NOAEL Studies
Cosmetic Ingredient
Basic Blue 99 NOAEL Studies
INCI: BASIC BLUE 99
CAS: 68123-13-7
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
SCCS_vision_codex 12 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCS_vision_codex | NOAEL | =62.8 | % | - | - | - | NOAEL study | {"dose":"ecovery end in high dose males is considered of equivocal toxicological relevance At necropsy the absolute and relative mean organ weights were not affected, and macroscopic changes were restricted to bluish discoloration in the stomach at mid and high dose males and high dose females.","effect":"ecovery end in high dose males is considered of equivocal toxicological relevance At necropsy the absolute and relative mean organ weights were not affected, and macroscopic changes were restricted to bluish discoloration in the stomach at mid and high dose males and high dose females. At the recovery end, accentuated lobular pattern was noted in all high dose males Microscopically there were no change of toxicological relevance to the morphology of tissue and organs. Conclusion Under the condition of this study a NOEL could not be established. In the absence of morphological changes to organs and tissue and minimal and reversible effects on clinical laboratory parameter the NOAEL is defined at 60 mg/kb bw/ day for male and female According to the Applicant, as the dye content of the test substance is only 62.8 %, the NOAEL value is re-calculated to be 37 mg/kg/bw/day.","page":33,"pdf":"sccs_o_304.pdf","row_type":"noael_study","study_id":"sccs_o_304_noael_001"} |
| SCCS_vision_codex | NOAEL | =62.8 | % | - | - | - | NOAEL study | {"dose":"ecovery end in high dose males is considered of equivocal toxicological relevance At necropsy the absolute and relative mean organ weights were not affected, and macroscopic changes were restricted to bluish discoloration in the stomach at mid and high dose males and high dose females.","effect":"ecovery end in high dose males is considered of equivocal toxicological relevance At necropsy the absolute and relative mean organ weights were not affected, and macroscopic changes were restricted to bluish discoloration in the stomach at mid and high dose males and high dose females. At the recovery end, accentuated lobular pattern was noted in all high dose males Microscopically there were no change of toxicological relevance to the morphology of tissue and organs. Conclusion Under the condition of this study a NOEL could not be established. In the absence of morphological changes to organs and tissue and minimal and reversible effects on clinical laboratory parameter the NOAEL is defined at 60 mg/kb bw/ day for male and female According to the Applicant, as the dye content of the test substance is only 62.8 %, the NOAEL value is re-calculated to be 37 mg/kg/bw/day.","page":33,"pdf":"sccs_o_304.pdf","row_type":"noael_study","study_id":"sccs_o_304_noael_001"} |
| SCCS_vision_codex | NOAEL | =62.8 | % | - | - | - | NOAEL study | {"dose":"ecovery end in high dose males is considered of equivocal toxicological relevance At necropsy the absolute and relative mean organ weights were not affected, and macroscopic changes were restricted to bluish discoloration in the stomach at mid and high dose males and high dose females.","effect":"ecovery end in high dose males is considered of equivocal toxicological relevance At necropsy the absolute and relative mean organ weights were not affected, and macroscopic changes were restricted to bluish discoloration in the stomach at mid and high dose males and high dose females. At the recovery end, accentuated lobular pattern was noted in all high dose males Microscopically there were no change of toxicological relevance to the morphology of tissue and organs. Conclusion Under the condition of this study a NOEL could not be established. In the absence of morphological changes to organs and tissue and minimal and reversible effects on clinical laboratory parameter the NOAEL is defined at 60 mg/kb bw/ day for male and female According to the Applicant, as the dye content of the test substance is only 62.8 %, the NOAEL value is re-calculated to be 37 mg/kg/bw/day.","page":33,"pdf":"sccs_o_304.pdf","row_type":"noael_study","study_id":"sccs_o_304_noael_001"} |
| SCCS_vision_codex | NOAEL | =62.8 | % | - | - | - | NOAEL study | {"dose":"ecovery end in high dose males is considered of equivocal toxicological relevance At necropsy the absolute and relative mean organ weights were not affected, and macroscopic changes were restricted to bluish discoloration in the stomach at mid and high dose males and high dose females.","effect":"ecovery end in high dose males is considered of equivocal toxicological relevance At necropsy the absolute and relative mean organ weights were not affected, and macroscopic changes were restricted to bluish discoloration in the stomach at mid and high dose males and high dose females. At the recovery end, accentuated lobular pattern was noted in all high dose males Microscopically there were no change of toxicological relevance to the morphology of tissue and organs. Conclusion Under the condition of this study a NOEL could not be established. In the absence of morphological changes to organs and tissue and minimal and reversible effects on clinical laboratory parameter the NOAEL is defined at 60 mg/kb bw/ day for male and female According to the Applicant, as the dye content of the test substance is only 62.8 %, the NOAEL value is re-calculated to be 37 mg/kg/bw/day.","page":33,"pdf":"sccs_o_304.pdf","row_type":"noael_study","study_id":"sccs_o_304_noael_001"} |
| SCCS_vision_codex | NOAEL | =74 | - | - | dermal | - | dermal absorption | {"effect":"SCCS-rejected applicant NOAEL: onditions of use must be performed by using the same HPLC-PDA method (at λmax) used to analyse impurities and full reports should be submitted. General toxicity There is a variation in both the composition and impurity profile between the new batches and the Batch 74/75 used in the submitted toxicological studies. Thus, the toxicological data that are based on Batch 74/75 or other old batches may not fully correspond to the material specifications outlined in the current Submission and cannot be used to derive a NOAEL without proper in silico justification. Irritation/sensitisation Acknowledging the uncertainty regarding the exact nature of the Basic Blue 99 batch that caused (partly severe) immediate-type hypersensitivity reactions, the SCCS considers this an alert that such a risk may also be associated with the current new batch under consideration. Basic Blue 99 should therefore be regarded as a skin sensitiser, despite the fact that the available supporting studies were conducted with older batches. Dermal absorption T","page":51,"pdf":"sccs_o_304.pdf","row_type":"noael_study","study_id":"sccs_o_304_noael_007"} |
| SCCS_vision_codex | NOAEL | =74 | - | - | dermal | - | dermal absorption | {"effect":"SCCS-rejected applicant NOAEL: onditions of use must be performed by using the same HPLC-PDA method (at λmax) used to analyse impurities and full reports should be submitted. General toxicity There is a variation in both the composition and impurity profile between the new batches and the Batch 74/75 used in the submitted toxicological studies. Thus, the toxicological data that are based on Batch 74/75 or other old batches may not fully correspond to the material specifications outlined in the current Submission and cannot be used to derive a NOAEL without proper in silico justification. Irritation/sensitisation Acknowledging the uncertainty regarding the exact nature of the Basic Blue 99 batch that caused (partly severe) immediate-type hypersensitivity reactions, the SCCS considers this an alert that such a risk may also be associated with the current new batch under consideration. Basic Blue 99 should therefore be regarded as a skin sensitiser, despite the fact that the available supporting studies were conducted with older batches. Dermal absorption T","page":51,"pdf":"sccs_o_304.pdf","row_type":"noael_study","study_id":"sccs_o_304_noael_007"} |
| SCCS_vision_codex | NOAEL | =74 | - | - | dermal | - | dermal absorption | {"effect":"SCCS-rejected applicant NOAEL: onditions of use must be performed by using the same HPLC-PDA method (at λmax) used to analyse impurities and full reports should be submitted. General toxicity There is a variation in both the composition and impurity profile between the new batches and the Batch 74/75 used in the submitted toxicological studies. Thus, the toxicological data that are based on Batch 74/75 or other old batches may not fully correspond to the material specifications outlined in the current Submission and cannot be used to derive a NOAEL without proper in silico justification. Irritation/sensitisation Acknowledging the uncertainty regarding the exact nature of the Basic Blue 99 batch that caused (partly severe) immediate-type hypersensitivity reactions, the SCCS considers this an alert that such a risk may also be associated with the current new batch under consideration. Basic Blue 99 should therefore be regarded as a skin sensitiser, despite the fact that the available supporting studies were conducted with older batches. Dermal absorption T","page":51,"pdf":"sccs_o_304.pdf","row_type":"noael_study","study_id":"sccs_o_304_noael_007"} |
| SCCS_vision_codex | NOAEL | =74 | - | - | dermal | - | dermal absorption | {"effect":"SCCS-rejected applicant NOAEL: onditions of use must be performed by using the same HPLC-PDA method (at λmax) used to analyse impurities and full reports should be submitted. General toxicity There is a variation in both the composition and impurity profile between the new batches and the Batch 74/75 used in the submitted toxicological studies. Thus, the toxicological data that are based on Batch 74/75 or other old batches may not fully correspond to the material specifications outlined in the current Submission and cannot be used to derive a NOAEL without proper in silico justification. Irritation/sensitisation Acknowledging the uncertainty regarding the exact nature of the Basic Blue 99 batch that caused (partly severe) immediate-type hypersensitivity reactions, the SCCS considers this an alert that such a risk may also be associated with the current new batch under consideration. Basic Blue 99 should therefore be regarded as a skin sensitiser, despite the fact that the available supporting studies were conducted with older batches. Dermal absorption T","page":51,"pdf":"sccs_o_304.pdf","row_type":"noael_study","study_id":"sccs_o_304_noael_007"} |
| SCCS_vision_codex | NOAEL | =200 | mg/kg | - | - | - | NOAEL study | {"citation":"Ref.: Gerspach, RFD (2006) SCCS comment There is a variation in both the composition and impurity profile between Bat","dose":"Conclusion A NOAEL for embryo/fetal toxicity was at the dose level of 200 mg/kg.bw/day.","effect":"est item. Statistically significantly increased mean body weights were calculated in group 4 male and female fetuses. External examination did not reveal any item related findings Visceral examination did not reveal any item related findings Referring to Skeletal and cartilage examination: no test item abnormalities were observed. Only both individual and litter basis, statistically significant decreased incidences of non-ossified talus and non-ossified cervical vertebral body 1 were found in group 4. Conclusion A NOAEL for embryo/fetal toxicity was at the dose level of 200 mg/kg.bw/day. The NOEL for embryo/fetal toxicity was at the dose of 60 mg/kg.bw/day. The study did not reveal any teratological or embryo lethal effect up to the high dose level of 500 mg/kg body weight. According to the Applicant, as the dye content of the test substance is only 62.8%, the NOAEL value is re-calculated to 125.8 mg/kg bw/day. Ref.: Gerspach, RFD (2006) SCCS comment There is a variation in both the composition and impurity profile between Bat","page":48,"pdf":"sccs_o_304.pdf","row_type":"noael_study","study_id":"sccs_o_304_noael_004"} |
| SCCS_vision_codex | NOAEL | =200 | mg/kg | - | - | - | NOAEL study | {"citation":"Ref.: Gerspach, RFD (2006) SCCS comment There is a variation in both the composition and impurity profile between Bat","dose":"Conclusion A NOAEL for embryo/fetal toxicity was at the dose level of 200 mg/kg.bw/day.","effect":"est item. Statistically significantly increased mean body weights were calculated in group 4 male and female fetuses. External examination did not reveal any item related findings Visceral examination did not reveal any item related findings Referring to Skeletal and cartilage examination: no test item abnormalities were observed. Only both individual and litter basis, statistically significant decreased incidences of non-ossified talus and non-ossified cervical vertebral body 1 were found in group 4. Conclusion A NOAEL for embryo/fetal toxicity was at the dose level of 200 mg/kg.bw/day. The NOEL for embryo/fetal toxicity was at the dose of 60 mg/kg.bw/day. The study did not reveal any teratological or embryo lethal effect up to the high dose level of 500 mg/kg body weight. According to the Applicant, as the dye content of the test substance is only 62.8%, the NOAEL value is re-calculated to 125.8 mg/kg bw/day. Ref.: Gerspach, RFD (2006) SCCS comment There is a variation in both the composition and impurity profile between Bat","page":48,"pdf":"sccs_o_304.pdf","row_type":"noael_study","study_id":"sccs_o_304_noael_004"} |
| SCCS_vision_codex | NOAEL | =200 | mg/kg | - | - | - | NOAEL study | {"citation":"Ref.: Gerspach, RFD (2006) SCCS comment There is a variation in both the composition and impurity profile between Bat","dose":"Conclusion A NOAEL for embryo/fetal toxicity was at the dose level of 200 mg/kg.bw/day.","effect":"est item. Statistically significantly increased mean body weights were calculated in group 4 male and female fetuses. External examination did not reveal any item related findings Visceral examination did not reveal any item related findings Referring to Skeletal and cartilage examination: no test item abnormalities were observed. Only both individual and litter basis, statistically significant decreased incidences of non-ossified talus and non-ossified cervical vertebral body 1 were found in group 4. Conclusion A NOAEL for embryo/fetal toxicity was at the dose level of 200 mg/kg.bw/day. The NOEL for embryo/fetal toxicity was at the dose of 60 mg/kg.bw/day. The study did not reveal any teratological or embryo lethal effect up to the high dose level of 500 mg/kg body weight. According to the Applicant, as the dye content of the test substance is only 62.8%, the NOAEL value is re-calculated to 125.8 mg/kg bw/day. Ref.: Gerspach, RFD (2006) SCCS comment There is a variation in both the composition and impurity profile between Bat","page":48,"pdf":"sccs_o_304.pdf","row_type":"noael_study","study_id":"sccs_o_304_noael_004"} |
| SCCS_vision_codex | NOAEL | =200 | mg/kg | - | - | - | NOAEL study | {"citation":"Ref.: Gerspach, RFD (2006) SCCS comment There is a variation in both the composition and impurity profile between Bat","dose":"Conclusion A NOAEL for embryo/fetal toxicity was at the dose level of 200 mg/kg.bw/day.","effect":"est item. Statistically significantly increased mean body weights were calculated in group 4 male and female fetuses. External examination did not reveal any item related findings Visceral examination did not reveal any item related findings Referring to Skeletal and cartilage examination: no test item abnormalities were observed. Only both individual and litter basis, statistically significant decreased incidences of non-ossified talus and non-ossified cervical vertebral body 1 were found in group 4. Conclusion A NOAEL for embryo/fetal toxicity was at the dose level of 200 mg/kg.bw/day. The NOEL for embryo/fetal toxicity was at the dose of 60 mg/kg.bw/day. The study did not reveal any teratological or embryo lethal effect up to the high dose level of 500 mg/kg body weight. According to the Applicant, as the dye content of the test substance is only 62.8%, the NOAEL value is re-calculated to 125.8 mg/kg bw/day. Ref.: Gerspach, RFD (2006) SCCS comment There is a variation in both the composition and impurity profile between Bat","page":48,"pdf":"sccs_o_304.pdf","row_type":"noael_study","study_id":"sccs_o_304_noael_004"} |
ToxValDB_ECHA_IUCLID 5 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_ECHA_IUCLID | NOAEL | =50 | mg/kg bw/day | Rat | oral | - | reproduction developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eab36e4b0a7c65d1b9475; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/17371/7/9/2?documentUUID=c84a52de-1d48-42ef-8efe-1f0b8e890562; YEAR=2015; ORIGINAL_YEAR=2015; TOXICOLOGICAL_EFFECT=P0: organ weights and organ / body weight ratios|P0: reproductive function (oestrous cycle); TOXICOLOGICAL_EFFECT_CATEGORY=organ weight|reproduction; STUDY_GROUP=ECHA IUCLID:15857642:F:P0-; 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_1a189213568b06af84c0784eccab0c77 |
| ToxValDB_ECHA_IUCLID | NOEL | =50 | mg/kg bw/day | Rat | oral | - | developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eac56e4b0a7c65d1be8de; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/17371/7/9/3?documentUUID=c84a52de-1d48-42ef-8efe-1f0b8e890562; YEAR=2015; ORIGINAL_YEAR=2015; STUDY_GROUP=ECHA IUCLID:15821060:-:-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_e6eb065b2e6eaedf51395b501a8f8f18 |
| ToxValDB_ECHA_IUCLID | NOEL | =500 | ppm | Mouse | oral | subchronic; 90 days | subchronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaea5e4b0a7c65d1ca4f6; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/17371/7/6/2?documentUUID=c84a52de-1d48-42ef-8efe-1f0b8e890562; YEAR=2015; ORIGINAL_YEAR=2015; STUDY_GROUP=ECHA IUCLID:15833164: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_d7973504cb9fa3d10378d161b0af7d16 |
| ToxValDB_ECHA_IUCLID | NOEL | >=180 | mg/kg bw/day | Rat | oral | subchronic; 90 days | subchronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaea5e4b0a7c65d1ca4fa; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/17371/7/6/2?documentUUID=c84a52de-1d48-42ef-8efe-1f0b8e890562; YEAR=2015; ORIGINAL_YEAR=2015; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Oral_15846870_15846871: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_725b49c327bdae26529cd08190e62dfa |
| ToxValDB_ECHA_IUCLID | NOEL | <=360 | mg/kg bw/day | Rat | oral | subchronic; 90 days | subchronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaea5e4b0a7c65d1ca4fa; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/17371/7/6/2?documentUUID=c84a52de-1d48-42ef-8efe-1f0b8e890562; YEAR=2015; ORIGINAL_YEAR=2015; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Oral_15846870_15846871: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_25415c5719b2b3d3c26d88499fb9aa92 |
openFDA substances 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | P0U7VBC51E | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C19H20BrN4O2.Cl","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"P0U7VBC51E"} |
| openFDA substances | FDA UNII substance identifier | P0U7VBC51E | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C19H20BrN4O2.Cl","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"P0U7VBC51E"} |
| openFDA substances | FDA UNII substance identifier | P0U7VBC51E | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C19H20BrN4O2.Cl","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"P0U7VBC51E"} |
| openFDA substances | FDA UNII substance identifier | P0U7VBC51E | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C19H20BrN4O2.Cl","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"P0U7VBC51E"} |