was compared to the | NOAEL sys | of 58.33 mg/ | kg bw derive | d | in SC | CS/1559/20 | 18.","endpoint":"","ingredient":"Vetiveria zizanioides ext., acetylated","loael_value":"","noael_unit":"","noael_value":"unclear:Table 11 N: was compared to the | NOAEL sys | of 58.33 mg/ | kg bw derive | d | in SC | CS/1559/20 | 18.","page":30,"route":"","species":"","study_id":"sccs_o_285_noael_004"}

sccs_o_285.pdf

SOURCE_SUBDIR=sccs_o_285; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION ON the inhalation toxicity of the fragrance ingredient Acetylated Vetiver Oil – AVO (CAS No 84082-84-8, EC No 282-031-1); OPINION_NUMBER=SCCS/1663/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=unclear:Table 13 : SED calculation: on of | SED | NOAEL sys; EFFECT=Table 13 : SED calculation: on of | SED | NOAEL sys; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"84082-84-8","citation":"","dose":"","duration":"","effect":"Table 13 : SED calculation: on of | SED | NOAEL sys","endpoint":"","ingredient":"Vetiveria zizanioides ext., acetylated","loael_value":"","noael_unit":"","noael_value":"unclear:Table 13 : SED calculation: on of | SED | NOAEL sys","page":31,"route":"","species":"","study_id":"sccs_o_285_noael_006"}

sccs_o_285.pdf

SOURCE_SUBDIR=sccs_o_285; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION ON the inhalation toxicity of the fragrance ingredient Acetylated Vetiver Oil – AVO (CAS No 84082-84-8, EC No 282-031-1); OPINION_NUMBER=SCCS/1663/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=2018. The; EFFECT=Table 11 N: used in SCCS/1559/ | 2018. The | aggregation | was done us | in | g eithe | r the spraya | ble or the non-; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"84082-84-8","citation":"","dose":"","duration":"","effect":"Table 11 N: used in SCCS/1559/ | 2018. The | aggregation | was done us | in | g eithe | r the spraya | ble or the non-","endpoint":"","ingredient":"Vetiveria zizanioides ext., acetylated","loael_value":"","noael_unit":"","noael_value":"2018. The","page":30,"route":"","species":"","study_id":"sccs_o_285_noael_005"}

sccs_o_285.pdf

SOURCE_SUBDIR=sccs_o_285; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION ON the inhalation toxicity of the fragrance ingredient Acetylated Vetiver Oil – AVO (CAS No 84082-84-8, EC No 282-031-1); OPINION_NUMBER=SCCS/1663/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=58,330; EFFECT=Table 13 : SED calculation: fragrance non- spray | 0.9 | 21.0 | 58,330 | 2778; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"84082-84-8","citation":"","dose":"","duration":"","effect":"Table 13 : SED calculation: fragrance non- spray | 0.9 | 21.0 | 58,330 | 2778","endpoint":"","ingredient":"Vetiveria zizanioides ext., acetylated","loael_value":"","noael_unit":"","noael_value":"58,330","page":31,"route":"","species":"","study_id":"sccs_o_285_noael_007"}

sccs_o_285.pdf

SOURCE_SUBDIR=sccs_o_285; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION ON the inhalation toxicity of the fragrance ingredient Acetylated Vetiver Oil – AVO (CAS No 84082-84-8, EC No 282-031-1); OPINION_NUMBER=SCCS/1663/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=58,330; EFFECT=Table 13 : SED calculation: deodorant sprays | 0.05 | 7.6 | 58,330 | 7675; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"84082-84-8","citation":"","dose":"","duration":"","effect":"Table 13 : SED calculation: deodorant sprays | 0.05 | 7.6 | 58,330 | 7675","endpoint":"","ingredient":"Vetiveria zizanioides ext., acetylated","loael_value":"","noael_unit":"","noael_value":"58,330","page":31,"route":"","species":"","study_id":"sccs_o_285_noael_008"}

sccs_o_285.pdf

SOURCE_SUBDIR=sccs_o_285; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION ON the inhalation toxicity of the fragrance ingredient Acetylated Vetiver Oil – AVO (CAS No 84082-84-8, EC No 282-031-1); OPINION_NUMBER=SCCS/1663/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=58,330; EFFECT=Table 13 : SED calculation: hairsprays | 0.1 | 5.59 | 58,330 | 10435; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"84082-84-8","citation":"","dose":"","duration":"","effect":"Table 13 : SED calculation: hairsprays | 0.1 | 5.59 | 58,330 | 10435","endpoint":"","ingredient":"Vetiveria zizanioides ext., acetylated","loael_value":"","noael_unit":"","noael_value":"58,330","page":31,"route":"","species":"","study_id":"sccs_o_285_noael_009"}

sccs_o_285.pdf

SOURCE_SUBDIR=sccs_o_285; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION ON the inhalation toxicity of the fragrance ingredient Acetylated Vetiver Oil – AVO (CAS No 84082-84-8, EC No 282-031-1); OPINION_NUMBER=SCCS/1663/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=58,330; EFFECT=Table 13 : SED calculation: Make-up products | 0.05 | 4.7 | 58,330 | 12411; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"84082-84-8","citation":"","dose":"","duration":"","effect":"Table 13 : SED calculation: Make-up products | 0.05 | 4.7 | 58,330 | 12411","endpoint":"","ingredient":"Vetiveria zizanioides ext., acetylated","loael_value":"","noael_unit":"","noael_value":"58,330","page":31,"route":"","species":"","study_id":"sccs_o_285_noael_010"}

sccs_o_285.pdf

SOURCE_SUBDIR=sccs_o_285; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION ON the inhalation toxicity of the fragrance ingredient Acetylated Vetiver Oil – AVO (CAS No 84082-84-8, EC No 282-031-1); OPINION_NUMBER=SCCS/1663/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=58,330; EFFECT=Table 13 : SED calculation: Face cream | 0.1 | 12.8 | 58,330 | 4557; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"84082-84-8","citation":"","dose":"","duration":"","effect":"Table 13 : SED calculation: Face cream | 0.1 | 12.8 | 58,330 | 4557","endpoint":"","ingredient":"Vetiveria zizanioides ext., acetylated","loael_value":"","noael_unit":"","noael_value":"58,330","page":31,"route":"","species":"","study_id":"sccs_o_285_noael_011"}

sccs_o_285.pdf

SOURCE_SUBDIR=sccs_o_285; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION ON the inhalation toxicity of the fragrance ingredient Acetylated Vetiver Oil – AVO (CAS No 84082-84-8, EC No 282-031-1); OPINION_NUMBER=SCCS/1663/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=58,330; EFFECT=Table 13 : SED calculation: Hand Cream | 0.1 | 18 | 58,330 | 3241; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"84082-84-8","citation":"","dose":"","duration":"","effect":"Table 13 : SED calculation: Hand Cream | 0.1 | 18 | 58,330 | 3241","endpoint":"","ingredient":"Vetiveria zizanioides ext., acetylated","loael_value":"","noael_unit":"","noael_value":"58,330","page":31,"route":"","species":"","study_id":"sccs_o_285_noael_012"}

sccs_o_285.pdf

SOURCE_SUBDIR=sccs_o_285; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION ON the inhalation toxicity of the fragrance ingredient Acetylated Vetiver Oil – AVO (CAS No 84082-84-8, EC No 282-031-1); OPINION_NUMBER=SCCS/1663/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=58,330; EFFECT=Table 13 : SED calculation: Body lotion non- spray | 0.1 | 65.2 | 58,330 | 895; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"84082-84-8","citation":"","dose":"","duration":"","effect":"Table 13 : SED calculation: Body lotion non- spray | 0.1 | 65.2 | 58,330 | 895","endpoint":"","ingredient":"Vetiveria zizanioides ext., acetylated","loael_value":"","noael_unit":"","noael_value":"58,330","page":31,"route":"","species":"","study_id":"sccs_o_285_noael_013"}

sccs_o_285.pdf

SOURCE_SUBDIR=sccs_o_285; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION ON the inhalation toxicity of the fragrance ingredient Acetylated Vetiver Oil – AVO (CAS No 84082-84-8, EC No 282-031-1); OPINION_NUMBER=SCCS/1663/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=58,330; EFFECT=Table 13 : SED calculation: Bath cleansing* | 0.2 | 9 | 58,330 | 6481; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"84082-84-8","citation":"","dose":"","duration":"","effect":"Table 13 : SED calculation: Bath cleansing* | 0.2 | 9 | 58,330 | 6481","endpoint":"","ingredient":"Vetiveria zizanioides ext., acetylated","loael_value":"","noael_unit":"","noael_value":"58,330","page":31,"route":"","species":"","study_id":"sccs_o_285_noael_014"}

sccs_o_285.pdf

SOURCE_SUBDIR=sccs_o_285; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION ON the inhalation toxicity of the fragrance ingredient Acetylated Vetiver Oil – AVO (CAS No 84082-84-8, EC No 282-031-1); OPINION_NUMBER=SCCS/1663/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=58,330; EFFECT=Table 13 : SED calculation: Aggregated SED for consumer | 143.9 | 58,330 | 405; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"84082-84-8","citation":"","dose":"","duration":"","effect":"Table 13 : SED calculation: Aggregated SED for consumer | 143.9 | 58,330 | 405","endpoint":"","ingredient":"Vetiveria zizanioides ext., acetylated","loael_value":"","noael_unit":"","noael_value":"58,330","page":31,"route":"","species":"","study_id":"sccs_o_285_noael_015"}

sccs_o_285.pdf

SOURCE_SUBDIR=sccs_o_285; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION ON the inhalation toxicity of the fragrance ingredient Acetylated Vetiver Oil – AVO (CAS No 84082-84-8, EC No 282-031-1); OPINION_NUMBER=SCCS/1663/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=350; DOSE=8, EC No 282-031-1) in sprayable cosmetic products - Submission IV _________________________________________________________________________ ___________________________________________________________________________________________ 17 SCCS confirms the evaluation performed in Submission II, which considers as adverse effects the variations of c...; EFFECT=8, EC No 282-031-1) in sprayable cosmetic products - Submission IV _________________________________________________________________________ ___________________________________________________________________________________________ 17 SCCS confirms the evaluation performed in Submission II, which considers as adverse effects the variations of cholesterol, total protein and alanine transferase concentrations in females treated with 1000 mg/kg bw and the increase of absolute and relative liver weights identifying a NOAEL of 350 mg / kg bw for AVO. The SCCS noted that the NOAEL value was incorrectly reported as 300 mg/kg bw in Submission II instead of 350 mg/kg bw. Ref. 27 3.3.5.2 Sub-chronic (90 days) oral / dermal / inhalation toxicity / 3.3.5.3 Chronic (> 12 months) toxicity / 3.3.6 Reproductive toxicity / 3.3.7 Mutagenicity / genotoxicity 3.3.7.1 Mutagenicity / genotoxicity in vitro SCCS overall comment on in vitro mutagenicity/genotoxicity testing (from SCCS/1599/18) Based on available data and additional explanations; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"84082-84-8","citation":"","dose":"8, EC No 282-031-1) in sprayable cosmetic products - Submission IV _________________________________________________________________________ ___________________________________________________________________________________________ 17 SCCS confirms the evaluation performed in Submission II, which considers as adverse effects the variations of c...","duration":"Sub-chronic","effect":"8, EC No 282-031-1) in sprayable cosmetic products - Submission IV _________________________________________________________________________ ___________________________________________________________________________________________ 17 SCCS confirms the evaluation performed in Submission II, which considers as adverse effects the variations of cholesterol, total protein and alanine transferase concentrations in females treated with 1000 mg/kg bw and the increase of absolute and relative liver weights identifying a NOAEL of 350 mg / kg bw for AVO. The SCCS noted that the NOAEL value was incorrectly reported as 300 mg/kg bw in Submission II instead of 350 mg/kg bw. Ref. 27 3.3.5.2 Sub-chronic (90 days) oral / dermal / inhalation toxicity / 3.3.5.3 Chronic (> 12 months) toxicity / 3.3.6 Reproductive toxicity / 3.3.7 Mutagenicity / genotoxicity 3.3.7.1 Mutagenicity / genotoxicity in vitro SCCS overall comment on in vitro mutagenicity/genotoxicity testing (from SCCS/1599/18) Based on available data and additional explanations","endpoint":"repeated dose toxicity","ingredient":"Vetiveria zizanioides ext., acetylated","loael_value":"","noael_unit":"mg / kg bw","noael_value":"350","page":17,"route":"oral","species":"","study_id":"sccs_o_285_noael_001"}

sccs_o_285.pdf

SOURCE_SUBDIR=sccs_o_285; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION ON the inhalation toxicity of the fragrance ingredient Acetylated Vetiver Oil – AVO (CAS No 84082-84-8, EC No 282-031-1); OPINION_NUMBER=SCCS/1663/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=350; DOSE=ission IV _________________________________________________________________________ ___________________________________________________________________________________________ 17 SCCS confirms the evaluation performed in Submission II, which considers as adverse effects the variations of cholesterol, total protein and alanine transferase concent...; EFFECT=ission IV _________________________________________________________________________ ___________________________________________________________________________________________ 17 SCCS confirms the evaluation performed in Submission II, which considers as adverse effects the variations of cholesterol, total protein and alanine transferase concentrations in females treated with 1000 mg/kg bw and the increase of absolute and relative liver weights identifying a NOAEL of 350 mg / kg bw for AVO. The SCCS noted that the NOAEL value was incorrectly reported as 300 mg/kg bw in Submission II instead of 350 mg/kg bw. Ref. 27 3.3.5.2 Sub-chronic (90 days) oral / dermal / inhalation toxicity / 3.3.5.3 Chronic (> 12 months) toxicity / 3.3.6 Reproductive toxicity / 3.3.7 Mutagenicity / genotoxicity 3.3.7.1 Mutagenicity / genotoxicity in vitro SCCS overall comment on in vitro mutagenicity/genotoxicity testing (from SCCS/1599/18) Based on available data and additional explanations provided by the Applicant, the SCCS is of the following o; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"84082-84-8","citation":"","dose":"ission IV _________________________________________________________________________ ___________________________________________________________________________________________ 17 SCCS confirms the evaluation performed in Submission II, which considers as adverse effects the variations of cholesterol, total protein and alanine transferase concent...","duration":"Sub-chronic","effect":"ission IV _________________________________________________________________________ ___________________________________________________________________________________________ 17 SCCS confirms the evaluation performed in Submission II, which considers as adverse effects the variations of cholesterol, total protein and alanine transferase concentrations in females treated with 1000 mg/kg bw and the increase of absolute and relative liver weights identifying a NOAEL of 350 mg / kg bw for AVO. The SCCS noted that the NOAEL value was incorrectly reported as 300 mg/kg bw in Submission II instead of 350 mg/kg bw. Ref. 27 3.3.5.2 Sub-chronic (90 days) oral / dermal / inhalation toxicity / 3.3.5.3 Chronic (> 12 months) toxicity / 3.3.6 Reproductive toxicity / 3.3.7 Mutagenicity / genotoxicity 3.3.7.1 Mutagenicity / genotoxicity in vitro SCCS overall comment on in vitro mutagenicity/genotoxicity testing (from SCCS/1599/18) Based on available data and additional explanations provided by the Applicant, the SCCS is of the following o","endpoint":"repeated dose toxicity","ingredient":"Vetiveria zizanioides ext., acetylated","loael_value":"","noael_unit":"mg / kg bw","noael_value":"350","page":17,"route":"oral","species":"","study_id":"sccs_o_285_noael_002"}

sccs_o_285.pdf

SOURCE_SUBDIR=sccs_o_285; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION ON the inhalation toxicity of the fragrance ingredient Acetylated Vetiver Oil – AVO (CAS No 84082-84-8, EC No 282-031-1); OPINION_NUMBER=SCCS/1663/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 25 October 2024; VALUE_TEXT=350; DOSE=General toxicological evaluation In view of the data provided, the SCCS confirms the evaluation performed in Submission II considering as adverse effects the variations of cholesterol, total protein and alanine transferase concentrations in females treated with 1000 mg/kg bw and the increase of absolute and relative liver weights.; EFFECT=eptable for a plant-derived material of natural origin and, on the basis of this presumption, considered AVO as a single entity on which to assess the toxicity. General toxicological evaluation In view of the data provided, the SCCS confirms the evaluation performed in Submission II considering as adverse effects the variations of cholesterol, total protein and alanine transferase concentrations in females treated with 1000 mg/kg bw and the increase of absolute and relative liver weights. Based on these data, the NOAEL is set at 350 mg/kg bw. Skin sensitisation Based on the animal studies, AVO can be regarded as a moderate skin sensitiser. AVO did not induce skin sensitisation in human RIPT study. In the public literature there are no reports on sensitisation from AVO in humans. Considering the results of the HRIPT study and the fact that AVO has been used for years in cosmetics without evidence of sensitising potential, it is unlikely that AVO would cause contact allergy in humans. Inhalation exposure As part of the submissio; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"84082-84-8","citation":"","dose":"General toxicological evaluation In view of the data provided, the SCCS confirms the evaluation performed in Submission II considering as adverse effects the variations of cholesterol, total protein and alanine transferase concentrations in females treated with 1000 mg/kg bw and the increase of absolute and relative liver weights.","duration":"","effect":"eptable for a plant-derived material of natural origin and, on the basis of this presumption, considered AVO as a single entity on which to assess the toxicity. General toxicological evaluation In view of the data provided, the SCCS confirms the evaluation performed in Submission II considering as adverse effects the variations of cholesterol, total protein and alanine transferase concentrations in females treated with 1000 mg/kg bw and the increase of absolute and relative liver weights. Based on these data, the NOAEL is set at 350 mg/kg bw. Skin sensitisation Based on the animal studies, AVO can be regarded as a moderate skin sensitiser. AVO did not induce skin sensitisation in human RIPT study. In the public literature there are no reports on sensitisation from AVO in humans. Considering the results of the HRIPT study and the fact that AVO has been used for years in cosmetics without evidence of sensitising potential, it is unlikely that AVO would cause contact allergy in humans. Inhalation exposure As part of the submissio","endpoint":"sensitisation","ingredient":"Vetiveria zizanioides ext., acetylated","loael_value":"","noael_unit":"mg/kg bw","noael_value":"350","page":32,"route":"inhalation","species":"human","study_id":"sccs_o_285_noael_003"}

sccs_o_285.pdf