NOAEL Studies
Cosmetic Ingredient
Indigofera Tinctoria Leaf Extract NOAEL Studies
INCI: INDIGOFERA TINCTORIA LEAF EXTRACT
CAS: 84775-63-3
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
SCCS Opinion 12 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCS Opinion | NOAEL | =0.87 | mg/kg bw | rat | oral | 90 day | carcinogenicity | {"dose":"As there was no NOAEL, the applicant proposed back-calculations for a MOS of 100 (NOAEL/SED), assuming NOAEL of 0.87 mg/kg bw or a MOS of 1000 if the NOAEL was 8.7 mg/kg bw using the systemic exposure dose (SED) of 0.0087 mg/kg bw.","effect":"essary. Carcinogenicity No data submitted Comparison between the toxicology of leaf extract of Indigofera tinctoria and synthetic indigo (95% pure) is not feasible. The sole chemical information provided in this dossier is that the aqueous leaf extract of Indigofera tinctoria contains ~3% of the glycoside indican that hydrolyses to the aglycone, indigo and β-D-glucose. A complete chemical analysis of Indigofera tinctoria powder and knowledge of exposure from all of its constituents is required. As there was no NOAEL, the applicant proposed back-calculations for a MOS of 100 (NOAEL/SED), assuming NOAEL of 0.87 mg/kg bw or a MOS of 1000 if the NOAEL was 8.7 mg/kg bw using the systemic exposure dose (SED) of 0.0087 mg/kg bw. This SED was based on the percutaneous absorption of Indican (Indoxyl β-D-glucoside) through dermatomed pig skin in vitro. The applicant considered such low postulated NOAELs were unlikely, if compared with other plant powders (e.g. NOAEL of Lawsonia inermis = 40 mg/kg bw from a 90 day oral rat study). An ad","page":24,"pdf":"sccs_o_110.pdf","row_type":"noael_study","study_id":"sccs_o_110_noael_001"} |
| SCCS Opinion | NOAEL | =0.87 | mg/kg bw | rat | oral | 90 day | carcinogenicity | {"dose":"As there was no NOAEL, the applicant proposed back-calculations for a MOS of 100 (NOAEL/SED), assuming NOAEL of 0.87 mg/kg bw or a MOS of 1000 if the NOAEL was 8.7 mg/kg bw using the systemic exposure dose (SED) of 0.0087 mg/kg bw.","effect":"essary. Carcinogenicity No data submitted Comparison between the toxicology of leaf extract of Indigofera tinctoria and synthetic indigo (95% pure) is not feasible. The sole chemical information provided in this dossier is that the aqueous leaf extract of Indigofera tinctoria contains ~3% of the glycoside indican that hydrolyses to the aglycone, indigo and β-D-glucose. A complete chemical analysis of Indigofera tinctoria powder and knowledge of exposure from all of its constituents is required. As there was no NOAEL, the applicant proposed back-calculations for a MOS of 100 (NOAEL/SED), assuming NOAEL of 0.87 mg/kg bw or a MOS of 1000 if the NOAEL was 8.7 mg/kg bw using the systemic exposure dose (SED) of 0.0087 mg/kg bw. This SED was based on the percutaneous absorption of Indican (Indoxyl β-D-glucoside) through dermatomed pig skin in vitro. The applicant considered such low postulated NOAELs were unlikely, if compared with other plant powders (e.g. NOAEL of Lawsonia inermis = 40 mg/kg bw from a 90 day oral rat study). An ad","page":24,"pdf":"sccs_o_110.pdf","row_type":"noael_study","study_id":"sccs_o_110_noael_001"} |
| SCCS Opinion | NOAEL | =0.87 | mg/kg bw | rat | oral | 90 day | carcinogenicity | {"dose":"As there was no NOAEL, the applicant proposed back-calculations for a MOS of 100 (NOAEL/SED), assuming NOAEL of 0.87 mg/kg bw or a MOS of 1000 if the NOAEL was 8.7 mg/kg bw using the systemic exposure dose (SED) of 0.0087 mg/kg bw.","effect":"essary. Carcinogenicity No data submitted Comparison between the toxicology of leaf extract of Indigofera tinctoria and synthetic indigo (95% pure) is not feasible. The sole chemical information provided in this dossier is that the aqueous leaf extract of Indigofera tinctoria contains ~3% of the glycoside indican that hydrolyses to the aglycone, indigo and β-D-glucose. A complete chemical analysis of Indigofera tinctoria powder and knowledge of exposure from all of its constituents is required. As there was no NOAEL, the applicant proposed back-calculations for a MOS of 100 (NOAEL/SED), assuming NOAEL of 0.87 mg/kg bw or a MOS of 1000 if the NOAEL was 8.7 mg/kg bw using the systemic exposure dose (SED) of 0.0087 mg/kg bw. This SED was based on the percutaneous absorption of Indican (Indoxyl β-D-glucoside) through dermatomed pig skin in vitro. The applicant considered such low postulated NOAELs were unlikely, if compared with other plant powders (e.g. NOAEL of Lawsonia inermis = 40 mg/kg bw from a 90 day oral rat study). An ad","page":24,"pdf":"sccs_o_110.pdf","row_type":"noael_study","study_id":"sccs_o_110_noael_001"} |
| SCCS Opinion | NOAEL | =0.87 | mg/kg bw | rat | oral | 90 day | carcinogenicity | {"dose":"As there was no NOAEL, the applicant proposed back-calculations for a MOS of 100 (NOAEL/SED), assuming NOAEL of 0.87 mg/kg bw or a MOS of 1000 if the NOAEL was 8.7 mg/kg bw using the systemic exposure dose (SED) of 0.0087 mg/kg bw.","effect":"essary. Carcinogenicity No data submitted Comparison between the toxicology of leaf extract of Indigofera tinctoria and synthetic indigo (95% pure) is not feasible. The sole chemical information provided in this dossier is that the aqueous leaf extract of Indigofera tinctoria contains ~3% of the glycoside indican that hydrolyses to the aglycone, indigo and β-D-glucose. A complete chemical analysis of Indigofera tinctoria powder and knowledge of exposure from all of its constituents is required. As there was no NOAEL, the applicant proposed back-calculations for a MOS of 100 (NOAEL/SED), assuming NOAEL of 0.87 mg/kg bw or a MOS of 1000 if the NOAEL was 8.7 mg/kg bw using the systemic exposure dose (SED) of 0.0087 mg/kg bw. This SED was based on the percutaneous absorption of Indican (Indoxyl β-D-glucoside) through dermatomed pig skin in vitro. The applicant considered such low postulated NOAELs were unlikely, if compared with other plant powders (e.g. NOAEL of Lawsonia inermis = 40 mg/kg bw from a 90 day oral rat study). An ad","page":24,"pdf":"sccs_o_110.pdf","row_type":"noael_study","study_id":"sccs_o_110_noael_001"} |
| SCCS Opinion | NOAEL | =8.7 | mg/kg bw | rat | oral | 90 day | dermal absorption | {"dose":"As there was no NOAEL, the applicant proposed back-calculations for a MOS of 100 (NOAEL/SED), assuming NOAEL of 0.87 mg/kg bw or a MOS of 1000 if the NOAEL was 8.7 mg/kg bw using the systemic exposure dose (SED) of 0.0087 mg/kg bw.","effect":"indigo (95% pure) is not feasible. The sole chemical information provided in this dossier is that the aqueous leaf extract of Indigofera tinctoria contains ~3% of the glycoside indican that hydrolyses to the aglycone, indigo and β-D-glucose. A complete chemical analysis of Indigofera tinctoria powder and knowledge of exposure from all of its constituents is required. As there was no NOAEL, the applicant proposed back-calculations for a MOS of 100 (NOAEL/SED), assuming NOAEL of 0.87 mg/kg bw or a MOS of 1000 if the NOAEL was 8.7 mg/kg bw using the systemic exposure dose (SED) of 0.0087 mg/kg bw. This SED was based on the percutaneous absorption of Indican (Indoxyl β-D-glucoside) through dermatomed pig skin in vitro. The applicant considered such low postulated NOAELs were unlikely, if compared with other plant powders (e.g. NOAEL of Lawsonia inermis = 40 mg/kg bw from a 90 day oral rat study). An additional argument was that they considered the NOAEL would be much higher, especially for a plant powder used in traditional Chinese m","page":24,"pdf":"sccs_o_110.pdf","row_type":"noael_study","study_id":"sccs_o_110_noael_004"} |
| SCCS Opinion | NOAEL | =8.7 | mg/kg bw | rat | oral | 90 day | dermal absorption | {"dose":"As there was no NOAEL, the applicant proposed back-calculations for a MOS of 100 (NOAEL/SED), assuming NOAEL of 0.87 mg/kg bw or a MOS of 1000 if the NOAEL was 8.7 mg/kg bw using the systemic exposure dose (SED) of 0.0087 mg/kg bw.","effect":"indigo (95% pure) is not feasible. The sole chemical information provided in this dossier is that the aqueous leaf extract of Indigofera tinctoria contains ~3% of the glycoside indican that hydrolyses to the aglycone, indigo and β-D-glucose. A complete chemical analysis of Indigofera tinctoria powder and knowledge of exposure from all of its constituents is required. As there was no NOAEL, the applicant proposed back-calculations for a MOS of 100 (NOAEL/SED), assuming NOAEL of 0.87 mg/kg bw or a MOS of 1000 if the NOAEL was 8.7 mg/kg bw using the systemic exposure dose (SED) of 0.0087 mg/kg bw. This SED was based on the percutaneous absorption of Indican (Indoxyl β-D-glucoside) through dermatomed pig skin in vitro. The applicant considered such low postulated NOAELs were unlikely, if compared with other plant powders (e.g. NOAEL of Lawsonia inermis = 40 mg/kg bw from a 90 day oral rat study). An additional argument was that they considered the NOAEL would be much higher, especially for a plant powder used in traditional Chinese m","page":24,"pdf":"sccs_o_110.pdf","row_type":"noael_study","study_id":"sccs_o_110_noael_004"} |
| SCCS Opinion | NOAEL | =8.7 | mg/kg bw | rat | oral | 90 day | dermal absorption | {"dose":"As there was no NOAEL, the applicant proposed back-calculations for a MOS of 100 (NOAEL/SED), assuming NOAEL of 0.87 mg/kg bw or a MOS of 1000 if the NOAEL was 8.7 mg/kg bw using the systemic exposure dose (SED) of 0.0087 mg/kg bw.","effect":"indigo (95% pure) is not feasible. The sole chemical information provided in this dossier is that the aqueous leaf extract of Indigofera tinctoria contains ~3% of the glycoside indican that hydrolyses to the aglycone, indigo and β-D-glucose. A complete chemical analysis of Indigofera tinctoria powder and knowledge of exposure from all of its constituents is required. As there was no NOAEL, the applicant proposed back-calculations for a MOS of 100 (NOAEL/SED), assuming NOAEL of 0.87 mg/kg bw or a MOS of 1000 if the NOAEL was 8.7 mg/kg bw using the systemic exposure dose (SED) of 0.0087 mg/kg bw. This SED was based on the percutaneous absorption of Indican (Indoxyl β-D-glucoside) through dermatomed pig skin in vitro. The applicant considered such low postulated NOAELs were unlikely, if compared with other plant powders (e.g. NOAEL of Lawsonia inermis = 40 mg/kg bw from a 90 day oral rat study). An additional argument was that they considered the NOAEL would be much higher, especially for a plant powder used in traditional Chinese m","page":24,"pdf":"sccs_o_110.pdf","row_type":"noael_study","study_id":"sccs_o_110_noael_004"} |
| SCCS Opinion | NOAEL | =8.7 | mg/kg bw | rat | oral | 90 day | dermal absorption | {"dose":"As there was no NOAEL, the applicant proposed back-calculations for a MOS of 100 (NOAEL/SED), assuming NOAEL of 0.87 mg/kg bw or a MOS of 1000 if the NOAEL was 8.7 mg/kg bw using the systemic exposure dose (SED) of 0.0087 mg/kg bw.","effect":"indigo (95% pure) is not feasible. The sole chemical information provided in this dossier is that the aqueous leaf extract of Indigofera tinctoria contains ~3% of the glycoside indican that hydrolyses to the aglycone, indigo and β-D-glucose. A complete chemical analysis of Indigofera tinctoria powder and knowledge of exposure from all of its constituents is required. As there was no NOAEL, the applicant proposed back-calculations for a MOS of 100 (NOAEL/SED), assuming NOAEL of 0.87 mg/kg bw or a MOS of 1000 if the NOAEL was 8.7 mg/kg bw using the systemic exposure dose (SED) of 0.0087 mg/kg bw. This SED was based on the percutaneous absorption of Indican (Indoxyl β-D-glucoside) through dermatomed pig skin in vitro. The applicant considered such low postulated NOAELs were unlikely, if compared with other plant powders (e.g. NOAEL of Lawsonia inermis = 40 mg/kg bw from a 90 day oral rat study). An additional argument was that they considered the NOAEL would be much higher, especially for a plant powder used in traditional Chinese m","page":24,"pdf":"sccs_o_110.pdf","row_type":"noael_study","study_id":"sccs_o_110_noael_004"} |
| SCCS Opinion | NOAEL | =40 | mg/kg bw | rat | oral | 90 day | dermal absorption | {"dose":"As there was no NOAEL, the applicant proposed back-calculations for a MOS of 100 (NOAEL/SED), assuming NOAEL of 0.87 mg/kg bw or a MOS of 1000 if the NOAEL was 8.7 mg/kg bw using the systemic exposure dose (SED) of 0.0087 mg/kg bw.","effect":"of exposure from all of its constituents is required. As there was no NOAEL, the applicant proposed back-calculations for a MOS of 100 (NOAEL/SED), assuming NOAEL of 0.87 mg/kg bw or a MOS of 1000 if the NOAEL was 8.7 mg/kg bw using the systemic exposure dose (SED) of 0.0087 mg/kg bw. This SED was based on the percutaneous absorption of Indican (Indoxyl β-D-glucoside) through dermatomed pig skin in vitro. The applicant considered such low postulated NOAELs were unlikely, if compared with other plant powders (e.g. NOAEL of Lawsonia inermis = 40 mg/kg bw from a 90 day oral rat study). An additional argument was that they considered the NOAEL would be much higher, especially for a plant powder used in traditional Chinese medicine. The SCCS considered the argumentation, but felt extrapolation from such a poor knowledge base is invalid. 4. CONCLUSION The SCCS is of the opinion that the safety of Indigofera tinctoria used as a hair dye at a maximum concentration on the head of 25% cannot be assessed due to incomplete information.","page":24,"pdf":"sccs_o_110.pdf","row_type":"noael_study","study_id":"sccs_o_110_noael_005"} |
| SCCS Opinion | NOAEL | =40 | mg/kg bw | rat | oral | 90 day | dermal absorption | {"dose":"As there was no NOAEL, the applicant proposed back-calculations for a MOS of 100 (NOAEL/SED), assuming NOAEL of 0.87 mg/kg bw or a MOS of 1000 if the NOAEL was 8.7 mg/kg bw using the systemic exposure dose (SED) of 0.0087 mg/kg bw.","effect":"of exposure from all of its constituents is required. As there was no NOAEL, the applicant proposed back-calculations for a MOS of 100 (NOAEL/SED), assuming NOAEL of 0.87 mg/kg bw or a MOS of 1000 if the NOAEL was 8.7 mg/kg bw using the systemic exposure dose (SED) of 0.0087 mg/kg bw. This SED was based on the percutaneous absorption of Indican (Indoxyl β-D-glucoside) through dermatomed pig skin in vitro. The applicant considered such low postulated NOAELs were unlikely, if compared with other plant powders (e.g. NOAEL of Lawsonia inermis = 40 mg/kg bw from a 90 day oral rat study). An additional argument was that they considered the NOAEL would be much higher, especially for a plant powder used in traditional Chinese medicine. The SCCS considered the argumentation, but felt extrapolation from such a poor knowledge base is invalid. 4. CONCLUSION The SCCS is of the opinion that the safety of Indigofera tinctoria used as a hair dye at a maximum concentration on the head of 25% cannot be assessed due to incomplete information.","page":24,"pdf":"sccs_o_110.pdf","row_type":"noael_study","study_id":"sccs_o_110_noael_005"} |
| SCCS Opinion | NOAEL | =40 | mg/kg bw | rat | oral | 90 day | dermal absorption | {"dose":"As there was no NOAEL, the applicant proposed back-calculations for a MOS of 100 (NOAEL/SED), assuming NOAEL of 0.87 mg/kg bw or a MOS of 1000 if the NOAEL was 8.7 mg/kg bw using the systemic exposure dose (SED) of 0.0087 mg/kg bw.","effect":"of exposure from all of its constituents is required. As there was no NOAEL, the applicant proposed back-calculations for a MOS of 100 (NOAEL/SED), assuming NOAEL of 0.87 mg/kg bw or a MOS of 1000 if the NOAEL was 8.7 mg/kg bw using the systemic exposure dose (SED) of 0.0087 mg/kg bw. This SED was based on the percutaneous absorption of Indican (Indoxyl β-D-glucoside) through dermatomed pig skin in vitro. The applicant considered such low postulated NOAELs were unlikely, if compared with other plant powders (e.g. NOAEL of Lawsonia inermis = 40 mg/kg bw from a 90 day oral rat study). An additional argument was that they considered the NOAEL would be much higher, especially for a plant powder used in traditional Chinese medicine. The SCCS considered the argumentation, but felt extrapolation from such a poor knowledge base is invalid. 4. CONCLUSION The SCCS is of the opinion that the safety of Indigofera tinctoria used as a hair dye at a maximum concentration on the head of 25% cannot be assessed due to incomplete information.","page":24,"pdf":"sccs_o_110.pdf","row_type":"noael_study","study_id":"sccs_o_110_noael_005"} |
| SCCS Opinion | NOAEL | =40 | mg/kg bw | rat | oral | 90 day | dermal absorption | {"dose":"As there was no NOAEL, the applicant proposed back-calculations for a MOS of 100 (NOAEL/SED), assuming NOAEL of 0.87 mg/kg bw or a MOS of 1000 if the NOAEL was 8.7 mg/kg bw using the systemic exposure dose (SED) of 0.0087 mg/kg bw.","effect":"of exposure from all of its constituents is required. As there was no NOAEL, the applicant proposed back-calculations for a MOS of 100 (NOAEL/SED), assuming NOAEL of 0.87 mg/kg bw or a MOS of 1000 if the NOAEL was 8.7 mg/kg bw using the systemic exposure dose (SED) of 0.0087 mg/kg bw. This SED was based on the percutaneous absorption of Indican (Indoxyl β-D-glucoside) through dermatomed pig skin in vitro. The applicant considered such low postulated NOAELs were unlikely, if compared with other plant powders (e.g. NOAEL of Lawsonia inermis = 40 mg/kg bw from a 90 day oral rat study). An additional argument was that they considered the NOAEL would be much higher, especially for a plant powder used in traditional Chinese medicine. The SCCS considered the argumentation, but felt extrapolation from such a poor knowledge base is invalid. 4. CONCLUSION The SCCS is of the opinion that the safety of Indigofera tinctoria used as a hair dye at a maximum concentration on the head of 25% cannot be assessed due to incomplete information.","page":24,"pdf":"sccs_o_110.pdf","row_type":"noael_study","study_id":"sccs_o_110_noael_005"} |
Regulatory source 6 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| Regulatory source | carcinogenicity | 0.87 | mg/kg bw | rat | oral | 90 day | carcinogenicity | SOURCE_SUBDIR=sccs_o_110; REPORT_TITLE=OPINION ON Indigofera tinctoria COLIPA n° C170; OPINION_NUMBER=SCCS/1439/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 September 2012; VALUE_TEXT=0.87; DOSE=As there was no NOAEL, the applicant proposed back-calculations for a MOS of 100 (NOAEL/SED), assuming NOAEL of 0.87 mg/kg bw or a MOS of 1000 if the NOAEL was 8.7 mg/kg bw using the systemic exposure dose (SED) of 0.0087 mg/kg bw.; EFFECT=essary. Carcinogenicity No data submitted Comparison between the toxicology of leaf extract of Indigofera tinctoria and synthetic indigo (95% pure) is not feasible. The sole chemical information provided in this dossier is that the aqueous leaf extract of Indigofera tinctoria contains ~3% of the glycoside indican that hydrolyses to the aglycone, indigo and β-D-glucose. A complete chemical analysis of Indigofera tinctoria powder and knowledge of exposure from all of its constituents is required. As there was no NOAEL, the applicant proposed back-calculations for a MOS of 100 (NOAEL/SED), assuming NOAEL of 0.87 mg/kg bw or a MOS of 1000 if the NOAEL was 8.7 mg/kg bw using the systemic exposure dose (SED) of 0.0087 mg/kg bw. This SED was based on the percutaneous absorption of Indican (Indoxyl β-D-glucoside) through dermatomed pig skin in vitro. The applicant considered such low postulated NOAELs were unlikely, if compared with other plant powders (e.g. NOAEL of Lawsonia inermis = 40 mg/kg bw from a 90 day oral rat study). An ad; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"84775-63-3","citation":"","dose":"As there was no NOAEL, the applicant proposed back-calculations for a MOS of 100 (NOAEL/SED), assuming NOAEL of 0.87 mg/kg bw or a MOS of 1000 if the NOAEL was 8.7 mg/kg bw using the systemic exposure dose (SED) of 0.0087 mg/kg bw.","duration":"90 day","effect":"essary. Carcinogenicity No data submitted Comparison between the toxicology of leaf extract of Indigofera tinctoria and synthetic indigo (95% pure) is not feasible. The sole chemical information provided in this dossier is that the aqueous leaf extract of Indigofera tinctoria contains ~3% of the glycoside indican that hydrolyses to the aglycone, indigo and β-D-glucose. A complete chemical analysis of Indigofera tinctoria powder and knowledge of exposure from all of its constituents is required. As there was no NOAEL, the applicant proposed back-calculations for a MOS of 100 (NOAEL/SED), assuming NOAEL of 0.87 mg/kg bw or a MOS of 1000 if the NOAEL was 8.7 mg/kg bw using the systemic exposure dose (SED) of 0.0087 mg/kg bw. This SED was based on the percutaneous absorption of Indican (Indoxyl β-D-glucoside) through dermatomed pig skin in vitro. The applicant considered such low postulated NOAELs were unlikely, if compared with other plant powders (e.g. NOAEL of Lawsonia inermis = 40 mg/kg bw from a 90 day oral rat study). An ad","endpoint":"carcinogenicity","ingredient":"Indigofera tinctoria","loael_value":"","noael_unit":"mg/kg bw","noael_value":"0.87","page":24,"route":"oral","species":"rat","study_id":"sccs_o_110_noael_001"} |
| Regulatory source | dermal absorption | 0.87 | mg/kg bw | rat | oral | 90 day | dermal absorption | SOURCE_SUBDIR=sccs_o_110; REPORT_TITLE=OPINION ON Indigofera tinctoria COLIPA n° C170; OPINION_NUMBER=SCCS/1439/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 September 2012; VALUE_TEXT=0.87; DOSE=As there was no NOAEL, the applicant proposed back-calculations for a MOS of 100 (NOAEL/SED), assuming NOAEL of 0.87 mg/kg bw or a MOS of 1000 if the NOAEL was 8.7 mg/kg bw using the systemic exposure dose (SED) of 0.0087 mg/kg bw.; EFFECT=he toxicology of leaf extract of Indigofera tinctoria and synthetic indigo (95% pure) is not feasible. The sole chemical information provided in this dossier is that the aqueous leaf extract of Indigofera tinctoria contains ~3% of the glycoside indican that hydrolyses to the aglycone, indigo and β-D-glucose. A complete chemical analysis of Indigofera tinctoria powder and knowledge of exposure from all of its constituents is required. As there was no NOAEL, the applicant proposed back-calculations for a MOS of 100 (NOAEL/SED), assuming NOAEL of 0.87 mg/kg bw or a MOS of 1000 if the NOAEL was 8.7 mg/kg bw using the systemic exposure dose (SED) of 0.0087 mg/kg bw. This SED was based on the percutaneous absorption of Indican (Indoxyl β-D-glucoside) through dermatomed pig skin in vitro. The applicant considered such low postulated NOAELs were unlikely, if compared with other plant powders (e.g. NOAEL of Lawsonia inermis = 40 mg/kg bw from a 90 day oral rat study). An additional argument was that they considered the NOAEL would be much; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"84775-63-3","citation":"","dose":"As there was no NOAEL, the applicant proposed back-calculations for a MOS of 100 (NOAEL/SED), assuming NOAEL of 0.87 mg/kg bw or a MOS of 1000 if the NOAEL was 8.7 mg/kg bw using the systemic exposure dose (SED) of 0.0087 mg/kg bw.","duration":"90 day","effect":"he toxicology of leaf extract of Indigofera tinctoria and synthetic indigo (95% pure) is not feasible. The sole chemical information provided in this dossier is that the aqueous leaf extract of Indigofera tinctoria contains ~3% of the glycoside indican that hydrolyses to the aglycone, indigo and β-D-glucose. A complete chemical analysis of Indigofera tinctoria powder and knowledge of exposure from all of its constituents is required. As there was no NOAEL, the applicant proposed back-calculations for a MOS of 100 (NOAEL/SED), assuming NOAEL of 0.87 mg/kg bw or a MOS of 1000 if the NOAEL was 8.7 mg/kg bw using the systemic exposure dose (SED) of 0.0087 mg/kg bw. This SED was based on the percutaneous absorption of Indican (Indoxyl β-D-glucoside) through dermatomed pig skin in vitro. The applicant considered such low postulated NOAELs were unlikely, if compared with other plant powders (e.g. NOAEL of Lawsonia inermis = 40 mg/kg bw from a 90 day oral rat study). An additional argument was that they considered the NOAEL would be much","endpoint":"dermal absorption","ingredient":"Indigofera tinctoria","loael_value":"","noael_unit":"mg/kg bw","noael_value":"0.87","page":24,"route":"oral","species":"rat","study_id":"sccs_o_110_noael_002"} |
| Regulatory source | dermal absorption | 0.87 | mg/kg bw | rat | oral | 90 day | dermal absorption | SOURCE_SUBDIR=sccs_o_110; REPORT_TITLE=OPINION ON Indigofera tinctoria COLIPA n° C170; OPINION_NUMBER=SCCS/1439/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 September 2012; VALUE_TEXT=0.87; DOSE=As there was no NOAEL, the applicant proposed back-calculations for a MOS of 100 (NOAEL/SED), assuming NOAEL of 0.87 mg/kg bw or a MOS of 1000 if the NOAEL was 8.7 mg/kg bw using the systemic exposure dose (SED) of 0.0087 mg/kg bw.; EFFECT=extract of Indigofera tinctoria and synthetic indigo (95% pure) is not feasible. The sole chemical information provided in this dossier is that the aqueous leaf extract of Indigofera tinctoria contains ~3% of the glycoside indican that hydrolyses to the aglycone, indigo and β-D-glucose. A complete chemical analysis of Indigofera tinctoria powder and knowledge of exposure from all of its constituents is required. As there was no NOAEL, the applicant proposed back-calculations for a MOS of 100 (NOAEL/SED), assuming NOAEL of 0.87 mg/kg bw or a MOS of 1000 if the NOAEL was 8.7 mg/kg bw using the systemic exposure dose (SED) of 0.0087 mg/kg bw. This SED was based on the percutaneous absorption of Indican (Indoxyl β-D-glucoside) through dermatomed pig skin in vitro. The applicant considered such low postulated NOAELs were unlikely, if compared with other plant powders (e.g. NOAEL of Lawsonia inermis = 40 mg/kg bw from a 90 day oral rat study). An additional argument was that they considered the NOAEL would be much higher, especially f; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"84775-63-3","citation":"","dose":"As there was no NOAEL, the applicant proposed back-calculations for a MOS of 100 (NOAEL/SED), assuming NOAEL of 0.87 mg/kg bw or a MOS of 1000 if the NOAEL was 8.7 mg/kg bw using the systemic exposure dose (SED) of 0.0087 mg/kg bw.","duration":"90 day","effect":"extract of Indigofera tinctoria and synthetic indigo (95% pure) is not feasible. The sole chemical information provided in this dossier is that the aqueous leaf extract of Indigofera tinctoria contains ~3% of the glycoside indican that hydrolyses to the aglycone, indigo and β-D-glucose. A complete chemical analysis of Indigofera tinctoria powder and knowledge of exposure from all of its constituents is required. As there was no NOAEL, the applicant proposed back-calculations for a MOS of 100 (NOAEL/SED), assuming NOAEL of 0.87 mg/kg bw or a MOS of 1000 if the NOAEL was 8.7 mg/kg bw using the systemic exposure dose (SED) of 0.0087 mg/kg bw. This SED was based on the percutaneous absorption of Indican (Indoxyl β-D-glucoside) through dermatomed pig skin in vitro. The applicant considered such low postulated NOAELs were unlikely, if compared with other plant powders (e.g. NOAEL of Lawsonia inermis = 40 mg/kg bw from a 90 day oral rat study). An additional argument was that they considered the NOAEL would be much higher, especially f","endpoint":"dermal absorption","ingredient":"Indigofera tinctoria","loael_value":"","noael_unit":"mg/kg bw","noael_value":"0.87","page":24,"route":"oral","species":"rat","study_id":"sccs_o_110_noael_003"} |
| Regulatory source | dermal absorption | 8.7 | mg/kg bw | rat | oral | 90 day | dermal absorption | SOURCE_SUBDIR=sccs_o_110; REPORT_TITLE=OPINION ON Indigofera tinctoria COLIPA n° C170; OPINION_NUMBER=SCCS/1439/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 September 2012; VALUE_TEXT=8.7; DOSE=As there was no NOAEL, the applicant proposed back-calculations for a MOS of 100 (NOAEL/SED), assuming NOAEL of 0.87 mg/kg bw or a MOS of 1000 if the NOAEL was 8.7 mg/kg bw using the systemic exposure dose (SED) of 0.0087 mg/kg bw.; EFFECT=indigo (95% pure) is not feasible. The sole chemical information provided in this dossier is that the aqueous leaf extract of Indigofera tinctoria contains ~3% of the glycoside indican that hydrolyses to the aglycone, indigo and β-D-glucose. A complete chemical analysis of Indigofera tinctoria powder and knowledge of exposure from all of its constituents is required. As there was no NOAEL, the applicant proposed back-calculations for a MOS of 100 (NOAEL/SED), assuming NOAEL of 0.87 mg/kg bw or a MOS of 1000 if the NOAEL was 8.7 mg/kg bw using the systemic exposure dose (SED) of 0.0087 mg/kg bw. This SED was based on the percutaneous absorption of Indican (Indoxyl β-D-glucoside) through dermatomed pig skin in vitro. The applicant considered such low postulated NOAELs were unlikely, if compared with other plant powders (e.g. NOAEL of Lawsonia inermis = 40 mg/kg bw from a 90 day oral rat study). An additional argument was that they considered the NOAEL would be much higher, especially for a plant powder used in traditional Chinese m; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"84775-63-3","citation":"","dose":"As there was no NOAEL, the applicant proposed back-calculations for a MOS of 100 (NOAEL/SED), assuming NOAEL of 0.87 mg/kg bw or a MOS of 1000 if the NOAEL was 8.7 mg/kg bw using the systemic exposure dose (SED) of 0.0087 mg/kg bw.","duration":"90 day","effect":"indigo (95% pure) is not feasible. The sole chemical information provided in this dossier is that the aqueous leaf extract of Indigofera tinctoria contains ~3% of the glycoside indican that hydrolyses to the aglycone, indigo and β-D-glucose. A complete chemical analysis of Indigofera tinctoria powder and knowledge of exposure from all of its constituents is required. As there was no NOAEL, the applicant proposed back-calculations for a MOS of 100 (NOAEL/SED), assuming NOAEL of 0.87 mg/kg bw or a MOS of 1000 if the NOAEL was 8.7 mg/kg bw using the systemic exposure dose (SED) of 0.0087 mg/kg bw. This SED was based on the percutaneous absorption of Indican (Indoxyl β-D-glucoside) through dermatomed pig skin in vitro. The applicant considered such low postulated NOAELs were unlikely, if compared with other plant powders (e.g. NOAEL of Lawsonia inermis = 40 mg/kg bw from a 90 day oral rat study). An additional argument was that they considered the NOAEL would be much higher, especially for a plant powder used in traditional Chinese m","endpoint":"dermal absorption","ingredient":"Indigofera tinctoria","loael_value":"","noael_unit":"mg/kg bw","noael_value":"8.7","page":24,"route":"oral","species":"rat","study_id":"sccs_o_110_noael_004"} |
| Regulatory source | dermal absorption | =40 | mg/kg bw | rat | oral | 90 day | dermal absorption | SOURCE_SUBDIR=sccs_o_110; REPORT_TITLE=OPINION ON Indigofera tinctoria COLIPA n° C170; OPINION_NUMBER=SCCS/1439/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 September 2012; VALUE_TEXT== 40; DOSE=As there was no NOAEL, the applicant proposed back-calculations for a MOS of 100 (NOAEL/SED), assuming NOAEL of 0.87 mg/kg bw or a MOS of 1000 if the NOAEL was 8.7 mg/kg bw using the systemic exposure dose (SED) of 0.0087 mg/kg bw.; EFFECT=of exposure from all of its constituents is required. As there was no NOAEL, the applicant proposed back-calculations for a MOS of 100 (NOAEL/SED), assuming NOAEL of 0.87 mg/kg bw or a MOS of 1000 if the NOAEL was 8.7 mg/kg bw using the systemic exposure dose (SED) of 0.0087 mg/kg bw. This SED was based on the percutaneous absorption of Indican (Indoxyl β-D-glucoside) through dermatomed pig skin in vitro. The applicant considered such low postulated NOAELs were unlikely, if compared with other plant powders (e.g. NOAEL of Lawsonia inermis = 40 mg/kg bw from a 90 day oral rat study). An additional argument was that they considered the NOAEL would be much higher, especially for a plant powder used in traditional Chinese medicine. The SCCS considered the argumentation, but felt extrapolation from such a poor knowledge base is invalid. 4. CONCLUSION The SCCS is of the opinion that the safety of Indigofera tinctoria used as a hair dye at a maximum concentration on the head of 25% cannot be assessed due to incomplete information.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"84775-63-3","citation":"","dose":"As there was no NOAEL, the applicant proposed back-calculations for a MOS of 100 (NOAEL/SED), assuming NOAEL of 0.87 mg/kg bw or a MOS of 1000 if the NOAEL was 8.7 mg/kg bw using the systemic exposure dose (SED) of 0.0087 mg/kg bw.","duration":"90 day","effect":"of exposure from all of its constituents is required. As there was no NOAEL, the applicant proposed back-calculations for a MOS of 100 (NOAEL/SED), assuming NOAEL of 0.87 mg/kg bw or a MOS of 1000 if the NOAEL was 8.7 mg/kg bw using the systemic exposure dose (SED) of 0.0087 mg/kg bw. This SED was based on the percutaneous absorption of Indican (Indoxyl β-D-glucoside) through dermatomed pig skin in vitro. The applicant considered such low postulated NOAELs were unlikely, if compared with other plant powders (e.g. NOAEL of Lawsonia inermis = 40 mg/kg bw from a 90 day oral rat study). An additional argument was that they considered the NOAEL would be much higher, especially for a plant powder used in traditional Chinese medicine. The SCCS considered the argumentation, but felt extrapolation from such a poor knowledge base is invalid. 4. CONCLUSION The SCCS is of the opinion that the safety of Indigofera tinctoria used as a hair dye at a maximum concentration on the head of 25% cannot be assessed due to incomplete information.","endpoint":"dermal absorption","ingredient":"Indigofera tinctoria","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 40","page":24,"route":"oral","species":"rat","study_id":"sccs_o_110_noael_005"} |
| Regulatory source | dermal absorption | =40 | mg/kg bw | rat | oral | 90 day | dermal absorption | SOURCE_SUBDIR=sccs_o_110; REPORT_TITLE=OPINION ON Indigofera tinctoria COLIPA n° C170; OPINION_NUMBER=SCCS/1439/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 September 2012; VALUE_TEXT== 40; DOSE=a MOS of 100 (NOAEL/SED), assuming NOAEL of 0.87 mg/kg bw or a MOS of 1000 if the NOAEL was 8.7 mg/kg bw using the systemic exposure dose (SED) of 0.0087 mg/kg bw.; EFFECT=a MOS of 100 (NOAEL/SED), assuming NOAEL of 0.87 mg/kg bw or a MOS of 1000 if the NOAEL was 8.7 mg/kg bw using the systemic exposure dose (SED) of 0.0087 mg/kg bw. This SED was based on the percutaneous absorption of Indican (Indoxyl β-D-glucoside) through dermatomed pig skin in vitro. The applicant considered such low postulated NOAELs were unlikely, if compared with other plant powders (e.g. NOAEL of Lawsonia inermis = 40 mg/kg bw from a 90 day oral rat study). An additional argument was that they considered the NOAEL would be much higher, especially for a plant powder used in traditional Chinese medicine. The SCCS considered the argumentation, but felt extrapolation from such a poor knowledge base is invalid. 4. CONCLUSION The SCCS is of the opinion that the safety of Indigofera tinctoria used as a hair dye at a maximum concentration on the head of 25% cannot be assessed due to incomplete information. The safety of Indigo (CI 73 000) used as a colorant should be re-assessed. 5. MINORITY OPINION Not applicable 6. REFER; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"84775-63-3","citation":"","dose":"a MOS of 100 (NOAEL/SED), assuming NOAEL of 0.87 mg/kg bw or a MOS of 1000 if the NOAEL was 8.7 mg/kg bw using the systemic exposure dose (SED) of 0.0087 mg/kg bw.","duration":"90 day","effect":"a MOS of 100 (NOAEL/SED), assuming NOAEL of 0.87 mg/kg bw or a MOS of 1000 if the NOAEL was 8.7 mg/kg bw using the systemic exposure dose (SED) of 0.0087 mg/kg bw. This SED was based on the percutaneous absorption of Indican (Indoxyl β-D-glucoside) through dermatomed pig skin in vitro. The applicant considered such low postulated NOAELs were unlikely, if compared with other plant powders (e.g. NOAEL of Lawsonia inermis = 40 mg/kg bw from a 90 day oral rat study). An additional argument was that they considered the NOAEL would be much higher, especially for a plant powder used in traditional Chinese medicine. The SCCS considered the argumentation, but felt extrapolation from such a poor knowledge base is invalid. 4. CONCLUSION The SCCS is of the opinion that the safety of Indigofera tinctoria used as a hair dye at a maximum concentration on the head of 25% cannot be assessed due to incomplete information. The safety of Indigo (CI 73 000) used as a colorant should be re-assessed. 5. MINORITY OPINION Not applicable 6. REFER","endpoint":"dermal absorption","ingredient":"Indigofera tinctoria","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 40","page":24,"route":"oral","species":"rat","study_id":"sccs_o_110_noael_006"} |