NOAEL Studies
Active Ingredient
Piroctone Olamine NOAEL Studies
INCI: PIROCTONE OLAMINE
CAS: 68890-66-4
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
SCCNFP_vision_codex 12 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCNFP_vision_codex | NOAEL | =100 | mg/kg/day | rat | oral | 90-day | developmental toxicity | {"dose":"100 mg/kg/day; in 90-day topical application NOEL in rabbits:","effect":"ckground of earlier submissions. Submission I : February 1980 Submission II : January 1985 The result of the respective evaluation and the opinion of the Scientific Committee of Cosmetology (SCC) is laid down in Reports of the SCC, sixth series, EUR 11139 EN, 1987. PO had been approved for use in cosmetic products at a maximal concentration of 1 % (rinse-off products) or 0.5 % in other products. PO is non-sensitising , non-genotoxic, non-teratogenic and the systemic toxicity has been measured in a 90-day oral test NOEL in rats: 100 mg/kg/day; in 90-day topical application NOEL in rabbits: 16 mg/kg/day (one dose test). The percutaneous penetration rate in rats was in the order to 4.5 % of a topically applied dose. Since 1983, no reports have appeared in the literature indicating that the substance could be attributed to unwanted adverse effects. In HRIPT, the test cpd. PO at 0.5 % in a vehicle did not induce irritation or sensitisation. In a human use test 0.2 % or 1.0 % in shampoos provided no evidence of adverse reactions. Rabb","page":3,"pdf":"out162_en.pdf","row_type":"noael_study","study_id":"out162_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =16 | mg/kg/day | rat | oral | 90-day | developmental toxicity | {"dose":"100 mg/kg/day; in 90-day topical application NOEL in rabbits:","effect":"80 Submission II : January 1985 The result of the respective evaluation and the opinion of the Scientific Committee of Cosmetology (SCC) is laid down in Reports of the SCC, sixth series, EUR 11139 EN, 1987. PO had been approved for use in cosmetic products at a maximal concentration of 1 % (rinse-off products) or 0.5 % in other products. PO is non-sensitising , non-genotoxic, non-teratogenic and the systemic toxicity has been measured in a 90-day oral test NOEL in rats: 100 mg/kg/day; in 90-day topical application NOEL in rabbits: 16 mg/kg/day (one dose test). The percutaneous penetration rate in rats was in the order to 4.5 % of a topically applied dose. Since 1983, no reports have appeared in the literature indicating that the substance could be attributed to unwanted adverse effects. In HRIPT, the test cpd. PO at 0.5 % in a vehicle did not induce irritation or sensitisation. In a human use test 0.2 % or 1.0 % in shampoos provided no evidence of adverse reactions. Rabbit irritation tests indicated that PO was slightly irritati","page":3,"pdf":"out162_en.pdf","row_type":"noael_study","study_id":"out162_en_noael_002"} |
| SCCNFP_vision_codex | NOAEL | =1 | % | human | dermal | - | dermal absorption | {"dose":"Safety evaluation CALCULATION OF SAFETY MARGIN Piroctone Olamine (Octopirox) Based on a usage volume of X ml, containing at maximum X % 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 =...","effect":"noted in the tolerance of these formulations. Both creams showed a good acceptance and tolerance. These data support the tolerance of 1.0 % PO in face creams. Ref. : 2.11. Safety evaluation CALCULATION OF SAFETY MARGIN Piroctone Olamine (Octopirox) Based on a usage volume of X ml, containing at maximum X % 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 = Margin of Safety NOAEL / SED =","page":6,"pdf":"out162_en.pdf","row_type":"noael_study","study_id":"out162_en_noael_003"} |
| SCCNFP_vision_codex | NOAEL | =100 | mg/kg/day | rat | oral | 90-day | developmental toxicity | {"dose":"100 mg/kg/day; in 90-day topical application NOEL in rabbits:","effect":"ckground of earlier submissions. Submission I : February 1980 Submission II : January 1985 The result of the respective evaluation and the opinion of the Scientific Committee of Cosmetology (SCC) is laid down in Reports of the SCC, sixth series, EUR 11139 EN, 1987. PO had been approved for use in cosmetic products at a maximal concentration of 1 % (rinse-off products) or 0.5 % in other products. PO is non-sensitising , non-genotoxic, non-teratogenic and the systemic toxicity has been measured in a 90-day oral test NOEL in rats: 100 mg/kg/day; in 90-day topical application NOEL in rabbits: 16 mg/kg/day (one dose test). The percutaneous penetration rate in rats was in the order to 4.5 % of a topically applied dose. Since 1983, no reports have appeared in the literature indicating that the substance could be attributed to unwanted adverse effects. In HRIPT, the test cpd. PO at 0.5 % in a vehicle did not induce irritation or sensitisation. In a human use test 0.2 % or 1.0 % in shampoos provided no evidence of adverse reactions. Rabb","page":3,"pdf":"out162_en.pdf","row_type":"noael_study","study_id":"out162_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =16 | mg/kg/day | rat | oral | 90-day | developmental toxicity | {"dose":"100 mg/kg/day; in 90-day topical application NOEL in rabbits:","effect":"80 Submission II : January 1985 The result of the respective evaluation and the opinion of the Scientific Committee of Cosmetology (SCC) is laid down in Reports of the SCC, sixth series, EUR 11139 EN, 1987. PO had been approved for use in cosmetic products at a maximal concentration of 1 % (rinse-off products) or 0.5 % in other products. PO is non-sensitising , non-genotoxic, non-teratogenic and the systemic toxicity has been measured in a 90-day oral test NOEL in rats: 100 mg/kg/day; in 90-day topical application NOEL in rabbits: 16 mg/kg/day (one dose test). The percutaneous penetration rate in rats was in the order to 4.5 % of a topically applied dose. Since 1983, no reports have appeared in the literature indicating that the substance could be attributed to unwanted adverse effects. In HRIPT, the test cpd. PO at 0.5 % in a vehicle did not induce irritation or sensitisation. In a human use test 0.2 % or 1.0 % in shampoos provided no evidence of adverse reactions. Rabbit irritation tests indicated that PO was slightly irritati","page":3,"pdf":"out162_en.pdf","row_type":"noael_study","study_id":"out162_en_noael_002"} |
| SCCNFP_vision_codex | NOAEL | =1 | % | human | dermal | - | dermal absorption | {"dose":"Safety evaluation CALCULATION OF SAFETY MARGIN Piroctone Olamine (Octopirox) Based on a usage volume of X ml, containing at maximum X % 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 =...","effect":"noted in the tolerance of these formulations. Both creams showed a good acceptance and tolerance. These data support the tolerance of 1.0 % PO in face creams. Ref. : 2.11. Safety evaluation CALCULATION OF SAFETY MARGIN Piroctone Olamine (Octopirox) Based on a usage volume of X ml, containing at maximum X % 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 = Margin of Safety NOAEL / SED =","page":6,"pdf":"out162_en.pdf","row_type":"noael_study","study_id":"out162_en_noael_003"} |
| SCCNFP_vision_codex | NOAEL | =100 | mg/kg/day | rat | oral | 90-day | developmental toxicity | {"dose":"100 mg/kg/day; in 90-day topical application NOEL in rabbits:","effect":"ckground of earlier submissions. Submission I : February 1980 Submission II : January 1985 The result of the respective evaluation and the opinion of the Scientific Committee of Cosmetology (SCC) is laid down in Reports of the SCC, sixth series, EUR 11139 EN, 1987. PO had been approved for use in cosmetic products at a maximal concentration of 1 % (rinse-off products) or 0.5 % in other products. PO is non-sensitising , non-genotoxic, non-teratogenic and the systemic toxicity has been measured in a 90-day oral test NOEL in rats: 100 mg/kg/day; in 90-day topical application NOEL in rabbits: 16 mg/kg/day (one dose test). The percutaneous penetration rate in rats was in the order to 4.5 % of a topically applied dose. Since 1983, no reports have appeared in the literature indicating that the substance could be attributed to unwanted adverse effects. In HRIPT, the test cpd. PO at 0.5 % in a vehicle did not induce irritation or sensitisation. In a human use test 0.2 % or 1.0 % in shampoos provided no evidence of adverse reactions. Rabb","page":3,"pdf":"out162_en.pdf","row_type":"noael_study","study_id":"out162_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =16 | mg/kg/day | rat | oral | 90-day | developmental toxicity | {"dose":"100 mg/kg/day; in 90-day topical application NOEL in rabbits:","effect":"80 Submission II : January 1985 The result of the respective evaluation and the opinion of the Scientific Committee of Cosmetology (SCC) is laid down in Reports of the SCC, sixth series, EUR 11139 EN, 1987. PO had been approved for use in cosmetic products at a maximal concentration of 1 % (rinse-off products) or 0.5 % in other products. PO is non-sensitising , non-genotoxic, non-teratogenic and the systemic toxicity has been measured in a 90-day oral test NOEL in rats: 100 mg/kg/day; in 90-day topical application NOEL in rabbits: 16 mg/kg/day (one dose test). The percutaneous penetration rate in rats was in the order to 4.5 % of a topically applied dose. Since 1983, no reports have appeared in the literature indicating that the substance could be attributed to unwanted adverse effects. In HRIPT, the test cpd. PO at 0.5 % in a vehicle did not induce irritation or sensitisation. In a human use test 0.2 % or 1.0 % in shampoos provided no evidence of adverse reactions. Rabbit irritation tests indicated that PO was slightly irritati","page":3,"pdf":"out162_en.pdf","row_type":"noael_study","study_id":"out162_en_noael_002"} |
| SCCNFP_vision_codex | NOAEL | =1 | % | human | dermal | - | dermal absorption | {"dose":"Safety evaluation CALCULATION OF SAFETY MARGIN Piroctone Olamine (Octopirox) Based on a usage volume of X ml, containing at maximum X % 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 =...","effect":"noted in the tolerance of these formulations. Both creams showed a good acceptance and tolerance. These data support the tolerance of 1.0 % PO in face creams. Ref. : 2.11. Safety evaluation CALCULATION OF SAFETY MARGIN Piroctone Olamine (Octopirox) Based on a usage volume of X ml, containing at maximum X % 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 = Margin of Safety NOAEL / SED =","page":6,"pdf":"out162_en.pdf","row_type":"noael_study","study_id":"out162_en_noael_003"} |
| SCCNFP_vision_codex | NOAEL | =100 | mg/kg/day | rat | oral | 90-day | developmental toxicity | {"dose":"100 mg/kg/day; in 90-day topical application NOEL in rabbits:","effect":"ckground of earlier submissions. Submission I : February 1980 Submission II : January 1985 The result of the respective evaluation and the opinion of the Scientific Committee of Cosmetology (SCC) is laid down in Reports of the SCC, sixth series, EUR 11139 EN, 1987. PO had been approved for use in cosmetic products at a maximal concentration of 1 % (rinse-off products) or 0.5 % in other products. PO is non-sensitising , non-genotoxic, non-teratogenic and the systemic toxicity has been measured in a 90-day oral test NOEL in rats: 100 mg/kg/day; in 90-day topical application NOEL in rabbits: 16 mg/kg/day (one dose test). The percutaneous penetration rate in rats was in the order to 4.5 % of a topically applied dose. Since 1983, no reports have appeared in the literature indicating that the substance could be attributed to unwanted adverse effects. In HRIPT, the test cpd. PO at 0.5 % in a vehicle did not induce irritation or sensitisation. In a human use test 0.2 % or 1.0 % in shampoos provided no evidence of adverse reactions. Rabb","page":3,"pdf":"out162_en.pdf","row_type":"noael_study","study_id":"out162_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =16 | mg/kg/day | rat | oral | 90-day | developmental toxicity | {"dose":"100 mg/kg/day; in 90-day topical application NOEL in rabbits:","effect":"80 Submission II : January 1985 The result of the respective evaluation and the opinion of the Scientific Committee of Cosmetology (SCC) is laid down in Reports of the SCC, sixth series, EUR 11139 EN, 1987. PO had been approved for use in cosmetic products at a maximal concentration of 1 % (rinse-off products) or 0.5 % in other products. PO is non-sensitising , non-genotoxic, non-teratogenic and the systemic toxicity has been measured in a 90-day oral test NOEL in rats: 100 mg/kg/day; in 90-day topical application NOEL in rabbits: 16 mg/kg/day (one dose test). The percutaneous penetration rate in rats was in the order to 4.5 % of a topically applied dose. Since 1983, no reports have appeared in the literature indicating that the substance could be attributed to unwanted adverse effects. In HRIPT, the test cpd. PO at 0.5 % in a vehicle did not induce irritation or sensitisation. In a human use test 0.2 % or 1.0 % in shampoos provided no evidence of adverse reactions. Rabbit irritation tests indicated that PO was slightly irritati","page":3,"pdf":"out162_en.pdf","row_type":"noael_study","study_id":"out162_en_noael_002"} |
| SCCNFP_vision_codex | NOAEL | =1 | % | human | dermal | - | dermal absorption | {"dose":"Safety evaluation CALCULATION OF SAFETY MARGIN Piroctone Olamine (Octopirox) Based on a usage volume of X ml, containing at maximum X % 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 =...","effect":"noted in the tolerance of these formulations. Both creams showed a good acceptance and tolerance. These data support the tolerance of 1.0 % PO in face creams. Ref. : 2.11. Safety evaluation CALCULATION OF SAFETY MARGIN Piroctone Olamine (Octopirox) Based on a usage volume of X ml, containing at maximum X % 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 = Margin of Safety NOAEL / SED =","page":6,"pdf":"out162_en.pdf","row_type":"noael_study","study_id":"out162_en_noael_003"} |
ToxValDB_ECHA_IUCLID 13 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_ECHA_IUCLID | LOAEL | =225 | mg/kg bw/day | Rat | oral | subchronic; 6 weeks | subchronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaec9e4b0a7c65d1cae33; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/5490/7/6/2?documentUUID=9a0b1291-c12a-4109-b96c-def3ae3999de; YEAR=2009; ORIGINAL_YEAR=2009; STUDY_GROUP=ECHA IUCLID:15849757:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_d23b8c9ac74b07e76fd60b184e080d9c |
| ToxValDB_ECHA_IUCLID | NOAEL | <2000 | mg/kg bw/day | Rat | injection | - | reproduction developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7d206e4b0a7c65d231435; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/5490/7/9/3?documentUUID=9a0b1291-c12a-4109-b96c-def3ae3999de; YEAR=2009; ORIGINAL_YEAR=2009; STUDY_GROUP=ECHA IUCLID_dup_Developmental Toxicity Teratogenicity_15822512_15822606:F:-maternal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_b9b3058eb4d1c15fb74c259a0c6e30f4 |
| ToxValDB_ECHA_IUCLID | NOAEL | =250 | mg/kg bw/day | Rat | oral | - | reproduction developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eac56e4b0a7c65d1bea74; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/5490/7/9/3?documentUUID=9a0b1291-c12a-4109-b96c-def3ae3999de; YEAR=2009; ORIGINAL_YEAR=2009; TOXICOLOGICAL_EFFECT=maternal: body weight and weight gain|maternal: clinical biochemistry|maternal: clinical signs|maternal: food consumption and compound intake|maternal: haematology|maternal: mortality; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|clinical chemistry|clinical signs|food and/or water consumption|hematology|mortality/survival; STUDY_GROUP=ECHA IUCLID:15825104:F:-maternal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_4a0d2833a6f260ce7a247cbc428c3cf8 |
| ToxValDB_ECHA_IUCLID | NOAEL | =100 | mg/kg bw/day | Rat | oral | - | developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eac56e4b0a7c65d1bea74; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/5490/7/9/3?documentUUID=9a0b1291-c12a-4109-b96c-def3ae3999de; YEAR=2009; ORIGINAL_YEAR=2009; TOXICOLOGICAL_EFFECT=fetus: reduction in number of live offspring|fetus: changes in litter size and weights|fetus: external malformations; TOXICOLOGICAL_EFFECT_CATEGORY=development; STUDY_GROUP=ECHA IUCLID:15825105:-:-fetal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_c00de8ae88b91d9688fc12a416cdf0b1 |
| ToxValDB_ECHA_IUCLID | NOAEL | =225 | mg/kg bw/day | Rat | oral | - | reproduction developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eab47e4b0a7c65d1b9886; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/5490/7/9/2?documentUUID=9a0b1291-c12a-4109-b96c-def3ae3999de; YEAR=2009; ORIGINAL_YEAR=2009; TOXICOLOGICAL_EFFECT=P0: clinical signs|P0: mortality|P0: body weight and weight gain|P0: food consumption and compound intake|P0: haematology|P0: clinical biochemistry; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|clinical chemistry|clinical signs|food and/or water consumption|hematology|mortality/survival; STUDY_GROUP=ECHA IUCLID:15862964:M/F:P0-; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_98e22b2284c65cf7fba02bb4bde388a6 |
| ToxValDB_ECHA_IUCLID | NOEL | >=2000 | mg/kg bw/day | Rat | injection | - | developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7d206e4b0a7c65d23140f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/5490/7/9/3?documentUUID=9a0b1291-c12a-4109-b96c-def3ae3999de; YEAR=2009; ORIGINAL_YEAR=2009; STUDY_GROUP=ECHA IUCLID:15821192:-:-fetal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_113cbcbd46919311320ad14a58312c25 |
| ToxValDB_ECHA_IUCLID | NOEL | >=500 | mg/kg bw/day | Rat | injection | - | reproduction developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7d206e4b0a7c65d23140f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/5490/7/9/3?documentUUID=9a0b1291-c12a-4109-b96c-def3ae3999de; YEAR=2009; ORIGINAL_YEAR=2009; STUDY_GROUP=ECHA IUCLID_dup_Developmental Toxicity Teratogenicity_15822512_15822606:F:-maternal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_9695414b39793e6d0c14fff8c322797e |
| ToxValDB_ECHA_IUCLID | NOEL | >63 | mg/kg bw/day | Rabbit | oral | - | developmental | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eac56e4b0a7c65d1bea7b; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/5490/7/9/3?documentUUID=9a0b1291-c12a-4109-b96c-def3ae3999de; YEAR=2009; ORIGINAL_YEAR=2009; STUDY_GROUP=ECHA IUCLID:15825106:-:-fetal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_775816a99f66e3e943af9c204d5f5a83 |
| ToxValDB_ECHA_IUCLID | NOEL | >=100 | mg/cm2-day | Rabbit | dermal | subchronic; 36 days | subchronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/67c61d3ae4b096bca8774f41; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/5490/7/6/4?documentUUID=9a0b1291-c12a-4109-b96c-def3ae3999de; YEAR=2009; ORIGINAL_YEAR=2009; STUDY_GROUP=ECHA IUCLID:15826086:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_21da451c0e954695081cac42e6c3f9d8 |
| ToxValDB_ECHA_IUCLID | NOEL | >=2 | mg/cm2-day | Rat | dermal | chronic; 6 months | chronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/67c61e4be4b096bca8779143; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/5490/7/6/4?documentUUID=9a0b1291-c12a-4109-b96c-def3ae3999de; YEAR=2009; ORIGINAL_YEAR=2009; STUDY_GROUP=ECHA IUCLID:15826457:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_4f79e0f820b8edd6851194e6aace9ca9 |
| ToxValDB_ECHA_IUCLID | NOEL | >=100 | mg/kg bw/day | Rat | dermal | subchronic; 5 weeks | subchronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/67c61d93e4b096bca87764c8; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/5490/7/6/4?documentUUID=9a0b1291-c12a-4109-b96c-def3ae3999de; YEAR=2009; ORIGINAL_YEAR=2009; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Dermal_15826900_15826901:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_c684db2d49a3b8e2521101b80b8a9b53 |
| ToxValDB_ECHA_IUCLID | NOEL | >=55 | mg/kg bw/day | Rat | oral | short-term; 30 days | short-term | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaec8e4b0a7c65d1cae2c; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/5490/7/6/2?documentUUID=9a0b1291-c12a-4109-b96c-def3ae3999de; YEAR=2009; ORIGINAL_YEAR=2009; STUDY_GROUP=ECHA IUCLID:15849755:M:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_7626a49cd5f35939fe26bb13cebd1128 |
| ToxValDB_ECHA_IUCLID | NOEL | >=210 | mg/kg bw/day | Rat | oral | short-term; 30 days | short-term | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaec8e4b0a7c65d1cae2c; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/5490/7/6/2?documentUUID=9a0b1291-c12a-4109-b96c-def3ae3999de; YEAR=2009; ORIGINAL_YEAR=2009; STUDY_GROUP=ECHA IUCLID:15849756:F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_dfe675b8cf71b37313997d99c70bd5f7 |
ToxValDB_GESTIS_DNEL 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_GESTIS_DNEL | DNEL systemic | =14.7 | mg/m3 | Human | inhalation | - | Toxicity Value | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6543dd69e4b045b9ff7cd87e; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.dguv.de/ifa/gestis/gestis-dnel-liste/index-2.jsp; STUDY_GROUP=GESTIS DNEL_dup_-_15632727_15632728:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_89412c732a28cc5e7a5ce2a4814efc80 |
| ToxValDB_GESTIS_DNEL | DNEL systemic | =12.3 | mg/m3 | Human | inhalation | - | Toxicity Value | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6543dd69e4b045b9ff7cd87e; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.dguv.de/ifa/gestis/gestis-dnel-liste/index-2.jsp; STUDY_GROUP=GESTIS DNEL_dup_-_15632727_15632728:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_8099a72608e8f0e9263b004d6264be4f |
UnifiedCodex:SCCNFP:beta.noael_studies 5 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:SCCNFP:beta.noael_studies | dermal absorption | 1 | % | human | dermal | - | dermal absorption | SOURCE_SUBDIR=out162_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING PIROCTONE OLAMINE AND ITS MONOETHANOLAMINE SALT Colipa n° P59; OPINION_NUMBER=SCCNFP/0525/01; COMMITTEE=SCCNFP; REPORT_DATE=27 February 2002; VALUE_TEXT=1.0; DOSE=Safety evaluation CALCULATION OF SAFETY MARGIN Piroctone Olamine (Octopirox) Based on a usage volume of X ml, containing at maximum X % 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 =...; EFFECT=noted in the tolerance of these formulations. Both creams showed a good acceptance and tolerance. These data support the tolerance of 1.0 % PO in face creams. Ref. : 2.11. Safety evaluation CALCULATION OF SAFETY MARGIN Piroctone Olamine (Octopirox) Based on a usage volume of X ml, containing at maximum X % 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 = Margin of Safety NOAEL / SED =; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"68890-66-4","citation":"","dose":"Safety evaluation CALCULATION OF SAFETY MARGIN Piroctone Olamine (Octopirox) Based on a usage volume of X ml, containing at maximum X % 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 =...","duration":"","effect":"noted in the tolerance of these formulations. Both creams showed a good acceptance and tolerance. These data support the tolerance of 1.0 % PO in face creams. Ref. : 2.11. Safety evaluation CALCULATION OF SAFETY MARGIN Piroctone Olamine (Octopirox) Based on a usage volume of X ml, containing at maximum X % 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 = Margin of Safety NOAEL / SED =","endpoint":"dermal absorption","ingredient":"s indicated","loael_value":"","noael_unit":"%","noael_value":"1.0","page":6,"route":"dermal","species":"human","study_id":"out162_en_noael_003"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | dermal absorption | 1 | % | human | dermal | - | dermal absorption | SOURCE_SUBDIR=out162_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING PIROCTONE OLAMINE AND ITS MONOETHANOLAMINE SALT Colipa n° P59; OPINION_NUMBER=SCCNFP/0525/01; COMMITTEE=SCCNFP; REPORT_DATE=27 February 2002; VALUE_TEXT=1.0; DOSE=Safety evaluation CALCULATION OF SAFETY MARGIN Piroctone Olamine (Octopirox) Based on a usage volume of X ml, containing at maximum X % 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 =...; EFFECT=ons. Both creams showed a good acceptance and tolerance. These data support the tolerance of 1.0 % PO in face creams. Ref. : 2.11. Safety evaluation CALCULATION OF SAFETY MARGIN Piroctone Olamine (Octopirox) Based on a usage volume of X ml, containing at maximum X % 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 = Margin of Safety NOAEL / SED =; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"68890-66-4","citation":"","dose":"Safety evaluation CALCULATION OF SAFETY MARGIN Piroctone Olamine (Octopirox) Based on a usage volume of X ml, containing at maximum X % 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 =...","duration":"","effect":"ons. Both creams showed a good acceptance and tolerance. These data support the tolerance of 1.0 % PO in face creams. Ref. : 2.11. Safety evaluation CALCULATION OF SAFETY MARGIN Piroctone Olamine (Octopirox) Based on a usage volume of X ml, containing at maximum X % 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 = Margin of Safety NOAEL / SED =","endpoint":"dermal absorption","ingredient":"s indicated","loael_value":"","noael_unit":"%","noael_value":"1.0","page":6,"route":"dermal","species":"human","study_id":"out162_en_noael_004"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | dermal absorption | 1 | % | human | dermal | - | dermal absorption | SOURCE_SUBDIR=out162_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING PIROCTONE OLAMINE AND ITS MONOETHANOLAMINE SALT Colipa n° P59; OPINION_NUMBER=SCCNFP/0525/01; COMMITTEE=SCCNFP; REPORT_DATE=27 February 2002; VALUE_TEXT=1.0; DOSE=Safety evaluation CALCULATION OF SAFETY MARGIN Piroctone Olamine (Octopirox) Based on a usage volume of X ml, containing at maximum X % 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 =...; EFFECT=good acceptance and tolerance. These data support the tolerance of 1.0 % PO in face creams. Ref. : 2.11. Safety evaluation CALCULATION OF SAFETY MARGIN Piroctone Olamine (Octopirox) Based on a usage volume of X ml, containing at maximum X % 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 = Margin of Safety NOAEL / SED =; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"68890-66-4","citation":"","dose":"Safety evaluation CALCULATION OF SAFETY MARGIN Piroctone Olamine (Octopirox) Based on a usage volume of X ml, containing at maximum X % 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 =...","duration":"","effect":"good acceptance and tolerance. These data support the tolerance of 1.0 % PO in face creams. Ref. : 2.11. Safety evaluation CALCULATION OF SAFETY MARGIN Piroctone Olamine (Octopirox) Based on a usage volume of X ml, containing at maximum X % 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 = Margin of Safety NOAEL / SED =","endpoint":"dermal absorption","ingredient":"s indicated","loael_value":"","noael_unit":"%","noael_value":"1.0","page":6,"route":"dermal","species":"human","study_id":"out162_en_noael_005"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | developmental toxicity | 100 | mg/kg/day | rat | oral | 90-day | developmental toxicity | SOURCE_SUBDIR=out162_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING PIROCTONE OLAMINE AND ITS MONOETHANOLAMINE SALT Colipa n° P59; OPINION_NUMBER=SCCNFP/0525/01; COMMITTEE=SCCNFP; REPORT_DATE=27 February 2002; VALUE_TEXT=100; DOSE=100 mg/kg/day; in 90-day topical application NOEL in rabbits:; EFFECT=ckground of earlier submissions. Submission I : February 1980 Submission II : January 1985 The result of the respective evaluation and the opinion of the Scientific Committee of Cosmetology (SCC) is laid down in Reports of the SCC, sixth series, EUR 11139 EN, 1987. PO had been approved for use in cosmetic products at a maximal concentration of 1 % (rinse-off products) or 0.5 % in other products. PO is non-sensitising , non-genotoxic, non-teratogenic and the systemic toxicity has been measured in a 90-day oral test NOEL in rats: 100 mg/kg/day; in 90-day topical application NOEL in rabbits: 16 mg/kg/day (one dose test). The percutaneous penetration rate in rats was in the order to 4.5 % of a topically applied dose. Since 1983, no reports have appeared in the literature indicating that the substance could be attributed to unwanted adverse effects. In HRIPT, the test cpd. PO at 0.5 % in a vehicle did not induce irritation or sensitisation. In a human use test 0.2 % or 1.0 % in shampoos provided no evidence of adverse reactions. Rabb; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"68890-66-4","citation":"","dose":"100 mg/kg/day; in 90-day topical application NOEL in rabbits:","duration":"90-day","effect":"ckground of earlier submissions. Submission I : February 1980 Submission II : January 1985 The result of the respective evaluation and the opinion of the Scientific Committee of Cosmetology (SCC) is laid down in Reports of the SCC, sixth series, EUR 11139 EN, 1987. PO had been approved for use in cosmetic products at a maximal concentration of 1 % (rinse-off products) or 0.5 % in other products. PO is non-sensitising , non-genotoxic, non-teratogenic and the systemic toxicity has been measured in a 90-day oral test NOEL in rats: 100 mg/kg/day; in 90-day topical application NOEL in rabbits: 16 mg/kg/day (one dose test). The percutaneous penetration rate in rats was in the order to 4.5 % of a topically applied dose. Since 1983, no reports have appeared in the literature indicating that the substance could be attributed to unwanted adverse effects. In HRIPT, the test cpd. PO at 0.5 % in a vehicle did not induce irritation or sensitisation. In a human use test 0.2 % or 1.0 % in shampoos provided no evidence of adverse reactions. Rabb","endpoint":"developmental toxicity","ingredient":"s indicated","loael_value":"","noael_unit":"mg/kg/day","noael_value":"100","page":3,"route":"oral","species":"rat","study_id":"out162_en_noael_001"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | developmental toxicity | 16 | mg/kg/day | rat | oral | 90-day | developmental toxicity | SOURCE_SUBDIR=out162_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING PIROCTONE OLAMINE AND ITS MONOETHANOLAMINE SALT Colipa n° P59; OPINION_NUMBER=SCCNFP/0525/01; COMMITTEE=SCCNFP; REPORT_DATE=27 February 2002; VALUE_TEXT=16; DOSE=100 mg/kg/day; in 90-day topical application NOEL in rabbits:; EFFECT=80 Submission II : January 1985 The result of the respective evaluation and the opinion of the Scientific Committee of Cosmetology (SCC) is laid down in Reports of the SCC, sixth series, EUR 11139 EN, 1987. PO had been approved for use in cosmetic products at a maximal concentration of 1 % (rinse-off products) or 0.5 % in other products. PO is non-sensitising , non-genotoxic, non-teratogenic and the systemic toxicity has been measured in a 90-day oral test NOEL in rats: 100 mg/kg/day; in 90-day topical application NOEL in rabbits: 16 mg/kg/day (one dose test). The percutaneous penetration rate in rats was in the order to 4.5 % of a topically applied dose. Since 1983, no reports have appeared in the literature indicating that the substance could be attributed to unwanted adverse effects. In HRIPT, the test cpd. PO at 0.5 % in a vehicle did not induce irritation or sensitisation. In a human use test 0.2 % or 1.0 % in shampoos provided no evidence of adverse reactions. Rabbit irritation tests indicated that PO was slightly irritati; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"68890-66-4","citation":"","dose":"100 mg/kg/day; in 90-day topical application NOEL in rabbits:","duration":"90-day","effect":"80 Submission II : January 1985 The result of the respective evaluation and the opinion of the Scientific Committee of Cosmetology (SCC) is laid down in Reports of the SCC, sixth series, EUR 11139 EN, 1987. PO had been approved for use in cosmetic products at a maximal concentration of 1 % (rinse-off products) or 0.5 % in other products. PO is non-sensitising , non-genotoxic, non-teratogenic and the systemic toxicity has been measured in a 90-day oral test NOEL in rats: 100 mg/kg/day; in 90-day topical application NOEL in rabbits: 16 mg/kg/day (one dose test). The percutaneous penetration rate in rats was in the order to 4.5 % of a topically applied dose. Since 1983, no reports have appeared in the literature indicating that the substance could be attributed to unwanted adverse effects. In HRIPT, the test cpd. PO at 0.5 % in a vehicle did not induce irritation or sensitisation. In a human use test 0.2 % or 1.0 % in shampoos provided no evidence of adverse reactions. Rabbit irritation tests indicated that PO was slightly irritati","endpoint":"developmental toxicity","ingredient":"s indicated","loael_value":"","noael_unit":"mg/kg/day","noael_value":"16","page":3,"route":"oral","species":"rat","study_id":"out162_en_noael_002"} |
openFDA substances 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | A4V5C6R9FB | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C14H23NO2.C2H7NO","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"A4V5C6R9FB"} |
| openFDA substances | FDA UNII substance identifier | A4V5C6R9FB | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C14H23NO2.C2H7NO","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"A4V5C6R9FB"} |
| openFDA substances | FDA UNII substance identifier | A4V5C6R9FB | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C14H23NO2.C2H7NO","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"A4V5C6R9FB"} |
| openFDA substances | FDA UNII substance identifier | A4V5C6R9FB | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C14H23NO2.C2H7NO","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"A4V5C6R9FB"} |