NOAEL Studies Cosmetic Ingredient

Lawsonia Inermis Callus Culture Extract NOAEL Studies

INCI: LAWSONIA INERMIS CALLUS CULTURE EXTRACT

CAS: 84988-66-9

Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.

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SCCNFP_vision_codex 16 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCNFP_vision_codex NOAEL =40 mg/kg bw - - - irritation {"citation":"Ref. : 3 2","dose":"In the high dose group, minimal to moderate accumulation of acidophilic globules in the cortical tubular epithelium of the kidneys were recorded and were considered to be treatment- related.","effect":"leen. In the high dose group, minimal to moderate accumulation of acidophilic globules in the cortical tubular epithelium of the kidneys were recorded and were considered to be treatment- related. In the 200 mg/kg/day and in the 1000 mg/kg/day groups, minimal to slight hemosiderosis and some extramedullary hemopoiesis were noted in the spleen. Except for the hemosiderosis in the spleen and the dying effects in the high dose group, all findings were reversible during the recovery period. Based on these results, the NOAEL (No-Observed-Adverse-Effect-Level) of Henna Rot was established to be 40 mg/kg bw. Ref. : 3 2.4. Irritation & corrosivity","page":5,"pdf":"out178_en.pdf","row_type":"noael_study","study_id":"out178_en_noael_001"}
SCCNFP_vision_codex NOAEL =200 mg/kg/day rat - - dermal absorption {"citation":"Ref. : 12 2","dose":"Lawsonia inermis, Henna ____________________________________________________________________________________________ 9 increase in reduced ossification of the 1st to 4th metatarsals and of the pubic bone were noted in the 1000 mg/kg/day group.","effect":"SCCNFP/0505/01, final Evaluation and opinion on : Lawsonia inermis, Henna ____________________________________________________________________________________________ 9 increase in reduced ossification of the 1st to 4th metatarsals and of the pubic bone were noted in the 1000 mg/kg/day group. These foetal findings recorded at 200 and 1000 mg/kg/day were considered by investigators to be probably treatment-related. Under the experimental conditions adopted, the NOAEL of the test product, Henna Rot, was established at 200 mg/kg/day for the pregnant female rats and at 40 mg/kg/day for the rats foetuses. Ref. : 12 2.7. Toxicokinetics (incl. Percutaneous Absorption) Percutaneous absorption in vitro Guideline : Not available Tissue : Isolated pig skin, frozen samples (-20°) Method : Permeation chambers (flow through system) Test substance : 2-hydroxy-1,4-naphthoquinone (C146) (purity 98%) and 25% Lawsonia powder in aqueous preparation Batch no : Not given Dose levels : 2% C146 etha","page":9,"pdf":"out178_en.pdf","row_type":"noael_study","study_id":"out178_en_noael_003"}
SCCNFP_vision_codex NOAEL =20 % rabbit dermal - dermal absorption {"dose":"Lawsonia inermis, Henna ____________________________________________________________________________________________ 14 NOT APPLICABLE Based on a usage volume of … ml, containing at maximum … % Maximum amount of ingredient applied I (mg) = mg Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = % Dermal absorption per...","effect":"SCCNFP/0505/01, final Evaluation and opinion on : Lawsonia inermis, Henna ____________________________________________________________________________________________ 14 NOT APPLICABLE Based on a usage volume of … ml, containing at maximum … % Maximum amount of ingredient applied I (mg) = mg Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = % Dermal absorption per treatment I x A = mg Systemic exposure dose (SED) I x A / 60 kg = mg No observed adverse effect level (mg/kg) NOAEL = mg/kg bw (species, route of application) Margin of Safety NOAEL / SED = 2.12. Conclusions Lawsonia inermis (Henna Rot) is not properly characterised. It is derived from dried powdered leaves of the specified plant and is intended to be used as a hair dye at a maximal concentration of 20 %, based on the staining properties of the main active ingredient 2-hydroxy-1,4- naphthoquinone. * Lawsonia inermis is not irritant for the rabbit skin and eye. Lawsonia inermis 10 % in petrolatum was considered not","page":14,"pdf":"out178_en.pdf","row_type":"noael_study","study_id":"out178_en_noael_004"}
SCCNFP_vision_codex NOAEL =40 mg/kg/day rat oral sub-chronic repeated dose toxicity {"dose":"Few case reports on contact allergies are published. * Based on the results obtained from the sub-chronic toxicity study conducted by oral route in the rat, the NOAEL of 40 mg/kg/day for embryo-toxicity and of 200 mg/kg/day for maternal toxicity was obtained. * Several mutagenicity/genotoxicity assays have been performed.","effect":"0 %, based on the staining properties of the main active ingredient 2-hydroxy-1,4- naphthoquinone. * Lawsonia inermis is not irritant for the rabbit skin and eye. Lawsonia inermis 10 % in petrolatum was considered not irritating on human skin after repeated insult patch tests. * Lawsonia inermis can be considered a weak sensitiser in the conditions of use. Few case reports on contact allergies are published. * Based on the results obtained from the sub-chronic toxicity study conducted by oral route in the rat, the NOAEL of 40 mg/kg/day for embryo-toxicity and of 200 mg/kg/day for maternal toxicity was obtained. * Several mutagenicity/genotoxicity assays have been performed. Positive reactions were observed only with mouse lymphoma assay and with metaphase analysis in human lymphocytes assay. Negative results have been observed with all other in vitro tests and with the in vivo micronucleus test in mice. However, Henna Rot contains 1,4-naphthoquinone which appears to be a genotoxic chemical. Moreover, the sample of Henna Rot which","page":14,"pdf":"out178_en.pdf","row_type":"noael_study","study_id":"out178_en_noael_006"}
SCCNFP_vision_codex NOAEL =40 mg/kg bw - - - irritation {"citation":"Ref. : 3 2","dose":"In the high dose group, minimal to moderate accumulation of acidophilic globules in the cortical tubular epithelium of the kidneys were recorded and were considered to be treatment- related.","effect":"leen. In the high dose group, minimal to moderate accumulation of acidophilic globules in the cortical tubular epithelium of the kidneys were recorded and were considered to be treatment- related. In the 200 mg/kg/day and in the 1000 mg/kg/day groups, minimal to slight hemosiderosis and some extramedullary hemopoiesis were noted in the spleen. Except for the hemosiderosis in the spleen and the dying effects in the high dose group, all findings were reversible during the recovery period. Based on these results, the NOAEL (No-Observed-Adverse-Effect-Level) of Henna Rot was established to be 40 mg/kg bw. Ref. : 3 2.4. Irritation & corrosivity","page":5,"pdf":"out178_en.pdf","row_type":"noael_study","study_id":"out178_en_noael_001"}
SCCNFP_vision_codex NOAEL =200 mg/kg/day rat - - dermal absorption {"citation":"Ref. : 12 2","dose":"Lawsonia inermis, Henna ____________________________________________________________________________________________ 9 increase in reduced ossification of the 1st to 4th metatarsals and of the pubic bone were noted in the 1000 mg/kg/day group.","effect":"SCCNFP/0505/01, final Evaluation and opinion on : Lawsonia inermis, Henna ____________________________________________________________________________________________ 9 increase in reduced ossification of the 1st to 4th metatarsals and of the pubic bone were noted in the 1000 mg/kg/day group. These foetal findings recorded at 200 and 1000 mg/kg/day were considered by investigators to be probably treatment-related. Under the experimental conditions adopted, the NOAEL of the test product, Henna Rot, was established at 200 mg/kg/day for the pregnant female rats and at 40 mg/kg/day for the rats foetuses. Ref. : 12 2.7. Toxicokinetics (incl. Percutaneous Absorption) Percutaneous absorption in vitro Guideline : Not available Tissue : Isolated pig skin, frozen samples (-20°) Method : Permeation chambers (flow through system) Test substance : 2-hydroxy-1,4-naphthoquinone (C146) (purity 98%) and 25% Lawsonia powder in aqueous preparation Batch no : Not given Dose levels : 2% C146 etha","page":9,"pdf":"out178_en.pdf","row_type":"noael_study","study_id":"out178_en_noael_003"}
SCCNFP_vision_codex NOAEL =20 % rabbit dermal - dermal absorption {"dose":"Lawsonia inermis, Henna ____________________________________________________________________________________________ 14 NOT APPLICABLE Based on a usage volume of … ml, containing at maximum … % Maximum amount of ingredient applied I (mg) = mg Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = % Dermal absorption per...","effect":"SCCNFP/0505/01, final Evaluation and opinion on : Lawsonia inermis, Henna ____________________________________________________________________________________________ 14 NOT APPLICABLE Based on a usage volume of … ml, containing at maximum … % Maximum amount of ingredient applied I (mg) = mg Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = % Dermal absorption per treatment I x A = mg Systemic exposure dose (SED) I x A / 60 kg = mg No observed adverse effect level (mg/kg) NOAEL = mg/kg bw (species, route of application) Margin of Safety NOAEL / SED = 2.12. Conclusions Lawsonia inermis (Henna Rot) is not properly characterised. It is derived from dried powdered leaves of the specified plant and is intended to be used as a hair dye at a maximal concentration of 20 %, based on the staining properties of the main active ingredient 2-hydroxy-1,4- naphthoquinone. * Lawsonia inermis is not irritant for the rabbit skin and eye. Lawsonia inermis 10 % in petrolatum was considered not","page":14,"pdf":"out178_en.pdf","row_type":"noael_study","study_id":"out178_en_noael_004"}
SCCNFP_vision_codex NOAEL =40 mg/kg/day rat oral sub-chronic repeated dose toxicity {"dose":"Few case reports on contact allergies are published. * Based on the results obtained from the sub-chronic toxicity study conducted by oral route in the rat, the NOAEL of 40 mg/kg/day for embryo-toxicity and of 200 mg/kg/day for maternal toxicity was obtained. * Several mutagenicity/genotoxicity assays have been performed.","effect":"0 %, based on the staining properties of the main active ingredient 2-hydroxy-1,4- naphthoquinone. * Lawsonia inermis is not irritant for the rabbit skin and eye. Lawsonia inermis 10 % in petrolatum was considered not irritating on human skin after repeated insult patch tests. * Lawsonia inermis can be considered a weak sensitiser in the conditions of use. Few case reports on contact allergies are published. * Based on the results obtained from the sub-chronic toxicity study conducted by oral route in the rat, the NOAEL of 40 mg/kg/day for embryo-toxicity and of 200 mg/kg/day for maternal toxicity was obtained. * Several mutagenicity/genotoxicity assays have been performed. Positive reactions were observed only with mouse lymphoma assay and with metaphase analysis in human lymphocytes assay. Negative results have been observed with all other in vitro tests and with the in vivo micronucleus test in mice. However, Henna Rot contains 1,4-naphthoquinone which appears to be a genotoxic chemical. Moreover, the sample of Henna Rot which","page":14,"pdf":"out178_en.pdf","row_type":"noael_study","study_id":"out178_en_noael_006"}
SCCNFP_vision_codex NOAEL =40 mg/kg bw - - - irritation {"citation":"Ref. : 3 2","dose":"In the high dose group, minimal to moderate accumulation of acidophilic globules in the cortical tubular epithelium of the kidneys were recorded and were considered to be treatment- related.","effect":"leen. In the high dose group, minimal to moderate accumulation of acidophilic globules in the cortical tubular epithelium of the kidneys were recorded and were considered to be treatment- related. In the 200 mg/kg/day and in the 1000 mg/kg/day groups, minimal to slight hemosiderosis and some extramedullary hemopoiesis were noted in the spleen. Except for the hemosiderosis in the spleen and the dying effects in the high dose group, all findings were reversible during the recovery period. Based on these results, the NOAEL (No-Observed-Adverse-Effect-Level) of Henna Rot was established to be 40 mg/kg bw. Ref. : 3 2.4. Irritation & corrosivity","page":5,"pdf":"out178_en.pdf","row_type":"noael_study","study_id":"out178_en_noael_001"}
SCCNFP_vision_codex NOAEL =200 mg/kg/day rat - - dermal absorption {"citation":"Ref. : 12 2","dose":"Lawsonia inermis, Henna ____________________________________________________________________________________________ 9 increase in reduced ossification of the 1st to 4th metatarsals and of the pubic bone were noted in the 1000 mg/kg/day group.","effect":"SCCNFP/0505/01, final Evaluation and opinion on : Lawsonia inermis, Henna ____________________________________________________________________________________________ 9 increase in reduced ossification of the 1st to 4th metatarsals and of the pubic bone were noted in the 1000 mg/kg/day group. These foetal findings recorded at 200 and 1000 mg/kg/day were considered by investigators to be probably treatment-related. Under the experimental conditions adopted, the NOAEL of the test product, Henna Rot, was established at 200 mg/kg/day for the pregnant female rats and at 40 mg/kg/day for the rats foetuses. Ref. : 12 2.7. Toxicokinetics (incl. Percutaneous Absorption) Percutaneous absorption in vitro Guideline : Not available Tissue : Isolated pig skin, frozen samples (-20°) Method : Permeation chambers (flow through system) Test substance : 2-hydroxy-1,4-naphthoquinone (C146) (purity 98%) and 25% Lawsonia powder in aqueous preparation Batch no : Not given Dose levels : 2% C146 etha","page":9,"pdf":"out178_en.pdf","row_type":"noael_study","study_id":"out178_en_noael_003"}
SCCNFP_vision_codex NOAEL =20 % rabbit dermal - dermal absorption {"dose":"Lawsonia inermis, Henna ____________________________________________________________________________________________ 14 NOT APPLICABLE Based on a usage volume of … ml, containing at maximum … % Maximum amount of ingredient applied I (mg) = mg Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = % Dermal absorption per...","effect":"SCCNFP/0505/01, final Evaluation and opinion on : Lawsonia inermis, Henna ____________________________________________________________________________________________ 14 NOT APPLICABLE Based on a usage volume of … ml, containing at maximum … % Maximum amount of ingredient applied I (mg) = mg Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = % Dermal absorption per treatment I x A = mg Systemic exposure dose (SED) I x A / 60 kg = mg No observed adverse effect level (mg/kg) NOAEL = mg/kg bw (species, route of application) Margin of Safety NOAEL / SED = 2.12. Conclusions Lawsonia inermis (Henna Rot) is not properly characterised. It is derived from dried powdered leaves of the specified plant and is intended to be used as a hair dye at a maximal concentration of 20 %, based on the staining properties of the main active ingredient 2-hydroxy-1,4- naphthoquinone. * Lawsonia inermis is not irritant for the rabbit skin and eye. Lawsonia inermis 10 % in petrolatum was considered not","page":14,"pdf":"out178_en.pdf","row_type":"noael_study","study_id":"out178_en_noael_004"}
SCCNFP_vision_codex NOAEL =40 mg/kg/day rat oral sub-chronic repeated dose toxicity {"dose":"Few case reports on contact allergies are published. * Based on the results obtained from the sub-chronic toxicity study conducted by oral route in the rat, the NOAEL of 40 mg/kg/day for embryo-toxicity and of 200 mg/kg/day for maternal toxicity was obtained. * Several mutagenicity/genotoxicity assays have been performed.","effect":"0 %, based on the staining properties of the main active ingredient 2-hydroxy-1,4- naphthoquinone. * Lawsonia inermis is not irritant for the rabbit skin and eye. Lawsonia inermis 10 % in petrolatum was considered not irritating on human skin after repeated insult patch tests. * Lawsonia inermis can be considered a weak sensitiser in the conditions of use. Few case reports on contact allergies are published. * Based on the results obtained from the sub-chronic toxicity study conducted by oral route in the rat, the NOAEL of 40 mg/kg/day for embryo-toxicity and of 200 mg/kg/day for maternal toxicity was obtained. * Several mutagenicity/genotoxicity assays have been performed. Positive reactions were observed only with mouse lymphoma assay and with metaphase analysis in human lymphocytes assay. Negative results have been observed with all other in vitro tests and with the in vivo micronucleus test in mice. However, Henna Rot contains 1,4-naphthoquinone which appears to be a genotoxic chemical. Moreover, the sample of Henna Rot which","page":14,"pdf":"out178_en.pdf","row_type":"noael_study","study_id":"out178_en_noael_006"}
SCCNFP_vision_codex NOAEL =40 mg/kg bw - - - irritation {"citation":"Ref. : 3 2","dose":"In the high dose group, minimal to moderate accumulation of acidophilic globules in the cortical tubular epithelium of the kidneys were recorded and were considered to be treatment- related.","effect":"leen. In the high dose group, minimal to moderate accumulation of acidophilic globules in the cortical tubular epithelium of the kidneys were recorded and were considered to be treatment- related. In the 200 mg/kg/day and in the 1000 mg/kg/day groups, minimal to slight hemosiderosis and some extramedullary hemopoiesis were noted in the spleen. Except for the hemosiderosis in the spleen and the dying effects in the high dose group, all findings were reversible during the recovery period. Based on these results, the NOAEL (No-Observed-Adverse-Effect-Level) of Henna Rot was established to be 40 mg/kg bw. Ref. : 3 2.4. Irritation & corrosivity","page":5,"pdf":"out178_en.pdf","row_type":"noael_study","study_id":"out178_en_noael_001"}
SCCNFP_vision_codex NOAEL =200 mg/kg/day rat - - dermal absorption {"citation":"Ref. : 12 2","dose":"Lawsonia inermis, Henna ____________________________________________________________________________________________ 9 increase in reduced ossification of the 1st to 4th metatarsals and of the pubic bone were noted in the 1000 mg/kg/day group.","effect":"SCCNFP/0505/01, final Evaluation and opinion on : Lawsonia inermis, Henna ____________________________________________________________________________________________ 9 increase in reduced ossification of the 1st to 4th metatarsals and of the pubic bone were noted in the 1000 mg/kg/day group. These foetal findings recorded at 200 and 1000 mg/kg/day were considered by investigators to be probably treatment-related. Under the experimental conditions adopted, the NOAEL of the test product, Henna Rot, was established at 200 mg/kg/day for the pregnant female rats and at 40 mg/kg/day for the rats foetuses. Ref. : 12 2.7. Toxicokinetics (incl. Percutaneous Absorption) Percutaneous absorption in vitro Guideline : Not available Tissue : Isolated pig skin, frozen samples (-20°) Method : Permeation chambers (flow through system) Test substance : 2-hydroxy-1,4-naphthoquinone (C146) (purity 98%) and 25% Lawsonia powder in aqueous preparation Batch no : Not given Dose levels : 2% C146 etha","page":9,"pdf":"out178_en.pdf","row_type":"noael_study","study_id":"out178_en_noael_003"}
SCCNFP_vision_codex NOAEL =20 % rabbit dermal - dermal absorption {"dose":"Lawsonia inermis, Henna ____________________________________________________________________________________________ 14 NOT APPLICABLE Based on a usage volume of … ml, containing at maximum … % Maximum amount of ingredient applied I (mg) = mg Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = % Dermal absorption per...","effect":"SCCNFP/0505/01, final Evaluation and opinion on : Lawsonia inermis, Henna ____________________________________________________________________________________________ 14 NOT APPLICABLE Based on a usage volume of … ml, containing at maximum … % Maximum amount of ingredient applied I (mg) = mg Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = % Dermal absorption per treatment I x A = mg Systemic exposure dose (SED) I x A / 60 kg = mg No observed adverse effect level (mg/kg) NOAEL = mg/kg bw (species, route of application) Margin of Safety NOAEL / SED = 2.12. Conclusions Lawsonia inermis (Henna Rot) is not properly characterised. It is derived from dried powdered leaves of the specified plant and is intended to be used as a hair dye at a maximal concentration of 20 %, based on the staining properties of the main active ingredient 2-hydroxy-1,4- naphthoquinone. * Lawsonia inermis is not irritant for the rabbit skin and eye. Lawsonia inermis 10 % in petrolatum was considered not","page":14,"pdf":"out178_en.pdf","row_type":"noael_study","study_id":"out178_en_noael_004"}
SCCNFP_vision_codex NOAEL =40 mg/kg/day rat oral sub-chronic repeated dose toxicity {"dose":"Few case reports on contact allergies are published. * Based on the results obtained from the sub-chronic toxicity study conducted by oral route in the rat, the NOAEL of 40 mg/kg/day for embryo-toxicity and of 200 mg/kg/day for maternal toxicity was obtained. * Several mutagenicity/genotoxicity assays have been performed.","effect":"0 %, based on the staining properties of the main active ingredient 2-hydroxy-1,4- naphthoquinone. * Lawsonia inermis is not irritant for the rabbit skin and eye. Lawsonia inermis 10 % in petrolatum was considered not irritating on human skin after repeated insult patch tests. * Lawsonia inermis can be considered a weak sensitiser in the conditions of use. Few case reports on contact allergies are published. * Based on the results obtained from the sub-chronic toxicity study conducted by oral route in the rat, the NOAEL of 40 mg/kg/day for embryo-toxicity and of 200 mg/kg/day for maternal toxicity was obtained. * Several mutagenicity/genotoxicity assays have been performed. Positive reactions were observed only with mouse lymphoma assay and with metaphase analysis in human lymphocytes assay. Negative results have been observed with all other in vitro tests and with the in vivo micronucleus test in mice. However, Henna Rot contains 1,4-naphthoquinone which appears to be a genotoxic chemical. Moreover, the sample of Henna Rot which","page":14,"pdf":"out178_en.pdf","row_type":"noael_study","study_id":"out178_en_noael_006"}
SCCS_vision_codex 40 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS_vision_codex NOAEL =40 mg/kg bw - - Chronic genotoxicity {"citation":"Ref.: 3 (subm","dose":"In the high dose group, minimal to moderate accumulation of acidophilic globules in the cortical tubular epithelium of the kidneys were recorded and were considered to be treatment- related.","effect":"en. In the high dose group, minimal to moderate accumulation of acidophilic globules in the cortical tubular epithelium of the kidneys were recorded and were considered to be treatment- related. In the 200 mg/kg/day and in the 1000 mg/kg/day groups, minimal to slight hemosiderosis and some extramedullary hemopoiesis were noted in the spleen. Except for the hemosiderosis in the spleen and the dyeing effects in the high dose group, all findings were reversible during the recovery period. Based on these results, the NOAEL (No-Observed-Adverse-Effect-Level) of Henna Rot was established to be 40 mg/kg bw. Ref.: 3 (subm. I) 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay (I) Guideline: OECD 471 (1983) Test system: Salmonella typhimurium, TA98, TA100, TA1535, TA1537, TA1538 Replicates: triplicate plates, two independent assays Test substance: Henna rot Batch: 830.72 Concentrations: 50 – 5000 µg/plate with and w","page":13,"pdf":"sccp_o_034.pdf","row_type":"noael_study","study_id":"sccp_o_034_noael_001"}
SCCS_vision_codex NOAEL =200 mg/kg/day rat - - NOAEL study {"citation":"Ref.: 12 (subm","dose":"fication of the pubic bone and cleft palate in one foetus were noted in the 200 mg/kg/day group; a significant reduced ossification of caudal vertebra and unossification of the 5th sternebra and the caudal vertebra, an increase in reduced ossification of the 1st to 4th metatarsals and of the pubic bone were noted in the 1000 mg/kg/day group.","effect":"fication of the pubic bone and cleft palate in one foetus were noted in the 200 mg/kg/day group; a significant reduced ossification of caudal vertebra and unossification of the 5th sternebra and the caudal vertebra, an increase in reduced ossification of the 1st to 4th metatarsals and of the pubic bone were noted in the 1000 mg/kg/day group. These foetal findings recorded at 200 and 1000 mg/kg/day were considered by the investigators to be probably treatment-related. Under the experimental conditions adopted, the NOAEL of the test product, Henna Rot, was established at 200 mg/kg/day for the pregnant female rats and at 40 mg/kg/day for the rat foetuses. Ref.: 12 (subm. I) 3.3.9. Toxicokinetics","page":21,"pdf":"sccp_o_034.pdf","row_type":"noael_study","study_id":"sccp_o_034_noael_003"}
SCCS_vision_codex NOAEL >2000 mg/kg bw rat oral 13 week irritation {"dose":"Toxicity The calculated median lethal dose was > 2000 mg/kg bw (acute oral and dermal).","effect":"tituents, e.g. Lawsone. Modified Henna products, such as Black Henna are also available to consumers. The content of Lawsone among various modified Henna products may vary significantly, but these products contain some other substances for modifying the intensity of the colour provided by Henna alone. Aqueous pastes of Henna are also used for skin decoration. The present opinion only refers to the use of Henna as hair dye. Toxicity The calculated median lethal dose was > 2000 mg/kg bw (acute oral and dermal). The NOAEL (No-Observed-Adverse-Effect-Level) of Henna Rot was 40 mg/kg bw (13 week day rat study); the NOAEL was 200 mg/kg/day for the pregnant female rats and 40 mg/kg/day for the rat foetuses (teratogenicity study). Irritation, sensitisation","page":22,"pdf":"sccp_o_034.pdf","row_type":"noael_study","study_id":"sccp_o_034_noael_004"}
SCCS_vision_codex NOAEL =2 mg/kg bw/d - dermal - dermal absorption {"dose":"NOAEL of 2 mg/kg bw/d will be used for the MoS.","effect":"__ ___________________________________________________________________________________________ 4 Keywords: SCCS, scientific opinion, hair dye, C169, lawsonia inermis, henna, directive 76/768/ECC, CAS 84988-66-9, EC 284-854-1 Opinion to be cited as: SCCS (Scientific Committee on Consumer Safety), Opinion on Lawsonia inermis (henna), 19 September 2013, corrigendum 12 November 2021 Corrigenda made in the Opinion: Page 19: Percutaneous absorption in vitro. DAp of 4.08 % to be used for MoS calculation. Page 22: NOAEL of 2 mg/kg bw/d will be used for the MoS. Page 37: Revision of the calculation of the Margin of Safety (MoS) from 210 to 156. Page 39: Discussion on dermal absorption: DAp revised from 5.3% to 4.08%.","page":4,"pdf":"sccs_o_140.pdf","row_type":"noael_study","study_id":"sccs_o_140_noael_001"}
SCCS_vision_codex NOAEL =40 mg/kg bw/day rat oral 90-day genotoxicity {"citation":"Ref.: 3 (subm","dose":"Haemosiderosis (mid and high dose groups) and extramedullary haemopoiesis (high dose group) were noted in the spleen and were considered to be treatment related for both males and females.","effect":"obules in the cortical tubular epithelium of the kidneys were recorded and were considered to be treatment related for both males and females. Haemosiderosis (mid and high dose groups) and extramedullary haemopoiesis (high dose group) were noted in the spleen and were considered to be treatment related for both males and females. Except for the haemosiderosis in the spleen and the dyeing effects in the high dose group, all findings were reversible during the recovery period. Conclusion Based on these results, the NOAEL (No-Observed-Adverse-Effect-Level) of Henna Rot was established to be 40 mg/kg bw/day.Ref.: 3 (subm. I) SCCS comment Because Henna Rot contains besides Lawsone several other ingredients, the results of this study will not be used for the calculations of the MoS. According to SCCNFP/0583/02, the NOAEL of Lawsone is 2 mg/kg bw/d. In the context of a genotoxicity study (AR6 -Kirkland 2003), a 90-day oral toxicity study in rats was performed: the authors considered the NOAEL for Lawsone to be 2–7 mg/kg bw per day. The","page":22,"pdf":"sccs_o_140.pdf","row_type":"noael_study","study_id":"sccs_o_140_noael_002"}
SCCS_vision_codex NOAEL =7 mg/kg bw rat oral 90-day genotoxicity {"citation":"Ref.: 3 (subm","dose":"Conclusion Based on these results, the NOAEL (No-Observed-Adverse-Effect-Level) of Henna Rot was established to be 40 mg/kg bw/day.Ref.:","effect":"od. Conclusion Based on these results, the NOAEL (No-Observed-Adverse-Effect-Level) of Henna Rot was established to be 40 mg/kg bw/day.Ref.: 3 (subm. I) SCCS comment Because Henna Rot contains besides Lawsone several other ingredients, the results of this study will not be used for the calculations of the MoS. According to SCCNFP/0583/02, the NOAEL of Lawsone is 2 mg/kg bw/d. In the context of a genotoxicity study (AR6 -Kirkland 2003), a 90-day oral toxicity study in rats was performed: the authors considered the NOAEL for Lawsone to be 2–7 mg/kg bw per day. The SCCS will use a NOAEL of 2 mg/kg bw/d for the calculation of the MoS. 3.3.5.3 Chronic (> 12 months) toxicity No data submitted 3.3.6 Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 (1983) Test system: Salmonella typhimurium, TA98, TA100, TA1535, TA1537, TA1538 Replicates: triplicate plates, two independent assays Test substance: Henna Rot Batch: 830.72 Purity: / Solvent: DMSO Concentrations","page":22,"pdf":"sccs_o_140.pdf","row_type":"noael_study","study_id":"sccs_o_140_noael_005"}
SCCS_vision_codex NOAEL =200 mg/kg/day rat - - NOAEL study {"citation":"Ref.: 12 (subm","dose":"tion of the pubic bone and cleft palate in one foetus were noted in the 200 mg/kg/day group; a significant reduced ossification of caudal vertebra and no ossification of the 5th sternebra and the caudal vertebra, an increase in reduced ossification of the 1st to 4th metatarsals and of the pubic bone were noted in the 1000 mg/kg/day group.","effect":"tion of the pubic bone and cleft palate in one foetus were noted in the 200 mg/kg/day group; a significant reduced ossification of caudal vertebra and no ossification of the 5th sternebra and the caudal vertebra, an increase in reduced ossification of the 1st to 4th metatarsals and of the pubic bone were noted in the 1000 mg/kg/day group. These foetal findings recorded at 200 and 1000 mg/kg/day were considered by the investigators to be probably treatment-related. Conclusion Under the experimental conditions, the NOAEL of the test product, Henna Rot, was established at 200 mg/kg/day for the pregnant female rats and at 40 mg/kg/day for the rat foetuses. Ref.: 12 (subm. I)","page":35,"pdf":"sccs_o_140.pdf","row_type":"noael_study","study_id":"sccs_o_140_noael_007"}
SCCS_vision_codex NOAEL =0.00833 mg/kg bw/d - dermal - dermal absorption {"dose":"According to SCCNFP/0583/02, the NOAEL of Lawsone is 2 mg/kg bw/d.","effect":"lculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Lawsonia Inermis (Henna) The calculation will be based on the default hair dye amount of 35000 mg, with a retention factor of 0.1. Henna contains max. 1.4% Lawsone. A dermal absorption of 4.08% is used. According to SCCNFP/0583/02, the NOAEL of Lawsone is 2 mg/kg bw/d. SED= E product (expressed in mg/kgbw/d) x C (%) x DA (%) SED = (35000 mg/ d x 0.1 (Rf) x 1/4(dilution factor) x 1.4/100 x 4.08/100) / 60 kg = 0.00833 SED = 0.00833 mg/kg bw/d No Observed Adverse Effect Level (NOAEL) = 2 mg/kg bw/d Bioavailability 65% NOAELadj = 1.3 MOS = 156 3.3.14 Discussion Marketed Henna represents a natural material derived from dried and powdered leaves of the plant Lawsonia inermis. Henna is used as a hair dye, based on the staining properties of one of its constituents, e.g. Lawsone. The batches 1271 and 830.72 of Henna do not vary considerably with regard to the water soluble extract. Since also the Lawsone content is comparable the results of the toxicological studies of these differ","page":37,"pdf":"sccs_o_140.pdf","row_type":"noael_study","study_id":"sccs_o_140_noael_009"}
SCCS_vision_codex NOAEL >2000 mg/kg bw rat oral 13 week irritation {"dose":"SCCS/1511/13 Opinion on Lawsonia Inermis (Henna) C169 - Corrigendum ___________________________________________________________________________________________ ___________________________________________________________________________________________ 38 The calculated median lethal dose was > 2000 mg/kg bw (acute oral and dermal).","effect":"SCCS/1511/13 Opinion on Lawsonia Inermis (Henna) C169 - Corrigendum ___________________________________________________________________________________________ ___________________________________________________________________________________________ 38 The calculated median lethal dose was > 2000 mg/kg bw (acute oral and dermal). The NOAEL (No-Observed-Adverse-Effect-Level) of Henna Rot was 40 mg/kg bw/day (13 week day rat study); the NOAEL was 200 mg/kg bw/day for the pregnant female rats and 40 mg/kg bw/day for the rat foetuses (teratogenicity study). Irritation, sensitisation No separate skin irritation study was performed in experimental animals. However, Lawsonia inermis showed no irritant potential for the skin after a single occlusive application for 24 hours, when tested for acute dermal toxicity (described above) under enforced conditions.","page":38,"pdf":"sccs_o_140.pdf","row_type":"noael_study","study_id":"sccs_o_140_noael_011"}
SCCS_vision_codex NOAEL =200 mg/kg bw/day rat oral 13 week irritation {"dose":"SCCS/1511/13 Opinion on Lawsonia Inermis (Henna) C169 - Corrigendum ___________________________________________________________________________________________ ___________________________________________________________________________________________ 38 The calculated median lethal dose was > 2000 mg/kg bw (acute oral and dermal).","effect":"SCCS/1511/13 Opinion on Lawsonia Inermis (Henna) C169 - Corrigendum ___________________________________________________________________________________________ ___________________________________________________________________________________________ 38 The calculated median lethal dose was > 2000 mg/kg bw (acute oral and dermal). The NOAEL (No-Observed-Adverse-Effect-Level) of Henna Rot was 40 mg/kg bw/day (13 week day rat study); the NOAEL was 200 mg/kg bw/day for the pregnant female rats and 40 mg/kg bw/day for the rat foetuses (teratogenicity study). Irritation, sensitisation No separate skin irritation study was performed in experimental animals. However, Lawsonia inermis showed no irritant potential for the skin after a single occlusive application for 24 hours, when tested for acute dermal toxicity (described above) under enforced conditions. Lawsonia inermis is slightly and transiently irritating to the eyes. The results of a Buehler test sug","page":38,"pdf":"sccs_o_140.pdf","row_type":"noael_study","study_id":"sccs_o_140_noael_012"}
SCCS_vision_codex NOAEL =40 mg/kg bw - - Chronic genotoxicity {"citation":"Ref.: 3 (subm","dose":"In the high dose group, minimal to moderate accumulation of acidophilic globules in the cortical tubular epithelium of the kidneys were recorded and were considered to be treatment- related.","effect":"en. In the high dose group, minimal to moderate accumulation of acidophilic globules in the cortical tubular epithelium of the kidneys were recorded and were considered to be treatment- related. In the 200 mg/kg/day and in the 1000 mg/kg/day groups, minimal to slight hemosiderosis and some extramedullary hemopoiesis were noted in the spleen. Except for the hemosiderosis in the spleen and the dyeing effects in the high dose group, all findings were reversible during the recovery period. Based on these results, the NOAEL (No-Observed-Adverse-Effect-Level) of Henna Rot was established to be 40 mg/kg bw. Ref.: 3 (subm. I) 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay (I) Guideline: OECD 471 (1983) Test system: Salmonella typhimurium, TA98, TA100, TA1535, TA1537, TA1538 Replicates: triplicate plates, two independent assays Test substance: Henna rot Batch: 830.72 Concentrations: 50 – 5000 µg/plate with and w","page":13,"pdf":"sccp_o_034.pdf","row_type":"noael_study","study_id":"sccp_o_034_noael_001"}
SCCS_vision_codex NOAEL =200 mg/kg/day rat - - NOAEL study {"citation":"Ref.: 12 (subm","dose":"fication of the pubic bone and cleft palate in one foetus were noted in the 200 mg/kg/day group; a significant reduced ossification of caudal vertebra and unossification of the 5th sternebra and the caudal vertebra, an increase in reduced ossification of the 1st to 4th metatarsals and of the pubic bone were noted in the 1000 mg/kg/day group.","effect":"fication of the pubic bone and cleft palate in one foetus were noted in the 200 mg/kg/day group; a significant reduced ossification of caudal vertebra and unossification of the 5th sternebra and the caudal vertebra, an increase in reduced ossification of the 1st to 4th metatarsals and of the pubic bone were noted in the 1000 mg/kg/day group. These foetal findings recorded at 200 and 1000 mg/kg/day were considered by the investigators to be probably treatment-related. Under the experimental conditions adopted, the NOAEL of the test product, Henna Rot, was established at 200 mg/kg/day for the pregnant female rats and at 40 mg/kg/day for the rat foetuses. Ref.: 12 (subm. I) 3.3.9. Toxicokinetics","page":21,"pdf":"sccp_o_034.pdf","row_type":"noael_study","study_id":"sccp_o_034_noael_003"}
SCCS_vision_codex NOAEL >2000 mg/kg bw rat oral 13 week irritation {"dose":"Toxicity The calculated median lethal dose was > 2000 mg/kg bw (acute oral and dermal).","effect":"tituents, e.g. Lawsone. Modified Henna products, such as Black Henna are also available to consumers. The content of Lawsone among various modified Henna products may vary significantly, but these products contain some other substances for modifying the intensity of the colour provided by Henna alone. Aqueous pastes of Henna are also used for skin decoration. The present opinion only refers to the use of Henna as hair dye. Toxicity The calculated median lethal dose was > 2000 mg/kg bw (acute oral and dermal). The NOAEL (No-Observed-Adverse-Effect-Level) of Henna Rot was 40 mg/kg bw (13 week day rat study); the NOAEL was 200 mg/kg/day for the pregnant female rats and 40 mg/kg/day for the rat foetuses (teratogenicity study). Irritation, sensitisation","page":22,"pdf":"sccp_o_034.pdf","row_type":"noael_study","study_id":"sccp_o_034_noael_004"}
SCCS_vision_codex NOAEL =40 mg/kg bw - - Chronic genotoxicity {"citation":"Ref.: 3 (subm","dose":"In the high dose group, minimal to moderate accumulation of acidophilic globules in the cortical tubular epithelium of the kidneys were recorded and were considered to be treatment- related.","effect":"en. In the high dose group, minimal to moderate accumulation of acidophilic globules in the cortical tubular epithelium of the kidneys were recorded and were considered to be treatment- related. In the 200 mg/kg/day and in the 1000 mg/kg/day groups, minimal to slight hemosiderosis and some extramedullary hemopoiesis were noted in the spleen. Except for the hemosiderosis in the spleen and the dyeing effects in the high dose group, all findings were reversible during the recovery period. Based on these results, the NOAEL (No-Observed-Adverse-Effect-Level) of Henna Rot was established to be 40 mg/kg bw. Ref.: 3 (subm. I) 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay (I) Guideline: OECD 471 (1983) Test system: Salmonella typhimurium, TA98, TA100, TA1535, TA1537, TA1538 Replicates: triplicate plates, two independent assays Test substance: Henna rot Batch: 830.72 Concentrations: 50 – 5000 µg/plate with and w","page":13,"pdf":"sccp_o_034.pdf","row_type":"noael_study","study_id":"sccp_o_034_noael_001"}
SCCS_vision_codex NOAEL =200 mg/kg/day rat - - NOAEL study {"citation":"Ref.: 12 (subm","dose":"fication of the pubic bone and cleft palate in one foetus were noted in the 200 mg/kg/day group; a significant reduced ossification of caudal vertebra and unossification of the 5th sternebra and the caudal vertebra, an increase in reduced ossification of the 1st to 4th metatarsals and of the pubic bone were noted in the 1000 mg/kg/day group.","effect":"fication of the pubic bone and cleft palate in one foetus were noted in the 200 mg/kg/day group; a significant reduced ossification of caudal vertebra and unossification of the 5th sternebra and the caudal vertebra, an increase in reduced ossification of the 1st to 4th metatarsals and of the pubic bone were noted in the 1000 mg/kg/day group. These foetal findings recorded at 200 and 1000 mg/kg/day were considered by the investigators to be probably treatment-related. Under the experimental conditions adopted, the NOAEL of the test product, Henna Rot, was established at 200 mg/kg/day for the pregnant female rats and at 40 mg/kg/day for the rat foetuses. Ref.: 12 (subm. I) 3.3.9. Toxicokinetics","page":21,"pdf":"sccp_o_034.pdf","row_type":"noael_study","study_id":"sccp_o_034_noael_003"}
SCCS_vision_codex NOAEL >2000 mg/kg bw rat oral 13 week irritation {"dose":"Toxicity The calculated median lethal dose was > 2000 mg/kg bw (acute oral and dermal).","effect":"tituents, e.g. Lawsone. Modified Henna products, such as Black Henna are also available to consumers. The content of Lawsone among various modified Henna products may vary significantly, but these products contain some other substances for modifying the intensity of the colour provided by Henna alone. Aqueous pastes of Henna are also used for skin decoration. The present opinion only refers to the use of Henna as hair dye. Toxicity The calculated median lethal dose was > 2000 mg/kg bw (acute oral and dermal). The NOAEL (No-Observed-Adverse-Effect-Level) of Henna Rot was 40 mg/kg bw (13 week day rat study); the NOAEL was 200 mg/kg/day for the pregnant female rats and 40 mg/kg/day for the rat foetuses (teratogenicity study). Irritation, sensitisation","page":22,"pdf":"sccp_o_034.pdf","row_type":"noael_study","study_id":"sccp_o_034_noael_004"}
SCCS_vision_codex NOAEL =2 mg/kg bw/d - dermal - dermal absorption {"dose":"NOAEL of 2 mg/kg bw/d will be used for the MoS.","effect":"__ ___________________________________________________________________________________________ 4 Keywords: SCCS, scientific opinion, hair dye, C169, lawsonia inermis, henna, directive 76/768/ECC, CAS 84988-66-9, EC 284-854-1 Opinion to be cited as: SCCS (Scientific Committee on Consumer Safety), Opinion on Lawsonia inermis (henna), 19 September 2013, corrigendum 12 November 2021 Corrigenda made in the Opinion: Page 19: Percutaneous absorption in vitro. DAp of 4.08 % to be used for MoS calculation. Page 22: NOAEL of 2 mg/kg bw/d will be used for the MoS. Page 37: Revision of the calculation of the Margin of Safety (MoS) from 210 to 156. Page 39: Discussion on dermal absorption: DAp revised from 5.3% to 4.08%.","page":4,"pdf":"sccs_o_140.pdf","row_type":"noael_study","study_id":"sccs_o_140_noael_001"}
SCCS_vision_codex NOAEL =40 mg/kg bw/day rat oral 90-day genotoxicity {"citation":"Ref.: 3 (subm","dose":"Haemosiderosis (mid and high dose groups) and extramedullary haemopoiesis (high dose group) were noted in the spleen and were considered to be treatment related for both males and females.","effect":"obules in the cortical tubular epithelium of the kidneys were recorded and were considered to be treatment related for both males and females. Haemosiderosis (mid and high dose groups) and extramedullary haemopoiesis (high dose group) were noted in the spleen and were considered to be treatment related for both males and females. Except for the haemosiderosis in the spleen and the dyeing effects in the high dose group, all findings were reversible during the recovery period. Conclusion Based on these results, the NOAEL (No-Observed-Adverse-Effect-Level) of Henna Rot was established to be 40 mg/kg bw/day.Ref.: 3 (subm. I) SCCS comment Because Henna Rot contains besides Lawsone several other ingredients, the results of this study will not be used for the calculations of the MoS. According to SCCNFP/0583/02, the NOAEL of Lawsone is 2 mg/kg bw/d. In the context of a genotoxicity study (AR6 -Kirkland 2003), a 90-day oral toxicity study in rats was performed: the authors considered the NOAEL for Lawsone to be 2–7 mg/kg bw per day. The","page":22,"pdf":"sccs_o_140.pdf","row_type":"noael_study","study_id":"sccs_o_140_noael_002"}
SCCS_vision_codex NOAEL =7 mg/kg bw rat oral 90-day genotoxicity {"citation":"Ref.: 3 (subm","dose":"Conclusion Based on these results, the NOAEL (No-Observed-Adverse-Effect-Level) of Henna Rot was established to be 40 mg/kg bw/day.Ref.:","effect":"od. Conclusion Based on these results, the NOAEL (No-Observed-Adverse-Effect-Level) of Henna Rot was established to be 40 mg/kg bw/day.Ref.: 3 (subm. I) SCCS comment Because Henna Rot contains besides Lawsone several other ingredients, the results of this study will not be used for the calculations of the MoS. According to SCCNFP/0583/02, the NOAEL of Lawsone is 2 mg/kg bw/d. In the context of a genotoxicity study (AR6 -Kirkland 2003), a 90-day oral toxicity study in rats was performed: the authors considered the NOAEL for Lawsone to be 2–7 mg/kg bw per day. The SCCS will use a NOAEL of 2 mg/kg bw/d for the calculation of the MoS. 3.3.5.3 Chronic (> 12 months) toxicity No data submitted 3.3.6 Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 (1983) Test system: Salmonella typhimurium, TA98, TA100, TA1535, TA1537, TA1538 Replicates: triplicate plates, two independent assays Test substance: Henna Rot Batch: 830.72 Purity: / Solvent: DMSO Concentrations","page":22,"pdf":"sccs_o_140.pdf","row_type":"noael_study","study_id":"sccs_o_140_noael_005"}
SCCS_vision_codex NOAEL =200 mg/kg/day rat - - NOAEL study {"citation":"Ref.: 12 (subm","dose":"tion of the pubic bone and cleft palate in one foetus were noted in the 200 mg/kg/day group; a significant reduced ossification of caudal vertebra and no ossification of the 5th sternebra and the caudal vertebra, an increase in reduced ossification of the 1st to 4th metatarsals and of the pubic bone were noted in the 1000 mg/kg/day group.","effect":"tion of the pubic bone and cleft palate in one foetus were noted in the 200 mg/kg/day group; a significant reduced ossification of caudal vertebra and no ossification of the 5th sternebra and the caudal vertebra, an increase in reduced ossification of the 1st to 4th metatarsals and of the pubic bone were noted in the 1000 mg/kg/day group. These foetal findings recorded at 200 and 1000 mg/kg/day were considered by the investigators to be probably treatment-related. Conclusion Under the experimental conditions, the NOAEL of the test product, Henna Rot, was established at 200 mg/kg/day for the pregnant female rats and at 40 mg/kg/day for the rat foetuses. Ref.: 12 (subm. I)","page":35,"pdf":"sccs_o_140.pdf","row_type":"noael_study","study_id":"sccs_o_140_noael_007"}
SCCS_vision_codex NOAEL =0.00833 mg/kg bw/d - dermal - dermal absorption {"dose":"According to SCCNFP/0583/02, the NOAEL of Lawsone is 2 mg/kg bw/d.","effect":"lculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Lawsonia Inermis (Henna) The calculation will be based on the default hair dye amount of 35000 mg, with a retention factor of 0.1. Henna contains max. 1.4% Lawsone. A dermal absorption of 4.08% is used. According to SCCNFP/0583/02, the NOAEL of Lawsone is 2 mg/kg bw/d. SED= E product (expressed in mg/kgbw/d) x C (%) x DA (%) SED = (35000 mg/ d x 0.1 (Rf) x 1/4(dilution factor) x 1.4/100 x 4.08/100) / 60 kg = 0.00833 SED = 0.00833 mg/kg bw/d No Observed Adverse Effect Level (NOAEL) = 2 mg/kg bw/d Bioavailability 65% NOAELadj = 1.3 MOS = 156 3.3.14 Discussion Marketed Henna represents a natural material derived from dried and powdered leaves of the plant Lawsonia inermis. Henna is used as a hair dye, based on the staining properties of one of its constituents, e.g. Lawsone. The batches 1271 and 830.72 of Henna do not vary considerably with regard to the water soluble extract. Since also the Lawsone content is comparable the results of the toxicological studies of these differ","page":37,"pdf":"sccs_o_140.pdf","row_type":"noael_study","study_id":"sccs_o_140_noael_009"}
SCCS_vision_codex NOAEL >2000 mg/kg bw rat oral 13 week irritation {"dose":"SCCS/1511/13 Opinion on Lawsonia Inermis (Henna) C169 - Corrigendum ___________________________________________________________________________________________ ___________________________________________________________________________________________ 38 The calculated median lethal dose was > 2000 mg/kg bw (acute oral and dermal).","effect":"SCCS/1511/13 Opinion on Lawsonia Inermis (Henna) C169 - Corrigendum ___________________________________________________________________________________________ ___________________________________________________________________________________________ 38 The calculated median lethal dose was > 2000 mg/kg bw (acute oral and dermal). The NOAEL (No-Observed-Adverse-Effect-Level) of Henna Rot was 40 mg/kg bw/day (13 week day rat study); the NOAEL was 200 mg/kg bw/day for the pregnant female rats and 40 mg/kg bw/day for the rat foetuses (teratogenicity study). Irritation, sensitisation No separate skin irritation study was performed in experimental animals. However, Lawsonia inermis showed no irritant potential for the skin after a single occlusive application for 24 hours, when tested for acute dermal toxicity (described above) under enforced conditions.","page":38,"pdf":"sccs_o_140.pdf","row_type":"noael_study","study_id":"sccs_o_140_noael_011"}
SCCS_vision_codex NOAEL =200 mg/kg bw/day rat oral 13 week irritation {"dose":"SCCS/1511/13 Opinion on Lawsonia Inermis (Henna) C169 - Corrigendum ___________________________________________________________________________________________ ___________________________________________________________________________________________ 38 The calculated median lethal dose was > 2000 mg/kg bw (acute oral and dermal).","effect":"SCCS/1511/13 Opinion on Lawsonia Inermis (Henna) C169 - Corrigendum ___________________________________________________________________________________________ ___________________________________________________________________________________________ 38 The calculated median lethal dose was > 2000 mg/kg bw (acute oral and dermal). The NOAEL (No-Observed-Adverse-Effect-Level) of Henna Rot was 40 mg/kg bw/day (13 week day rat study); the NOAEL was 200 mg/kg bw/day for the pregnant female rats and 40 mg/kg bw/day for the rat foetuses (teratogenicity study). Irritation, sensitisation No separate skin irritation study was performed in experimental animals. However, Lawsonia inermis showed no irritant potential for the skin after a single occlusive application for 24 hours, when tested for acute dermal toxicity (described above) under enforced conditions. Lawsonia inermis is slightly and transiently irritating to the eyes. The results of a Buehler test sug","page":38,"pdf":"sccs_o_140.pdf","row_type":"noael_study","study_id":"sccs_o_140_noael_012"}
SCCS_vision_codex NOAEL =2 mg/kg bw/d - dermal - dermal absorption {"dose":"NOAEL of 2 mg/kg bw/d will be used for the MoS.","effect":"__ ___________________________________________________________________________________________ 4 Keywords: SCCS, scientific opinion, hair dye, C169, lawsonia inermis, henna, directive 76/768/ECC, CAS 84988-66-9, EC 284-854-1 Opinion to be cited as: SCCS (Scientific Committee on Consumer Safety), Opinion on Lawsonia inermis (henna), 19 September 2013, corrigendum 12 November 2021 Corrigenda made in the Opinion: Page 19: Percutaneous absorption in vitro. DAp of 4.08 % to be used for MoS calculation. Page 22: NOAEL of 2 mg/kg bw/d will be used for the MoS. Page 37: Revision of the calculation of the Margin of Safety (MoS) from 210 to 156. Page 39: Discussion on dermal absorption: DAp revised from 5.3% to 4.08%.","page":4,"pdf":"sccs_o_140.pdf","row_type":"noael_study","study_id":"sccs_o_140_noael_001"}
SCCS_vision_codex NOAEL =40 mg/kg bw/day rat oral 90-day genotoxicity {"citation":"Ref.: 3 (subm","dose":"Haemosiderosis (mid and high dose groups) and extramedullary haemopoiesis (high dose group) were noted in the spleen and were considered to be treatment related for both males and females.","effect":"obules in the cortical tubular epithelium of the kidneys were recorded and were considered to be treatment related for both males and females. Haemosiderosis (mid and high dose groups) and extramedullary haemopoiesis (high dose group) were noted in the spleen and were considered to be treatment related for both males and females. Except for the haemosiderosis in the spleen and the dyeing effects in the high dose group, all findings were reversible during the recovery period. Conclusion Based on these results, the NOAEL (No-Observed-Adverse-Effect-Level) of Henna Rot was established to be 40 mg/kg bw/day.Ref.: 3 (subm. I) SCCS comment Because Henna Rot contains besides Lawsone several other ingredients, the results of this study will not be used for the calculations of the MoS. According to SCCNFP/0583/02, the NOAEL of Lawsone is 2 mg/kg bw/d. In the context of a genotoxicity study (AR6 -Kirkland 2003), a 90-day oral toxicity study in rats was performed: the authors considered the NOAEL for Lawsone to be 2–7 mg/kg bw per day. The","page":22,"pdf":"sccs_o_140.pdf","row_type":"noael_study","study_id":"sccs_o_140_noael_002"}
SCCS_vision_codex NOAEL =7 mg/kg bw rat oral 90-day genotoxicity {"citation":"Ref.: 3 (subm","dose":"Conclusion Based on these results, the NOAEL (No-Observed-Adverse-Effect-Level) of Henna Rot was established to be 40 mg/kg bw/day.Ref.:","effect":"od. Conclusion Based on these results, the NOAEL (No-Observed-Adverse-Effect-Level) of Henna Rot was established to be 40 mg/kg bw/day.Ref.: 3 (subm. I) SCCS comment Because Henna Rot contains besides Lawsone several other ingredients, the results of this study will not be used for the calculations of the MoS. According to SCCNFP/0583/02, the NOAEL of Lawsone is 2 mg/kg bw/d. In the context of a genotoxicity study (AR6 -Kirkland 2003), a 90-day oral toxicity study in rats was performed: the authors considered the NOAEL for Lawsone to be 2–7 mg/kg bw per day. The SCCS will use a NOAEL of 2 mg/kg bw/d for the calculation of the MoS. 3.3.5.3 Chronic (> 12 months) toxicity No data submitted 3.3.6 Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 (1983) Test system: Salmonella typhimurium, TA98, TA100, TA1535, TA1537, TA1538 Replicates: triplicate plates, two independent assays Test substance: Henna Rot Batch: 830.72 Purity: / Solvent: DMSO Concentrations","page":22,"pdf":"sccs_o_140.pdf","row_type":"noael_study","study_id":"sccs_o_140_noael_005"}
SCCS_vision_codex NOAEL =200 mg/kg/day rat - - NOAEL study {"citation":"Ref.: 12 (subm","dose":"tion of the pubic bone and cleft palate in one foetus were noted in the 200 mg/kg/day group; a significant reduced ossification of caudal vertebra and no ossification of the 5th sternebra and the caudal vertebra, an increase in reduced ossification of the 1st to 4th metatarsals and of the pubic bone were noted in the 1000 mg/kg/day group.","effect":"tion of the pubic bone and cleft palate in one foetus were noted in the 200 mg/kg/day group; a significant reduced ossification of caudal vertebra and no ossification of the 5th sternebra and the caudal vertebra, an increase in reduced ossification of the 1st to 4th metatarsals and of the pubic bone were noted in the 1000 mg/kg/day group. These foetal findings recorded at 200 and 1000 mg/kg/day were considered by the investigators to be probably treatment-related. Conclusion Under the experimental conditions, the NOAEL of the test product, Henna Rot, was established at 200 mg/kg/day for the pregnant female rats and at 40 mg/kg/day for the rat foetuses. Ref.: 12 (subm. I)","page":35,"pdf":"sccs_o_140.pdf","row_type":"noael_study","study_id":"sccs_o_140_noael_007"}
SCCS_vision_codex NOAEL =0.00833 mg/kg bw/d - dermal - dermal absorption {"dose":"According to SCCNFP/0583/02, the NOAEL of Lawsone is 2 mg/kg bw/d.","effect":"lculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Lawsonia Inermis (Henna) The calculation will be based on the default hair dye amount of 35000 mg, with a retention factor of 0.1. Henna contains max. 1.4% Lawsone. A dermal absorption of 4.08% is used. According to SCCNFP/0583/02, the NOAEL of Lawsone is 2 mg/kg bw/d. SED= E product (expressed in mg/kgbw/d) x C (%) x DA (%) SED = (35000 mg/ d x 0.1 (Rf) x 1/4(dilution factor) x 1.4/100 x 4.08/100) / 60 kg = 0.00833 SED = 0.00833 mg/kg bw/d No Observed Adverse Effect Level (NOAEL) = 2 mg/kg bw/d Bioavailability 65% NOAELadj = 1.3 MOS = 156 3.3.14 Discussion Marketed Henna represents a natural material derived from dried and powdered leaves of the plant Lawsonia inermis. Henna is used as a hair dye, based on the staining properties of one of its constituents, e.g. Lawsone. The batches 1271 and 830.72 of Henna do not vary considerably with regard to the water soluble extract. Since also the Lawsone content is comparable the results of the toxicological studies of these differ","page":37,"pdf":"sccs_o_140.pdf","row_type":"noael_study","study_id":"sccs_o_140_noael_009"}
SCCS_vision_codex NOAEL >2000 mg/kg bw rat oral 13 week irritation {"dose":"SCCS/1511/13 Opinion on Lawsonia Inermis (Henna) C169 - Corrigendum ___________________________________________________________________________________________ ___________________________________________________________________________________________ 38 The calculated median lethal dose was > 2000 mg/kg bw (acute oral and dermal).","effect":"SCCS/1511/13 Opinion on Lawsonia Inermis (Henna) C169 - Corrigendum ___________________________________________________________________________________________ ___________________________________________________________________________________________ 38 The calculated median lethal dose was > 2000 mg/kg bw (acute oral and dermal). The NOAEL (No-Observed-Adverse-Effect-Level) of Henna Rot was 40 mg/kg bw/day (13 week day rat study); the NOAEL was 200 mg/kg bw/day for the pregnant female rats and 40 mg/kg bw/day for the rat foetuses (teratogenicity study). Irritation, sensitisation No separate skin irritation study was performed in experimental animals. However, Lawsonia inermis showed no irritant potential for the skin after a single occlusive application for 24 hours, when tested for acute dermal toxicity (described above) under enforced conditions.","page":38,"pdf":"sccs_o_140.pdf","row_type":"noael_study","study_id":"sccs_o_140_noael_011"}
SCCS_vision_codex NOAEL =200 mg/kg bw/day rat oral 13 week irritation {"dose":"SCCS/1511/13 Opinion on Lawsonia Inermis (Henna) C169 - Corrigendum ___________________________________________________________________________________________ ___________________________________________________________________________________________ 38 The calculated median lethal dose was > 2000 mg/kg bw (acute oral and dermal).","effect":"SCCS/1511/13 Opinion on Lawsonia Inermis (Henna) C169 - Corrigendum ___________________________________________________________________________________________ ___________________________________________________________________________________________ 38 The calculated median lethal dose was > 2000 mg/kg bw (acute oral and dermal). The NOAEL (No-Observed-Adverse-Effect-Level) of Henna Rot was 40 mg/kg bw/day (13 week day rat study); the NOAEL was 200 mg/kg bw/day for the pregnant female rats and 40 mg/kg bw/day for the rat foetuses (teratogenicity study). Irritation, sensitisation No separate skin irritation study was performed in experimental animals. However, Lawsonia inermis showed no irritant potential for the skin after a single occlusive application for 24 hours, when tested for acute dermal toxicity (described above) under enforced conditions. Lawsonia inermis is slightly and transiently irritating to the eyes. The results of a Buehler test sug","page":38,"pdf":"sccs_o_140.pdf","row_type":"noael_study","study_id":"sccs_o_140_noael_012"}
SCCS_vision_codex NOAEL =40 mg/kg bw - - Chronic genotoxicity {"citation":"Ref.: 3 (subm","dose":"In the high dose group, minimal to moderate accumulation of acidophilic globules in the cortical tubular epithelium of the kidneys were recorded and were considered to be treatment- related.","effect":"en. In the high dose group, minimal to moderate accumulation of acidophilic globules in the cortical tubular epithelium of the kidneys were recorded and were considered to be treatment- related. In the 200 mg/kg/day and in the 1000 mg/kg/day groups, minimal to slight hemosiderosis and some extramedullary hemopoiesis were noted in the spleen. Except for the hemosiderosis in the spleen and the dyeing effects in the high dose group, all findings were reversible during the recovery period. Based on these results, the NOAEL (No-Observed-Adverse-Effect-Level) of Henna Rot was established to be 40 mg/kg bw. Ref.: 3 (subm. I) 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay (I) Guideline: OECD 471 (1983) Test system: Salmonella typhimurium, TA98, TA100, TA1535, TA1537, TA1538 Replicates: triplicate plates, two independent assays Test substance: Henna rot Batch: 830.72 Concentrations: 50 – 5000 µg/plate with and w","page":13,"pdf":"sccp_o_034.pdf","row_type":"noael_study","study_id":"sccp_o_034_noael_001"}
SCCS_vision_codex NOAEL =200 mg/kg/day rat - - NOAEL study {"citation":"Ref.: 12 (subm","dose":"fication of the pubic bone and cleft palate in one foetus were noted in the 200 mg/kg/day group; a significant reduced ossification of caudal vertebra and unossification of the 5th sternebra and the caudal vertebra, an increase in reduced ossification of the 1st to 4th metatarsals and of the pubic bone were noted in the 1000 mg/kg/day group.","effect":"fication of the pubic bone and cleft palate in one foetus were noted in the 200 mg/kg/day group; a significant reduced ossification of caudal vertebra and unossification of the 5th sternebra and the caudal vertebra, an increase in reduced ossification of the 1st to 4th metatarsals and of the pubic bone were noted in the 1000 mg/kg/day group. These foetal findings recorded at 200 and 1000 mg/kg/day were considered by the investigators to be probably treatment-related. Under the experimental conditions adopted, the NOAEL of the test product, Henna Rot, was established at 200 mg/kg/day for the pregnant female rats and at 40 mg/kg/day for the rat foetuses. Ref.: 12 (subm. I) 3.3.9. Toxicokinetics","page":21,"pdf":"sccp_o_034.pdf","row_type":"noael_study","study_id":"sccp_o_034_noael_003"}
SCCS_vision_codex NOAEL >2000 mg/kg bw rat oral 13 week irritation {"dose":"Toxicity The calculated median lethal dose was > 2000 mg/kg bw (acute oral and dermal).","effect":"tituents, e.g. Lawsone. Modified Henna products, such as Black Henna are also available to consumers. The content of Lawsone among various modified Henna products may vary significantly, but these products contain some other substances for modifying the intensity of the colour provided by Henna alone. Aqueous pastes of Henna are also used for skin decoration. The present opinion only refers to the use of Henna as hair dye. Toxicity The calculated median lethal dose was > 2000 mg/kg bw (acute oral and dermal). The NOAEL (No-Observed-Adverse-Effect-Level) of Henna Rot was 40 mg/kg bw (13 week day rat study); the NOAEL was 200 mg/kg/day for the pregnant female rats and 40 mg/kg/day for the rat foetuses (teratogenicity study). Irritation, sensitisation","page":22,"pdf":"sccp_o_034.pdf","row_type":"noael_study","study_id":"sccp_o_034_noael_004"}
SCCS_vision_codex NOAEL =2 mg/kg bw/d - dermal - dermal absorption {"dose":"NOAEL of 2 mg/kg bw/d will be used for the MoS.","effect":"__ ___________________________________________________________________________________________ 4 Keywords: SCCS, scientific opinion, hair dye, C169, lawsonia inermis, henna, directive 76/768/ECC, CAS 84988-66-9, EC 284-854-1 Opinion to be cited as: SCCS (Scientific Committee on Consumer Safety), Opinion on Lawsonia inermis (henna), 19 September 2013, corrigendum 12 November 2021 Corrigenda made in the Opinion: Page 19: Percutaneous absorption in vitro. DAp of 4.08 % to be used for MoS calculation. Page 22: NOAEL of 2 mg/kg bw/d will be used for the MoS. Page 37: Revision of the calculation of the Margin of Safety (MoS) from 210 to 156. Page 39: Discussion on dermal absorption: DAp revised from 5.3% to 4.08%.","page":4,"pdf":"sccs_o_140.pdf","row_type":"noael_study","study_id":"sccs_o_140_noael_001"}
SCCS_vision_codex NOAEL =40 mg/kg bw/day rat oral 90-day genotoxicity {"citation":"Ref.: 3 (subm","dose":"Haemosiderosis (mid and high dose groups) and extramedullary haemopoiesis (high dose group) were noted in the spleen and were considered to be treatment related for both males and females.","effect":"obules in the cortical tubular epithelium of the kidneys were recorded and were considered to be treatment related for both males and females. Haemosiderosis (mid and high dose groups) and extramedullary haemopoiesis (high dose group) were noted in the spleen and were considered to be treatment related for both males and females. Except for the haemosiderosis in the spleen and the dyeing effects in the high dose group, all findings were reversible during the recovery period. Conclusion Based on these results, the NOAEL (No-Observed-Adverse-Effect-Level) of Henna Rot was established to be 40 mg/kg bw/day.Ref.: 3 (subm. I) SCCS comment Because Henna Rot contains besides Lawsone several other ingredients, the results of this study will not be used for the calculations of the MoS. According to SCCNFP/0583/02, the NOAEL of Lawsone is 2 mg/kg bw/d. In the context of a genotoxicity study (AR6 -Kirkland 2003), a 90-day oral toxicity study in rats was performed: the authors considered the NOAEL for Lawsone to be 2–7 mg/kg bw per day. The","page":22,"pdf":"sccs_o_140.pdf","row_type":"noael_study","study_id":"sccs_o_140_noael_002"}
SCCS_vision_codex NOAEL =7 mg/kg bw rat oral 90-day genotoxicity {"citation":"Ref.: 3 (subm","dose":"Conclusion Based on these results, the NOAEL (No-Observed-Adverse-Effect-Level) of Henna Rot was established to be 40 mg/kg bw/day.Ref.:","effect":"od. Conclusion Based on these results, the NOAEL (No-Observed-Adverse-Effect-Level) of Henna Rot was established to be 40 mg/kg bw/day.Ref.: 3 (subm. I) SCCS comment Because Henna Rot contains besides Lawsone several other ingredients, the results of this study will not be used for the calculations of the MoS. According to SCCNFP/0583/02, the NOAEL of Lawsone is 2 mg/kg bw/d. In the context of a genotoxicity study (AR6 -Kirkland 2003), a 90-day oral toxicity study in rats was performed: the authors considered the NOAEL for Lawsone to be 2–7 mg/kg bw per day. The SCCS will use a NOAEL of 2 mg/kg bw/d for the calculation of the MoS. 3.3.5.3 Chronic (> 12 months) toxicity No data submitted 3.3.6 Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 (1983) Test system: Salmonella typhimurium, TA98, TA100, TA1535, TA1537, TA1538 Replicates: triplicate plates, two independent assays Test substance: Henna Rot Batch: 830.72 Purity: / Solvent: DMSO Concentrations","page":22,"pdf":"sccs_o_140.pdf","row_type":"noael_study","study_id":"sccs_o_140_noael_005"}
SCCS_vision_codex NOAEL =200 mg/kg/day rat - - NOAEL study {"citation":"Ref.: 12 (subm","dose":"tion of the pubic bone and cleft palate in one foetus were noted in the 200 mg/kg/day group; a significant reduced ossification of caudal vertebra and no ossification of the 5th sternebra and the caudal vertebra, an increase in reduced ossification of the 1st to 4th metatarsals and of the pubic bone were noted in the 1000 mg/kg/day group.","effect":"tion of the pubic bone and cleft palate in one foetus were noted in the 200 mg/kg/day group; a significant reduced ossification of caudal vertebra and no ossification of the 5th sternebra and the caudal vertebra, an increase in reduced ossification of the 1st to 4th metatarsals and of the pubic bone were noted in the 1000 mg/kg/day group. These foetal findings recorded at 200 and 1000 mg/kg/day were considered by the investigators to be probably treatment-related. Conclusion Under the experimental conditions, the NOAEL of the test product, Henna Rot, was established at 200 mg/kg/day for the pregnant female rats and at 40 mg/kg/day for the rat foetuses. Ref.: 12 (subm. I)","page":35,"pdf":"sccs_o_140.pdf","row_type":"noael_study","study_id":"sccs_o_140_noael_007"}
SCCS_vision_codex NOAEL =0.00833 mg/kg bw/d - dermal - dermal absorption {"dose":"According to SCCNFP/0583/02, the NOAEL of Lawsone is 2 mg/kg bw/d.","effect":"lculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Lawsonia Inermis (Henna) The calculation will be based on the default hair dye amount of 35000 mg, with a retention factor of 0.1. Henna contains max. 1.4% Lawsone. A dermal absorption of 4.08% is used. According to SCCNFP/0583/02, the NOAEL of Lawsone is 2 mg/kg bw/d. SED= E product (expressed in mg/kgbw/d) x C (%) x DA (%) SED = (35000 mg/ d x 0.1 (Rf) x 1/4(dilution factor) x 1.4/100 x 4.08/100) / 60 kg = 0.00833 SED = 0.00833 mg/kg bw/d No Observed Adverse Effect Level (NOAEL) = 2 mg/kg bw/d Bioavailability 65% NOAELadj = 1.3 MOS = 156 3.3.14 Discussion Marketed Henna represents a natural material derived from dried and powdered leaves of the plant Lawsonia inermis. Henna is used as a hair dye, based on the staining properties of one of its constituents, e.g. Lawsone. The batches 1271 and 830.72 of Henna do not vary considerably with regard to the water soluble extract. Since also the Lawsone content is comparable the results of the toxicological studies of these differ","page":37,"pdf":"sccs_o_140.pdf","row_type":"noael_study","study_id":"sccs_o_140_noael_009"}
SCCS_vision_codex NOAEL >2000 mg/kg bw rat oral 13 week irritation {"dose":"SCCS/1511/13 Opinion on Lawsonia Inermis (Henna) C169 - Corrigendum ___________________________________________________________________________________________ ___________________________________________________________________________________________ 38 The calculated median lethal dose was > 2000 mg/kg bw (acute oral and dermal).","effect":"SCCS/1511/13 Opinion on Lawsonia Inermis (Henna) C169 - Corrigendum ___________________________________________________________________________________________ ___________________________________________________________________________________________ 38 The calculated median lethal dose was > 2000 mg/kg bw (acute oral and dermal). The NOAEL (No-Observed-Adverse-Effect-Level) of Henna Rot was 40 mg/kg bw/day (13 week day rat study); the NOAEL was 200 mg/kg bw/day for the pregnant female rats and 40 mg/kg bw/day for the rat foetuses (teratogenicity study). Irritation, sensitisation No separate skin irritation study was performed in experimental animals. However, Lawsonia inermis showed no irritant potential for the skin after a single occlusive application for 24 hours, when tested for acute dermal toxicity (described above) under enforced conditions.","page":38,"pdf":"sccs_o_140.pdf","row_type":"noael_study","study_id":"sccs_o_140_noael_011"}
SCCS_vision_codex NOAEL =200 mg/kg bw/day rat oral 13 week irritation {"dose":"SCCS/1511/13 Opinion on Lawsonia Inermis (Henna) C169 - Corrigendum ___________________________________________________________________________________________ ___________________________________________________________________________________________ 38 The calculated median lethal dose was > 2000 mg/kg bw (acute oral and dermal).","effect":"SCCS/1511/13 Opinion on Lawsonia Inermis (Henna) C169 - Corrigendum ___________________________________________________________________________________________ ___________________________________________________________________________________________ 38 The calculated median lethal dose was > 2000 mg/kg bw (acute oral and dermal). The NOAEL (No-Observed-Adverse-Effect-Level) of Henna Rot was 40 mg/kg bw/day (13 week day rat study); the NOAEL was 200 mg/kg bw/day for the pregnant female rats and 40 mg/kg bw/day for the rat foetuses (teratogenicity study). Irritation, sensitisation No separate skin irritation study was performed in experimental animals. However, Lawsonia inermis showed no irritant potential for the skin after a single occlusive application for 24 hours, when tested for acute dermal toxicity (described above) under enforced conditions. Lawsonia inermis is slightly and transiently irritating to the eyes. The results of a Buehler test sug","page":38,"pdf":"sccs_o_140.pdf","row_type":"noael_study","study_id":"sccs_o_140_noael_012"}
UnifiedCodex:SCCNFP:beta.noael_studies 6 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
UnifiedCodex:SCCNFP:beta.noael_studies dermal absorption 200 mg/kg/day rat - - dermal absorption SOURCE_SUBDIR=out178_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING LAWSONIA INERMIS, HENNA COLIPA n° C169; OPINION_NUMBER=SCCNFP/0505/01; COMMITTEE=SCCNFP; REPORT_DATE=17 September 2002; VALUE_TEXT=200; DOSE=Lawsonia inermis, Henna ____________________________________________________________________________________________ 9 increase in reduced ossification of the 1st to 4th metatarsals and of the pubic bone were noted in the 1000 mg/kg/day group.; EFFECT=SCCNFP/0505/01, final Evaluation and opinion on : Lawsonia inermis, Henna ____________________________________________________________________________________________ 9 increase in reduced ossification of the 1st to 4th metatarsals and of the pubic bone were noted in the 1000 mg/kg/day group. These foetal findings recorded at 200 and 1000 mg/kg/day were considered by investigators to be probably treatment-related. Under the experimental conditions adopted, the NOAEL of the test product, Henna Rot, was established at 200 mg/kg/day for the pregnant female rats and at 40 mg/kg/day for the rats foetuses. Ref. : 12 2.7. Toxicokinetics (incl. Percutaneous Absorption) Percutaneous absorption in vitro Guideline : Not available Tissue : Isolated pig skin, frozen samples (-20°) Method : Permeation chambers (flow through system) Test substance : 2-hydroxy-1,4-naphthoquinone (C146) (purity 98%) and 25% Lawsonia powder in aqueous preparation Batch no : Not given Dose levels : 2% C146 etha; CITATION=Ref. : 12 2; CITATION_NUMBERS=[12,2]; REFERENCE=Ref. : 12 2; DETAILS_JSON={"cas_number":"84988-66-9","citation":"Ref. : 12 2","dose":"Lawsonia inermis, Henna ____________________________________________________________________________________________ 9 increase in reduced ossification of the 1st to 4th metatarsals and of the pubic bone were noted in the 1000 mg/kg/day group.","duration":"","effect":"SCCNFP/0505/01, final Evaluation and opinion on : Lawsonia inermis, Henna ____________________________________________________________________________________________ 9 increase in reduced ossification of the 1st to 4th metatarsals and of the pubic bone were noted in the 1000 mg/kg/day group. These foetal findings recorded at 200 and 1000 mg/kg/day were considered by investigators to be probably treatment-related. Under the experimental conditions adopted, the NOAEL of the test product, Henna Rot, was established at 200 mg/kg/day for the pregnant female rats and at 40 mg/kg/day for the rats foetuses. Ref. : 12 2.7. Toxicokinetics (incl. Percutaneous Absorption) Percutaneous absorption in vitro Guideline : Not available Tissue : Isolated pig skin, frozen samples (-20°) Method : Permeation chambers (flow through system) Test substance : 2-hydroxy-1,4-naphthoquinone (C146) (purity 98%) and 25% Lawsonia powder in aqueous preparation Batch no : Not given Dose levels : 2% C146 etha","endpoint":"dermal absorption","ingredient":"codes","loael_value":"","noael_unit":"mg/kg/day","noael_value":"200","page":9,"route":"","species":"rat","study_id":"out178_en_noael_003"}
UnifiedCodex:SCCNFP:beta.noael_studies dermal absorption 20 % rabbit dermal - dermal absorption SOURCE_SUBDIR=out178_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING LAWSONIA INERMIS, HENNA COLIPA n° C169; OPINION_NUMBER=SCCNFP/0505/01; COMMITTEE=SCCNFP; REPORT_DATE=17 September 2002; VALUE_TEXT=20; DOSE=Lawsonia inermis, Henna ____________________________________________________________________________________________ 14 NOT APPLICABLE Based on a usage volume of … ml, containing at maximum … % Maximum amount of ingredient applied I (mg) = mg Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = % Dermal absorption per...; EFFECT=SCCNFP/0505/01, final Evaluation and opinion on : Lawsonia inermis, Henna ____________________________________________________________________________________________ 14 NOT APPLICABLE Based on a usage volume of … ml, containing at maximum … % Maximum amount of ingredient applied I (mg) = mg Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = % Dermal absorption per treatment I x A = mg Systemic exposure dose (SED) I x A / 60 kg = mg No observed adverse effect level (mg/kg) NOAEL = mg/kg bw (species, route of application) Margin of Safety NOAEL / SED = 2.12. Conclusions Lawsonia inermis (Henna Rot) is not properly characterised. It is derived from dried powdered leaves of the specified plant and is intended to be used as a hair dye at a maximal concentration of 20 %, based on the staining properties of the main active ingredient 2-hydroxy-1,4- naphthoquinone. * Lawsonia inermis is not irritant for the rabbit skin and eye. Lawsonia inermis 10 % in petrolatum was considered not; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"84988-66-9","citation":"","dose":"Lawsonia inermis, Henna ____________________________________________________________________________________________ 14 NOT APPLICABLE Based on a usage volume of … ml, containing at maximum … % Maximum amount of ingredient applied I (mg) = mg Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = % Dermal absorption per...","duration":"","effect":"SCCNFP/0505/01, final Evaluation and opinion on : Lawsonia inermis, Henna ____________________________________________________________________________________________ 14 NOT APPLICABLE Based on a usage volume of … ml, containing at maximum … % Maximum amount of ingredient applied I (mg) = mg Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = % Dermal absorption per treatment I x A = mg Systemic exposure dose (SED) I x A / 60 kg = mg No observed adverse effect level (mg/kg) NOAEL = mg/kg bw (species, route of application) Margin of Safety NOAEL / SED = 2.12. Conclusions Lawsonia inermis (Henna Rot) is not properly characterised. It is derived from dried powdered leaves of the specified plant and is intended to be used as a hair dye at a maximal concentration of 20 %, based on the staining properties of the main active ingredient 2-hydroxy-1,4- naphthoquinone. * Lawsonia inermis is not irritant for the rabbit skin and eye. Lawsonia inermis 10 % in petrolatum was considered not","endpoint":"dermal absorption","ingredient":"codes","loael_value":"","noael_unit":"%","noael_value":"20","page":14,"route":"dermal","species":"rabbit","study_id":"out178_en_noael_004"}
UnifiedCodex:SCCNFP:beta.noael_studies dermal absorption 20 % rabbit dermal - dermal absorption SOURCE_SUBDIR=out178_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING LAWSONIA INERMIS, HENNA COLIPA n° C169; OPINION_NUMBER=SCCNFP/0505/01; COMMITTEE=SCCNFP; REPORT_DATE=17 September 2002; VALUE_TEXT=20; DOSE=onia inermis, Henna ____________________________________________________________________________________________ 14 NOT APPLICABLE Based on a usage volume of … ml, containing at maximum … % Maximum amount of ingredient applied I (mg) = mg Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = % Dermal absorption per tre...; EFFECT=onia inermis, Henna ____________________________________________________________________________________________ 14 NOT APPLICABLE Based on a usage volume of … ml, containing at maximum … % Maximum amount of ingredient applied I (mg) = mg Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = % Dermal absorption per treatment I x A = mg Systemic exposure dose (SED) I x A / 60 kg = mg No observed adverse effect level (mg/kg) NOAEL = mg/kg bw (species, route of application) Margin of Safety NOAEL / SED = 2.12. Conclusions Lawsonia inermis (Henna Rot) is not properly characterised. It is derived from dried powdered leaves of the specified plant and is intended to be used as a hair dye at a maximal concentration of 20 %, based on the staining properties of the main active ingredient 2-hydroxy-1,4- naphthoquinone. * Lawsonia inermis is not irritant for the rabbit skin and eye. Lawsonia inermis 10 % in petrolatum was considered not irritating on human skin after repeated insult patch tests. * Lawsonia inermis; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"84988-66-9","citation":"","dose":"onia inermis, Henna ____________________________________________________________________________________________ 14 NOT APPLICABLE Based on a usage volume of … ml, containing at maximum … % Maximum amount of ingredient applied I (mg) = mg Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = % Dermal absorption per tre...","duration":"","effect":"onia inermis, Henna ____________________________________________________________________________________________ 14 NOT APPLICABLE Based on a usage volume of … ml, containing at maximum … % Maximum amount of ingredient applied I (mg) = mg Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = % Dermal absorption per treatment I x A = mg Systemic exposure dose (SED) I x A / 60 kg = mg No observed adverse effect level (mg/kg) NOAEL = mg/kg bw (species, route of application) Margin of Safety NOAEL / SED = 2.12. Conclusions Lawsonia inermis (Henna Rot) is not properly characterised. It is derived from dried powdered leaves of the specified plant and is intended to be used as a hair dye at a maximal concentration of 20 %, based on the staining properties of the main active ingredient 2-hydroxy-1,4- naphthoquinone. * Lawsonia inermis is not irritant for the rabbit skin and eye. Lawsonia inermis 10 % in petrolatum was considered not irritating on human skin after repeated insult patch tests. * Lawsonia inermis","endpoint":"dermal absorption","ingredient":"codes","loael_value":"","noael_unit":"%","noael_value":"20","page":14,"route":"dermal","species":"rabbit","study_id":"out178_en_noael_005"}
UnifiedCodex:SCCNFP:beta.noael_studies irritation 40 mg/kg bw - - - irritation SOURCE_SUBDIR=out178_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING LAWSONIA INERMIS, HENNA COLIPA n° C169; OPINION_NUMBER=SCCNFP/0505/01; COMMITTEE=SCCNFP; REPORT_DATE=17 September 2002; VALUE_TEXT=40; DOSE=In the high dose group, minimal to moderate accumulation of acidophilic globules in the cortical tubular epithelium of the kidneys were recorded and were considered to be treatment- related.; EFFECT=leen. In the high dose group, minimal to moderate accumulation of acidophilic globules in the cortical tubular epithelium of the kidneys were recorded and were considered to be treatment- related. In the 200 mg/kg/day and in the 1000 mg/kg/day groups, minimal to slight hemosiderosis and some extramedullary hemopoiesis were noted in the spleen. Except for the hemosiderosis in the spleen and the dying effects in the high dose group, all findings were reversible during the recovery period. Based on these results, the NOAEL (No-Observed-Adverse-Effect-Level) of Henna Rot was established to be 40 mg/kg bw. Ref. : 3 2.4. Irritation & corrosivity; CITATION=Ref. : 3 2; CITATION_NUMBERS=[3,2]; REFERENCE=Ref. : 3 2; DETAILS_JSON={"cas_number":"84988-66-9","citation":"Ref. : 3 2","dose":"In the high dose group, minimal to moderate accumulation of acidophilic globules in the cortical tubular epithelium of the kidneys were recorded and were considered to be treatment- related.","duration":"","effect":"leen. In the high dose group, minimal to moderate accumulation of acidophilic globules in the cortical tubular epithelium of the kidneys were recorded and were considered to be treatment- related. In the 200 mg/kg/day and in the 1000 mg/kg/day groups, minimal to slight hemosiderosis and some extramedullary hemopoiesis were noted in the spleen. Except for the hemosiderosis in the spleen and the dying effects in the high dose group, all findings were reversible during the recovery period. Based on these results, the NOAEL (No-Observed-Adverse-Effect-Level) of Henna Rot was established to be 40 mg/kg bw. Ref. : 3 2.4. Irritation & corrosivity","endpoint":"irritation","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw","noael_value":"40","page":5,"route":"","species":"","study_id":"out178_en_noael_001"}
UnifiedCodex:SCCNFP:beta.noael_studies irritation 40 mg/kg bw - - - irritation SOURCE_SUBDIR=out178_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING LAWSONIA INERMIS, HENNA COLIPA n° C169; OPINION_NUMBER=SCCNFP/0505/01; COMMITTEE=SCCNFP; REPORT_DATE=17 September 2002; VALUE_TEXT=40; DOSE=n the high dose group, minimal to moderate accumulation of acidophilic globules in the cortical tubular epithelium of the kidneys were recorded and were considered to be treatment- related.; EFFECT=n the high dose group, minimal to moderate accumulation of acidophilic globules in the cortical tubular epithelium of the kidneys were recorded and were considered to be treatment- related. In the 200 mg/kg/day and in the 1000 mg/kg/day groups, minimal to slight hemosiderosis and some extramedullary hemopoiesis were noted in the spleen. Except for the hemosiderosis in the spleen and the dying effects in the high dose group, all findings were reversible during the recovery period. Based on these results, the NOAEL (No-Observed-Adverse-Effect-Level) of Henna Rot was established to be 40 mg/kg bw. Ref. : 3 2.4. Irritation & corrosivity; CITATION=Ref. : 3 2; CITATION_NUMBERS=[3,2]; REFERENCE=Ref. : 3 2; DETAILS_JSON={"cas_number":"84988-66-9","citation":"Ref. : 3 2","dose":"n the high dose group, minimal to moderate accumulation of acidophilic globules in the cortical tubular epithelium of the kidneys were recorded and were considered to be treatment- related.","duration":"","effect":"n the high dose group, minimal to moderate accumulation of acidophilic globules in the cortical tubular epithelium of the kidneys were recorded and were considered to be treatment- related. In the 200 mg/kg/day and in the 1000 mg/kg/day groups, minimal to slight hemosiderosis and some extramedullary hemopoiesis were noted in the spleen. Except for the hemosiderosis in the spleen and the dying effects in the high dose group, all findings were reversible during the recovery period. Based on these results, the NOAEL (No-Observed-Adverse-Effect-Level) of Henna Rot was established to be 40 mg/kg bw. Ref. : 3 2.4. Irritation & corrosivity","endpoint":"irritation","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw","noael_value":"40","page":5,"route":"","species":"","study_id":"out178_en_noael_002"}
UnifiedCodex:SCCNFP:beta.noael_studies repeated dose toxicity 40 mg/kg/day rat oral sub-chronic repeated dose toxicity SOURCE_SUBDIR=out178_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING LAWSONIA INERMIS, HENNA COLIPA n° C169; OPINION_NUMBER=SCCNFP/0505/01; COMMITTEE=SCCNFP; REPORT_DATE=17 September 2002; VALUE_TEXT=40; DOSE=Few case reports on contact allergies are published. * Based on the results obtained from the sub-chronic toxicity study conducted by oral route in the rat, the NOAEL of 40 mg/kg/day for embryo-toxicity and of 200 mg/kg/day for maternal toxicity was obtained. * Several mutagenicity/genotoxicity assays have been performed.; EFFECT=0 %, based on the staining properties of the main active ingredient 2-hydroxy-1,4- naphthoquinone. * Lawsonia inermis is not irritant for the rabbit skin and eye. Lawsonia inermis 10 % in petrolatum was considered not irritating on human skin after repeated insult patch tests. * Lawsonia inermis can be considered a weak sensitiser in the conditions of use. Few case reports on contact allergies are published. * Based on the results obtained from the sub-chronic toxicity study conducted by oral route in the rat, the NOAEL of 40 mg/kg/day for embryo-toxicity and of 200 mg/kg/day for maternal toxicity was obtained. * Several mutagenicity/genotoxicity assays have been performed. Positive reactions were observed only with mouse lymphoma assay and with metaphase analysis in human lymphocytes assay. Negative results have been observed with all other in vitro tests and with the in vivo micronucleus test in mice. However, Henna Rot contains 1,4-naphthoquinone which appears to be a genotoxic chemical. Moreover, the sample of Henna Rot which; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"84988-66-9","citation":"","dose":"Few case reports on contact allergies are published. * Based on the results obtained from the sub-chronic toxicity study conducted by oral route in the rat, the NOAEL of 40 mg/kg/day for embryo-toxicity and of 200 mg/kg/day for maternal toxicity was obtained. * Several mutagenicity/genotoxicity assays have been performed.","duration":"sub-chronic","effect":"0 %, based on the staining properties of the main active ingredient 2-hydroxy-1,4- naphthoquinone. * Lawsonia inermis is not irritant for the rabbit skin and eye. Lawsonia inermis 10 % in petrolatum was considered not irritating on human skin after repeated insult patch tests. * Lawsonia inermis can be considered a weak sensitiser in the conditions of use. Few case reports on contact allergies are published. * Based on the results obtained from the sub-chronic toxicity study conducted by oral route in the rat, the NOAEL of 40 mg/kg/day for embryo-toxicity and of 200 mg/kg/day for maternal toxicity was obtained. * Several mutagenicity/genotoxicity assays have been performed. Positive reactions were observed only with mouse lymphoma assay and with metaphase analysis in human lymphocytes assay. Negative results have been observed with all other in vitro tests and with the in vivo micronucleus test in mice. However, Henna Rot contains 1,4-naphthoquinone which appears to be a genotoxic chemical. Moreover, the sample of Henna Rot which","endpoint":"repeated dose toxicity","ingredient":"codes","loael_value":"","noael_unit":"mg/kg/day","noael_value":"40","page":14,"route":"oral","species":"rat","study_id":"out178_en_noael_006"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 18 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 200 mg/kg/day rat - - - SOURCE_SUBDIR=sccp_o_034; REPORT_TITLE=Opinion on Lawsonia inermis (Henna) COLIPA N° C169; OPINION_NUMBER=SCCP/0943/05; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 16 February 2004; VALUE_TEXT=200; DOSE=fication of the pubic bone and cleft palate in one foetus were noted in the 200 mg/kg/day group; a significant reduced ossification of caudal vertebra and unossification of the 5th sternebra and the caudal vertebra, an increase in reduced ossification of the 1st to 4th metatarsals and of the pubic bone were noted in the 1000 mg/kg/day group.; EFFECT=fication of the pubic bone and cleft palate in one foetus were noted in the 200 mg/kg/day group; a significant reduced ossification of caudal vertebra and unossification of the 5th sternebra and the caudal vertebra, an increase in reduced ossification of the 1st to 4th metatarsals and of the pubic bone were noted in the 1000 mg/kg/day group. These foetal findings recorded at 200 and 1000 mg/kg/day were considered by the investigators to be probably treatment-related. Under the experimental conditions adopted, the NOAEL of the test product, Henna Rot, was established at 200 mg/kg/day for the pregnant female rats and at 40 mg/kg/day for the rat foetuses. Ref.: 12 (subm. I) 3.3.9. Toxicokinetics; CITATION=Ref.: 12 (subm; CITATION_NUMBERS=[12]; REFERENCE=Ref.: 12 (subm; DETAILS_JSON={"cas_number":"84988-66-9","citation":"Ref.: 12 (subm","dose":"fication of the pubic bone and cleft palate in one foetus were noted in the 200 mg/kg/day group; a significant reduced ossification of caudal vertebra and unossification of the 5th sternebra and the caudal vertebra, an increase in reduced ossification of the 1st to 4th metatarsals and of the pubic bone were noted in the 1000 mg/kg/day group.","duration":"","effect":"fication of the pubic bone and cleft palate in one foetus were noted in the 200 mg/kg/day group; a significant reduced ossification of caudal vertebra and unossification of the 5th sternebra and the caudal vertebra, an increase in reduced ossification of the 1st to 4th metatarsals and of the pubic bone were noted in the 1000 mg/kg/day group. These foetal findings recorded at 200 and 1000 mg/kg/day were considered by the investigators to be probably treatment-related. Under the experimental conditions adopted, the NOAEL of the test product, Henna Rot, was established at 200 mg/kg/day for the pregnant female rats and at 40 mg/kg/day for the rat foetuses. Ref.: 12 (subm. I) 3.3.9. Toxicokinetics","endpoint":"","ingredient":"Lawsonia inermis","loael_value":"","noael_unit":"mg/kg/day","noael_value":"200","page":21,"route":"","species":"rat","study_id":"sccp_o_034_noael_003"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 200 mg/kg/day rat - - - SOURCE_SUBDIR=sccs_o_140; REPORT_TITLE=OPINION ON Lawsonia inermis (Henna) COLIPA n° C169; OPINION_NUMBER=SCCS/1511/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=19 September 2013; VALUE_TEXT=200; DOSE=tion of the pubic bone and cleft palate in one foetus were noted in the 200 mg/kg/day group; a significant reduced ossification of caudal vertebra and no ossification of the 5th sternebra and the caudal vertebra, an increase in reduced ossification of the 1st to 4th metatarsals and of the pubic bone were noted in the 1000 mg/kg/day group.; EFFECT=tion of the pubic bone and cleft palate in one foetus were noted in the 200 mg/kg/day group; a significant reduced ossification of caudal vertebra and no ossification of the 5th sternebra and the caudal vertebra, an increase in reduced ossification of the 1st to 4th metatarsals and of the pubic bone were noted in the 1000 mg/kg/day group. These foetal findings recorded at 200 and 1000 mg/kg/day were considered by the investigators to be probably treatment-related. Conclusion Under the experimental conditions, the NOAEL of the test product, Henna Rot, was established at 200 mg/kg/day for the pregnant female rats and at 40 mg/kg/day for the rat foetuses. Ref.: 12 (subm. I); CITATION=Ref.: 12 (subm; CITATION_NUMBERS=[12]; REFERENCE=Ref.: 12 (subm; DETAILS_JSON={"cas_number":"84988-66-9","citation":"Ref.: 12 (subm","dose":"tion of the pubic bone and cleft palate in one foetus were noted in the 200 mg/kg/day group; a significant reduced ossification of caudal vertebra and no ossification of the 5th sternebra and the caudal vertebra, an increase in reduced ossification of the 1st to 4th metatarsals and of the pubic bone were noted in the 1000 mg/kg/day group.","duration":"","effect":"tion of the pubic bone and cleft palate in one foetus were noted in the 200 mg/kg/day group; a significant reduced ossification of caudal vertebra and no ossification of the 5th sternebra and the caudal vertebra, an increase in reduced ossification of the 1st to 4th metatarsals and of the pubic bone were noted in the 1000 mg/kg/day group. These foetal findings recorded at 200 and 1000 mg/kg/day were considered by the investigators to be probably treatment-related. Conclusion Under the experimental conditions, the NOAEL of the test product, Henna Rot, was established at 200 mg/kg/day for the pregnant female rats and at 40 mg/kg/day for the rat foetuses. Ref.: 12 (subm. I)","endpoint":"","ingredient":"Lawsonia inermis (Henna)","loael_value":"","noael_unit":"mg/kg/day","noael_value":"200","page":35,"route":"","species":"rat","study_id":"sccs_o_140_noael_007"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption 2 mg/kg bw/d - dermal - dermal absorption SOURCE_SUBDIR=sccs_o_140; REPORT_TITLE=OPINION ON Lawsonia inermis (Henna) COLIPA n° C169; OPINION_NUMBER=SCCS/1511/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=19 September 2013; VALUE_TEXT=2; DOSE=NOAEL of 2 mg/kg bw/d will be used for the MoS.; EFFECT=__ ___________________________________________________________________________________________ 4 Keywords: SCCS, scientific opinion, hair dye, C169, lawsonia inermis, henna, directive 76/768/ECC, CAS 84988-66-9, EC 284-854-1 Opinion to be cited as: SCCS (Scientific Committee on Consumer Safety), Opinion on Lawsonia inermis (henna), 19 September 2013, corrigendum 12 November 2021 Corrigenda made in the Opinion: Page 19: Percutaneous absorption in vitro. DAp of 4.08 % to be used for MoS calculation. Page 22: NOAEL of 2 mg/kg bw/d will be used for the MoS. Page 37: Revision of the calculation of the Margin of Safety (MoS) from 210 to 156. Page 39: Discussion on dermal absorption: DAp revised from 5.3% to 4.08%.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"84988-66-9","citation":"","dose":"NOAEL of 2 mg/kg bw/d will be used for the MoS.","duration":"","effect":"__ ___________________________________________________________________________________________ 4 Keywords: SCCS, scientific opinion, hair dye, C169, lawsonia inermis, henna, directive 76/768/ECC, CAS 84988-66-9, EC 284-854-1 Opinion to be cited as: SCCS (Scientific Committee on Consumer Safety), Opinion on Lawsonia inermis (henna), 19 September 2013, corrigendum 12 November 2021 Corrigenda made in the Opinion: Page 19: Percutaneous absorption in vitro. DAp of 4.08 % to be used for MoS calculation. Page 22: NOAEL of 2 mg/kg bw/d will be used for the MoS. Page 37: Revision of the calculation of the Margin of Safety (MoS) from 210 to 156. Page 39: Discussion on dermal absorption: DAp revised from 5.3% to 4.08%.","endpoint":"dermal absorption","ingredient":"Lawsonia inermis (Henna)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"2","page":4,"route":"dermal","species":"","study_id":"sccs_o_140_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption 2 mg/kg bw/d - dermal - dermal absorption SOURCE_SUBDIR=sccs_o_140; REPORT_TITLE=OPINION ON Lawsonia inermis (Henna) COLIPA n° C169; OPINION_NUMBER=SCCS/1511/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=19 September 2013; VALUE_TEXT=2; DOSE=According to SCCNFP/0583/02, the NOAEL of Lawsone is 2 mg/kg bw/d.; EFFECT=ysis in a newborn male with glucose-6- phosphatase deficiency. Ref.: AR2 SCCS Comment There is insufficient evidence to draw any conclusion based on the evidence given in this report. 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Lawsonia Inermis (Henna) The calculation will be based on the default hair dye amount of 35000 mg, with a retention factor of 0.1. Henna contains max. 1.4% Lawsone. A dermal absorption of 4.08% is used. According to SCCNFP/0583/02, the NOAEL of Lawsone is 2 mg/kg bw/d. SED= E product (expressed in mg/kgbw/d) x C (%) x DA (%) SED = (35000 mg/ d x 0.1 (Rf) x 1/4(dilution factor) x 1.4/100 x 4.08/100) / 60 kg = 0.00833 SED = 0.00833 mg/kg bw/d No Observed Adverse Effect Level (NOAEL) = 2 mg/kg bw/d Bioavailability 65% NOAELadj = 1.3 MOS = 156 3.3.14 Discussion Marketed Henna represents a natural material derived from dried and powdered leaves of the plant Lawsonia inermis. Henna is used as a hair dye, based on the staining properti; CITATION=Ref.: AR2 SCCS Comment There is insufficient evidence to draw any conclusion based on the evidence given in this report; CITATION_NUMBERS=[2]; REFERENCE=Ref.: AR2 SCCS Comment There is insufficient evidence to draw any conclusion based on the evidence given in this report; DETAILS_JSON={"cas_number":"84988-66-9","citation":"Ref.: AR2 SCCS Comment There is insufficient evidence to draw any conclusion based on the evidence given in this report","dose":"According to SCCNFP/0583/02, the NOAEL of Lawsone is 2 mg/kg bw/d.","duration":"","effect":"ysis in a newborn male with glucose-6- phosphatase deficiency. Ref.: AR2 SCCS Comment There is insufficient evidence to draw any conclusion based on the evidence given in this report. 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Lawsonia Inermis (Henna) The calculation will be based on the default hair dye amount of 35000 mg, with a retention factor of 0.1. Henna contains max. 1.4% Lawsone. A dermal absorption of 4.08% is used. According to SCCNFP/0583/02, the NOAEL of Lawsone is 2 mg/kg bw/d. SED= E product (expressed in mg/kgbw/d) x C (%) x DA (%) SED = (35000 mg/ d x 0.1 (Rf) x 1/4(dilution factor) x 1.4/100 x 4.08/100) / 60 kg = 0.00833 SED = 0.00833 mg/kg bw/d No Observed Adverse Effect Level (NOAEL) = 2 mg/kg bw/d Bioavailability 65% NOAELadj = 1.3 MOS = 156 3.3.14 Discussion Marketed Henna represents a natural material derived from dried and powdered leaves of the plant Lawsonia inermis. Henna is used as a hair dye, based on the staining properti","endpoint":"dermal absorption","ingredient":"Lawsonia inermis (Henna)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"2","page":37,"route":"dermal","species":"","study_id":"sccs_o_140_noael_008"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =0.00833 mg/kg bw/d - dermal - dermal absorption SOURCE_SUBDIR=sccs_o_140; REPORT_TITLE=OPINION ON Lawsonia inermis (Henna) COLIPA n° C169; OPINION_NUMBER=SCCS/1511/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=19 September 2013; VALUE_TEXT== 0.00833; DOSE=According to SCCNFP/0583/02, the NOAEL of Lawsone is 2 mg/kg bw/d.; EFFECT=lculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Lawsonia Inermis (Henna) The calculation will be based on the default hair dye amount of 35000 mg, with a retention factor of 0.1. Henna contains max. 1.4% Lawsone. A dermal absorption of 4.08% is used. According to SCCNFP/0583/02, the NOAEL of Lawsone is 2 mg/kg bw/d. SED= E product (expressed in mg/kgbw/d) x C (%) x DA (%) SED = (35000 mg/ d x 0.1 (Rf) x 1/4(dilution factor) x 1.4/100 x 4.08/100) / 60 kg = 0.00833 SED = 0.00833 mg/kg bw/d No Observed Adverse Effect Level (NOAEL) = 2 mg/kg bw/d Bioavailability 65% NOAELadj = 1.3 MOS = 156 3.3.14 Discussion Marketed Henna represents a natural material derived from dried and powdered leaves of the plant Lawsonia inermis. Henna is used as a hair dye, based on the staining properties of one of its constituents, e.g. Lawsone. The batches 1271 and 830.72 of Henna do not vary considerably with regard to the water soluble extract. Since also the Lawsone content is comparable the results of the toxicological studies of these differ; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"84988-66-9","citation":"","dose":"According to SCCNFP/0583/02, the NOAEL of Lawsone is 2 mg/kg bw/d.","duration":"","effect":"lculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Lawsonia Inermis (Henna) The calculation will be based on the default hair dye amount of 35000 mg, with a retention factor of 0.1. Henna contains max. 1.4% Lawsone. A dermal absorption of 4.08% is used. According to SCCNFP/0583/02, the NOAEL of Lawsone is 2 mg/kg bw/d. SED= E product (expressed in mg/kgbw/d) x C (%) x DA (%) SED = (35000 mg/ d x 0.1 (Rf) x 1/4(dilution factor) x 1.4/100 x 4.08/100) / 60 kg = 0.00833 SED = 0.00833 mg/kg bw/d No Observed Adverse Effect Level (NOAEL) = 2 mg/kg bw/d Bioavailability 65% NOAELadj = 1.3 MOS = 156 3.3.14 Discussion Marketed Henna represents a natural material derived from dried and powdered leaves of the plant Lawsonia inermis. Henna is used as a hair dye, based on the staining properties of one of its constituents, e.g. Lawsone. The batches 1271 and 830.72 of Henna do not vary considerably with regard to the water soluble extract. Since also the Lawsone content is comparable the results of the toxicological studies of these differ","endpoint":"dermal absorption","ingredient":"Lawsonia inermis (Henna)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 0.00833","page":37,"route":"dermal","species":"","study_id":"sccs_o_140_noael_009"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =2 mg/kg bw/d - dermal - dermal absorption SOURCE_SUBDIR=sccs_o_140; REPORT_TITLE=OPINION ON Lawsonia inermis (Henna) COLIPA n° C169; OPINION_NUMBER=SCCS/1511/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=19 September 2013; VALUE_TEXT== 2; DOSE=According to SCCNFP/0583/02, the NOAEL of Lawsone is 2 mg/kg bw/d.; EFFECT=OF THE MARGIN OF SAFETY Lawsonia Inermis (Henna) The calculation will be based on the default hair dye amount of 35000 mg, with a retention factor of 0.1. Henna contains max. 1.4% Lawsone. A dermal absorption of 4.08% is used. According to SCCNFP/0583/02, the NOAEL of Lawsone is 2 mg/kg bw/d. SED= E product (expressed in mg/kgbw/d) x C (%) x DA (%) SED = (35000 mg/ d x 0.1 (Rf) x 1/4(dilution factor) x 1.4/100 x 4.08/100) / 60 kg = 0.00833 SED = 0.00833 mg/kg bw/d No Observed Adverse Effect Level (NOAEL) = 2 mg/kg bw/d Bioavailability 65% NOAELadj = 1.3 MOS = 156 3.3.14 Discussion Marketed Henna represents a natural material derived from dried and powdered leaves of the plant Lawsonia inermis. Henna is used as a hair dye, based on the staining properties of one of its constituents, e.g. Lawsone. The batches 1271 and 830.72 of Henna do not vary considerably with regard to the water soluble extract. Since also the Lawsone content is comparable the results of the toxicological studies of these different bat; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"84988-66-9","citation":"","dose":"According to SCCNFP/0583/02, the NOAEL of Lawsone is 2 mg/kg bw/d.","duration":"","effect":"OF THE MARGIN OF SAFETY Lawsonia Inermis (Henna) The calculation will be based on the default hair dye amount of 35000 mg, with a retention factor of 0.1. Henna contains max. 1.4% Lawsone. A dermal absorption of 4.08% is used. According to SCCNFP/0583/02, the NOAEL of Lawsone is 2 mg/kg bw/d. SED= E product (expressed in mg/kgbw/d) x C (%) x DA (%) SED = (35000 mg/ d x 0.1 (Rf) x 1/4(dilution factor) x 1.4/100 x 4.08/100) / 60 kg = 0.00833 SED = 0.00833 mg/kg bw/d No Observed Adverse Effect Level (NOAEL) = 2 mg/kg bw/d Bioavailability 65% NOAELadj = 1.3 MOS = 156 3.3.14 Discussion Marketed Henna represents a natural material derived from dried and powdered leaves of the plant Lawsonia inermis. Henna is used as a hair dye, based on the staining properties of one of its constituents, e.g. Lawsone. The batches 1271 and 830.72 of Henna do not vary considerably with regard to the water soluble extract. Since also the Lawsone content is comparable the results of the toxicological studies of these different bat","endpoint":"dermal absorption","ingredient":"Lawsonia inermis (Henna)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 2","page":37,"route":"dermal","species":"","study_id":"sccs_o_140_noael_010"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies genotoxicity 40 mg/kg bw - - Chronic genotoxicity SOURCE_SUBDIR=sccp_o_034; REPORT_TITLE=Opinion on Lawsonia inermis (Henna) COLIPA N° C169; OPINION_NUMBER=SCCP/0943/05; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 16 February 2004; VALUE_TEXT=40; DOSE=In the high dose group, minimal to moderate accumulation of acidophilic globules in the cortical tubular epithelium of the kidneys were recorded and were considered to be treatment- related.; EFFECT=en. In the high dose group, minimal to moderate accumulation of acidophilic globules in the cortical tubular epithelium of the kidneys were recorded and were considered to be treatment- related. In the 200 mg/kg/day and in the 1000 mg/kg/day groups, minimal to slight hemosiderosis and some extramedullary hemopoiesis were noted in the spleen. Except for the hemosiderosis in the spleen and the dyeing effects in the high dose group, all findings were reversible during the recovery period. Based on these results, the NOAEL (No-Observed-Adverse-Effect-Level) of Henna Rot was established to be 40 mg/kg bw. Ref.: 3 (subm. I) 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay (I) Guideline: OECD 471 (1983) Test system: Salmonella typhimurium, TA98, TA100, TA1535, TA1537, TA1538 Replicates: triplicate plates, two independent assays Test substance: Henna rot Batch: 830.72 Concentrations: 50 – 5000 µg/plate with and w; CITATION=Ref.: 3 (subm; CITATION_NUMBERS=[3]; REFERENCE=Ref.: 3 (subm; DETAILS_JSON={"cas_number":"84988-66-9","citation":"Ref.: 3 (subm","dose":"In the high dose group, minimal to moderate accumulation of acidophilic globules in the cortical tubular epithelium of the kidneys were recorded and were considered to be treatment- related.","duration":"Chronic","effect":"en. In the high dose group, minimal to moderate accumulation of acidophilic globules in the cortical tubular epithelium of the kidneys were recorded and were considered to be treatment- related. In the 200 mg/kg/day and in the 1000 mg/kg/day groups, minimal to slight hemosiderosis and some extramedullary hemopoiesis were noted in the spleen. Except for the hemosiderosis in the spleen and the dyeing effects in the high dose group, all findings were reversible during the recovery period. Based on these results, the NOAEL (No-Observed-Adverse-Effect-Level) of Henna Rot was established to be 40 mg/kg bw. Ref.: 3 (subm. I) 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay (I) Guideline: OECD 471 (1983) Test system: Salmonella typhimurium, TA98, TA100, TA1535, TA1537, TA1538 Replicates: triplicate plates, two independent assays Test substance: Henna rot Batch: 830.72 Concentrations: 50 – 5000 µg/plate with and w","endpoint":"genotoxicity","ingredient":"Lawsonia inermis","loael_value":"","noael_unit":"mg/kg bw","noael_value":"40","page":13,"route":"","species":"","study_id":"sccp_o_034_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies genotoxicity 40 mg/kg bw - - Chronic genotoxicity SOURCE_SUBDIR=sccp_o_034; REPORT_TITLE=Opinion on Lawsonia inermis (Henna) COLIPA N° C169; OPINION_NUMBER=SCCP/0943/05; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 16 February 2004; VALUE_TEXT=40; DOSE=the high dose group, minimal to moderate accumulation of acidophilic globules in the cortical tubular epithelium of the kidneys were recorded and were considered to be treatment- related.; EFFECT=the high dose group, minimal to moderate accumulation of acidophilic globules in the cortical tubular epithelium of the kidneys were recorded and were considered to be treatment- related. In the 200 mg/kg/day and in the 1000 mg/kg/day groups, minimal to slight hemosiderosis and some extramedullary hemopoiesis were noted in the spleen. Except for the hemosiderosis in the spleen and the dyeing effects in the high dose group, all findings were reversible during the recovery period. Based on these results, the NOAEL (No-Observed-Adverse-Effect-Level) of Henna Rot was established to be 40 mg/kg bw. Ref.: 3 (subm. I) 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay (I) Guideline: OECD 471 (1983) Test system: Salmonella typhimurium, TA98, TA100, TA1535, TA1537, TA1538 Replicates: triplicate plates, two independent assays Test substance: Henna rot Batch: 830.72 Concentrations: 50 – 5000 µg/plate with and without metabolic activation Solven; CITATION=Ref.: 3 (subm; CITATION_NUMBERS=[3]; REFERENCE=Ref.: 3 (subm; DETAILS_JSON={"cas_number":"84988-66-9","citation":"Ref.: 3 (subm","dose":"the high dose group, minimal to moderate accumulation of acidophilic globules in the cortical tubular epithelium of the kidneys were recorded and were considered to be treatment- related.","duration":"Chronic","effect":"the high dose group, minimal to moderate accumulation of acidophilic globules in the cortical tubular epithelium of the kidneys were recorded and were considered to be treatment- related. In the 200 mg/kg/day and in the 1000 mg/kg/day groups, minimal to slight hemosiderosis and some extramedullary hemopoiesis were noted in the spleen. Except for the hemosiderosis in the spleen and the dyeing effects in the high dose group, all findings were reversible during the recovery period. Based on these results, the NOAEL (No-Observed-Adverse-Effect-Level) of Henna Rot was established to be 40 mg/kg bw. Ref.: 3 (subm. I) 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay (I) Guideline: OECD 471 (1983) Test system: Salmonella typhimurium, TA98, TA100, TA1535, TA1537, TA1538 Replicates: triplicate plates, two independent assays Test substance: Henna rot Batch: 830.72 Concentrations: 50 – 5000 µg/plate with and without metabolic activation Solven","endpoint":"genotoxicity","ingredient":"Lawsonia inermis","loael_value":"","noael_unit":"mg/kg bw","noael_value":"40","page":13,"route":"","species":"","study_id":"sccp_o_034_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies genotoxicity 40 mg/kg bw/day rat oral 90-day genotoxicity SOURCE_SUBDIR=sccs_o_140; REPORT_TITLE=OPINION ON Lawsonia inermis (Henna) COLIPA n° C169; OPINION_NUMBER=SCCS/1511/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=19 September 2013; VALUE_TEXT=40; DOSE=Haemosiderosis (mid and high dose groups) and extramedullary haemopoiesis (high dose group) were noted in the spleen and were considered to be treatment related for both males and females.; EFFECT=obules in the cortical tubular epithelium of the kidneys were recorded and were considered to be treatment related for both males and females. Haemosiderosis (mid and high dose groups) and extramedullary haemopoiesis (high dose group) were noted in the spleen and were considered to be treatment related for both males and females. Except for the haemosiderosis in the spleen and the dyeing effects in the high dose group, all findings were reversible during the recovery period. Conclusion Based on these results, the NOAEL (No-Observed-Adverse-Effect-Level) of Henna Rot was established to be 40 mg/kg bw/day.Ref.: 3 (subm. I) SCCS comment Because Henna Rot contains besides Lawsone several other ingredients, the results of this study will not be used for the calculations of the MoS. According to SCCNFP/0583/02, the NOAEL of Lawsone is 2 mg/kg bw/d. In the context of a genotoxicity study (AR6 -Kirkland 2003), a 90-day oral toxicity study in rats was performed: the authors considered the NOAEL for Lawsone to be 2–7 mg/kg bw per day. The; CITATION=Ref.: 3 (subm; CITATION_NUMBERS=[3]; REFERENCE=Ref.: 3 (subm; DETAILS_JSON={"cas_number":"84988-66-9","citation":"Ref.: 3 (subm","dose":"Haemosiderosis (mid and high dose groups) and extramedullary haemopoiesis (high dose group) were noted in the spleen and were considered to be treatment related for both males and females.","duration":"90-day","effect":"obules in the cortical tubular epithelium of the kidneys were recorded and were considered to be treatment related for both males and females. Haemosiderosis (mid and high dose groups) and extramedullary haemopoiesis (high dose group) were noted in the spleen and were considered to be treatment related for both males and females. Except for the haemosiderosis in the spleen and the dyeing effects in the high dose group, all findings were reversible during the recovery period. Conclusion Based on these results, the NOAEL (No-Observed-Adverse-Effect-Level) of Henna Rot was established to be 40 mg/kg bw/day.Ref.: 3 (subm. I) SCCS comment Because Henna Rot contains besides Lawsone several other ingredients, the results of this study will not be used for the calculations of the MoS. According to SCCNFP/0583/02, the NOAEL of Lawsone is 2 mg/kg bw/d. In the context of a genotoxicity study (AR6 -Kirkland 2003), a 90-day oral toxicity study in rats was performed: the authors considered the NOAEL for Lawsone to be 2–7 mg/kg bw per day. The","endpoint":"genotoxicity","ingredient":"Lawsonia inermis (Henna)","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"40","page":22,"route":"oral","species":"rat","study_id":"sccs_o_140_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies genotoxicity 40 mg/kg bw/day rat oral 90-day genotoxicity SOURCE_SUBDIR=sccs_o_140; REPORT_TITLE=OPINION ON Lawsonia inermis (Henna) COLIPA n° C169; OPINION_NUMBER=SCCS/1511/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=19 September 2013; VALUE_TEXT=40; DOSE=Haemosiderosis (mid and high dose groups) and extramedullary haemopoiesis (high dose group) were noted in the spleen and were considered to be treatment related for both males and females.; EFFECT=in the cortical tubular epithelium of the kidneys were recorded and were considered to be treatment related for both males and females. Haemosiderosis (mid and high dose groups) and extramedullary haemopoiesis (high dose group) were noted in the spleen and were considered to be treatment related for both males and females. Except for the haemosiderosis in the spleen and the dyeing effects in the high dose group, all findings were reversible during the recovery period. Conclusion Based on these results, the NOAEL (No-Observed-Adverse-Effect-Level) of Henna Rot was established to be 40 mg/kg bw/day.Ref.: 3 (subm. I) SCCS comment Because Henna Rot contains besides Lawsone several other ingredients, the results of this study will not be used for the calculations of the MoS. According to SCCNFP/0583/02, the NOAEL of Lawsone is 2 mg/kg bw/d. In the context of a genotoxicity study (AR6 -Kirkland 2003), a 90-day oral toxicity study in rats was performed: the authors considered the NOAEL for Lawsone to be 2–7 mg/kg bw per day. The SCCS will use a NOAEL of 2 mg/kg; CITATION=Ref.: 3 (subm; CITATION_NUMBERS=[3]; REFERENCE=Ref.: 3 (subm; DETAILS_JSON={"cas_number":"84988-66-9","citation":"Ref.: 3 (subm","dose":"Haemosiderosis (mid and high dose groups) and extramedullary haemopoiesis (high dose group) were noted in the spleen and were considered to be treatment related for both males and females.","duration":"90-day","effect":"in the cortical tubular epithelium of the kidneys were recorded and were considered to be treatment related for both males and females. Haemosiderosis (mid and high dose groups) and extramedullary haemopoiesis (high dose group) were noted in the spleen and were considered to be treatment related for both males and females. Except for the haemosiderosis in the spleen and the dyeing effects in the high dose group, all findings were reversible during the recovery period. Conclusion Based on these results, the NOAEL (No-Observed-Adverse-Effect-Level) of Henna Rot was established to be 40 mg/kg bw/day.Ref.: 3 (subm. I) SCCS comment Because Henna Rot contains besides Lawsone several other ingredients, the results of this study will not be used for the calculations of the MoS. According to SCCNFP/0583/02, the NOAEL of Lawsone is 2 mg/kg bw/d. In the context of a genotoxicity study (AR6 -Kirkland 2003), a 90-day oral toxicity study in rats was performed: the authors considered the NOAEL for Lawsone to be 2–7 mg/kg bw per day. The SCCS will use a NOAEL of 2 mg/kg","endpoint":"genotoxicity","ingredient":"Lawsonia inermis (Henna)","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"40","page":22,"route":"oral","species":"rat","study_id":"sccs_o_140_noael_003"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies genotoxicity 2 mg/kg bw/d rat oral 90-day genotoxicity SOURCE_SUBDIR=sccs_o_140; REPORT_TITLE=OPINION ON Lawsonia inermis (Henna) COLIPA n° C169; OPINION_NUMBER=SCCS/1511/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=19 September 2013; VALUE_TEXT=2; DOSE=Except for the haemosiderosis in the spleen and the dyeing effects in the high dose group, all findings were reversible during the recovery period.; EFFECT=d for both males and females. Except for the haemosiderosis in the spleen and the dyeing effects in the high dose group, all findings were reversible during the recovery period. Conclusion Based on these results, the NOAEL (No-Observed-Adverse-Effect-Level) of Henna Rot was established to be 40 mg/kg bw/day.Ref.: 3 (subm. I) SCCS comment Because Henna Rot contains besides Lawsone several other ingredients, the results of this study will not be used for the calculations of the MoS. According to SCCNFP/0583/02, the NOAEL of Lawsone is 2 mg/kg bw/d. In the context of a genotoxicity study (AR6 -Kirkland 2003), a 90-day oral toxicity study in rats was performed: the authors considered the NOAEL for Lawsone to be 2–7 mg/kg bw per day. The SCCS will use a NOAEL of 2 mg/kg bw/d for the calculation of the MoS. 3.3.5.3 Chronic (> 12 months) toxicity No data submitted 3.3.6 Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 (1983) Test system: Salmonella typhimu; CITATION=Ref.: 3 (subm; CITATION_NUMBERS=[3]; REFERENCE=Ref.: 3 (subm; DETAILS_JSON={"cas_number":"84988-66-9","citation":"Ref.: 3 (subm","dose":"Except for the haemosiderosis in the spleen and the dyeing effects in the high dose group, all findings were reversible during the recovery period.","duration":"90-day","effect":"d for both males and females. Except for the haemosiderosis in the spleen and the dyeing effects in the high dose group, all findings were reversible during the recovery period. Conclusion Based on these results, the NOAEL (No-Observed-Adverse-Effect-Level) of Henna Rot was established to be 40 mg/kg bw/day.Ref.: 3 (subm. I) SCCS comment Because Henna Rot contains besides Lawsone several other ingredients, the results of this study will not be used for the calculations of the MoS. According to SCCNFP/0583/02, the NOAEL of Lawsone is 2 mg/kg bw/d. In the context of a genotoxicity study (AR6 -Kirkland 2003), a 90-day oral toxicity study in rats was performed: the authors considered the NOAEL for Lawsone to be 2–7 mg/kg bw per day. The SCCS will use a NOAEL of 2 mg/kg bw/d for the calculation of the MoS. 3.3.5.3 Chronic (> 12 months) toxicity No data submitted 3.3.6 Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 (1983) Test system: Salmonella typhimu","endpoint":"genotoxicity","ingredient":"Lawsonia inermis (Henna)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"2","page":22,"route":"oral","species":"rat","study_id":"sccs_o_140_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies genotoxicity 7 mg/kg bw rat oral 90-day genotoxicity SOURCE_SUBDIR=sccs_o_140; REPORT_TITLE=OPINION ON Lawsonia inermis (Henna) COLIPA n° C169; OPINION_NUMBER=SCCS/1511/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=19 September 2013; VALUE_TEXT=7; DOSE=Conclusion Based on these results, the NOAEL (No-Observed-Adverse-Effect-Level) of Henna Rot was established to be 40 mg/kg bw/day.Ref.:; EFFECT=od. Conclusion Based on these results, the NOAEL (No-Observed-Adverse-Effect-Level) of Henna Rot was established to be 40 mg/kg bw/day.Ref.: 3 (subm. I) SCCS comment Because Henna Rot contains besides Lawsone several other ingredients, the results of this study will not be used for the calculations of the MoS. According to SCCNFP/0583/02, the NOAEL of Lawsone is 2 mg/kg bw/d. In the context of a genotoxicity study (AR6 -Kirkland 2003), a 90-day oral toxicity study in rats was performed: the authors considered the NOAEL for Lawsone to be 2–7 mg/kg bw per day. The SCCS will use a NOAEL of 2 mg/kg bw/d for the calculation of the MoS. 3.3.5.3 Chronic (> 12 months) toxicity No data submitted 3.3.6 Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 (1983) Test system: Salmonella typhimurium, TA98, TA100, TA1535, TA1537, TA1538 Replicates: triplicate plates, two independent assays Test substance: Henna Rot Batch: 830.72 Purity: / Solvent: DMSO Concentrations; CITATION=Ref.: 3 (subm; CITATION_NUMBERS=[3]; REFERENCE=Ref.: 3 (subm; DETAILS_JSON={"cas_number":"84988-66-9","citation":"Ref.: 3 (subm","dose":"Conclusion Based on these results, the NOAEL (No-Observed-Adverse-Effect-Level) of Henna Rot was established to be 40 mg/kg bw/day.Ref.:","duration":"90-day","effect":"od. Conclusion Based on these results, the NOAEL (No-Observed-Adverse-Effect-Level) of Henna Rot was established to be 40 mg/kg bw/day.Ref.: 3 (subm. I) SCCS comment Because Henna Rot contains besides Lawsone several other ingredients, the results of this study will not be used for the calculations of the MoS. According to SCCNFP/0583/02, the NOAEL of Lawsone is 2 mg/kg bw/d. In the context of a genotoxicity study (AR6 -Kirkland 2003), a 90-day oral toxicity study in rats was performed: the authors considered the NOAEL for Lawsone to be 2–7 mg/kg bw per day. The SCCS will use a NOAEL of 2 mg/kg bw/d for the calculation of the MoS. 3.3.5.3 Chronic (> 12 months) toxicity No data submitted 3.3.6 Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 (1983) Test system: Salmonella typhimurium, TA98, TA100, TA1535, TA1537, TA1538 Replicates: triplicate plates, two independent assays Test substance: Henna Rot Batch: 830.72 Purity: / Solvent: DMSO Concentrations","endpoint":"genotoxicity","ingredient":"Lawsonia inermis (Henna)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"7","page":22,"route":"oral","species":"rat","study_id":"sccs_o_140_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies genotoxicity 2 mg/kg bw/d rat oral 90-day genotoxicity SOURCE_SUBDIR=sccs_o_140; REPORT_TITLE=OPINION ON Lawsonia inermis (Henna) COLIPA n° C169; OPINION_NUMBER=SCCS/1511/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=19 September 2013; VALUE_TEXT=2; DOSE=erse-Effect-Level) of Henna Rot was established to be 40 mg/kg bw/day.Ref.:; EFFECT=erse-Effect-Level) of Henna Rot was established to be 40 mg/kg bw/day.Ref.: 3 (subm. I) SCCS comment Because Henna Rot contains besides Lawsone several other ingredients, the results of this study will not be used for the calculations of the MoS. According to SCCNFP/0583/02, the NOAEL of Lawsone is 2 mg/kg bw/d. In the context of a genotoxicity study (AR6 -Kirkland 2003), a 90-day oral toxicity study in rats was performed: the authors considered the NOAEL for Lawsone to be 2–7 mg/kg bw per day. The SCCS will use a NOAEL of 2 mg/kg bw/d for the calculation of the MoS. 3.3.5.3 Chronic (> 12 months) toxicity No data submitted 3.3.6 Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 (1983) Test system: Salmonella typhimurium, TA98, TA100, TA1535, TA1537, TA1538 Replicates: triplicate plates, two independent assays Test substance: Henna Rot Batch: 830.72 Purity: / Solvent: DMSO Concentrations: 50, 100, 500, 1000, 2500 and 5000 μg/plate with and without meta; CITATION=Ref.: 3 (subm; CITATION_NUMBERS=[3]; REFERENCE=Ref.: 3 (subm; DETAILS_JSON={"cas_number":"84988-66-9","citation":"Ref.: 3 (subm","dose":"erse-Effect-Level) of Henna Rot was established to be 40 mg/kg bw/day.Ref.:","duration":"90-day","effect":"erse-Effect-Level) of Henna Rot was established to be 40 mg/kg bw/day.Ref.: 3 (subm. I) SCCS comment Because Henna Rot contains besides Lawsone several other ingredients, the results of this study will not be used for the calculations of the MoS. According to SCCNFP/0583/02, the NOAEL of Lawsone is 2 mg/kg bw/d. In the context of a genotoxicity study (AR6 -Kirkland 2003), a 90-day oral toxicity study in rats was performed: the authors considered the NOAEL for Lawsone to be 2–7 mg/kg bw per day. The SCCS will use a NOAEL of 2 mg/kg bw/d for the calculation of the MoS. 3.3.5.3 Chronic (> 12 months) toxicity No data submitted 3.3.6 Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 (1983) Test system: Salmonella typhimurium, TA98, TA100, TA1535, TA1537, TA1538 Replicates: triplicate plates, two independent assays Test substance: Henna Rot Batch: 830.72 Purity: / Solvent: DMSO Concentrations: 50, 100, 500, 1000, 2500 and 5000 μg/plate with and without meta","endpoint":"genotoxicity","ingredient":"Lawsonia inermis (Henna)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"2","page":22,"route":"oral","species":"rat","study_id":"sccs_o_140_noael_006"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies irritation >2000 mg/kg bw rat oral 13 week irritation SOURCE_SUBDIR=sccp_o_034; REPORT_TITLE=Opinion on Lawsonia inermis (Henna) COLIPA N° C169; OPINION_NUMBER=SCCP/0943/05; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 16 February 2004; VALUE_TEXT=> 2000; DOSE=Toxicity The calculated median lethal dose was > 2000 mg/kg bw (acute oral and dermal).; EFFECT=tituents, e.g. Lawsone. Modified Henna products, such as Black Henna are also available to consumers. The content of Lawsone among various modified Henna products may vary significantly, but these products contain some other substances for modifying the intensity of the colour provided by Henna alone. Aqueous pastes of Henna are also used for skin decoration. The present opinion only refers to the use of Henna as hair dye. Toxicity The calculated median lethal dose was > 2000 mg/kg bw (acute oral and dermal). The NOAEL (No-Observed-Adverse-Effect-Level) of Henna Rot was 40 mg/kg bw (13 week day rat study); the NOAEL was 200 mg/kg/day for the pregnant female rats and 40 mg/kg/day for the rat foetuses (teratogenicity study). Irritation, sensitisation; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"84988-66-9","citation":"","dose":"Toxicity The calculated median lethal dose was > 2000 mg/kg bw (acute oral and dermal).","duration":"13 week","effect":"tituents, e.g. Lawsone. Modified Henna products, such as Black Henna are also available to consumers. The content of Lawsone among various modified Henna products may vary significantly, but these products contain some other substances for modifying the intensity of the colour provided by Henna alone. Aqueous pastes of Henna are also used for skin decoration. The present opinion only refers to the use of Henna as hair dye. Toxicity The calculated median lethal dose was > 2000 mg/kg bw (acute oral and dermal). The NOAEL (No-Observed-Adverse-Effect-Level) of Henna Rot was 40 mg/kg bw (13 week day rat study); the NOAEL was 200 mg/kg/day for the pregnant female rats and 40 mg/kg/day for the rat foetuses (teratogenicity study). Irritation, sensitisation","endpoint":"irritation","ingredient":"Lawsonia inermis","loael_value":"","noael_unit":"mg/kg bw","noael_value":"> 2000","page":22,"route":"oral","species":"rat","study_id":"sccp_o_034_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies irritation >2000 mg/kg bw rat oral 13 week irritation SOURCE_SUBDIR=sccp_o_034; REPORT_TITLE=Opinion on Lawsonia inermis (Henna) COLIPA N° C169; OPINION_NUMBER=SCCP/0943/05; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 16 February 2004; VALUE_TEXT=> 2000; DOSE=Toxicity The calculated median lethal dose was > 2000 mg/kg bw (acute oral and dermal).; EFFECT=s, e.g. Lawsone. Modified Henna products, such as Black Henna are also available to consumers. The content of Lawsone among various modified Henna products may vary significantly, but these products contain some other substances for modifying the intensity of the colour provided by Henna alone. Aqueous pastes of Henna are also used for skin decoration. The present opinion only refers to the use of Henna as hair dye. Toxicity The calculated median lethal dose was > 2000 mg/kg bw (acute oral and dermal). The NOAEL (No-Observed-Adverse-Effect-Level) of Henna Rot was 40 mg/kg bw (13 week day rat study); the NOAEL was 200 mg/kg/day for the pregnant female rats and 40 mg/kg/day for the rat foetuses (teratogenicity study). Irritation, sensitisation; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"84988-66-9","citation":"","dose":"Toxicity The calculated median lethal dose was > 2000 mg/kg bw (acute oral and dermal).","duration":"13 week","effect":"s, e.g. Lawsone. Modified Henna products, such as Black Henna are also available to consumers. The content of Lawsone among various modified Henna products may vary significantly, but these products contain some other substances for modifying the intensity of the colour provided by Henna alone. Aqueous pastes of Henna are also used for skin decoration. The present opinion only refers to the use of Henna as hair dye. Toxicity The calculated median lethal dose was > 2000 mg/kg bw (acute oral and dermal). The NOAEL (No-Observed-Adverse-Effect-Level) of Henna Rot was 40 mg/kg bw (13 week day rat study); the NOAEL was 200 mg/kg/day for the pregnant female rats and 40 mg/kg/day for the rat foetuses (teratogenicity study). Irritation, sensitisation","endpoint":"irritation","ingredient":"Lawsonia inermis","loael_value":"","noael_unit":"mg/kg bw","noael_value":"> 2000","page":22,"route":"oral","species":"rat","study_id":"sccp_o_034_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies irritation 200 mg/kg/day rat oral 13 week irritation SOURCE_SUBDIR=sccp_o_034; REPORT_TITLE=Opinion on Lawsonia inermis (Henna) COLIPA N° C169; OPINION_NUMBER=SCCP/0943/05; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 16 February 2004; VALUE_TEXT=200; DOSE=Toxicity The calculated median lethal dose was > 2000 mg/kg bw (acute oral and dermal).; EFFECT=s. The content of Lawsone among various modified Henna products may vary significantly, but these products contain some other substances for modifying the intensity of the colour provided by Henna alone. Aqueous pastes of Henna are also used for skin decoration. The present opinion only refers to the use of Henna as hair dye. Toxicity The calculated median lethal dose was > 2000 mg/kg bw (acute oral and dermal). The NOAEL (No-Observed-Adverse-Effect-Level) of Henna Rot was 40 mg/kg bw (13 week day rat study); the NOAEL was 200 mg/kg/day for the pregnant female rats and 40 mg/kg/day for the rat foetuses (teratogenicity study). Irritation, sensitisation; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"84988-66-9","citation":"","dose":"Toxicity The calculated median lethal dose was > 2000 mg/kg bw (acute oral and dermal).","duration":"13 week","effect":"s. The content of Lawsone among various modified Henna products may vary significantly, but these products contain some other substances for modifying the intensity of the colour provided by Henna alone. Aqueous pastes of Henna are also used for skin decoration. The present opinion only refers to the use of Henna as hair dye. Toxicity The calculated median lethal dose was > 2000 mg/kg bw (acute oral and dermal). The NOAEL (No-Observed-Adverse-Effect-Level) of Henna Rot was 40 mg/kg bw (13 week day rat study); the NOAEL was 200 mg/kg/day for the pregnant female rats and 40 mg/kg/day for the rat foetuses (teratogenicity study). Irritation, sensitisation","endpoint":"irritation","ingredient":"Lawsonia inermis","loael_value":"","noael_unit":"mg/kg/day","noael_value":"200","page":22,"route":"oral","species":"rat","study_id":"sccp_o_034_noael_006"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies irritation >2000 mg/kg bw rat oral 13 week irritation SOURCE_SUBDIR=sccs_o_140; REPORT_TITLE=OPINION ON Lawsonia inermis (Henna) COLIPA n° C169; OPINION_NUMBER=SCCS/1511/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=19 September 2013; VALUE_TEXT=> 2000; DOSE=SCCS/1511/13 Opinion on Lawsonia Inermis (Henna) C169 - Corrigendum ___________________________________________________________________________________________ ___________________________________________________________________________________________ 38 The calculated median lethal dose was > 2000 mg/kg bw (acute oral and dermal).; EFFECT=SCCS/1511/13 Opinion on Lawsonia Inermis (Henna) C169 - Corrigendum ___________________________________________________________________________________________ ___________________________________________________________________________________________ 38 The calculated median lethal dose was > 2000 mg/kg bw (acute oral and dermal). The NOAEL (No-Observed-Adverse-Effect-Level) of Henna Rot was 40 mg/kg bw/day (13 week day rat study); the NOAEL was 200 mg/kg bw/day for the pregnant female rats and 40 mg/kg bw/day for the rat foetuses (teratogenicity study). Irritation, sensitisation No separate skin irritation study was performed in experimental animals. However, Lawsonia inermis showed no irritant potential for the skin after a single occlusive application for 24 hours, when tested for acute dermal toxicity (described above) under enforced conditions.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"84988-66-9","citation":"","dose":"SCCS/1511/13 Opinion on Lawsonia Inermis (Henna) C169 - Corrigendum ___________________________________________________________________________________________ ___________________________________________________________________________________________ 38 The calculated median lethal dose was > 2000 mg/kg bw (acute oral and dermal).","duration":"13 week","effect":"SCCS/1511/13 Opinion on Lawsonia Inermis (Henna) C169 - Corrigendum ___________________________________________________________________________________________ ___________________________________________________________________________________________ 38 The calculated median lethal dose was > 2000 mg/kg bw (acute oral and dermal). The NOAEL (No-Observed-Adverse-Effect-Level) of Henna Rot was 40 mg/kg bw/day (13 week day rat study); the NOAEL was 200 mg/kg bw/day for the pregnant female rats and 40 mg/kg bw/day for the rat foetuses (teratogenicity study). Irritation, sensitisation No separate skin irritation study was performed in experimental animals. However, Lawsonia inermis showed no irritant potential for the skin after a single occlusive application for 24 hours, when tested for acute dermal toxicity (described above) under enforced conditions.","endpoint":"irritation","ingredient":"Lawsonia inermis (Henna)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"> 2000","page":38,"route":"oral","species":"rat","study_id":"sccs_o_140_noael_011"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies irritation 200 mg/kg bw/day rat oral 13 week irritation SOURCE_SUBDIR=sccs_o_140; REPORT_TITLE=OPINION ON Lawsonia inermis (Henna) COLIPA n° C169; OPINION_NUMBER=SCCS/1511/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=19 September 2013; VALUE_TEXT=200; DOSE=SCCS/1511/13 Opinion on Lawsonia Inermis (Henna) C169 - Corrigendum ___________________________________________________________________________________________ ___________________________________________________________________________________________ 38 The calculated median lethal dose was > 2000 mg/kg bw (acute oral and dermal).; EFFECT=SCCS/1511/13 Opinion on Lawsonia Inermis (Henna) C169 - Corrigendum ___________________________________________________________________________________________ ___________________________________________________________________________________________ 38 The calculated median lethal dose was > 2000 mg/kg bw (acute oral and dermal). The NOAEL (No-Observed-Adverse-Effect-Level) of Henna Rot was 40 mg/kg bw/day (13 week day rat study); the NOAEL was 200 mg/kg bw/day for the pregnant female rats and 40 mg/kg bw/day for the rat foetuses (teratogenicity study). Irritation, sensitisation No separate skin irritation study was performed in experimental animals. However, Lawsonia inermis showed no irritant potential for the skin after a single occlusive application for 24 hours, when tested for acute dermal toxicity (described above) under enforced conditions. Lawsonia inermis is slightly and transiently irritating to the eyes. The results of a Buehler test sug; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"84988-66-9","citation":"","dose":"SCCS/1511/13 Opinion on Lawsonia Inermis (Henna) C169 - Corrigendum ___________________________________________________________________________________________ ___________________________________________________________________________________________ 38 The calculated median lethal dose was > 2000 mg/kg bw (acute oral and dermal).","duration":"13 week","effect":"SCCS/1511/13 Opinion on Lawsonia Inermis (Henna) C169 - Corrigendum ___________________________________________________________________________________________ ___________________________________________________________________________________________ 38 The calculated median lethal dose was > 2000 mg/kg bw (acute oral and dermal). The NOAEL (No-Observed-Adverse-Effect-Level) of Henna Rot was 40 mg/kg bw/day (13 week day rat study); the NOAEL was 200 mg/kg bw/day for the pregnant female rats and 40 mg/kg bw/day for the rat foetuses (teratogenicity study). Irritation, sensitisation No separate skin irritation study was performed in experimental animals. However, Lawsonia inermis showed no irritant potential for the skin after a single occlusive application for 24 hours, when tested for acute dermal toxicity (described above) under enforced conditions. Lawsonia inermis is slightly and transiently irritating to the eyes. The results of a Buehler test sug","endpoint":"irritation","ingredient":"Lawsonia inermis (Henna)","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"200","page":38,"route":"oral","species":"rat","study_id":"sccs_o_140_noael_012"}