NOAEL Studies
Cosmetic Ingredient
Lawsone NOAEL Studies
INCI: LAWSONE (2-HYDROXY-1,4-NAPHTHOQUINONE)
CAS: 83-72-7
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
COSMOS_DB 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| COSMOS_DB | LOAEL | 2 | mg/kg bw/day | rat | oral | 91 day | Subchronic | SCCNFP; 13-Week toxicity study by oral route in rats - 2-Hydroxy-1,4-naphthoquinone. CIT, France. Report No: 11312 TCR. 10.4.1995 |
SCCNFP_vision_codex 44 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCNFP_vision_codex | NOAEL | =0.5 | % | rat | oral | 7 days | NOAEL study | {"dose":"Extramedullary haemopoiesis and haemosiderin accumulation were noted in the spleen of both sexes at high dose and mid dose males.","effect":"ectively). These changes in weight were accompanied by a number of histo-pathological abnormalities. Extramedullary haemopoiesis and haemosiderin accumulation were noted in the spleen of both sexes at high dose and mid dose males. Renal tubular pigment deposits (Perl’s positive) and tubular basophilia/dilatation/degeneration for both sexes at high dose. Acanthosis, hyperkeratosis and subepithelial inflammatory cell infiltrates were noted in the stomachs of animals of all dose groups. The study failed to identify a NOAEL for gastric and renal effects. Ref. : 5.1 Second study Guideline : OECD 408 (1981) Species/strain : Sprague Dawley Crl CD (SD)BR strain rat Group size : 10 male + 10 female Test substance : 2-Hydroxy-1,4-naphthoquinone suspended in 0.5% aqueous methylcellulose Batch no : 8160:FE (purity 99.4%) Dose levels : 0, 2, 7 and 20 mg/kg bw/day, 7 days/week by gavage Exposure period : 13 weeks GLP : Quality Assurance statement included Groups of 10 male and 10 female rats were dosed with the test substance by gavage at 0, 2","page":8,"pdf":"out139_en.pdf","row_type":"noael_study","study_id":"out139_en_noael_003"} |
| SCCNFP_vision_codex | NOAEL | =0.5 | % | rat | oral | 7 days | NOAEL study | {"dose":"Extramedullary haemopoiesis and haemosiderin accumulation were noted in the spleen of both sexes at high dose and mid dose males.","effect":"ectively). These changes in weight were accompanied by a number of histo-pathological abnormalities. Extramedullary haemopoiesis and haemosiderin accumulation were noted in the spleen of both sexes at high dose and mid dose males. Renal tubular pigment deposits (Perl’s positive) and tubular basophilia/dilatation/degeneration for both sexes at high dose. Acanthosis, hyperkeratosis and subepithelial inflammatory cell infiltrates were noted in the stomachs of animals of all dose groups. The study failed to identify a NOAEL for gastric and renal effects. Ref. : 5.1 Second study Guideline : OECD 408 (1981) Species/strain : Sprague Dawley Crl CD (SD)BR strain rat Group size : 10 male + 10 female Test substance : 2-Hydroxy-1,4-naphthoquinone suspended in 0.5% aqueous methylcellulose Batch no : 8160:FE (purity 99.4%) Dose levels : 0, 2, 7 and 20 mg/kg bw/day, 7 days/week by gavage Exposure period : 13 weeks GLP : Quality Assurance statement included Groups of 10 male and 10 female rats were dosed with the test substance by gavage at 0, 2","page":8,"pdf":"out139_en.pdf","row_type":"noael_study","study_id":"out139_en_noael_003"} |
| SCCNFP_vision_codex | NOAEL | =0.5 | % | rat | oral | 7 days | NOAEL study | {"dose":"Extramedullary haemopoiesis and haemosiderin accumulation were noted in the spleen of both sexes at high dose and mid dose males.","effect":"ectively). These changes in weight were accompanied by a number of histo-pathological abnormalities. Extramedullary haemopoiesis and haemosiderin accumulation were noted in the spleen of both sexes at high dose and mid dose males. Renal tubular pigment deposits (Perl’s positive) and tubular basophilia/dilatation/degeneration for both sexes at high dose. Acanthosis, hyperkeratosis and subepithelial inflammatory cell infiltrates were noted in the stomachs of animals of all dose groups. The study failed to identify a NOAEL for gastric and renal effects. Ref. : 5.1 Second study Guideline : OECD 408 (1981) Species/strain : Sprague Dawley Crl CD (SD)BR strain rat Group size : 10 male + 10 female Test substance : 2-Hydroxy-1,4-naphthoquinone suspended in 0.5% aqueous methylcellulose Batch no : 8160:FE (purity 99.4%) Dose levels : 0, 2, 7 and 20 mg/kg bw/day, 7 days/week by gavage Exposure period : 13 weeks GLP : Quality Assurance statement included Groups of 10 male and 10 female rats were dosed with the test substance by gavage at 0, 2","page":8,"pdf":"out139_en.pdf","row_type":"noael_study","study_id":"out139_en_noael_003"} |
| SCCNFP_vision_codex | NOAEL | =0.5 | % | rat | oral | 7 days | NOAEL study | {"dose":"Extramedullary haemopoiesis and haemosiderin accumulation were noted in the spleen of both sexes at high dose and mid dose males.","effect":"ectively). These changes in weight were accompanied by a number of histo-pathological abnormalities. Extramedullary haemopoiesis and haemosiderin accumulation were noted in the spleen of both sexes at high dose and mid dose males. Renal tubular pigment deposits (Perl’s positive) and tubular basophilia/dilatation/degeneration for both sexes at high dose. Acanthosis, hyperkeratosis and subepithelial inflammatory cell infiltrates were noted in the stomachs of animals of all dose groups. The study failed to identify a NOAEL for gastric and renal effects. Ref. : 5.1 Second study Guideline : OECD 408 (1981) Species/strain : Sprague Dawley Crl CD (SD)BR strain rat Group size : 10 male + 10 female Test substance : 2-Hydroxy-1,4-naphthoquinone suspended in 0.5% aqueous methylcellulose Batch no : 8160:FE (purity 99.4%) Dose levels : 0, 2, 7 and 20 mg/kg bw/day, 7 days/week by gavage Exposure period : 13 weeks GLP : Quality Assurance statement included Groups of 10 male and 10 female rats were dosed with the test substance by gavage at 0, 2","page":8,"pdf":"out139_en.pdf","row_type":"noael_study","study_id":"out139_en_noael_003"} |
| SCCNFP_vision_codex | NOAEL | =2 | mg/kg bw/day | rabbit | - | 13- week | irritation | {"dose":"It is moderately toxic on acute ingestion, with mortalities occurring at 300 mg/kg and above.","effect":". Safety Assessment & Classification The assessment followed the Notes of Guidance under scientifically based premises of consumer safety and leads to a classification 2A. This substance has been adequately tested, generally to appropriate guidelines and GLP. It is moderately toxic on acute ingestion, with mortalities occurring at 300 mg/kg and above. Two 13- week studies have shown clear signs of toxicity to the haemopoietic system, kidney, forestomach and liver. Effects were seen as low as 7 mg/kg bw/day and the NOAEL was 2 mg/kg bw/day. It was shown to be mildly irritant to the rabbit eye but not to cause appreciable skin irritation. This substance is clearly genotoxic in vitro and in vivo. It induced mutations and chromosome aberrations in mammalian cells in vitro. It was positive in two bone marrow micronucleus assays. The negative studies (inadequate studies) do not override the positive results and it is therefore necessary to conclude that it is not possible to establish a safe level for this substance. Percutaneous penet","page":2,"pdf":"out139_en.pdf","row_type":"noael_study","study_id":"out139_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =2 | mg/kg bw/day | rabbit | - | 13-week | irritation | {"citation":"(ref. 5.1)","dose":"focal or multifocal ulceration of the mucosa, or minimal to slight interstitial oedema were reported with an increased incidence in both sexes at 7 mg/kg bw/day.","effect":"focal or multifocal ulceration of the mucosa, or minimal to slight interstitial oedema were reported with an increased incidence in both sexes at 7 mg/kg bw/day. The authors concluded that treatment-related effects occurred at 20 mg/kg bw/day, affecting mainly the kidneys, forestomach and spleen, and that the NOAEL was 7 mg/kg bw/day. Significant changes were seen at 7 mg/kg bw/day which were consistent with the effects at 20 mg/kg bw/day in this study, and at higher doses in the first 13-week study (ref. 5.1). A NOAEL of 2 mg/kg bw/day should therefore be assumed. Ref. : 5.2 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : OECD 404 (1987) Species/strain : New Zealand albino rabbit Group size : 3 males Test substance : 2-Hydroxy-1,4-naphthoquinone, neat and suspended at 2% in 0.5% aqueous methylcellulose Batch no : 8160 FE (purity 99.4%) Dose : 0.5 g or 0.5 ml GLP : QA statement included The substance was applied neat (0.5 g) to the right flank and as a 2% suspension in 0.5% aqueous methylcellulose (0.5 ml) to","page":8,"pdf":"out177_en.pdf","row_type":"noael_study","study_id":"out177_en_noael_002"} |
| SCCNFP_vision_codex | NOAEL | =2 | mg/kg bw/day | - | oral | - | NOAEL study | {"dose":"The toxicity of lawsone; effects to the kidney, forestomach and haemopoietic system following repeat oral dosing at doses in the region of 7-20 mg/kg bw/day.","effect":"restrictions or conditions for its use? The opinion adopted by the SCCNFP during the 16th plenary meeting of 13 March 2001 was based on this first submission from May 1996. In this opinion, Lawsone was given Classification 2A : the available data support the conclusion that the substance constitutes a health hazard. This was based on three points : 1. The toxicity of lawsone; effects to the kidney, forestomach and haemopoietic system following repeat oral dosing at doses in the region of 7-20 mg/kg bw/day. The NOAEL is 2 mg/kg bw/day. 2. Percutaneous penetration of 0.374% is assumed from the available information, but the study conditions were not adequate and this value could be a considerable underestimation. 3. Lawsone is clearly mutagenic and clastogenic in vitro and in vivo (genotoxic substance, category 3 according to Directive 67/548/EEC relating to the classification, packaging and labelling of dangerous substances) In the light of this opinion, the SCCNFP was requested to evaluate 5 further submissions. Submissi","page":2,"pdf":"out254_en.pdf","row_type":"noael_study","study_id":"out254_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =2 | mg/kg bw/day | rabbit | - | 13- week | irritation | {"dose":"It is moderately toxic on acute ingestion, with mortalities occurring at 300 mg/kg and above.","effect":". Safety Assessment & Classification The assessment followed the Notes of Guidance under scientifically based premises of consumer safety and leads to a classification 2A. This substance has been adequately tested, generally to appropriate guidelines and GLP. It is moderately toxic on acute ingestion, with mortalities occurring at 300 mg/kg and above. Two 13- week studies have shown clear signs of toxicity to the haemopoietic system, kidney, forestomach and liver. Effects were seen as low as 7 mg/kg bw/day and the NOAEL was 2 mg/kg bw/day. It was shown to be mildly irritant to the rabbit eye but not to cause appreciable skin irritation. This substance is clearly genotoxic in vitro and in vivo. It induced mutations and chromosome aberrations in mammalian cells in vitro. It was positive in two bone marrow micronucleus assays. The negative studies (inadequate studies) do not override the positive results and it is therefore necessary to conclude that it is not possible to establish a safe level for this substance. Percutaneous penet","page":2,"pdf":"out139_en.pdf","row_type":"noael_study","study_id":"out139_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =2 | mg/kg bw/day | rabbit | - | 13-week | irritation | {"citation":"(ref. 5.1)","dose":"focal or multifocal ulceration of the mucosa, or minimal to slight interstitial oedema were reported with an increased incidence in both sexes at 7 mg/kg bw/day.","effect":"focal or multifocal ulceration of the mucosa, or minimal to slight interstitial oedema were reported with an increased incidence in both sexes at 7 mg/kg bw/day. The authors concluded that treatment-related effects occurred at 20 mg/kg bw/day, affecting mainly the kidneys, forestomach and spleen, and that the NOAEL was 7 mg/kg bw/day. Significant changes were seen at 7 mg/kg bw/day which were consistent with the effects at 20 mg/kg bw/day in this study, and at higher doses in the first 13-week study (ref. 5.1). A NOAEL of 2 mg/kg bw/day should therefore be assumed. Ref. : 5.2 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : OECD 404 (1987) Species/strain : New Zealand albino rabbit Group size : 3 males Test substance : 2-Hydroxy-1,4-naphthoquinone, neat and suspended at 2% in 0.5% aqueous methylcellulose Batch no : 8160 FE (purity 99.4%) Dose : 0.5 g or 0.5 ml GLP : QA statement included The substance was applied neat (0.5 g) to the right flank and as a 2% suspension in 0.5% aqueous methylcellulose (0.5 ml) to","page":8,"pdf":"out177_en.pdf","row_type":"noael_study","study_id":"out177_en_noael_002"} |
| SCCNFP_vision_codex | NOAEL | =2 | mg/kg bw/day | - | oral | - | NOAEL study | {"dose":"The toxicity of lawsone; effects to the kidney, forestomach and haemopoietic system following repeat oral dosing at doses in the region of 7-20 mg/kg bw/day.","effect":"restrictions or conditions for its use? The opinion adopted by the SCCNFP during the 16th plenary meeting of 13 March 2001 was based on this first submission from May 1996. In this opinion, Lawsone was given Classification 2A : the available data support the conclusion that the substance constitutes a health hazard. This was based on three points : 1. The toxicity of lawsone; effects to the kidney, forestomach and haemopoietic system following repeat oral dosing at doses in the region of 7-20 mg/kg bw/day. The NOAEL is 2 mg/kg bw/day. 2. Percutaneous penetration of 0.374% is assumed from the available information, but the study conditions were not adequate and this value could be a considerable underestimation. 3. Lawsone is clearly mutagenic and clastogenic in vitro and in vivo (genotoxic substance, category 3 according to Directive 67/548/EEC relating to the classification, packaging and labelling of dangerous substances) In the light of this opinion, the SCCNFP was requested to evaluate 5 further submissions. Submissi","page":2,"pdf":"out254_en.pdf","row_type":"noael_study","study_id":"out254_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =2 | mg/kg bw/day | rabbit | - | 13- week | irritation | {"dose":"It is moderately toxic on acute ingestion, with mortalities occurring at 300 mg/kg and above.","effect":". Safety Assessment & Classification The assessment followed the Notes of Guidance under scientifically based premises of consumer safety and leads to a classification 2A. This substance has been adequately tested, generally to appropriate guidelines and GLP. It is moderately toxic on acute ingestion, with mortalities occurring at 300 mg/kg and above. Two 13- week studies have shown clear signs of toxicity to the haemopoietic system, kidney, forestomach and liver. Effects were seen as low as 7 mg/kg bw/day and the NOAEL was 2 mg/kg bw/day. It was shown to be mildly irritant to the rabbit eye but not to cause appreciable skin irritation. This substance is clearly genotoxic in vitro and in vivo. It induced mutations and chromosome aberrations in mammalian cells in vitro. It was positive in two bone marrow micronucleus assays. The negative studies (inadequate studies) do not override the positive results and it is therefore necessary to conclude that it is not possible to establish a safe level for this substance. Percutaneous penet","page":2,"pdf":"out139_en.pdf","row_type":"noael_study","study_id":"out139_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =2 | mg/kg bw/day | rabbit | - | 13-week | irritation | {"citation":"(ref. 5.1)","dose":"focal or multifocal ulceration of the mucosa, or minimal to slight interstitial oedema were reported with an increased incidence in both sexes at 7 mg/kg bw/day.","effect":"focal or multifocal ulceration of the mucosa, or minimal to slight interstitial oedema were reported with an increased incidence in both sexes at 7 mg/kg bw/day. The authors concluded that treatment-related effects occurred at 20 mg/kg bw/day, affecting mainly the kidneys, forestomach and spleen, and that the NOAEL was 7 mg/kg bw/day. Significant changes were seen at 7 mg/kg bw/day which were consistent with the effects at 20 mg/kg bw/day in this study, and at higher doses in the first 13-week study (ref. 5.1). A NOAEL of 2 mg/kg bw/day should therefore be assumed. Ref. : 5.2 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : OECD 404 (1987) Species/strain : New Zealand albino rabbit Group size : 3 males Test substance : 2-Hydroxy-1,4-naphthoquinone, neat and suspended at 2% in 0.5% aqueous methylcellulose Batch no : 8160 FE (purity 99.4%) Dose : 0.5 g or 0.5 ml GLP : QA statement included The substance was applied neat (0.5 g) to the right flank and as a 2% suspension in 0.5% aqueous methylcellulose (0.5 ml) to","page":8,"pdf":"out177_en.pdf","row_type":"noael_study","study_id":"out177_en_noael_002"} |
| SCCNFP_vision_codex | NOAEL | =2 | mg/kg bw/day | - | oral | - | NOAEL study | {"dose":"The toxicity of lawsone; effects to the kidney, forestomach and haemopoietic system following repeat oral dosing at doses in the region of 7-20 mg/kg bw/day.","effect":"restrictions or conditions for its use? The opinion adopted by the SCCNFP during the 16th plenary meeting of 13 March 2001 was based on this first submission from May 1996. In this opinion, Lawsone was given Classification 2A : the available data support the conclusion that the substance constitutes a health hazard. This was based on three points : 1. The toxicity of lawsone; effects to the kidney, forestomach and haemopoietic system following repeat oral dosing at doses in the region of 7-20 mg/kg bw/day. The NOAEL is 2 mg/kg bw/day. 2. Percutaneous penetration of 0.374% is assumed from the available information, but the study conditions were not adequate and this value could be a considerable underestimation. 3. Lawsone is clearly mutagenic and clastogenic in vitro and in vivo (genotoxic substance, category 3 according to Directive 67/548/EEC relating to the classification, packaging and labelling of dangerous substances) In the light of this opinion, the SCCNFP was requested to evaluate 5 further submissions. Submissi","page":2,"pdf":"out254_en.pdf","row_type":"noael_study","study_id":"out254_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =2 | mg/kg bw/day | rabbit | - | 13- week | irritation | {"dose":"It is moderately toxic on acute ingestion, with mortalities occurring at 300 mg/kg and above.","effect":". Safety Assessment & Classification The assessment followed the Notes of Guidance under scientifically based premises of consumer safety and leads to a classification 2A. This substance has been adequately tested, generally to appropriate guidelines and GLP. It is moderately toxic on acute ingestion, with mortalities occurring at 300 mg/kg and above. Two 13- week studies have shown clear signs of toxicity to the haemopoietic system, kidney, forestomach and liver. Effects were seen as low as 7 mg/kg bw/day and the NOAEL was 2 mg/kg bw/day. It was shown to be mildly irritant to the rabbit eye but not to cause appreciable skin irritation. This substance is clearly genotoxic in vitro and in vivo. It induced mutations and chromosome aberrations in mammalian cells in vitro. It was positive in two bone marrow micronucleus assays. The negative studies (inadequate studies) do not override the positive results and it is therefore necessary to conclude that it is not possible to establish a safe level for this substance. Percutaneous penet","page":2,"pdf":"out139_en.pdf","row_type":"noael_study","study_id":"out139_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =2 | mg/kg bw/day | rabbit | - | 13-week | irritation | {"citation":"(ref. 5.1)","dose":"focal or multifocal ulceration of the mucosa, or minimal to slight interstitial oedema were reported with an increased incidence in both sexes at 7 mg/kg bw/day.","effect":"focal or multifocal ulceration of the mucosa, or minimal to slight interstitial oedema were reported with an increased incidence in both sexes at 7 mg/kg bw/day. The authors concluded that treatment-related effects occurred at 20 mg/kg bw/day, affecting mainly the kidneys, forestomach and spleen, and that the NOAEL was 7 mg/kg bw/day. Significant changes were seen at 7 mg/kg bw/day which were consistent with the effects at 20 mg/kg bw/day in this study, and at higher doses in the first 13-week study (ref. 5.1). A NOAEL of 2 mg/kg bw/day should therefore be assumed. Ref. : 5.2 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : OECD 404 (1987) Species/strain : New Zealand albino rabbit Group size : 3 males Test substance : 2-Hydroxy-1,4-naphthoquinone, neat and suspended at 2% in 0.5% aqueous methylcellulose Batch no : 8160 FE (purity 99.4%) Dose : 0.5 g or 0.5 ml GLP : QA statement included The substance was applied neat (0.5 g) to the right flank and as a 2% suspension in 0.5% aqueous methylcellulose (0.5 ml) to","page":8,"pdf":"out177_en.pdf","row_type":"noael_study","study_id":"out177_en_noael_002"} |
| SCCNFP_vision_codex | NOAEL | =2 | mg/kg bw/day | - | oral | - | NOAEL study | {"dose":"The toxicity of lawsone; effects to the kidney, forestomach and haemopoietic system following repeat oral dosing at doses in the region of 7-20 mg/kg bw/day.","effect":"restrictions or conditions for its use? The opinion adopted by the SCCNFP during the 16th plenary meeting of 13 March 2001 was based on this first submission from May 1996. In this opinion, Lawsone was given Classification 2A : the available data support the conclusion that the substance constitutes a health hazard. This was based on three points : 1. The toxicity of lawsone; effects to the kidney, forestomach and haemopoietic system following repeat oral dosing at doses in the region of 7-20 mg/kg bw/day. The NOAEL is 2 mg/kg bw/day. 2. Percutaneous penetration of 0.374% is assumed from the available information, but the study conditions were not adequate and this value could be a considerable underestimation. 3. Lawsone is clearly mutagenic and clastogenic in vitro and in vivo (genotoxic substance, category 3 according to Directive 67/548/EEC relating to the classification, packaging and labelling of dangerous substances) In the light of this opinion, the SCCNFP was requested to evaluate 5 further submissions. Submissi","page":2,"pdf":"out254_en.pdf","row_type":"noael_study","study_id":"out254_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =7 | mg/kg bw/day | rabbit | - | 13-week | irritation | {"citation":"(ref. 5.1)","dose":"w/day, at which dose it was accompanied by dilatation and/or pigment accumulation degeneration in some animals.","effect":"w/day, at which dose it was accompanied by dilatation and/or pigment accumulation degeneration in some animals. The incidence at 7 mg/kg bw/day was comparable to control. In the forestomach, minimal to slight focal or multifocal ulceration of the mucosa, or minimal to slight interstitial oedema were reported with an increased incidence in both sexes at 7 mg/kg bw/day. The authors concluded that treatment-related effects occurred at 20 mg/kg bw/day, affecting mainly the kidneys, forestomach and spleen, and that the NOAEL was 7 mg/kg bw/day. Significant changes were seen at 7 mg/kg bw/day which were consistent with the effects at 20 mg/kg bw/day in this study, and at higher doses in the first 13-week study (ref. 5.1). A NOAEL of 2 mg/kg bw/day should therefore be assumed. Ref. : 5.2 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : OECD 404 (1987) Species/strain : New Zealand albino rabbit Group size : 3 males Test substance : 2-Hydroxy-1,4-naphthoquinone, neat and suspended at 2% in 0.5% aqueous methylcellulose Ba","page":9,"pdf":"out139_en.pdf","row_type":"noael_study","study_id":"out139_en_noael_004"} |
| SCCNFP_vision_codex | NOAEL | =7 | mg/kg bw/day | rabbit | - | 13-week | irritation | {"citation":"(ref. 5.1)","dose":"w/day, at which dose it was accompanied by dilatation and/or pigment accumulation degeneration in some animals.","effect":"w/day, at which dose it was accompanied by dilatation and/or pigment accumulation degeneration in some animals. The incidence at 7 mg/kg bw/day was comparable to control. In the forestomach, minimal to slight focal or multifocal ulceration of the mucosa, or minimal to slight interstitial oedema were reported with an increased incidence in both sexes at 7 mg/kg bw/day. The authors concluded that treatment-related effects occurred at 20 mg/kg bw/day, affecting mainly the kidneys, forestomach and spleen, and that the NOAEL was 7 mg/kg bw/day. Significant changes were seen at 7 mg/kg bw/day which were consistent with the effects at 20 mg/kg bw/day in this study, and at higher doses in the first 13-week study (ref. 5.1). A NOAEL of 2 mg/kg bw/day should therefore be assumed. Ref. : 5.2 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : OECD 404 (1987) Species/strain : New Zealand albino rabbit Group size : 3 males Test substance : 2-Hydroxy-1,4-naphthoquinone, neat and suspended at 2% in 0.5% aqueous methylcellulose Ba","page":8,"pdf":"out177_en.pdf","row_type":"noael_study","study_id":"out177_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =7 | mg/kg bw/day | rabbit | - | 13-week | irritation | {"citation":"(ref. 5.1)","dose":"/day, at which dose it was accompanied by dilatation and/or pigment accumulation degeneration in some animals.","effect":"/day, at which dose it was accompanied by dilatation and/or pigment accumulation degeneration in some animals. The incidence at 7 mg/kg bw/day was comparable to control. In the forestomach, minimal to slight focal or multifocal ulceration of the mucosa, or minimal to slight interstitial oedema were reported with an increased incidence in both sexes at 7 mg/kg bw/day. The authors concluded that treatment-related effects occurred at 20 mg/kg bw/day, affecting mainly the kidneys, forestomach and spleen, and that the NOAEL was 7 mg/kg bw/day. Significant changes were seen at 7 mg/kg bw/day which were consistent with the effects at 20 mg/kg bw/day in this study, and at higher doses in the first 13-week study (ref. 5.1). A NOAEL of 2 mg/kg bw/day should therefore be assumed. Ref. : 5.2 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : OECD 404 (1987) Species/strain : New Zealand albino rabbit Group size : 3 males Test substance : 2-Hydroxy-1,4-naphthoquinone, neat and suspended at 2% in 0.5% aqueous methylcel","page":9,"pdf":"out254_en.pdf","row_type":"noael_study","study_id":"out254_en_noael_002"} |
| SCCNFP_vision_codex | NOAEL | =7 | mg/kg bw/day | rabbit | - | 13-week | irritation | {"citation":"(ref. 5.1)","dose":"w/day, at which dose it was accompanied by dilatation and/or pigment accumulation degeneration in some animals.","effect":"w/day, at which dose it was accompanied by dilatation and/or pigment accumulation degeneration in some animals. The incidence at 7 mg/kg bw/day was comparable to control. In the forestomach, minimal to slight focal or multifocal ulceration of the mucosa, or minimal to slight interstitial oedema were reported with an increased incidence in both sexes at 7 mg/kg bw/day. The authors concluded that treatment-related effects occurred at 20 mg/kg bw/day, affecting mainly the kidneys, forestomach and spleen, and that the NOAEL was 7 mg/kg bw/day. Significant changes were seen at 7 mg/kg bw/day which were consistent with the effects at 20 mg/kg bw/day in this study, and at higher doses in the first 13-week study (ref. 5.1). A NOAEL of 2 mg/kg bw/day should therefore be assumed. Ref. : 5.2 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : OECD 404 (1987) Species/strain : New Zealand albino rabbit Group size : 3 males Test substance : 2-Hydroxy-1,4-naphthoquinone, neat and suspended at 2% in 0.5% aqueous methylcellulose Ba","page":9,"pdf":"out139_en.pdf","row_type":"noael_study","study_id":"out139_en_noael_004"} |
| SCCNFP_vision_codex | NOAEL | =7 | mg/kg bw/day | rabbit | - | 13-week | irritation | {"citation":"(ref. 5.1)","dose":"w/day, at which dose it was accompanied by dilatation and/or pigment accumulation degeneration in some animals.","effect":"w/day, at which dose it was accompanied by dilatation and/or pigment accumulation degeneration in some animals. The incidence at 7 mg/kg bw/day was comparable to control. In the forestomach, minimal to slight focal or multifocal ulceration of the mucosa, or minimal to slight interstitial oedema were reported with an increased incidence in both sexes at 7 mg/kg bw/day. The authors concluded that treatment-related effects occurred at 20 mg/kg bw/day, affecting mainly the kidneys, forestomach and spleen, and that the NOAEL was 7 mg/kg bw/day. Significant changes were seen at 7 mg/kg bw/day which were consistent with the effects at 20 mg/kg bw/day in this study, and at higher doses in the first 13-week study (ref. 5.1). A NOAEL of 2 mg/kg bw/day should therefore be assumed. Ref. : 5.2 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : OECD 404 (1987) Species/strain : New Zealand albino rabbit Group size : 3 males Test substance : 2-Hydroxy-1,4-naphthoquinone, neat and suspended at 2% in 0.5% aqueous methylcellulose Ba","page":8,"pdf":"out177_en.pdf","row_type":"noael_study","study_id":"out177_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =7 | mg/kg bw/day | rabbit | - | 13-week | irritation | {"citation":"(ref. 5.1)","dose":"/day, at which dose it was accompanied by dilatation and/or pigment accumulation degeneration in some animals.","effect":"/day, at which dose it was accompanied by dilatation and/or pigment accumulation degeneration in some animals. The incidence at 7 mg/kg bw/day was comparable to control. In the forestomach, minimal to slight focal or multifocal ulceration of the mucosa, or minimal to slight interstitial oedema were reported with an increased incidence in both sexes at 7 mg/kg bw/day. The authors concluded that treatment-related effects occurred at 20 mg/kg bw/day, affecting mainly the kidneys, forestomach and spleen, and that the NOAEL was 7 mg/kg bw/day. Significant changes were seen at 7 mg/kg bw/day which were consistent with the effects at 20 mg/kg bw/day in this study, and at higher doses in the first 13-week study (ref. 5.1). A NOAEL of 2 mg/kg bw/day should therefore be assumed. Ref. : 5.2 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : OECD 404 (1987) Species/strain : New Zealand albino rabbit Group size : 3 males Test substance : 2-Hydroxy-1,4-naphthoquinone, neat and suspended at 2% in 0.5% aqueous methylcel","page":9,"pdf":"out254_en.pdf","row_type":"noael_study","study_id":"out254_en_noael_002"} |
| SCCNFP_vision_codex | NOAEL | =7 | mg/kg bw/day | rabbit | - | 13-week | irritation | {"citation":"(ref. 5.1)","dose":"w/day, at which dose it was accompanied by dilatation and/or pigment accumulation degeneration in some animals.","effect":"w/day, at which dose it was accompanied by dilatation and/or pigment accumulation degeneration in some animals. The incidence at 7 mg/kg bw/day was comparable to control. In the forestomach, minimal to slight focal or multifocal ulceration of the mucosa, or minimal to slight interstitial oedema were reported with an increased incidence in both sexes at 7 mg/kg bw/day. The authors concluded that treatment-related effects occurred at 20 mg/kg bw/day, affecting mainly the kidneys, forestomach and spleen, and that the NOAEL was 7 mg/kg bw/day. Significant changes were seen at 7 mg/kg bw/day which were consistent with the effects at 20 mg/kg bw/day in this study, and at higher doses in the first 13-week study (ref. 5.1). A NOAEL of 2 mg/kg bw/day should therefore be assumed. Ref. : 5.2 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : OECD 404 (1987) Species/strain : New Zealand albino rabbit Group size : 3 males Test substance : 2-Hydroxy-1,4-naphthoquinone, neat and suspended at 2% in 0.5% aqueous methylcellulose Ba","page":9,"pdf":"out139_en.pdf","row_type":"noael_study","study_id":"out139_en_noael_004"} |
| SCCNFP_vision_codex | NOAEL | =7 | mg/kg bw/day | rabbit | - | 13-week | irritation | {"citation":"(ref. 5.1)","dose":"w/day, at which dose it was accompanied by dilatation and/or pigment accumulation degeneration in some animals.","effect":"w/day, at which dose it was accompanied by dilatation and/or pigment accumulation degeneration in some animals. The incidence at 7 mg/kg bw/day was comparable to control. In the forestomach, minimal to slight focal or multifocal ulceration of the mucosa, or minimal to slight interstitial oedema were reported with an increased incidence in both sexes at 7 mg/kg bw/day. The authors concluded that treatment-related effects occurred at 20 mg/kg bw/day, affecting mainly the kidneys, forestomach and spleen, and that the NOAEL was 7 mg/kg bw/day. Significant changes were seen at 7 mg/kg bw/day which were consistent with the effects at 20 mg/kg bw/day in this study, and at higher doses in the first 13-week study (ref. 5.1). A NOAEL of 2 mg/kg bw/day should therefore be assumed. Ref. : 5.2 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : OECD 404 (1987) Species/strain : New Zealand albino rabbit Group size : 3 males Test substance : 2-Hydroxy-1,4-naphthoquinone, neat and suspended at 2% in 0.5% aqueous methylcellulose Ba","page":8,"pdf":"out177_en.pdf","row_type":"noael_study","study_id":"out177_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =7 | mg/kg bw/day | rabbit | - | 13-week | irritation | {"citation":"(ref. 5.1)","dose":"/day, at which dose it was accompanied by dilatation and/or pigment accumulation degeneration in some animals.","effect":"/day, at which dose it was accompanied by dilatation and/or pigment accumulation degeneration in some animals. The incidence at 7 mg/kg bw/day was comparable to control. In the forestomach, minimal to slight focal or multifocal ulceration of the mucosa, or minimal to slight interstitial oedema were reported with an increased incidence in both sexes at 7 mg/kg bw/day. The authors concluded that treatment-related effects occurred at 20 mg/kg bw/day, affecting mainly the kidneys, forestomach and spleen, and that the NOAEL was 7 mg/kg bw/day. Significant changes were seen at 7 mg/kg bw/day which were consistent with the effects at 20 mg/kg bw/day in this study, and at higher doses in the first 13-week study (ref. 5.1). A NOAEL of 2 mg/kg bw/day should therefore be assumed. Ref. : 5.2 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : OECD 404 (1987) Species/strain : New Zealand albino rabbit Group size : 3 males Test substance : 2-Hydroxy-1,4-naphthoquinone, neat and suspended at 2% in 0.5% aqueous methylcel","page":9,"pdf":"out254_en.pdf","row_type":"noael_study","study_id":"out254_en_noael_002"} |
| SCCNFP_vision_codex | NOAEL | =7 | mg/kg bw/day | rabbit | - | 13-week | irritation | {"citation":"(ref. 5.1)","dose":"w/day, at which dose it was accompanied by dilatation and/or pigment accumulation degeneration in some animals.","effect":"w/day, at which dose it was accompanied by dilatation and/or pigment accumulation degeneration in some animals. The incidence at 7 mg/kg bw/day was comparable to control. In the forestomach, minimal to slight focal or multifocal ulceration of the mucosa, or minimal to slight interstitial oedema were reported with an increased incidence in both sexes at 7 mg/kg bw/day. The authors concluded that treatment-related effects occurred at 20 mg/kg bw/day, affecting mainly the kidneys, forestomach and spleen, and that the NOAEL was 7 mg/kg bw/day. Significant changes were seen at 7 mg/kg bw/day which were consistent with the effects at 20 mg/kg bw/day in this study, and at higher doses in the first 13-week study (ref. 5.1). A NOAEL of 2 mg/kg bw/day should therefore be assumed. Ref. : 5.2 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : OECD 404 (1987) Species/strain : New Zealand albino rabbit Group size : 3 males Test substance : 2-Hydroxy-1,4-naphthoquinone, neat and suspended at 2% in 0.5% aqueous methylcellulose Ba","page":9,"pdf":"out139_en.pdf","row_type":"noael_study","study_id":"out139_en_noael_004"} |
| SCCNFP_vision_codex | NOAEL | =7 | mg/kg bw/day | rabbit | - | 13-week | irritation | {"citation":"(ref. 5.1)","dose":"w/day, at which dose it was accompanied by dilatation and/or pigment accumulation degeneration in some animals.","effect":"w/day, at which dose it was accompanied by dilatation and/or pigment accumulation degeneration in some animals. The incidence at 7 mg/kg bw/day was comparable to control. In the forestomach, minimal to slight focal or multifocal ulceration of the mucosa, or minimal to slight interstitial oedema were reported with an increased incidence in both sexes at 7 mg/kg bw/day. The authors concluded that treatment-related effects occurred at 20 mg/kg bw/day, affecting mainly the kidneys, forestomach and spleen, and that the NOAEL was 7 mg/kg bw/day. Significant changes were seen at 7 mg/kg bw/day which were consistent with the effects at 20 mg/kg bw/day in this study, and at higher doses in the first 13-week study (ref. 5.1). A NOAEL of 2 mg/kg bw/day should therefore be assumed. Ref. : 5.2 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : OECD 404 (1987) Species/strain : New Zealand albino rabbit Group size : 3 males Test substance : 2-Hydroxy-1,4-naphthoquinone, neat and suspended at 2% in 0.5% aqueous methylcellulose Ba","page":8,"pdf":"out177_en.pdf","row_type":"noael_study","study_id":"out177_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =7 | mg/kg bw/day | rabbit | - | 13-week | irritation | {"citation":"(ref. 5.1)","dose":"/day, at which dose it was accompanied by dilatation and/or pigment accumulation degeneration in some animals.","effect":"/day, at which dose it was accompanied by dilatation and/or pigment accumulation degeneration in some animals. The incidence at 7 mg/kg bw/day was comparable to control. In the forestomach, minimal to slight focal or multifocal ulceration of the mucosa, or minimal to slight interstitial oedema were reported with an increased incidence in both sexes at 7 mg/kg bw/day. The authors concluded that treatment-related effects occurred at 20 mg/kg bw/day, affecting mainly the kidneys, forestomach and spleen, and that the NOAEL was 7 mg/kg bw/day. Significant changes were seen at 7 mg/kg bw/day which were consistent with the effects at 20 mg/kg bw/day in this study, and at higher doses in the first 13-week study (ref. 5.1). A NOAEL of 2 mg/kg bw/day should therefore be assumed. Ref. : 5.2 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : OECD 404 (1987) Species/strain : New Zealand albino rabbit Group size : 3 males Test substance : 2-Hydroxy-1,4-naphthoquinone, neat and suspended at 2% in 0.5% aqueous methylcel","page":9,"pdf":"out254_en.pdf","row_type":"noael_study","study_id":"out254_en_noael_002"} |
| SCCNFP_vision_codex | NOAEL | =20 | mg/kg bw/day | - | - | - | NOAEL study | {"citation":"Ref. : 12","dose":"e mean numbers of corpora lutea, live foetuses, sex distribution and the mean foetal bodyweights were comparable for control and treated groups.","effect":"e mean numbers of corpora lutea, live foetuses, sex distribution and the mean foetal bodyweights were comparable for control and treated groups. The incidence of foetal abnormalities or malformations was comparable for all dose groups. There was slight maternal toxicity at 20 mg/kg bw/day but not embryo-toxicity or teratogenicity. The NOAEL was 7 mg/kg bw/day for materno-toxicity. The significance of the single abortion at 20 mg/kg bw/day is unclear. However it does not influence the conclusion with respect to the NOAEL. Ref. : 12","page":12,"pdf":"out139_en.pdf","row_type":"noael_study","study_id":"out139_en_noael_007"} |
| SCCNFP_vision_codex | NOAEL | =20 | mg/kg bw/day | human | - | - | dermal absorption | {"citation":"Ref. : 12 2","dose":"e mean numbers of corpora lutea, live foetuses, sex distribution and the mean foetal bodyweights were comparable for control and treated groups.","effect":"e mean numbers of corpora lutea, live foetuses, sex distribution and the mean foetal bodyweights were comparable for control and treated groups. The incidence of foetal abnormalities or malformations was comparable for all dose groups. There was slight maternal toxicity at 20 mg/kg bw/day but not embryo-toxicity or teratogenicity. The NOAEL was 7 mg/kg bw/day for materno-toxicity. The significance of the single abortion at 20 mg/kg bw/day is unclear. However it does not influence the conclusion with respect to the NOAEL. Ref. : 12 2.7. Toxicokinetics (incl. Percutaneous Absorption) 2.7.1. Percutaneous Absorption in vitro First Study Guideline : none available Tissue : Human mammary epidermis, heat-separated Method : Franz diffusion cell (static) Test substance : 2-Hydroxy-1,4-naphthoquinone, 1.78% in formulation Batch no : 8160:FE (purity: 99.4%) Dose levels : c. 40mg formulation in the presence/absence of 10 mg hair Replicate cells : 9 cells without hair and 15 cells with hair GLP : Study not in compliance The skin penetration o","page":11,"pdf":"out177_en.pdf","row_type":"noael_study","study_id":"out177_en_noael_004"} |
| SCCNFP_vision_codex | NOAEL | =20 | mg/kg bw/day | - | - | - | NOAEL study | {"citation":"Ref. : 12","dose":"e mean numbers of corpora lutea, live foetuses, sex distribution and the mean foetal bodyweights were comparable for control and treated groups.","effect":"e mean numbers of corpora lutea, live foetuses, sex distribution and the mean foetal bodyweights were comparable for control and treated groups. The incidence of foetal abnormalities or malformations was comparable for all dose groups. There was slight maternal toxicity at 20 mg/kg bw/day but not embryo-toxicity or teratogenicity. The NOAEL was 7 mg/kg bw/day for materno-toxicity. The significance of the single abortion at 20 mg/kg bw/day is unclear. However it does not influence the conclusion with respect to the NOAEL. Ref. : 12","page":12,"pdf":"out139_en.pdf","row_type":"noael_study","study_id":"out139_en_noael_007"} |
| SCCNFP_vision_codex | NOAEL | =20 | mg/kg bw/day | human | - | - | dermal absorption | {"citation":"Ref. : 12 2","dose":"e mean numbers of corpora lutea, live foetuses, sex distribution and the mean foetal bodyweights were comparable for control and treated groups.","effect":"e mean numbers of corpora lutea, live foetuses, sex distribution and the mean foetal bodyweights were comparable for control and treated groups. The incidence of foetal abnormalities or malformations was comparable for all dose groups. There was slight maternal toxicity at 20 mg/kg bw/day but not embryo-toxicity or teratogenicity. The NOAEL was 7 mg/kg bw/day for materno-toxicity. The significance of the single abortion at 20 mg/kg bw/day is unclear. However it does not influence the conclusion with respect to the NOAEL. Ref. : 12 2.7. Toxicokinetics (incl. Percutaneous Absorption) 2.7.1. Percutaneous Absorption in vitro First Study Guideline : none available Tissue : Human mammary epidermis, heat-separated Method : Franz diffusion cell (static) Test substance : 2-Hydroxy-1,4-naphthoquinone, 1.78% in formulation Batch no : 8160:FE (purity: 99.4%) Dose levels : c. 40mg formulation in the presence/absence of 10 mg hair Replicate cells : 9 cells without hair and 15 cells with hair GLP : Study not in compliance The skin penetration o","page":11,"pdf":"out177_en.pdf","row_type":"noael_study","study_id":"out177_en_noael_004"} |
| SCCNFP_vision_codex | NOAEL | =20 | mg/kg bw/day | - | - | - | NOAEL study | {"citation":"Ref. : 12","dose":"e mean numbers of corpora lutea, live foetuses, sex distribution and the mean foetal bodyweights were comparable for control and treated groups.","effect":"e mean numbers of corpora lutea, live foetuses, sex distribution and the mean foetal bodyweights were comparable for control and treated groups. The incidence of foetal abnormalities or malformations was comparable for all dose groups. There was slight maternal toxicity at 20 mg/kg bw/day but not embryo-toxicity or teratogenicity. The NOAEL was 7 mg/kg bw/day for materno-toxicity. The significance of the single abortion at 20 mg/kg bw/day is unclear. However it does not influence the conclusion with respect to the NOAEL. Ref. : 12","page":12,"pdf":"out139_en.pdf","row_type":"noael_study","study_id":"out139_en_noael_007"} |
| SCCNFP_vision_codex | NOAEL | =20 | mg/kg bw/day | human | - | - | dermal absorption | {"citation":"Ref. : 12 2","dose":"e mean numbers of corpora lutea, live foetuses, sex distribution and the mean foetal bodyweights were comparable for control and treated groups.","effect":"e mean numbers of corpora lutea, live foetuses, sex distribution and the mean foetal bodyweights were comparable for control and treated groups. The incidence of foetal abnormalities or malformations was comparable for all dose groups. There was slight maternal toxicity at 20 mg/kg bw/day but not embryo-toxicity or teratogenicity. The NOAEL was 7 mg/kg bw/day for materno-toxicity. The significance of the single abortion at 20 mg/kg bw/day is unclear. However it does not influence the conclusion with respect to the NOAEL. Ref. : 12 2.7. Toxicokinetics (incl. Percutaneous Absorption) 2.7.1. Percutaneous Absorption in vitro First Study Guideline : none available Tissue : Human mammary epidermis, heat-separated Method : Franz diffusion cell (static) Test substance : 2-Hydroxy-1,4-naphthoquinone, 1.78% in formulation Batch no : 8160:FE (purity: 99.4%) Dose levels : c. 40mg formulation in the presence/absence of 10 mg hair Replicate cells : 9 cells without hair and 15 cells with hair GLP : Study not in compliance The skin penetration o","page":11,"pdf":"out177_en.pdf","row_type":"noael_study","study_id":"out177_en_noael_004"} |
| SCCNFP_vision_codex | NOAEL | =20 | mg/kg bw/day | - | - | - | NOAEL study | {"citation":"Ref. : 12","dose":"e mean numbers of corpora lutea, live foetuses, sex distribution and the mean foetal bodyweights were comparable for control and treated groups.","effect":"e mean numbers of corpora lutea, live foetuses, sex distribution and the mean foetal bodyweights were comparable for control and treated groups. The incidence of foetal abnormalities or malformations was comparable for all dose groups. There was slight maternal toxicity at 20 mg/kg bw/day but not embryo-toxicity or teratogenicity. The NOAEL was 7 mg/kg bw/day for materno-toxicity. The significance of the single abortion at 20 mg/kg bw/day is unclear. However it does not influence the conclusion with respect to the NOAEL. Ref. : 12","page":12,"pdf":"out139_en.pdf","row_type":"noael_study","study_id":"out139_en_noael_007"} |
| SCCNFP_vision_codex | NOAEL | =20 | mg/kg bw/day | human | - | - | dermal absorption | {"citation":"Ref. : 12 2","dose":"e mean numbers of corpora lutea, live foetuses, sex distribution and the mean foetal bodyweights were comparable for control and treated groups.","effect":"e mean numbers of corpora lutea, live foetuses, sex distribution and the mean foetal bodyweights were comparable for control and treated groups. The incidence of foetal abnormalities or malformations was comparable for all dose groups. There was slight maternal toxicity at 20 mg/kg bw/day but not embryo-toxicity or teratogenicity. The NOAEL was 7 mg/kg bw/day for materno-toxicity. The significance of the single abortion at 20 mg/kg bw/day is unclear. However it does not influence the conclusion with respect to the NOAEL. Ref. : 12 2.7. Toxicokinetics (incl. Percutaneous Absorption) 2.7.1. Percutaneous Absorption in vitro First Study Guideline : none available Tissue : Human mammary epidermis, heat-separated Method : Franz diffusion cell (static) Test substance : 2-Hydroxy-1,4-naphthoquinone, 1.78% in formulation Batch no : 8160:FE (purity: 99.4%) Dose levels : c. 40mg formulation in the presence/absence of 10 mg hair Replicate cells : 9 cells without hair and 15 cells with hair GLP : Study not in compliance The skin penetration o","page":11,"pdf":"out177_en.pdf","row_type":"noael_study","study_id":"out177_en_noael_004"} |
| SCCNFP_vision_codex | NOAEL | =300 | mg/kg | rat | dermal | 13-week | dermal absorption | {"dose":"Safety evaluation CALCULATION OF THE MARGIN OF SAFETY Lawsone (Non-oxidising) NOT APPLICABLE Based on a usage volume of 35 ml, containing at maximum xx % Maximum amount of ingredient applied I (mg) = Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = Dermal absorption per treatment I x A = Systemic exposure dose (SE...","effect":"0385/00, final Evaluation and opinion on : Lawsone _____________________________________________________________________________________________ 19 2.11. Safety evaluation CALCULATION OF THE MARGIN OF SAFETY Lawsone (Non-oxidising) NOT APPLICABLE Based on a usage volume of 35 ml, containing at maximum xx % Maximum amount of ingredient applied I (mg) = Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = Dermal absorption per treatment I x A = Systemic exposure dose (SED) I x A / 60 kg = No observed adverse effect level (mg/kg) NOAEL = (rat, 13-week study) Margin of Safety NOAEL / SED = 2.12. Conclusions This substance has been adequately tested, generally to appropriate guidelines and GLP. It is moderately toxic on acute ingestion, with mortalities occurring at 300 mg/kg and above. Two 13-week studies have shown clear signs of toxicity to the haemopoietic system, kidney, forestomach and liver. Effects were seen as low as 7 mg/kg bw/day and the NOAEL was 2 mg/kg bw/day. It was shown to be mildly irritant to the rabbit eye but not","page":19,"pdf":"out139_en.pdf","row_type":"noael_study","study_id":"out139_en_noael_008"} |
| SCCNFP_vision_codex | NOAEL | =300 | mg/kg | rat | dermal | 13-week | dermal absorption | {"citation":"Ref. : 17 These publications do not supply relevant supplementary information for the safety evaluation of COLIPA C146","dose":"Safety evaluation CALCULATION OF THE MARGIN OF SAFETY Lawsone (Non-oxidising) NOT APPLICABLE Based on a usage volume of 35 ml, containing at maximum xx % Maximum amount of ingredient applied I (mg) = Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = Dermal absorption per treatment I x A = Systemic exposure dose (SE...","effect":"hydroxy-1,4-naphthoquinone. Ref. : 17 These publications do not supply relevant supplementary information for the safety evaluation of COLIPA C146. 2.11. Safety evaluation CALCULATION OF THE MARGIN OF SAFETY Lawsone (Non-oxidising) NOT APPLICABLE Based on a usage volume of 35 ml, containing at maximum xx % Maximum amount of ingredient applied I (mg) = Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = Dermal absorption per treatment I x A = Systemic exposure dose (SED) I x A / 60 kg = No observed adverse effect level (mg/kg) NOAEL = (rat, 13-week study) Margin of Safety NOAEL / SED = 2.12. Conclusions This substance has been tested, generally to appropriate guidelines and GLP. It is moderately toxic on acute ingestion, with mortalities occurring at 300 mg/kg and above. Two 13-week studies have shown clear signs of toxicity to the haemopoietic system, kidney, forestomach and liver. Effects were seen as low as 7 mg/kg bw/day and the NOAEL was 2 mg/kg bw/day. It was shown to be mildly irritant to the rabbit eye but not to cause a","page":21,"pdf":"out177_en.pdf","row_type":"noael_study","study_id":"out177_en_noael_005"} |
| SCCNFP_vision_codex | NOAEL | =300 | mg/kg | rat | dermal | 13-week | dermal absorption | {"dose":"Safety evaluation CALCULATION OF THE MARGIN OF SAFETY Lawsone (Non-oxidising) NOT APPLICABLE Based on a usage volume of 35 ml, containing at maximum xx % Maximum amount of ingredient applied I (mg) = Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = Dermal absorption per treatment I x A = Systemic exposure dose (SE...","effect":"0385/00, final Evaluation and opinion on : Lawsone _____________________________________________________________________________________________ 19 2.11. Safety evaluation CALCULATION OF THE MARGIN OF SAFETY Lawsone (Non-oxidising) NOT APPLICABLE Based on a usage volume of 35 ml, containing at maximum xx % Maximum amount of ingredient applied I (mg) = Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = Dermal absorption per treatment I x A = Systemic exposure dose (SED) I x A / 60 kg = No observed adverse effect level (mg/kg) NOAEL = (rat, 13-week study) Margin of Safety NOAEL / SED = 2.12. Conclusions This substance has been adequately tested, generally to appropriate guidelines and GLP. It is moderately toxic on acute ingestion, with mortalities occurring at 300 mg/kg and above. Two 13-week studies have shown clear signs of toxicity to the haemopoietic system, kidney, forestomach and liver. Effects were seen as low as 7 mg/kg bw/day and the NOAEL was 2 mg/kg bw/day. It was shown to be mildly irritant to the rabbit eye but not","page":19,"pdf":"out139_en.pdf","row_type":"noael_study","study_id":"out139_en_noael_008"} |
| SCCNFP_vision_codex | NOAEL | =300 | mg/kg | rat | dermal | 13-week | dermal absorption | {"citation":"Ref. : 17 These publications do not supply relevant supplementary information for the safety evaluation of COLIPA C146","dose":"Safety evaluation CALCULATION OF THE MARGIN OF SAFETY Lawsone (Non-oxidising) NOT APPLICABLE Based on a usage volume of 35 ml, containing at maximum xx % Maximum amount of ingredient applied I (mg) = Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = Dermal absorption per treatment I x A = Systemic exposure dose (SE...","effect":"hydroxy-1,4-naphthoquinone. Ref. : 17 These publications do not supply relevant supplementary information for the safety evaluation of COLIPA C146. 2.11. Safety evaluation CALCULATION OF THE MARGIN OF SAFETY Lawsone (Non-oxidising) NOT APPLICABLE Based on a usage volume of 35 ml, containing at maximum xx % Maximum amount of ingredient applied I (mg) = Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = Dermal absorption per treatment I x A = Systemic exposure dose (SED) I x A / 60 kg = No observed adverse effect level (mg/kg) NOAEL = (rat, 13-week study) Margin of Safety NOAEL / SED = 2.12. Conclusions This substance has been tested, generally to appropriate guidelines and GLP. It is moderately toxic on acute ingestion, with mortalities occurring at 300 mg/kg and above. Two 13-week studies have shown clear signs of toxicity to the haemopoietic system, kidney, forestomach and liver. Effects were seen as low as 7 mg/kg bw/day and the NOAEL was 2 mg/kg bw/day. It was shown to be mildly irritant to the rabbit eye but not to cause a","page":21,"pdf":"out177_en.pdf","row_type":"noael_study","study_id":"out177_en_noael_005"} |
| SCCNFP_vision_codex | NOAEL | =300 | mg/kg | rat | dermal | 13-week | dermal absorption | {"dose":"Safety evaluation CALCULATION OF THE MARGIN OF SAFETY Lawsone (Non-oxidising) NOT APPLICABLE Based on a usage volume of 35 ml, containing at maximum xx % Maximum amount of ingredient applied I (mg) = Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = Dermal absorption per treatment I x A = Systemic exposure dose (SE...","effect":"0385/00, final Evaluation and opinion on : Lawsone _____________________________________________________________________________________________ 19 2.11. Safety evaluation CALCULATION OF THE MARGIN OF SAFETY Lawsone (Non-oxidising) NOT APPLICABLE Based on a usage volume of 35 ml, containing at maximum xx % Maximum amount of ingredient applied I (mg) = Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = Dermal absorption per treatment I x A = Systemic exposure dose (SED) I x A / 60 kg = No observed adverse effect level (mg/kg) NOAEL = (rat, 13-week study) Margin of Safety NOAEL / SED = 2.12. Conclusions This substance has been adequately tested, generally to appropriate guidelines and GLP. It is moderately toxic on acute ingestion, with mortalities occurring at 300 mg/kg and above. Two 13-week studies have shown clear signs of toxicity to the haemopoietic system, kidney, forestomach and liver. Effects were seen as low as 7 mg/kg bw/day and the NOAEL was 2 mg/kg bw/day. It was shown to be mildly irritant to the rabbit eye but not","page":19,"pdf":"out139_en.pdf","row_type":"noael_study","study_id":"out139_en_noael_008"} |
| SCCNFP_vision_codex | NOAEL | =300 | mg/kg | rat | dermal | 13-week | dermal absorption | {"citation":"Ref. : 17 These publications do not supply relevant supplementary information for the safety evaluation of COLIPA C146","dose":"Safety evaluation CALCULATION OF THE MARGIN OF SAFETY Lawsone (Non-oxidising) NOT APPLICABLE Based on a usage volume of 35 ml, containing at maximum xx % Maximum amount of ingredient applied I (mg) = Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = Dermal absorption per treatment I x A = Systemic exposure dose (SE...","effect":"hydroxy-1,4-naphthoquinone. Ref. : 17 These publications do not supply relevant supplementary information for the safety evaluation of COLIPA C146. 2.11. Safety evaluation CALCULATION OF THE MARGIN OF SAFETY Lawsone (Non-oxidising) NOT APPLICABLE Based on a usage volume of 35 ml, containing at maximum xx % Maximum amount of ingredient applied I (mg) = Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = Dermal absorption per treatment I x A = Systemic exposure dose (SED) I x A / 60 kg = No observed adverse effect level (mg/kg) NOAEL = (rat, 13-week study) Margin of Safety NOAEL / SED = 2.12. Conclusions This substance has been tested, generally to appropriate guidelines and GLP. It is moderately toxic on acute ingestion, with mortalities occurring at 300 mg/kg and above. Two 13-week studies have shown clear signs of toxicity to the haemopoietic system, kidney, forestomach and liver. Effects were seen as low as 7 mg/kg bw/day and the NOAEL was 2 mg/kg bw/day. It was shown to be mildly irritant to the rabbit eye but not to cause a","page":21,"pdf":"out177_en.pdf","row_type":"noael_study","study_id":"out177_en_noael_005"} |
| SCCNFP_vision_codex | NOAEL | =300 | mg/kg | rat | dermal | 13-week | dermal absorption | {"dose":"Safety evaluation CALCULATION OF THE MARGIN OF SAFETY Lawsone (Non-oxidising) NOT APPLICABLE Based on a usage volume of 35 ml, containing at maximum xx % Maximum amount of ingredient applied I (mg) = Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = Dermal absorption per treatment I x A = Systemic exposure dose (SE...","effect":"0385/00, final Evaluation and opinion on : Lawsone _____________________________________________________________________________________________ 19 2.11. Safety evaluation CALCULATION OF THE MARGIN OF SAFETY Lawsone (Non-oxidising) NOT APPLICABLE Based on a usage volume of 35 ml, containing at maximum xx % Maximum amount of ingredient applied I (mg) = Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = Dermal absorption per treatment I x A = Systemic exposure dose (SED) I x A / 60 kg = No observed adverse effect level (mg/kg) NOAEL = (rat, 13-week study) Margin of Safety NOAEL / SED = 2.12. Conclusions This substance has been adequately tested, generally to appropriate guidelines and GLP. It is moderately toxic on acute ingestion, with mortalities occurring at 300 mg/kg and above. Two 13-week studies have shown clear signs of toxicity to the haemopoietic system, kidney, forestomach and liver. Effects were seen as low as 7 mg/kg bw/day and the NOAEL was 2 mg/kg bw/day. It was shown to be mildly irritant to the rabbit eye but not","page":19,"pdf":"out139_en.pdf","row_type":"noael_study","study_id":"out139_en_noael_008"} |
| SCCNFP_vision_codex | NOAEL | =300 | mg/kg | rat | dermal | 13-week | dermal absorption | {"citation":"Ref. : 17 These publications do not supply relevant supplementary information for the safety evaluation of COLIPA C146","dose":"Safety evaluation CALCULATION OF THE MARGIN OF SAFETY Lawsone (Non-oxidising) NOT APPLICABLE Based on a usage volume of 35 ml, containing at maximum xx % Maximum amount of ingredient applied I (mg) = Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = Dermal absorption per treatment I x A = Systemic exposure dose (SE...","effect":"hydroxy-1,4-naphthoquinone. Ref. : 17 These publications do not supply relevant supplementary information for the safety evaluation of COLIPA C146. 2.11. Safety evaluation CALCULATION OF THE MARGIN OF SAFETY Lawsone (Non-oxidising) NOT APPLICABLE Based on a usage volume of 35 ml, containing at maximum xx % Maximum amount of ingredient applied I (mg) = Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = Dermal absorption per treatment I x A = Systemic exposure dose (SED) I x A / 60 kg = No observed adverse effect level (mg/kg) NOAEL = (rat, 13-week study) Margin of Safety NOAEL / SED = 2.12. Conclusions This substance has been tested, generally to appropriate guidelines and GLP. It is moderately toxic on acute ingestion, with mortalities occurring at 300 mg/kg and above. Two 13-week studies have shown clear signs of toxicity to the haemopoietic system, kidney, forestomach and liver. Effects were seen as low as 7 mg/kg bw/day and the NOAEL was 2 mg/kg bw/day. It was shown to be mildly irritant to the rabbit eye but not to cause a","page":21,"pdf":"out177_en.pdf","row_type":"noael_study","study_id":"out177_en_noael_005"} |
UnifiedCodex:SCCNFP:beta.noael_studies 26 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:SCCNFP:beta.noael_studies | - | 0.5 | % | rat | oral | 7 days | - | SOURCE_SUBDIR=out139_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING LAWSONE Colipa n° C146; OPINION_NUMBER=SCCNFP/0385/00; COMMITTEE=SCCNFP; REPORT_DATE=13 March 2001; VALUE_TEXT=0.5; DOSE=Extramedullary haemopoiesis and haemosiderin accumulation were noted in the spleen of both sexes at high dose and mid dose males.; EFFECT=ectively). These changes in weight were accompanied by a number of histo-pathological abnormalities. Extramedullary haemopoiesis and haemosiderin accumulation were noted in the spleen of both sexes at high dose and mid dose males. Renal tubular pigment deposits (Perl’s positive) and tubular basophilia/dilatation/degeneration for both sexes at high dose. Acanthosis, hyperkeratosis and subepithelial inflammatory cell infiltrates were noted in the stomachs of animals of all dose groups. The study failed to identify a NOAEL for gastric and renal effects. Ref. : 5.1 Second study Guideline : OECD 408 (1981) Species/strain : Sprague Dawley Crl CD (SD)BR strain rat Group size : 10 male + 10 female Test substance : 2-Hydroxy-1,4-naphthoquinone suspended in 0.5% aqueous methylcellulose Batch no : 8160:FE (purity 99.4%) Dose levels : 0, 2, 7 and 20 mg/kg bw/day, 7 days/week by gavage Exposure period : 13 weeks GLP : Quality Assurance statement included Groups of 10 male and 10 female rats were dosed with the test substance by gavage at 0, 2; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"83-72-7","citation":"","dose":"Extramedullary haemopoiesis and haemosiderin accumulation were noted in the spleen of both sexes at high dose and mid dose males.","duration":"7 days","effect":"ectively). These changes in weight were accompanied by a number of histo-pathological abnormalities. Extramedullary haemopoiesis and haemosiderin accumulation were noted in the spleen of both sexes at high dose and mid dose males. Renal tubular pigment deposits (Perl’s positive) and tubular basophilia/dilatation/degeneration for both sexes at high dose. Acanthosis, hyperkeratosis and subepithelial inflammatory cell infiltrates were noted in the stomachs of animals of all dose groups. The study failed to identify a NOAEL for gastric and renal effects. Ref. : 5.1 Second study Guideline : OECD 408 (1981) Species/strain : Sprague Dawley Crl CD (SD)BR strain rat Group size : 10 male + 10 female Test substance : 2-Hydroxy-1,4-naphthoquinone suspended in 0.5% aqueous methylcellulose Batch no : 8160:FE (purity 99.4%) Dose levels : 0, 2, 7 and 20 mg/kg bw/day, 7 days/week by gavage Exposure period : 13 weeks GLP : Quality Assurance statement included Groups of 10 male and 10 female rats were dosed with the test substance by gavage at 0, 2","endpoint":"","ingredient":"has been adequately tested, generally to appropriate guidelines and GLP. It is","loael_value":"","noael_unit":"%","noael_value":"0.5","page":8,"route":"oral","species":"rat","study_id":"out139_en_noael_003"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | - | 2 | mg/kg bw/day | - | oral | - | - | SOURCE_SUBDIR=out139_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING LAWSONE Colipa n° C146; OPINION_NUMBER=SCCNFP/0385/00; COMMITTEE=SCCNFP; REPORT_DATE=13 March 2001; VALUE_TEXT=2; DOSE=Opinion Lawsone is toxic, showing toxicity to the kidney, forestomach and haemopoietic system following repeat oral dosing at doses in the region of 7-20 mg/kg bw/day.; EFFECT=SCCNFP/0385/00, final Evaluation and opinion on : Lawsone _____________________________________________________________________________________________ 3 4. Opinion Lawsone is toxic, showing toxicity to the kidney, forestomach and haemopoietic system following repeat oral dosing at doses in the region of 7-20 mg/kg bw/day. The NOAEL is 2 mg/kg bw/day. Percutaneous penetration of 0.374% is assumed from the available information, but the study conditions were not adequate and this value could be a considerable underestimation. Lawsone is clearly mutagenic and clastogenic in vitro and in vivo (genotoxic substance, category 3 according to Directive 67/548/EEC relating to the classification, packaging and labelling of dangerous substances) The SCCNFP is of the opinion that Lawsone is not suitable for use as a non-oxidising colouring agent for hair; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"83-72-7","citation":"","dose":"Opinion Lawsone is toxic, showing toxicity to the kidney, forestomach and haemopoietic system following repeat oral dosing at doses in the region of 7-20 mg/kg bw/day.","duration":"","effect":"SCCNFP/0385/00, final Evaluation and opinion on : Lawsone _____________________________________________________________________________________________ 3 4. Opinion Lawsone is toxic, showing toxicity to the kidney, forestomach and haemopoietic system following repeat oral dosing at doses in the region of 7-20 mg/kg bw/day. The NOAEL is 2 mg/kg bw/day. Percutaneous penetration of 0.374% is assumed from the available information, but the study conditions were not adequate and this value could be a considerable underestimation. Lawsone is clearly mutagenic and clastogenic in vitro and in vivo (genotoxic substance, category 3 according to Directive 67/548/EEC relating to the classification, packaging and labelling of dangerous substances) The SCCNFP is of the opinion that Lawsone is not suitable for use as a non-oxidising colouring agent for hair","endpoint":"","ingredient":"has been adequately tested, generally to appropriate guidelines and GLP. It is","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"2","page":3,"route":"oral","species":"","study_id":"out139_en_noael_002"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | - | 2 | mg/kg bw/day | - | oral | - | - | SOURCE_SUBDIR=out139_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING LAWSONE Colipa n° C146; OPINION_NUMBER=SCCNFP/0385/00; COMMITTEE=SCCNFP; REPORT_DATE=13 March 2001; VALUE_TEXT=2; DOSE=Opinion of the SCCNFP Lawsone is toxic, showing toxicity to the kidney, forestomach and haemopoietic system following repeat oral dosing at doses in the region of 7-20 mg/kg bw/day.; EFFECT=nn, W. J. and Marrs, P. J.M.Chem.26:570-574,1983 15. Kelkar, V. V., Dhumal, V. R., Bhavsar, V. H. and Mardikar, B. R. Arch. int. Pharmacodyn. 283: 71-79 (1985) 16. Tikkanen, L., Matsushima, T., Natori, S. and Yoshihira, K. Mutat. Res 124: 25-34 (1983) 17. Stamberg, J., Werczberger, R. and Kotlin, Y. Mutat. Res 62: 383-387 (1979) 3. Opinion of the SCCNFP Lawsone is toxic, showing toxicity to the kidney, forestomach and haemopoietic system following repeat oral dosing at doses in the region of 7-20 mg/kg bw/day. The NOAEL is 2 mg/kg bw/day. Percutaneous penetration of 0.374% is assumed from the available information, but the study conditions were not adequate and this value could be a considerable underestimation. Lawsone is clearly mutagenic and clastogenic in vitro and in vivo (genotoxic substance, category 3 according to Directive 67/548/EEC relating to the classification, packaging and labelling of dangerous substances) The SCCNFP is of the opinion that Lawsone is not suitable for use as a non-oxidising colouring agent for hair; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"83-72-7","citation":"","dose":"Opinion of the SCCNFP Lawsone is toxic, showing toxicity to the kidney, forestomach and haemopoietic system following repeat oral dosing at doses in the region of 7-20 mg/kg bw/day.","duration":"","effect":"nn, W. J. and Marrs, P. J.M.Chem.26:570-574,1983 15. Kelkar, V. V., Dhumal, V. R., Bhavsar, V. H. and Mardikar, B. R. Arch. int. Pharmacodyn. 283: 71-79 (1985) 16. Tikkanen, L., Matsushima, T., Natori, S. and Yoshihira, K. Mutat. Res 124: 25-34 (1983) 17. Stamberg, J., Werczberger, R. and Kotlin, Y. Mutat. Res 62: 383-387 (1979) 3. Opinion of the SCCNFP Lawsone is toxic, showing toxicity to the kidney, forestomach and haemopoietic system following repeat oral dosing at doses in the region of 7-20 mg/kg bw/day. The NOAEL is 2 mg/kg bw/day. Percutaneous penetration of 0.374% is assumed from the available information, but the study conditions were not adequate and this value could be a considerable underestimation. Lawsone is clearly mutagenic and clastogenic in vitro and in vivo (genotoxic substance, category 3 according to Directive 67/548/EEC relating to the classification, packaging and labelling of dangerous substances) The SCCNFP is of the opinion that Lawsone is not suitable for use as a non-oxidising colouring agent for hair","endpoint":"","ingredient":"has been adequately tested, generally to appropriate guidelines and GLP. It is","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"2","page":20,"route":"oral","species":"","study_id":"out139_en_noael_012"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | - | 2 | mg/kg bw/day | - | oral | - | - | SOURCE_SUBDIR=out177_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING LAWSONE COLIPA n° C146; OPINION_NUMBER=SCCNFP/0583/02; COMMITTEE=SCCNFP; REPORT_DATE=adopted on 12 March 2001; VALUE_TEXT=2; DOSE=Opinion Lawsone is toxic, showing toxicity to the kidney, forestomach and haemopoietic system following repeated oral dosing at doses in the region of 7-20 mg/kg bw/day.; EFFECT=taneous absorption of a 2.0% solution of lawsone in a hair dye formulation amounted to 2.6 ± 1.8 µg/cm2/24h. Overall, it is concluded that, based on the present available information, this substance is not suitable for use as a non-oxidising colouring agent for hair dyeing and, by extension, is not suitable for any other cosmetic use(s). 2.13. Opinion Lawsone is toxic, showing toxicity to the kidney, forestomach and haemopoietic system following repeated oral dosing at doses in the region of 7-20 mg/kg bw/day. The NOAEL is 2 mg/kg bw/day. Lawsone is mutagenic and clastogenic in vitro and in vivo in some experiments. The SCCNFP is of the opinion that, based on the present available information, lawsone is not suitable for use as a non-oxidising colouring agent for hair dyeing and, by extension, is not suitable for any other cosmetic use(s). 2.14. References Submissions II and III included as well several published scientific papers on general issues of genetic toxicology, not related with the evaluation of genotoxic potential of L; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"83-72-7","citation":"","dose":"Opinion Lawsone is toxic, showing toxicity to the kidney, forestomach and haemopoietic system following repeated oral dosing at doses in the region of 7-20 mg/kg bw/day.","duration":"","effect":"taneous absorption of a 2.0% solution of lawsone in a hair dye formulation amounted to 2.6 ± 1.8 µg/cm2/24h. Overall, it is concluded that, based on the present available information, this substance is not suitable for use as a non-oxidising colouring agent for hair dyeing and, by extension, is not suitable for any other cosmetic use(s). 2.13. Opinion Lawsone is toxic, showing toxicity to the kidney, forestomach and haemopoietic system following repeated oral dosing at doses in the region of 7-20 mg/kg bw/day. The NOAEL is 2 mg/kg bw/day. Lawsone is mutagenic and clastogenic in vitro and in vivo in some experiments. The SCCNFP is of the opinion that, based on the present available information, lawsone is not suitable for use as a non-oxidising colouring agent for hair dyeing and, by extension, is not suitable for any other cosmetic use(s). 2.14. References Submissions II and III included as well several published scientific papers on general issues of genetic toxicology, not related with the evaluation of genotoxic potential of L","endpoint":"","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"2","page":22,"route":"oral","species":"","study_id":"out177_en_noael_009"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | - | 2 | mg/kg bw/day | - | oral | - | - | SOURCE_SUBDIR=out254_en; REPORT_TITLE=OPINION CONCERNING LAWSONE COLIPA n° C146; OPINION_NUMBER=SCCNFP/0798/04; COMMITTEE=SCCNFP; REPORT_DATE=adopted by the SCCNFP on 16 February 2004; VALUE_TEXT=2; DOSE=The toxicity of lawsone; effects to the kidney, forestomach and haemopoietic system following repeat oral dosing at doses in the region of 7-20 mg/kg bw/day.; EFFECT=restrictions or conditions for its use? The opinion adopted by the SCCNFP during the 16th plenary meeting of 13 March 2001 was based on this first submission from May 1996. In this opinion, Lawsone was given Classification 2A : the available data support the conclusion that the substance constitutes a health hazard. This was based on three points : 1. The toxicity of lawsone; effects to the kidney, forestomach and haemopoietic system following repeat oral dosing at doses in the region of 7-20 mg/kg bw/day. The NOAEL is 2 mg/kg bw/day. 2. Percutaneous penetration of 0.374% is assumed from the available information, but the study conditions were not adequate and this value could be a considerable underestimation. 3. Lawsone is clearly mutagenic and clastogenic in vitro and in vivo (genotoxic substance, category 3 according to Directive 67/548/EEC relating to the classification, packaging and labelling of dangerous substances) In the light of this opinion, the SCCNFP was requested to evaluate 5 further submissions. Submissi; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"83-72-7","citation":"","dose":"The toxicity of lawsone; effects to the kidney, forestomach and haemopoietic system following repeat oral dosing at doses in the region of 7-20 mg/kg bw/day.","duration":"","effect":"restrictions or conditions for its use? The opinion adopted by the SCCNFP during the 16th plenary meeting of 13 March 2001 was based on this first submission from May 1996. In this opinion, Lawsone was given Classification 2A : the available data support the conclusion that the substance constitutes a health hazard. This was based on three points : 1. The toxicity of lawsone; effects to the kidney, forestomach and haemopoietic system following repeat oral dosing at doses in the region of 7-20 mg/kg bw/day. The NOAEL is 2 mg/kg bw/day. 2. Percutaneous penetration of 0.374% is assumed from the available information, but the study conditions were not adequate and this value could be a considerable underestimation. 3. Lawsone is clearly mutagenic and clastogenic in vitro and in vivo (genotoxic substance, category 3 according to Directive 67/548/EEC relating to the classification, packaging and labelling of dangerous substances) In the light of this opinion, the SCCNFP was requested to evaluate 5 further submissions. Submissi","endpoint":"","ingredient":"constitutes a health hazard.","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"2","page":2,"route":"oral","species":"","study_id":"out254_en_noael_001"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | - | 7 | mg/kg bw/day | - | - | - | - | SOURCE_SUBDIR=out139_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING LAWSONE Colipa n° C146; OPINION_NUMBER=SCCNFP/0385/00; COMMITTEE=SCCNFP; REPORT_DATE=13 March 2001; VALUE_TEXT=7; DOSE=n bodyweight of the high dose group was 97% of control at the end of the treatment period (day 15).; EFFECT=n bodyweight of the high dose group was 97% of control at the end of the treatment period (day 15). No treatment-related maternal abnormalities were noted at the scheduled autopsy. The mean numbers of corpora lutea, live foetuses, sex distribution and the mean foetal bodyweights were comparable for control and treated groups. The incidence of foetal abnormalities or malformations was comparable for all dose groups. There was slight maternal toxicity at 20 mg/kg bw/day but not embryo-toxicity or teratogenicity. The NOAEL was 7 mg/kg bw/day for materno-toxicity. The significance of the single abortion at 20 mg/kg bw/day is unclear. However it does not influence the conclusion with respect to the NOAEL. Ref. : 12; CITATION=Ref. : 12; CITATION_NUMBERS=[12]; REFERENCE=Ref. : 12; DETAILS_JSON={"cas_number":"83-72-7","citation":"Ref. : 12","dose":"n bodyweight of the high dose group was 97% of control at the end of the treatment period (day 15).","duration":"","effect":"n bodyweight of the high dose group was 97% of control at the end of the treatment period (day 15). No treatment-related maternal abnormalities were noted at the scheduled autopsy. The mean numbers of corpora lutea, live foetuses, sex distribution and the mean foetal bodyweights were comparable for control and treated groups. The incidence of foetal abnormalities or malformations was comparable for all dose groups. There was slight maternal toxicity at 20 mg/kg bw/day but not embryo-toxicity or teratogenicity. The NOAEL was 7 mg/kg bw/day for materno-toxicity. The significance of the single abortion at 20 mg/kg bw/day is unclear. However it does not influence the conclusion with respect to the NOAEL. Ref. : 12","endpoint":"","ingredient":"has been adequately tested, generally to appropriate guidelines and GLP. It is","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"7","page":12,"route":"","species":"","study_id":"out139_en_noael_006"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | - | 20 | mg/kg bw/day | - | - | - | - | SOURCE_SUBDIR=out139_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING LAWSONE Colipa n° C146; OPINION_NUMBER=SCCNFP/0385/00; COMMITTEE=SCCNFP; REPORT_DATE=13 March 2001; VALUE_TEXT=20; DOSE=e mean numbers of corpora lutea, live foetuses, sex distribution and the mean foetal bodyweights were comparable for control and treated groups.; EFFECT=e mean numbers of corpora lutea, live foetuses, sex distribution and the mean foetal bodyweights were comparable for control and treated groups. The incidence of foetal abnormalities or malformations was comparable for all dose groups. There was slight maternal toxicity at 20 mg/kg bw/day but not embryo-toxicity or teratogenicity. The NOAEL was 7 mg/kg bw/day for materno-toxicity. The significance of the single abortion at 20 mg/kg bw/day is unclear. However it does not influence the conclusion with respect to the NOAEL. Ref. : 12; CITATION=Ref. : 12; CITATION_NUMBERS=[12]; REFERENCE=Ref. : 12; DETAILS_JSON={"cas_number":"83-72-7","citation":"Ref. : 12","dose":"e mean numbers of corpora lutea, live foetuses, sex distribution and the mean foetal bodyweights were comparable for control and treated groups.","duration":"","effect":"e mean numbers of corpora lutea, live foetuses, sex distribution and the mean foetal bodyweights were comparable for control and treated groups. The incidence of foetal abnormalities or malformations was comparable for all dose groups. There was slight maternal toxicity at 20 mg/kg bw/day but not embryo-toxicity or teratogenicity. The NOAEL was 7 mg/kg bw/day for materno-toxicity. The significance of the single abortion at 20 mg/kg bw/day is unclear. However it does not influence the conclusion with respect to the NOAEL. Ref. : 12","endpoint":"","ingredient":"has been adequately tested, generally to appropriate guidelines and GLP. It is","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"20","page":12,"route":"","species":"","study_id":"out139_en_noael_007"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | dermal absorption | 2 | mg/kg bw/day | rat | oral | 13-week | dermal absorption | SOURCE_SUBDIR=out254_en; REPORT_TITLE=OPINION CONCERNING LAWSONE COLIPA n° C146; OPINION_NUMBER=SCCNFP/0798/04; COMMITTEE=SCCNFP; REPORT_DATE=adopted by the SCCNFP on 16 February 2004; VALUE_TEXT=2; DOSE=It is moderately toxic on acute ingestion, with mortalities occurring at 300 mg/kg and above.; EFFECT=toxicity of 2- hydroxy-1,4-naphthoquinone. Ref. : 17 These publications do not supply relevant supplementary information for the safety evaluation of COLIPA C146. 2.12. Conclusions This substance has been tested, generally to appropriate guidelines and GLP. It is moderately toxic on acute ingestion, with mortalities occurring at 300 mg/kg and above. Two 13-week studies have shown clear signs of toxicity to the haemopoietic system, kidney, forestomach and liver. Effects were seen as low as 7 mg/kg bw/day and the NOAEL was 2 mg/kg bw/day. It was shown to be mildly irritant to the rabbit eye but not to cause appreciable skin irritation. Studies on sensitisation are equivocal. In vitro percutaneous absorption of a 2.0% solution of lawsone in a hair dye formulation amounted to 2.6 ± 1.8 µg/cm2/24h. In the radio-labelled pharmacokinetic study in rats, a single oral dose of 4.9 mg/kg/bw in methylcellulose, showed quick uptake into the plasma within 30 min (Cmax of 14979/18545 ng- eq/g). There was a steady decrease down to 95.3/134; CITATION=Ref. : 17 These publications do not supply relevant supplementary information for the safety evaluation of COLIPA C146; CITATION_NUMBERS=[17,146]; REFERENCE=Ref. : 17 These publications do not supply relevant supplementary information for the safety evaluation of COLIPA C146; DETAILS_JSON={"cas_number":"83-72-7","citation":"Ref. : 17 These publications do not supply relevant supplementary information for the safety evaluation of COLIPA C146","dose":"It is moderately toxic on acute ingestion, with mortalities occurring at 300 mg/kg and above.","duration":"13-week","effect":"toxicity of 2- hydroxy-1,4-naphthoquinone. Ref. : 17 These publications do not supply relevant supplementary information for the safety evaluation of COLIPA C146. 2.12. Conclusions This substance has been tested, generally to appropriate guidelines and GLP. It is moderately toxic on acute ingestion, with mortalities occurring at 300 mg/kg and above. Two 13-week studies have shown clear signs of toxicity to the haemopoietic system, kidney, forestomach and liver. Effects were seen as low as 7 mg/kg bw/day and the NOAEL was 2 mg/kg bw/day. It was shown to be mildly irritant to the rabbit eye but not to cause appreciable skin irritation. Studies on sensitisation are equivocal. In vitro percutaneous absorption of a 2.0% solution of lawsone in a hair dye formulation amounted to 2.6 ± 1.8 µg/cm2/24h. In the radio-labelled pharmacokinetic study in rats, a single oral dose of 4.9 mg/kg/bw in methylcellulose, showed quick uptake into the plasma within 30 min (Cmax of 14979/18545 ng- eq/g). There was a steady decrease down to 95.3/134","endpoint":"dermal absorption","ingredient":"constitutes a health hazard.","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"2","page":27,"route":"oral","species":"rat","study_id":"out254_en_noael_005"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | dermal absorption | 7 | mg/kg bw/day | human | - | - | dermal absorption | SOURCE_SUBDIR=out177_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING LAWSONE COLIPA n° C146; OPINION_NUMBER=SCCNFP/0583/02; COMMITTEE=SCCNFP; REPORT_DATE=adopted on 12 March 2001; VALUE_TEXT=7; DOSE=n bodyweight of the high dose group was 97% of control at the end of the treatment period (day 15).; EFFECT=n bodyweight of the high dose group was 97% of control at the end of the treatment period (day 15). No treatment-related maternal abnormalities were noted at the scheduled autopsy. The mean numbers of corpora lutea, live foetuses, sex distribution and the mean foetal bodyweights were comparable for control and treated groups. The incidence of foetal abnormalities or malformations was comparable for all dose groups. There was slight maternal toxicity at 20 mg/kg bw/day but not embryo-toxicity or teratogenicity. The NOAEL was 7 mg/kg bw/day for materno-toxicity. The significance of the single abortion at 20 mg/kg bw/day is unclear. However it does not influence the conclusion with respect to the NOAEL. Ref. : 12 2.7. Toxicokinetics (incl. Percutaneous Absorption) 2.7.1. Percutaneous Absorption in vitro First Study Guideline : none available Tissue : Human mammary epidermis, heat-separated Method : Franz diffusion cell (static) Test substance : 2-Hydroxy-1,4-naphthoquinone, 1.78% in formulation Batch no : 8160:FE (purity: 99.4%) Dos; CITATION=Ref. : 12 2; CITATION_NUMBERS=[12,2]; REFERENCE=Ref. : 12 2; DETAILS_JSON={"cas_number":"83-72-7","citation":"Ref. : 12 2","dose":"n bodyweight of the high dose group was 97% of control at the end of the treatment period (day 15).","duration":"","effect":"n bodyweight of the high dose group was 97% of control at the end of the treatment period (day 15). No treatment-related maternal abnormalities were noted at the scheduled autopsy. The mean numbers of corpora lutea, live foetuses, sex distribution and the mean foetal bodyweights were comparable for control and treated groups. The incidence of foetal abnormalities or malformations was comparable for all dose groups. There was slight maternal toxicity at 20 mg/kg bw/day but not embryo-toxicity or teratogenicity. The NOAEL was 7 mg/kg bw/day for materno-toxicity. The significance of the single abortion at 20 mg/kg bw/day is unclear. However it does not influence the conclusion with respect to the NOAEL. Ref. : 12 2.7. Toxicokinetics (incl. Percutaneous Absorption) 2.7.1. Percutaneous Absorption in vitro First Study Guideline : none available Tissue : Human mammary epidermis, heat-separated Method : Franz diffusion cell (static) Test substance : 2-Hydroxy-1,4-naphthoquinone, 1.78% in formulation Batch no : 8160:FE (purity: 99.4%) Dos","endpoint":"dermal absorption","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"7","page":11,"route":"","species":"human","study_id":"out177_en_noael_003"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | dermal absorption | 7 | mg/kg bw/day | human | - | - | dermal absorption | SOURCE_SUBDIR=out254_en; REPORT_TITLE=OPINION CONCERNING LAWSONE COLIPA n° C146; OPINION_NUMBER=SCCNFP/0798/04; COMMITTEE=SCCNFP; REPORT_DATE=adopted by the SCCNFP on 16 February 2004; VALUE_TEXT=7; DOSE=n bodyweight of the high dose group was 97% of control at the end of the treatment period (day 15).; EFFECT=n bodyweight of the high dose group was 97% of control at the end of the treatment period (day 15). No treatment-related maternal abnormalities were noted at the scheduled autopsy. The mean numbers of corpora lutea, live foetuses, sex distribution and the mean foetal bodyweights were comparable for control and treated groups. The incidence of foetal abnormalities or malformations was comparable for all dose groups. There was slight maternal toxicity at 20 mg/kg bw/day but not embryo-toxicity or teratogenicity. The NOAEL was 7 mg/kg bw/day for materno-toxicity. The significance of the single abortion at 20 mg/kg bw/day is unclear. However it does not influence the conclusion. Ref. : 12 2.7. Toxicokinetics (incl. Percutaneous Absorption) 2.7.1. Percutaneous Absorption in vitro First Study Guideline : none available Tissue : Human mammary epidermis, heat-separated Method : Franz diffusion cell (static) Test substance : 2-Hydroxy-1,4-naphthoquinone, 1.78% in formulation Batch no : 8160:FE (purity: 99.4%) Dose levels : c. 40mg; CITATION=Ref. : 12 2; CITATION_NUMBERS=[12,2]; REFERENCE=Ref. : 12 2; DETAILS_JSON={"cas_number":"83-72-7","citation":"Ref. : 12 2","dose":"n bodyweight of the high dose group was 97% of control at the end of the treatment period (day 15).","duration":"","effect":"n bodyweight of the high dose group was 97% of control at the end of the treatment period (day 15). No treatment-related maternal abnormalities were noted at the scheduled autopsy. The mean numbers of corpora lutea, live foetuses, sex distribution and the mean foetal bodyweights were comparable for control and treated groups. The incidence of foetal abnormalities or malformations was comparable for all dose groups. There was slight maternal toxicity at 20 mg/kg bw/day but not embryo-toxicity or teratogenicity. The NOAEL was 7 mg/kg bw/day for materno-toxicity. The significance of the single abortion at 20 mg/kg bw/day is unclear. However it does not influence the conclusion. Ref. : 12 2.7. Toxicokinetics (incl. Percutaneous Absorption) 2.7.1. Percutaneous Absorption in vitro First Study Guideline : none available Tissue : Human mammary epidermis, heat-separated Method : Franz diffusion cell (static) Test substance : 2-Hydroxy-1,4-naphthoquinone, 1.78% in formulation Batch no : 8160:FE (purity: 99.4%) Dose levels : c. 40mg","endpoint":"dermal absorption","ingredient":"constitutes a health hazard.","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"7","page":12,"route":"","species":"human","study_id":"out254_en_noael_004"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | dermal absorption | 20 | mg/kg bw/day | human | - | - | dermal absorption | SOURCE_SUBDIR=out177_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING LAWSONE COLIPA n° C146; OPINION_NUMBER=SCCNFP/0583/02; COMMITTEE=SCCNFP; REPORT_DATE=adopted on 12 March 2001; VALUE_TEXT=20; DOSE=e mean numbers of corpora lutea, live foetuses, sex distribution and the mean foetal bodyweights were comparable for control and treated groups.; EFFECT=e mean numbers of corpora lutea, live foetuses, sex distribution and the mean foetal bodyweights were comparable for control and treated groups. The incidence of foetal abnormalities or malformations was comparable for all dose groups. There was slight maternal toxicity at 20 mg/kg bw/day but not embryo-toxicity or teratogenicity. The NOAEL was 7 mg/kg bw/day for materno-toxicity. The significance of the single abortion at 20 mg/kg bw/day is unclear. However it does not influence the conclusion with respect to the NOAEL. Ref. : 12 2.7. Toxicokinetics (incl. Percutaneous Absorption) 2.7.1. Percutaneous Absorption in vitro First Study Guideline : none available Tissue : Human mammary epidermis, heat-separated Method : Franz diffusion cell (static) Test substance : 2-Hydroxy-1,4-naphthoquinone, 1.78% in formulation Batch no : 8160:FE (purity: 99.4%) Dose levels : c. 40mg formulation in the presence/absence of 10 mg hair Replicate cells : 9 cells without hair and 15 cells with hair GLP : Study not in compliance The skin penetration o; CITATION=Ref. : 12 2; CITATION_NUMBERS=[12,2]; REFERENCE=Ref. : 12 2; DETAILS_JSON={"cas_number":"83-72-7","citation":"Ref. : 12 2","dose":"e mean numbers of corpora lutea, live foetuses, sex distribution and the mean foetal bodyweights were comparable for control and treated groups.","duration":"","effect":"e mean numbers of corpora lutea, live foetuses, sex distribution and the mean foetal bodyweights were comparable for control and treated groups. The incidence of foetal abnormalities or malformations was comparable for all dose groups. There was slight maternal toxicity at 20 mg/kg bw/day but not embryo-toxicity or teratogenicity. The NOAEL was 7 mg/kg bw/day for materno-toxicity. The significance of the single abortion at 20 mg/kg bw/day is unclear. However it does not influence the conclusion with respect to the NOAEL. Ref. : 12 2.7. Toxicokinetics (incl. Percutaneous Absorption) 2.7.1. Percutaneous Absorption in vitro First Study Guideline : none available Tissue : Human mammary epidermis, heat-separated Method : Franz diffusion cell (static) Test substance : 2-Hydroxy-1,4-naphthoquinone, 1.78% in formulation Batch no : 8160:FE (purity: 99.4%) Dose levels : c. 40mg formulation in the presence/absence of 10 mg hair Replicate cells : 9 cells without hair and 15 cells with hair GLP : Study not in compliance The skin penetration o","endpoint":"dermal absorption","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"20","page":11,"route":"","species":"human","study_id":"out177_en_noael_004"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | dermal absorption | 300 | mg/kg | rat | dermal | 13-week | dermal absorption | SOURCE_SUBDIR=out139_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING LAWSONE Colipa n° C146; OPINION_NUMBER=SCCNFP/0385/00; COMMITTEE=SCCNFP; REPORT_DATE=13 March 2001; VALUE_TEXT=300; DOSE=Safety evaluation CALCULATION OF THE MARGIN OF SAFETY Lawsone (Non-oxidising) NOT APPLICABLE Based on a usage volume of 35 ml, containing at maximum xx % Maximum amount of ingredient applied I (mg) = Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = Dermal absorption per treatment I x A = Systemic exposure dose (SE...; EFFECT=0385/00, final Evaluation and opinion on : Lawsone _____________________________________________________________________________________________ 19 2.11. Safety evaluation CALCULATION OF THE MARGIN OF SAFETY Lawsone (Non-oxidising) NOT APPLICABLE Based on a usage volume of 35 ml, containing at maximum xx % Maximum amount of ingredient applied I (mg) = Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = Dermal absorption per treatment I x A = Systemic exposure dose (SED) I x A / 60 kg = No observed adverse effect level (mg/kg) NOAEL = (rat, 13-week study) Margin of Safety NOAEL / SED = 2.12. Conclusions This substance has been adequately tested, generally to appropriate guidelines and GLP. It is moderately toxic on acute ingestion, with mortalities occurring at 300 mg/kg and above. Two 13-week studies have shown clear signs of toxicity to the haemopoietic system, kidney, forestomach and liver. Effects were seen as low as 7 mg/kg bw/day and the NOAEL was 2 mg/kg bw/day. It was shown to be mildly irritant to the rabbit eye but not; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"83-72-7","citation":"","dose":"Safety evaluation CALCULATION OF THE MARGIN OF SAFETY Lawsone (Non-oxidising) NOT APPLICABLE Based on a usage volume of 35 ml, containing at maximum xx % Maximum amount of ingredient applied I (mg) = Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = Dermal absorption per treatment I x A = Systemic exposure dose (SE...","duration":"13-week","effect":"0385/00, final Evaluation and opinion on : Lawsone _____________________________________________________________________________________________ 19 2.11. Safety evaluation CALCULATION OF THE MARGIN OF SAFETY Lawsone (Non-oxidising) NOT APPLICABLE Based on a usage volume of 35 ml, containing at maximum xx % Maximum amount of ingredient applied I (mg) = Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = Dermal absorption per treatment I x A = Systemic exposure dose (SED) I x A / 60 kg = No observed adverse effect level (mg/kg) NOAEL = (rat, 13-week study) Margin of Safety NOAEL / SED = 2.12. Conclusions This substance has been adequately tested, generally to appropriate guidelines and GLP. It is moderately toxic on acute ingestion, with mortalities occurring at 300 mg/kg and above. Two 13-week studies have shown clear signs of toxicity to the haemopoietic system, kidney, forestomach and liver. Effects were seen as low as 7 mg/kg bw/day and the NOAEL was 2 mg/kg bw/day. It was shown to be mildly irritant to the rabbit eye but not","endpoint":"dermal absorption","ingredient":"has been adequately tested, generally to appropriate guidelines and GLP. It is","loael_value":"","noael_unit":"mg/kg","noael_value":"300","page":19,"route":"dermal","species":"rat","study_id":"out139_en_noael_008"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | dermal absorption | 300 | mg/kg | rat | dermal | 13-week | dermal absorption | SOURCE_SUBDIR=out139_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING LAWSONE Colipa n° C146; OPINION_NUMBER=SCCNFP/0385/00; COMMITTEE=SCCNFP; REPORT_DATE=13 March 2001; VALUE_TEXT=300; DOSE=Safety evaluation CALCULATION OF THE MARGIN OF SAFETY Lawsone (Non-oxidising) NOT APPLICABLE Based on a usage volume of 35 ml, containing at maximum xx % Maximum amount of ingredient applied I (mg) = Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = Dermal absorption per treatment I x A = Systemic exposure dose (SE...; EFFECT=: Lawsone _____________________________________________________________________________________________ 19 2.11. Safety evaluation CALCULATION OF THE MARGIN OF SAFETY Lawsone (Non-oxidising) NOT APPLICABLE Based on a usage volume of 35 ml, containing at maximum xx % Maximum amount of ingredient applied I (mg) = Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = Dermal absorption per treatment I x A = Systemic exposure dose (SED) I x A / 60 kg = No observed adverse effect level (mg/kg) NOAEL = (rat, 13-week study) Margin of Safety NOAEL / SED = 2.12. Conclusions This substance has been adequately tested, generally to appropriate guidelines and GLP. It is moderately toxic on acute ingestion, with mortalities occurring at 300 mg/kg and above. Two 13-week studies have shown clear signs of toxicity to the haemopoietic system, kidney, forestomach and liver. Effects were seen as low as 7 mg/kg bw/day and the NOAEL was 2 mg/kg bw/day. It was shown to be mildly irritant to the rabbit eye but not to cause appr; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"83-72-7","citation":"","dose":"Safety evaluation CALCULATION OF THE MARGIN OF SAFETY Lawsone (Non-oxidising) NOT APPLICABLE Based on a usage volume of 35 ml, containing at maximum xx % Maximum amount of ingredient applied I (mg) = Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = Dermal absorption per treatment I x A = Systemic exposure dose (SE...","duration":"13-week","effect":": Lawsone _____________________________________________________________________________________________ 19 2.11. Safety evaluation CALCULATION OF THE MARGIN OF SAFETY Lawsone (Non-oxidising) NOT APPLICABLE Based on a usage volume of 35 ml, containing at maximum xx % Maximum amount of ingredient applied I (mg) = Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = Dermal absorption per treatment I x A = Systemic exposure dose (SED) I x A / 60 kg = No observed adverse effect level (mg/kg) NOAEL = (rat, 13-week study) Margin of Safety NOAEL / SED = 2.12. Conclusions This substance has been adequately tested, generally to appropriate guidelines and GLP. It is moderately toxic on acute ingestion, with mortalities occurring at 300 mg/kg and above. Two 13-week studies have shown clear signs of toxicity to the haemopoietic system, kidney, forestomach and liver. Effects were seen as low as 7 mg/kg bw/day and the NOAEL was 2 mg/kg bw/day. It was shown to be mildly irritant to the rabbit eye but not to cause appr","endpoint":"dermal absorption","ingredient":"has been adequately tested, generally to appropriate guidelines and GLP. It is","loael_value":"","noael_unit":"mg/kg","noael_value":"300","page":19,"route":"dermal","species":"rat","study_id":"out139_en_noael_009"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | dermal absorption | 300 | mg/kg | rat | dermal | 13-week | dermal absorption | SOURCE_SUBDIR=out139_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING LAWSONE Colipa n° C146; OPINION_NUMBER=SCCNFP/0385/00; COMMITTEE=SCCNFP; REPORT_DATE=13 March 2001; VALUE_TEXT=300; DOSE=Safety evaluation CALCULATION OF THE MARGIN OF SAFETY Lawsone (Non-oxidising) NOT APPLICABLE Based on a usage volume of 35 ml, containing at maximum xx % Maximum amount of ingredient applied I (mg) = Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = Dermal absorption per treatment I x A = Systemic exposure dose (SE...; EFFECT=_________________________________________________________ 19 2.11. Safety evaluation CALCULATION OF THE MARGIN OF SAFETY Lawsone (Non-oxidising) NOT APPLICABLE Based on a usage volume of 35 ml, containing at maximum xx % Maximum amount of ingredient applied I (mg) = Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = Dermal absorption per treatment I x A = Systemic exposure dose (SED) I x A / 60 kg = No observed adverse effect level (mg/kg) NOAEL = (rat, 13-week study) Margin of Safety NOAEL / SED = 2.12. Conclusions This substance has been adequately tested, generally to appropriate guidelines and GLP. It is moderately toxic on acute ingestion, with mortalities occurring at 300 mg/kg and above. Two 13-week studies have shown clear signs of toxicity to the haemopoietic system, kidney, forestomach and liver. Effects were seen as low as 7 mg/kg bw/day and the NOAEL was 2 mg/kg bw/day. It was shown to be mildly irritant to the rabbit eye but not to cause appreciable skin irritation. This substance is cle; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"83-72-7","citation":"","dose":"Safety evaluation CALCULATION OF THE MARGIN OF SAFETY Lawsone (Non-oxidising) NOT APPLICABLE Based on a usage volume of 35 ml, containing at maximum xx % Maximum amount of ingredient applied I (mg) = Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = Dermal absorption per treatment I x A = Systemic exposure dose (SE...","duration":"13-week","effect":"_________________________________________________________ 19 2.11. Safety evaluation CALCULATION OF THE MARGIN OF SAFETY Lawsone (Non-oxidising) NOT APPLICABLE Based on a usage volume of 35 ml, containing at maximum xx % Maximum amount of ingredient applied I (mg) = Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = Dermal absorption per treatment I x A = Systemic exposure dose (SED) I x A / 60 kg = No observed adverse effect level (mg/kg) NOAEL = (rat, 13-week study) Margin of Safety NOAEL / SED = 2.12. Conclusions This substance has been adequately tested, generally to appropriate guidelines and GLP. It is moderately toxic on acute ingestion, with mortalities occurring at 300 mg/kg and above. Two 13-week studies have shown clear signs of toxicity to the haemopoietic system, kidney, forestomach and liver. Effects were seen as low as 7 mg/kg bw/day and the NOAEL was 2 mg/kg bw/day. It was shown to be mildly irritant to the rabbit eye but not to cause appreciable skin irritation. This substance is cle","endpoint":"dermal absorption","ingredient":"has been adequately tested, generally to appropriate guidelines and GLP. It is","loael_value":"","noael_unit":"mg/kg","noael_value":"300","page":19,"route":"dermal","species":"rat","study_id":"out139_en_noael_010"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | dermal absorption | 300 | mg/kg | rat | dermal | 13-week | dermal absorption | SOURCE_SUBDIR=out177_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING LAWSONE COLIPA n° C146; OPINION_NUMBER=SCCNFP/0583/02; COMMITTEE=SCCNFP; REPORT_DATE=adopted on 12 March 2001; VALUE_TEXT=300; DOSE=Safety evaluation CALCULATION OF THE MARGIN OF SAFETY Lawsone (Non-oxidising) NOT APPLICABLE Based on a usage volume of 35 ml, containing at maximum xx % Maximum amount of ingredient applied I (mg) = Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = Dermal absorption per treatment I x A = Systemic exposure dose (SE...; EFFECT=hydroxy-1,4-naphthoquinone. Ref. : 17 These publications do not supply relevant supplementary information for the safety evaluation of COLIPA C146. 2.11. Safety evaluation CALCULATION OF THE MARGIN OF SAFETY Lawsone (Non-oxidising) NOT APPLICABLE Based on a usage volume of 35 ml, containing at maximum xx % Maximum amount of ingredient applied I (mg) = Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = Dermal absorption per treatment I x A = Systemic exposure dose (SED) I x A / 60 kg = No observed adverse effect level (mg/kg) NOAEL = (rat, 13-week study) Margin of Safety NOAEL / SED = 2.12. Conclusions This substance has been tested, generally to appropriate guidelines and GLP. It is moderately toxic on acute ingestion, with mortalities occurring at 300 mg/kg and above. Two 13-week studies have shown clear signs of toxicity to the haemopoietic system, kidney, forestomach and liver. Effects were seen as low as 7 mg/kg bw/day and the NOAEL was 2 mg/kg bw/day. It was shown to be mildly irritant to the rabbit eye but not to cause a; CITATION=Ref. : 17 These publications do not supply relevant supplementary information for the safety evaluation of COLIPA C146; CITATION_NUMBERS=[17,146]; REFERENCE=Ref. : 17 These publications do not supply relevant supplementary information for the safety evaluation of COLIPA C146; DETAILS_JSON={"cas_number":"83-72-7","citation":"Ref. : 17 These publications do not supply relevant supplementary information for the safety evaluation of COLIPA C146","dose":"Safety evaluation CALCULATION OF THE MARGIN OF SAFETY Lawsone (Non-oxidising) NOT APPLICABLE Based on a usage volume of 35 ml, containing at maximum xx % Maximum amount of ingredient applied I (mg) = Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = Dermal absorption per treatment I x A = Systemic exposure dose (SE...","duration":"13-week","effect":"hydroxy-1,4-naphthoquinone. Ref. : 17 These publications do not supply relevant supplementary information for the safety evaluation of COLIPA C146. 2.11. Safety evaluation CALCULATION OF THE MARGIN OF SAFETY Lawsone (Non-oxidising) NOT APPLICABLE Based on a usage volume of 35 ml, containing at maximum xx % Maximum amount of ingredient applied I (mg) = Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = Dermal absorption per treatment I x A = Systemic exposure dose (SED) I x A / 60 kg = No observed adverse effect level (mg/kg) NOAEL = (rat, 13-week study) Margin of Safety NOAEL / SED = 2.12. Conclusions This substance has been tested, generally to appropriate guidelines and GLP. It is moderately toxic on acute ingestion, with mortalities occurring at 300 mg/kg and above. Two 13-week studies have shown clear signs of toxicity to the haemopoietic system, kidney, forestomach and liver. Effects were seen as low as 7 mg/kg bw/day and the NOAEL was 2 mg/kg bw/day. It was shown to be mildly irritant to the rabbit eye but not to cause a","endpoint":"dermal absorption","ingredient":"codes","loael_value":"","noael_unit":"mg/kg","noael_value":"300","page":21,"route":"dermal","species":"rat","study_id":"out177_en_noael_005"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | dermal absorption | 300 | mg/kg | rat | dermal | 13-week | dermal absorption | SOURCE_SUBDIR=out177_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING LAWSONE COLIPA n° C146; OPINION_NUMBER=SCCNFP/0583/02; COMMITTEE=SCCNFP; REPORT_DATE=adopted on 12 March 2001; VALUE_TEXT=300; DOSE=Safety evaluation CALCULATION OF THE MARGIN OF SAFETY Lawsone (Non-oxidising) NOT APPLICABLE Based on a usage volume of 35 ml, containing at maximum xx % Maximum amount of ingredient applied I (mg) = Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = Dermal absorption per treatment I x A = Systemic exposure dose (SE...; EFFECT=se publications do not supply relevant supplementary information for the safety evaluation of COLIPA C146. 2.11. Safety evaluation CALCULATION OF THE MARGIN OF SAFETY Lawsone (Non-oxidising) NOT APPLICABLE Based on a usage volume of 35 ml, containing at maximum xx % Maximum amount of ingredient applied I (mg) = Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = Dermal absorption per treatment I x A = Systemic exposure dose (SED) I x A / 60 kg = No observed adverse effect level (mg/kg) NOAEL = (rat, 13-week study) Margin of Safety NOAEL / SED = 2.12. Conclusions This substance has been tested, generally to appropriate guidelines and GLP. It is moderately toxic on acute ingestion, with mortalities occurring at 300 mg/kg and above. Two 13-week studies have shown clear signs of toxicity to the haemopoietic system, kidney, forestomach and liver. Effects were seen as low as 7 mg/kg bw/day and the NOAEL was 2 mg/kg bw/day. It was shown to be mildly irritant to the rabbit eye but not to cause appreciable ski; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"83-72-7","citation":"","dose":"Safety evaluation CALCULATION OF THE MARGIN OF SAFETY Lawsone (Non-oxidising) NOT APPLICABLE Based on a usage volume of 35 ml, containing at maximum xx % Maximum amount of ingredient applied I (mg) = Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = Dermal absorption per treatment I x A = Systemic exposure dose (SE...","duration":"13-week","effect":"se publications do not supply relevant supplementary information for the safety evaluation of COLIPA C146. 2.11. Safety evaluation CALCULATION OF THE MARGIN OF SAFETY Lawsone (Non-oxidising) NOT APPLICABLE Based on a usage volume of 35 ml, containing at maximum xx % Maximum amount of ingredient applied I (mg) = Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = Dermal absorption per treatment I x A = Systemic exposure dose (SED) I x A / 60 kg = No observed adverse effect level (mg/kg) NOAEL = (rat, 13-week study) Margin of Safety NOAEL / SED = 2.12. Conclusions This substance has been tested, generally to appropriate guidelines and GLP. It is moderately toxic on acute ingestion, with mortalities occurring at 300 mg/kg and above. Two 13-week studies have shown clear signs of toxicity to the haemopoietic system, kidney, forestomach and liver. Effects were seen as low as 7 mg/kg bw/day and the NOAEL was 2 mg/kg bw/day. It was shown to be mildly irritant to the rabbit eye but not to cause appreciable ski","endpoint":"dermal absorption","ingredient":"codes","loael_value":"","noael_unit":"mg/kg","noael_value":"300","page":21,"route":"dermal","species":"rat","study_id":"out177_en_noael_006"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | dermal absorption | 300 | mg/kg | rat | dermal | 13-week | dermal absorption | SOURCE_SUBDIR=out177_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING LAWSONE COLIPA n° C146; OPINION_NUMBER=SCCNFP/0583/02; COMMITTEE=SCCNFP; REPORT_DATE=adopted on 12 March 2001; VALUE_TEXT=300; DOSE=Safety evaluation CALCULATION OF THE MARGIN OF SAFETY Lawsone (Non-oxidising) NOT APPLICABLE Based on a usage volume of 35 ml, containing at maximum xx % Maximum amount of ingredient applied I (mg) = Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = Dermal absorption per treatment I x A = Systemic exposure dose (SE...; EFFECT=entary information for the safety evaluation of COLIPA C146. 2.11. Safety evaluation CALCULATION OF THE MARGIN OF SAFETY Lawsone (Non-oxidising) NOT APPLICABLE Based on a usage volume of 35 ml, containing at maximum xx % Maximum amount of ingredient applied I (mg) = Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = Dermal absorption per treatment I x A = Systemic exposure dose (SED) I x A / 60 kg = No observed adverse effect level (mg/kg) NOAEL = (rat, 13-week study) Margin of Safety NOAEL / SED = 2.12. Conclusions This substance has been tested, generally to appropriate guidelines and GLP. It is moderately toxic on acute ingestion, with mortalities occurring at 300 mg/kg and above. Two 13-week studies have shown clear signs of toxicity to the haemopoietic system, kidney, forestomach and liver. Effects were seen as low as 7 mg/kg bw/day and the NOAEL was 2 mg/kg bw/day. It was shown to be mildly irritant to the rabbit eye but not to cause appreciable skin irritation. Studies on sensitisation are equ; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"83-72-7","citation":"","dose":"Safety evaluation CALCULATION OF THE MARGIN OF SAFETY Lawsone (Non-oxidising) NOT APPLICABLE Based on a usage volume of 35 ml, containing at maximum xx % Maximum amount of ingredient applied I (mg) = Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = Dermal absorption per treatment I x A = Systemic exposure dose (SE...","duration":"13-week","effect":"entary information for the safety evaluation of COLIPA C146. 2.11. Safety evaluation CALCULATION OF THE MARGIN OF SAFETY Lawsone (Non-oxidising) NOT APPLICABLE Based on a usage volume of 35 ml, containing at maximum xx % Maximum amount of ingredient applied I (mg) = Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = Dermal absorption per treatment I x A = Systemic exposure dose (SED) I x A / 60 kg = No observed adverse effect level (mg/kg) NOAEL = (rat, 13-week study) Margin of Safety NOAEL / SED = 2.12. Conclusions This substance has been tested, generally to appropriate guidelines and GLP. It is moderately toxic on acute ingestion, with mortalities occurring at 300 mg/kg and above. Two 13-week studies have shown clear signs of toxicity to the haemopoietic system, kidney, forestomach and liver. Effects were seen as low as 7 mg/kg bw/day and the NOAEL was 2 mg/kg bw/day. It was shown to be mildly irritant to the rabbit eye but not to cause appreciable skin irritation. Studies on sensitisation are equ","endpoint":"dermal absorption","ingredient":"codes","loael_value":"","noael_unit":"mg/kg","noael_value":"300","page":21,"route":"dermal","species":"rat","study_id":"out177_en_noael_007"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | irritation | 2 | mg/kg bw/day | rabbit | - | 13- week | irritation | SOURCE_SUBDIR=out139_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING LAWSONE Colipa n° C146; OPINION_NUMBER=SCCNFP/0385/00; COMMITTEE=SCCNFP; REPORT_DATE=13 March 2001; VALUE_TEXT=2; DOSE=It is moderately toxic on acute ingestion, with mortalities occurring at 300 mg/kg and above.; EFFECT=. Safety Assessment & Classification The assessment followed the Notes of Guidance under scientifically based premises of consumer safety and leads to a classification 2A. This substance has been adequately tested, generally to appropriate guidelines and GLP. It is moderately toxic on acute ingestion, with mortalities occurring at 300 mg/kg and above. Two 13- week studies have shown clear signs of toxicity to the haemopoietic system, kidney, forestomach and liver. Effects were seen as low as 7 mg/kg bw/day and the NOAEL was 2 mg/kg bw/day. It was shown to be mildly irritant to the rabbit eye but not to cause appreciable skin irritation. This substance is clearly genotoxic in vitro and in vivo. It induced mutations and chromosome aberrations in mammalian cells in vitro. It was positive in two bone marrow micronucleus assays. The negative studies (inadequate studies) do not override the positive results and it is therefore necessary to conclude that it is not possible to establish a safe level for this substance. Percutaneous penet; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"83-72-7","citation":"","dose":"It is moderately toxic on acute ingestion, with mortalities occurring at 300 mg/kg and above.","duration":"13- week","effect":". Safety Assessment & Classification The assessment followed the Notes of Guidance under scientifically based premises of consumer safety and leads to a classification 2A. This substance has been adequately tested, generally to appropriate guidelines and GLP. It is moderately toxic on acute ingestion, with mortalities occurring at 300 mg/kg and above. Two 13- week studies have shown clear signs of toxicity to the haemopoietic system, kidney, forestomach and liver. Effects were seen as low as 7 mg/kg bw/day and the NOAEL was 2 mg/kg bw/day. It was shown to be mildly irritant to the rabbit eye but not to cause appreciable skin irritation. This substance is clearly genotoxic in vitro and in vivo. It induced mutations and chromosome aberrations in mammalian cells in vitro. It was positive in two bone marrow micronucleus assays. The negative studies (inadequate studies) do not override the positive results and it is therefore necessary to conclude that it is not possible to establish a safe level for this substance. Percutaneous penet","endpoint":"irritation","ingredient":"has been adequately tested, generally to appropriate guidelines and GLP. It is","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"2","page":2,"route":"","species":"rabbit","study_id":"out139_en_noael_001"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | irritation | 2 | mg/kg bw/day | rabbit | - | 13-week | irritation | SOURCE_SUBDIR=out139_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING LAWSONE Colipa n° C146; OPINION_NUMBER=SCCNFP/0385/00; COMMITTEE=SCCNFP; REPORT_DATE=13 March 2001; VALUE_TEXT=2; DOSE=focal or multifocal ulceration of the mucosa, or minimal to slight interstitial oedema were reported with an increased incidence in both sexes at 7 mg/kg bw/day.; EFFECT=focal or multifocal ulceration of the mucosa, or minimal to slight interstitial oedema were reported with an increased incidence in both sexes at 7 mg/kg bw/day. The authors concluded that treatment-related effects occurred at 20 mg/kg bw/day, affecting mainly the kidneys, forestomach and spleen, and that the NOAEL was 7 mg/kg bw/day. Significant changes were seen at 7 mg/kg bw/day which were consistent with the effects at 20 mg/kg bw/day in this study, and at higher doses in the first 13-week study (ref. 5.1). A NOAEL of 2 mg/kg bw/day should therefore be assumed. Ref. : 5.2 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : OECD 404 (1987) Species/strain : New Zealand albino rabbit Group size : 3 males Test substance : 2-Hydroxy-1,4-naphthoquinone, neat and suspended at 2% in 0.5% aqueous methylcellulose Batch no : 8160 FE (purity 99.4%) Dose : 0.5 g or 0.5 ml; CITATION=(ref. 5.1); CITATION_NUMBERS=[5,1]; REFERENCE=(ref. 5.1); DETAILS_JSON={"cas_number":"83-72-7","citation":"(ref. 5.1)","dose":"focal or multifocal ulceration of the mucosa, or minimal to slight interstitial oedema were reported with an increased incidence in both sexes at 7 mg/kg bw/day.","duration":"13-week","effect":"focal or multifocal ulceration of the mucosa, or minimal to slight interstitial oedema were reported with an increased incidence in both sexes at 7 mg/kg bw/day. The authors concluded that treatment-related effects occurred at 20 mg/kg bw/day, affecting mainly the kidneys, forestomach and spleen, and that the NOAEL was 7 mg/kg bw/day. Significant changes were seen at 7 mg/kg bw/day which were consistent with the effects at 20 mg/kg bw/day in this study, and at higher doses in the first 13-week study (ref. 5.1). A NOAEL of 2 mg/kg bw/day should therefore be assumed. Ref. : 5.2 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : OECD 404 (1987) Species/strain : New Zealand albino rabbit Group size : 3 males Test substance : 2-Hydroxy-1,4-naphthoquinone, neat and suspended at 2% in 0.5% aqueous methylcellulose Batch no : 8160 FE (purity 99.4%) Dose : 0.5 g or 0.5 ml","endpoint":"irritation","ingredient":"has been adequately tested, generally to appropriate guidelines and GLP. It is","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"2","page":9,"route":"","species":"rabbit","study_id":"out139_en_noael_005"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | irritation | 2 | mg/kg bw/day | rat | - | 13-week | irritation | SOURCE_SUBDIR=out139_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING LAWSONE Colipa n° C146; OPINION_NUMBER=SCCNFP/0385/00; COMMITTEE=SCCNFP; REPORT_DATE=13 March 2001; VALUE_TEXT=2; DOSE=I x A = Systemic exposure dose (SED) I x A / 60 kg = No observed adverse effect level (mg/kg) NOAEL = (rat, 13-week study) Margin of Safety NOAEL / SED = 2.12.; EFFECT=I x A = Systemic exposure dose (SED) I x A / 60 kg = No observed adverse effect level (mg/kg) NOAEL = (rat, 13-week study) Margin of Safety NOAEL / SED = 2.12. Conclusions This substance has been adequately tested, generally to appropriate guidelines and GLP. It is moderately toxic on acute ingestion, with mortalities occurring at 300 mg/kg and above. Two 13-week studies have shown clear signs of toxicity to the haemopoietic system, kidney, forestomach and liver. Effects were seen as low as 7 mg/kg bw/day and the NOAEL was 2 mg/kg bw/day. It was shown to be mildly irritant to the rabbit eye but not to cause appreciable skin irritation. This substance is clearly genotoxic in vitro and in vivo. It induced mutations and chromosome aberrations in mammalian cells in vitro. It was positive in two bone marrow micronucleus assays. The negative studies do not override the positive results and it is therefore necessary to conclude that it is not possible to establish a safe level for this substance. According to Commission Directive 67/54; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"83-72-7","citation":"","dose":"I x A = Systemic exposure dose (SED) I x A / 60 kg = No observed adverse effect level (mg/kg) NOAEL = (rat, 13-week study) Margin of Safety NOAEL / SED = 2.12.","duration":"13-week","effect":"I x A = Systemic exposure dose (SED) I x A / 60 kg = No observed adverse effect level (mg/kg) NOAEL = (rat, 13-week study) Margin of Safety NOAEL / SED = 2.12. Conclusions This substance has been adequately tested, generally to appropriate guidelines and GLP. It is moderately toxic on acute ingestion, with mortalities occurring at 300 mg/kg and above. Two 13-week studies have shown clear signs of toxicity to the haemopoietic system, kidney, forestomach and liver. Effects were seen as low as 7 mg/kg bw/day and the NOAEL was 2 mg/kg bw/day. It was shown to be mildly irritant to the rabbit eye but not to cause appreciable skin irritation. This substance is clearly genotoxic in vitro and in vivo. It induced mutations and chromosome aberrations in mammalian cells in vitro. It was positive in two bone marrow micronucleus assays. The negative studies do not override the positive results and it is therefore necessary to conclude that it is not possible to establish a safe level for this substance. According to Commission Directive 67/54","endpoint":"irritation","ingredient":"has been adequately tested, generally to appropriate guidelines and GLP. It is","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"2","page":19,"route":"","species":"rat","study_id":"out139_en_noael_011"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | irritation | 2 | mg/kg bw/day | rabbit | - | 13-week | irritation | SOURCE_SUBDIR=out177_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING LAWSONE COLIPA n° C146; OPINION_NUMBER=SCCNFP/0583/02; COMMITTEE=SCCNFP; REPORT_DATE=adopted on 12 March 2001; VALUE_TEXT=2; DOSE=focal or multifocal ulceration of the mucosa, or minimal to slight interstitial oedema were reported with an increased incidence in both sexes at 7 mg/kg bw/day.; EFFECT=focal or multifocal ulceration of the mucosa, or minimal to slight interstitial oedema were reported with an increased incidence in both sexes at 7 mg/kg bw/day. The authors concluded that treatment-related effects occurred at 20 mg/kg bw/day, affecting mainly the kidneys, forestomach and spleen, and that the NOAEL was 7 mg/kg bw/day. Significant changes were seen at 7 mg/kg bw/day which were consistent with the effects at 20 mg/kg bw/day in this study, and at higher doses in the first 13-week study (ref. 5.1). A NOAEL of 2 mg/kg bw/day should therefore be assumed. Ref. : 5.2 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : OECD 404 (1987) Species/strain : New Zealand albino rabbit Group size : 3 males Test substance : 2-Hydroxy-1,4-naphthoquinone, neat and suspended at 2% in 0.5% aqueous methylcellulose Batch no : 8160 FE (purity 99.4%) Dose : 0.5 g or 0.5 ml GLP : QA statement included The substance was applied neat (0.5 g) to the right flank and as a 2% suspension in 0.5% aqueous methylcellulose (0.5 ml) to; CITATION=(ref. 5.1); CITATION_NUMBERS=[5,1]; REFERENCE=(ref. 5.1); DETAILS_JSON={"cas_number":"83-72-7","citation":"(ref. 5.1)","dose":"focal or multifocal ulceration of the mucosa, or minimal to slight interstitial oedema were reported with an increased incidence in both sexes at 7 mg/kg bw/day.","duration":"13-week","effect":"focal or multifocal ulceration of the mucosa, or minimal to slight interstitial oedema were reported with an increased incidence in both sexes at 7 mg/kg bw/day. The authors concluded that treatment-related effects occurred at 20 mg/kg bw/day, affecting mainly the kidneys, forestomach and spleen, and that the NOAEL was 7 mg/kg bw/day. Significant changes were seen at 7 mg/kg bw/day which were consistent with the effects at 20 mg/kg bw/day in this study, and at higher doses in the first 13-week study (ref. 5.1). A NOAEL of 2 mg/kg bw/day should therefore be assumed. Ref. : 5.2 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : OECD 404 (1987) Species/strain : New Zealand albino rabbit Group size : 3 males Test substance : 2-Hydroxy-1,4-naphthoquinone, neat and suspended at 2% in 0.5% aqueous methylcellulose Batch no : 8160 FE (purity 99.4%) Dose : 0.5 g or 0.5 ml GLP : QA statement included The substance was applied neat (0.5 g) to the right flank and as a 2% suspension in 0.5% aqueous methylcellulose (0.5 ml) to","endpoint":"irritation","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"2","page":8,"route":"","species":"rabbit","study_id":"out177_en_noael_002"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | irritation | 2 | mg/kg bw/day | rat | - | 13-week | irritation | SOURCE_SUBDIR=out177_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING LAWSONE COLIPA n° C146; OPINION_NUMBER=SCCNFP/0583/02; COMMITTEE=SCCNFP; REPORT_DATE=adopted on 12 March 2001; VALUE_TEXT=2; DOSE=r treatment I x A = Systemic exposure dose (SED) I x A / 60 kg = No observed adverse effect level (mg/kg) NOAEL = (rat, 13-week study) Margin of Safety NOAEL / SED = 2.12.; EFFECT=r treatment I x A = Systemic exposure dose (SED) I x A / 60 kg = No observed adverse effect level (mg/kg) NOAEL = (rat, 13-week study) Margin of Safety NOAEL / SED = 2.12. Conclusions This substance has been tested, generally to appropriate guidelines and GLP. It is moderately toxic on acute ingestion, with mortalities occurring at 300 mg/kg and above. Two 13-week studies have shown clear signs of toxicity to the haemopoietic system, kidney, forestomach and liver. Effects were seen as low as 7 mg/kg bw/day and the NOAEL was 2 mg/kg bw/day. It was shown to be mildly irritant to the rabbit eye but not to cause appreciable skin irritation. Studies on sensitisation are equivocal.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"83-72-7","citation":"","dose":"r treatment I x A = Systemic exposure dose (SED) I x A / 60 kg = No observed adverse effect level (mg/kg) NOAEL = (rat, 13-week study) Margin of Safety NOAEL / SED = 2.12.","duration":"13-week","effect":"r treatment I x A = Systemic exposure dose (SED) I x A / 60 kg = No observed adverse effect level (mg/kg) NOAEL = (rat, 13-week study) Margin of Safety NOAEL / SED = 2.12. Conclusions This substance has been tested, generally to appropriate guidelines and GLP. It is moderately toxic on acute ingestion, with mortalities occurring at 300 mg/kg and above. Two 13-week studies have shown clear signs of toxicity to the haemopoietic system, kidney, forestomach and liver. Effects were seen as low as 7 mg/kg bw/day and the NOAEL was 2 mg/kg bw/day. It was shown to be mildly irritant to the rabbit eye but not to cause appreciable skin irritation. Studies on sensitisation are equivocal.","endpoint":"irritation","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"2","page":21,"route":"","species":"rat","study_id":"out177_en_noael_008"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | irritation | 2 | mg/kg bw/day | rabbit | - | 13-week | irritation | SOURCE_SUBDIR=out254_en; REPORT_TITLE=OPINION CONCERNING LAWSONE COLIPA n° C146; OPINION_NUMBER=SCCNFP/0798/04; COMMITTEE=SCCNFP; REPORT_DATE=adopted by the SCCNFP on 16 February 2004; VALUE_TEXT=2; DOSE=focal or multifocal ulceration of the mucosa, or minimal to slight interstitial oedema were reported with an increased incidence in both sexes at 7 mg/kg bw/day.; EFFECT=focal or multifocal ulceration of the mucosa, or minimal to slight interstitial oedema were reported with an increased incidence in both sexes at 7 mg/kg bw/day. The authors concluded that treatment-related effects occurred at 20 mg/kg bw/day, affecting mainly the kidneys, forestomach and spleen, and that the NOAEL was 7 mg/kg bw/day. Significant changes were seen at 7 mg/kg bw/day which were consistent with the effects at 20 mg/kg bw/day in this study, and at higher doses in the first 13-week study (ref. 5.1). A NOAEL of 2 mg/kg bw/day should therefore be assumed. Ref. : 5.2 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : OECD 404 (1987) Species/strain : New Zealand albino rabbit Group size : 3 males Test substance : 2-Hydroxy-1,4-naphthoquinone, neat and suspended at 2% in 0.5% aqueous methylcellulose Batch no : 8160 FE (purity 99.4%) Dose : 0.5 g or 0.5 ml GLP : QA statement included The substance was applied neat (0.5 g) to the right flank and as a 2% suspension in 0.5% aqueous methylcellulose; CITATION=(ref. 5.1); CITATION_NUMBERS=[5,1]; REFERENCE=(ref. 5.1); DETAILS_JSON={"cas_number":"83-72-7","citation":"(ref. 5.1)","dose":"focal or multifocal ulceration of the mucosa, or minimal to slight interstitial oedema were reported with an increased incidence in both sexes at 7 mg/kg bw/day.","duration":"13-week","effect":"focal or multifocal ulceration of the mucosa, or minimal to slight interstitial oedema were reported with an increased incidence in both sexes at 7 mg/kg bw/day. The authors concluded that treatment-related effects occurred at 20 mg/kg bw/day, affecting mainly the kidneys, forestomach and spleen, and that the NOAEL was 7 mg/kg bw/day. Significant changes were seen at 7 mg/kg bw/day which were consistent with the effects at 20 mg/kg bw/day in this study, and at higher doses in the first 13-week study (ref. 5.1). A NOAEL of 2 mg/kg bw/day should therefore be assumed. Ref. : 5.2 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : OECD 404 (1987) Species/strain : New Zealand albino rabbit Group size : 3 males Test substance : 2-Hydroxy-1,4-naphthoquinone, neat and suspended at 2% in 0.5% aqueous methylcellulose Batch no : 8160 FE (purity 99.4%) Dose : 0.5 g or 0.5 ml GLP : QA statement included The substance was applied neat (0.5 g) to the right flank and as a 2% suspension in 0.5% aqueous methylcellulose","endpoint":"irritation","ingredient":"constitutes a health hazard.","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"2","page":9,"route":"","species":"rabbit","study_id":"out254_en_noael_003"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | irritation | 7 | mg/kg bw/day | rabbit | - | 13-week | irritation | SOURCE_SUBDIR=out139_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING LAWSONE Colipa n° C146; OPINION_NUMBER=SCCNFP/0385/00; COMMITTEE=SCCNFP; REPORT_DATE=13 March 2001; VALUE_TEXT=7; DOSE=w/day, at which dose it was accompanied by dilatation and/or pigment accumulation degeneration in some animals.; EFFECT=w/day, at which dose it was accompanied by dilatation and/or pigment accumulation degeneration in some animals. The incidence at 7 mg/kg bw/day was comparable to control. In the forestomach, minimal to slight focal or multifocal ulceration of the mucosa, or minimal to slight interstitial oedema were reported with an increased incidence in both sexes at 7 mg/kg bw/day. The authors concluded that treatment-related effects occurred at 20 mg/kg bw/day, affecting mainly the kidneys, forestomach and spleen, and that the NOAEL was 7 mg/kg bw/day. Significant changes were seen at 7 mg/kg bw/day which were consistent with the effects at 20 mg/kg bw/day in this study, and at higher doses in the first 13-week study (ref. 5.1). A NOAEL of 2 mg/kg bw/day should therefore be assumed. Ref. : 5.2 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : OECD 404 (1987) Species/strain : New Zealand albino rabbit Group size : 3 males Test substance : 2-Hydroxy-1,4-naphthoquinone, neat and suspended at 2% in 0.5% aqueous methylcellulose Ba; CITATION=(ref. 5.1); CITATION_NUMBERS=[5,1]; REFERENCE=(ref. 5.1); DETAILS_JSON={"cas_number":"83-72-7","citation":"(ref. 5.1)","dose":"w/day, at which dose it was accompanied by dilatation and/or pigment accumulation degeneration in some animals.","duration":"13-week","effect":"w/day, at which dose it was accompanied by dilatation and/or pigment accumulation degeneration in some animals. The incidence at 7 mg/kg bw/day was comparable to control. In the forestomach, minimal to slight focal or multifocal ulceration of the mucosa, or minimal to slight interstitial oedema were reported with an increased incidence in both sexes at 7 mg/kg bw/day. The authors concluded that treatment-related effects occurred at 20 mg/kg bw/day, affecting mainly the kidneys, forestomach and spleen, and that the NOAEL was 7 mg/kg bw/day. Significant changes were seen at 7 mg/kg bw/day which were consistent with the effects at 20 mg/kg bw/day in this study, and at higher doses in the first 13-week study (ref. 5.1). A NOAEL of 2 mg/kg bw/day should therefore be assumed. Ref. : 5.2 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : OECD 404 (1987) Species/strain : New Zealand albino rabbit Group size : 3 males Test substance : 2-Hydroxy-1,4-naphthoquinone, neat and suspended at 2% in 0.5% aqueous methylcellulose Ba","endpoint":"irritation","ingredient":"has been adequately tested, generally to appropriate guidelines and GLP. It is","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"7","page":9,"route":"","species":"rabbit","study_id":"out139_en_noael_004"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | irritation | 7 | mg/kg bw/day | rabbit | - | 13-week | irritation | SOURCE_SUBDIR=out177_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING LAWSONE COLIPA n° C146; OPINION_NUMBER=SCCNFP/0583/02; COMMITTEE=SCCNFP; REPORT_DATE=adopted on 12 March 2001; VALUE_TEXT=7; DOSE=w/day, at which dose it was accompanied by dilatation and/or pigment accumulation degeneration in some animals.; EFFECT=w/day, at which dose it was accompanied by dilatation and/or pigment accumulation degeneration in some animals. The incidence at 7 mg/kg bw/day was comparable to control. In the forestomach, minimal to slight focal or multifocal ulceration of the mucosa, or minimal to slight interstitial oedema were reported with an increased incidence in both sexes at 7 mg/kg bw/day. The authors concluded that treatment-related effects occurred at 20 mg/kg bw/day, affecting mainly the kidneys, forestomach and spleen, and that the NOAEL was 7 mg/kg bw/day. Significant changes were seen at 7 mg/kg bw/day which were consistent with the effects at 20 mg/kg bw/day in this study, and at higher doses in the first 13-week study (ref. 5.1). A NOAEL of 2 mg/kg bw/day should therefore be assumed. Ref. : 5.2 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : OECD 404 (1987) Species/strain : New Zealand albino rabbit Group size : 3 males Test substance : 2-Hydroxy-1,4-naphthoquinone, neat and suspended at 2% in 0.5% aqueous methylcellulose Ba; CITATION=(ref. 5.1); CITATION_NUMBERS=[5,1]; REFERENCE=(ref. 5.1); DETAILS_JSON={"cas_number":"83-72-7","citation":"(ref. 5.1)","dose":"w/day, at which dose it was accompanied by dilatation and/or pigment accumulation degeneration in some animals.","duration":"13-week","effect":"w/day, at which dose it was accompanied by dilatation and/or pigment accumulation degeneration in some animals. The incidence at 7 mg/kg bw/day was comparable to control. In the forestomach, minimal to slight focal or multifocal ulceration of the mucosa, or minimal to slight interstitial oedema were reported with an increased incidence in both sexes at 7 mg/kg bw/day. The authors concluded that treatment-related effects occurred at 20 mg/kg bw/day, affecting mainly the kidneys, forestomach and spleen, and that the NOAEL was 7 mg/kg bw/day. Significant changes were seen at 7 mg/kg bw/day which were consistent with the effects at 20 mg/kg bw/day in this study, and at higher doses in the first 13-week study (ref. 5.1). A NOAEL of 2 mg/kg bw/day should therefore be assumed. Ref. : 5.2 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : OECD 404 (1987) Species/strain : New Zealand albino rabbit Group size : 3 males Test substance : 2-Hydroxy-1,4-naphthoquinone, neat and suspended at 2% in 0.5% aqueous methylcellulose Ba","endpoint":"irritation","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"7","page":8,"route":"","species":"rabbit","study_id":"out177_en_noael_001"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | irritation | 7 | mg/kg bw/day | rabbit | - | 13-week | irritation | SOURCE_SUBDIR=out254_en; REPORT_TITLE=OPINION CONCERNING LAWSONE COLIPA n° C146; OPINION_NUMBER=SCCNFP/0798/04; COMMITTEE=SCCNFP; REPORT_DATE=adopted by the SCCNFP on 16 February 2004; VALUE_TEXT=7; DOSE=/day, at which dose it was accompanied by dilatation and/or pigment accumulation degeneration in some animals.; EFFECT=/day, at which dose it was accompanied by dilatation and/or pigment accumulation degeneration in some animals. The incidence at 7 mg/kg bw/day was comparable to control. In the forestomach, minimal to slight focal or multifocal ulceration of the mucosa, or minimal to slight interstitial oedema were reported with an increased incidence in both sexes at 7 mg/kg bw/day. The authors concluded that treatment-related effects occurred at 20 mg/kg bw/day, affecting mainly the kidneys, forestomach and spleen, and that the NOAEL was 7 mg/kg bw/day. Significant changes were seen at 7 mg/kg bw/day which were consistent with the effects at 20 mg/kg bw/day in this study, and at higher doses in the first 13-week study (ref. 5.1). A NOAEL of 2 mg/kg bw/day should therefore be assumed. Ref. : 5.2 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : OECD 404 (1987) Species/strain : New Zealand albino rabbit Group size : 3 males Test substance : 2-Hydroxy-1,4-naphthoquinone, neat and suspended at 2% in 0.5% aqueous methylcel; CITATION=(ref. 5.1); CITATION_NUMBERS=[5,1]; REFERENCE=(ref. 5.1); DETAILS_JSON={"cas_number":"83-72-7","citation":"(ref. 5.1)","dose":"/day, at which dose it was accompanied by dilatation and/or pigment accumulation degeneration in some animals.","duration":"13-week","effect":"/day, at which dose it was accompanied by dilatation and/or pigment accumulation degeneration in some animals. The incidence at 7 mg/kg bw/day was comparable to control. In the forestomach, minimal to slight focal or multifocal ulceration of the mucosa, or minimal to slight interstitial oedema were reported with an increased incidence in both sexes at 7 mg/kg bw/day. The authors concluded that treatment-related effects occurred at 20 mg/kg bw/day, affecting mainly the kidneys, forestomach and spleen, and that the NOAEL was 7 mg/kg bw/day. Significant changes were seen at 7 mg/kg bw/day which were consistent with the effects at 20 mg/kg bw/day in this study, and at higher doses in the first 13-week study (ref. 5.1). A NOAEL of 2 mg/kg bw/day should therefore be assumed. Ref. : 5.2 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : OECD 404 (1987) Species/strain : New Zealand albino rabbit Group size : 3 males Test substance : 2-Hydroxy-1,4-naphthoquinone, neat and suspended at 2% in 0.5% aqueous methylcel","endpoint":"irritation","ingredient":"constitutes a health hazard.","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"7","page":9,"route":"","species":"rabbit","study_id":"out254_en_noael_002"} |
openFDA substances 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | TLH4A6LV1W | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C10H6O3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"TLH4A6LV1W"} |
| openFDA substances | FDA UNII substance identifier | TLH4A6LV1W | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C10H6O3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"TLH4A6LV1W"} |
| openFDA substances | FDA UNII substance identifier | TLH4A6LV1W | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C10H6O3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"TLH4A6LV1W"} |
| openFDA substances | FDA UNII substance identifier | TLH4A6LV1W | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C10H6O3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"TLH4A6LV1W"} |