NOAEL Studies
Cosmetic Ingredient
Hydroxyethoxy Aminopyrazolopyridine HCl NOAEL Studies
INCI: HYDROXYETHOXY AMINOPYRAZOLOPYRIDINE HCL
CAS: 1079221-49-0
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
SCCS Opinion 24 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCS Opinion | NOAEL | =1.67 | mg/kg bw/d | human | oral | prenatal | developmental toxicity | {"dose":"(under oxidative conditions) Absorption through the skin A = 0.60 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.35 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0058 mg/kg bw Lowest observed adverse effect level LOAEL = 10 mg/kg bw/d (maternal toxicity in...","effect":"(under oxidative conditions) Absorption through the skin A = 0.60 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.35 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0058 mg/kg bw Lowest observed adverse effect level LOAEL = 10 mg/kg bw/d (maternal toxicity in prenatal oral developmental toxicity study) Assessment factor of 3 for LOAEL to NOAEL = 3.33 mg/kg bw/d Bioavailability 50%* = 1.67 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 287 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation.","page":24,"pdf":"sccs_o_150.pdf","row_type":"noael_study","study_id":"sccs_o_150_noael_007"} |
| SCCS Opinion | NOAEL | =1.67 | mg/kg bw/d | human | oral | prenatal | developmental toxicity | {"dose":"(under oxidative conditions) Absorption through the skin A = 0.60 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.35 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0058 mg/kg bw Lowest observed adverse effect level LOAEL = 10 mg/kg bw/d (maternal toxicity in...","effect":"(under oxidative conditions) Absorption through the skin A = 0.60 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.35 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0058 mg/kg bw Lowest observed adverse effect level LOAEL = 10 mg/kg bw/d (maternal toxicity in prenatal oral developmental toxicity study) Assessment factor of 3 for LOAEL to NOAEL = 3.33 mg/kg bw/d Bioavailability 50%* = 1.67 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 287 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation.","page":24,"pdf":"sccs_o_150.pdf","row_type":"noael_study","study_id":"sccs_o_150_noael_007"} |
| SCCS Opinion | NOAEL | =1.67 | mg/kg bw/d | human | oral | prenatal | developmental toxicity | {"dose":"(under oxidative conditions) Absorption through the skin A = 0.60 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.35 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0058 mg/kg bw Lowest observed adverse effect level LOAEL = 10 mg/kg bw/d (maternal toxicity in...","effect":"(under oxidative conditions) Absorption through the skin A = 0.60 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.35 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0058 mg/kg bw Lowest observed adverse effect level LOAEL = 10 mg/kg bw/d (maternal toxicity in prenatal oral developmental toxicity study) Assessment factor of 3 for LOAEL to NOAEL = 3.33 mg/kg bw/d Bioavailability 50%* = 1.67 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 287 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation.","page":24,"pdf":"sccs_o_150.pdf","row_type":"noael_study","study_id":"sccs_o_150_noael_007"} |
| SCCS Opinion | NOAEL | =1.67 | mg/kg bw/d | human | oral | prenatal | developmental toxicity | {"dose":"(under oxidative conditions) Absorption through the skin A = 0.60 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.35 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0058 mg/kg bw Lowest observed adverse effect level LOAEL = 10 mg/kg bw/d (maternal toxicity in...","effect":"(under oxidative conditions) Absorption through the skin A = 0.60 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.35 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0058 mg/kg bw Lowest observed adverse effect level LOAEL = 10 mg/kg bw/d (maternal toxicity in prenatal oral developmental toxicity study) Assessment factor of 3 for LOAEL to NOAEL = 3.33 mg/kg bw/d Bioavailability 50%* = 1.67 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 287 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation.","page":24,"pdf":"sccs_o_150.pdf","row_type":"noael_study","study_id":"sccs_o_150_noael_007"} |
| SCCS Opinion | NOAEL | =3.33 | mg/kg bw/d | human | oral | prenatal | developmental toxicity | {"dose":"afety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (under oxidative conditions) Absorption through the skin A = 0.60 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.35 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0058 mg...","effect":"afety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (under oxidative conditions) Absorption through the skin A = 0.60 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.35 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0058 mg/kg bw Lowest observed adverse effect level LOAEL = 10 mg/kg bw/d (maternal toxicity in prenatal oral developmental toxicity study) Assessment factor of 3 for LOAEL to NOAEL = 3.33 mg/kg bw/d Bioavailability 50%* = 1.67 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 287 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation.","page":24,"pdf":"sccs_o_150.pdf","row_type":"noael_study","study_id":"sccs_o_150_noael_006"} |
| SCCS Opinion | NOAEL | =3.33 | mg/kg bw/d | human | oral | prenatal | developmental toxicity | {"dose":"afety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (under oxidative conditions) Absorption through the skin A = 0.60 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.35 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0058 mg...","effect":"afety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (under oxidative conditions) Absorption through the skin A = 0.60 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.35 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0058 mg/kg bw Lowest observed adverse effect level LOAEL = 10 mg/kg bw/d (maternal toxicity in prenatal oral developmental toxicity study) Assessment factor of 3 for LOAEL to NOAEL = 3.33 mg/kg bw/d Bioavailability 50%* = 1.67 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 287 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation.","page":24,"pdf":"sccs_o_150.pdf","row_type":"noael_study","study_id":"sccs_o_150_noael_006"} |
| SCCS Opinion | NOAEL | =3.33 | mg/kg bw/d | human | oral | prenatal | developmental toxicity | {"dose":"afety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (under oxidative conditions) Absorption through the skin A = 0.60 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.35 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0058 mg...","effect":"afety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (under oxidative conditions) Absorption through the skin A = 0.60 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.35 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0058 mg/kg bw Lowest observed adverse effect level LOAEL = 10 mg/kg bw/d (maternal toxicity in prenatal oral developmental toxicity study) Assessment factor of 3 for LOAEL to NOAEL = 3.33 mg/kg bw/d Bioavailability 50%* = 1.67 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 287 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation.","page":24,"pdf":"sccs_o_150.pdf","row_type":"noael_study","study_id":"sccs_o_150_noael_006"} |
| SCCS Opinion | NOAEL | =3.33 | mg/kg bw/d | human | oral | prenatal | developmental toxicity | {"dose":"afety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (under oxidative conditions) Absorption through the skin A = 0.60 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.35 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0058 mg...","effect":"afety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (under oxidative conditions) Absorption through the skin A = 0.60 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.35 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0058 mg/kg bw Lowest observed adverse effect level LOAEL = 10 mg/kg bw/d (maternal toxicity in prenatal oral developmental toxicity study) Assessment factor of 3 for LOAEL to NOAEL = 3.33 mg/kg bw/d Bioavailability 50%* = 1.67 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 287 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation.","page":24,"pdf":"sccs_o_150.pdf","row_type":"noael_study","study_id":"sccs_o_150_noael_006"} |
| SCCS Opinion | NOAEL | =10 | mg/kg bw/day | - | - | Chronic | genotoxicity | {"dose":"Hydroxyethoxy aminopyrazolopyridine HCl (A161) ___________________________________________________________________________________________ 18 SCCS comment As the platelet counts were statistically significantly higher in both intermediate and high- dose females (+33% and +65%, respectively) and relative liver weights were statistically significa...","effect":"Hydroxyethoxy aminopyrazolopyridine HCl (A161) ___________________________________________________________________________________________ 18 SCCS comment As the platelet counts were statistically significantly higher in both intermediate and high- dose females (+33% and +65%, respectively) and relative liver weights were statistically significantly increased in intermediate and high-dose males (relative to body weight: +19% and +29%, respectively), the SCCS considers the intermediate dose level as a LOAEL. The NOAEL is consequently 10 mg/kg bw/day. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted. 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 (1997) Test system: Salmonella typhimurium TA1535, TA1537, TA98, TA100 and TA102 Replicates: triplicates per test concentration Test substance: R0056896C (IMEXINE® FAM) Solvent: purified water Batch: R0056896C 001 P 001 Purity: > 95% pure Concentrations: Experiment I: In the absence","page":18,"pdf":"sccs_o_150.pdf","row_type":"noael_study","study_id":"sccs_o_150_noael_002"} |
| SCCS Opinion | NOAEL | =10 | mg/kg/day | - | - | developmental | developmental toxicity | {"citation":"Ref.: 13","dose":"The foetal ossification level revealed no differences between foetuses from treated and control dams.","effect":"; this finding was not considered to be adverse by the study report authors as it was associated with maternal toxicity and concerned mainly 5th and 6th sternebrae which is a common finding. The foetal ossification level revealed no differences between foetuses from treated and control dams. Conclusion On the basis of the results obtained in the present study, and specifically the effects on maternal body weight, the Lowest Observed Effect level (LOEL) for maternal toxicity was established at 10 mg/kg/day and the NOAEL (No Observed Adverse Effect Level) for foetal and developmental toxicity was established at 30 mg/kg/day. Ref.: 13","page":23,"pdf":"sccs_o_150.pdf","row_type":"noael_study","study_id":"sccs_o_150_noael_003"} |
| SCCS Opinion | NOAEL | =10 | mg/kg bw/day | - | - | Chronic | genotoxicity | {"dose":"Hydroxyethoxy aminopyrazolopyridine HCl (A161) ___________________________________________________________________________________________ 18 SCCS comment As the platelet counts were statistically significantly higher in both intermediate and high- dose females (+33% and +65%, respectively) and relative liver weights were statistically significa...","effect":"Hydroxyethoxy aminopyrazolopyridine HCl (A161) ___________________________________________________________________________________________ 18 SCCS comment As the platelet counts were statistically significantly higher in both intermediate and high- dose females (+33% and +65%, respectively) and relative liver weights were statistically significantly increased in intermediate and high-dose males (relative to body weight: +19% and +29%, respectively), the SCCS considers the intermediate dose level as a LOAEL. The NOAEL is consequently 10 mg/kg bw/day. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted. 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 (1997) Test system: Salmonella typhimurium TA1535, TA1537, TA98, TA100 and TA102 Replicates: triplicates per test concentration Test substance: R0056896C (IMEXINE® FAM) Solvent: purified water Batch: R0056896C 001 P 001 Purity: > 95% pure Concentrations: Experiment I: In the absence","page":18,"pdf":"sccs_o_150.pdf","row_type":"noael_study","study_id":"sccs_o_150_noael_002"} |
| SCCS Opinion | NOAEL | =10 | mg/kg/day | - | - | developmental | developmental toxicity | {"citation":"Ref.: 13","dose":"The foetal ossification level revealed no differences between foetuses from treated and control dams.","effect":"; this finding was not considered to be adverse by the study report authors as it was associated with maternal toxicity and concerned mainly 5th and 6th sternebrae which is a common finding. The foetal ossification level revealed no differences between foetuses from treated and control dams. Conclusion On the basis of the results obtained in the present study, and specifically the effects on maternal body weight, the Lowest Observed Effect level (LOEL) for maternal toxicity was established at 10 mg/kg/day and the NOAEL (No Observed Adverse Effect Level) for foetal and developmental toxicity was established at 30 mg/kg/day. Ref.: 13","page":23,"pdf":"sccs_o_150.pdf","row_type":"noael_study","study_id":"sccs_o_150_noael_003"} |
| SCCS Opinion | NOAEL | =10 | mg/kg bw/day | - | - | Chronic | genotoxicity | {"dose":"Hydroxyethoxy aminopyrazolopyridine HCl (A161) ___________________________________________________________________________________________ 18 SCCS comment As the platelet counts were statistically significantly higher in both intermediate and high- dose females (+33% and +65%, respectively) and relative liver weights were statistically significa...","effect":"Hydroxyethoxy aminopyrazolopyridine HCl (A161) ___________________________________________________________________________________________ 18 SCCS comment As the platelet counts were statistically significantly higher in both intermediate and high- dose females (+33% and +65%, respectively) and relative liver weights were statistically significantly increased in intermediate and high-dose males (relative to body weight: +19% and +29%, respectively), the SCCS considers the intermediate dose level as a LOAEL. The NOAEL is consequently 10 mg/kg bw/day. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted. 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 (1997) Test system: Salmonella typhimurium TA1535, TA1537, TA98, TA100 and TA102 Replicates: triplicates per test concentration Test substance: R0056896C (IMEXINE® FAM) Solvent: purified water Batch: R0056896C 001 P 001 Purity: > 95% pure Concentrations: Experiment I: In the absence","page":18,"pdf":"sccs_o_150.pdf","row_type":"noael_study","study_id":"sccs_o_150_noael_002"} |
| SCCS Opinion | NOAEL | =10 | mg/kg/day | - | - | developmental | developmental toxicity | {"citation":"Ref.: 13","dose":"The foetal ossification level revealed no differences between foetuses from treated and control dams.","effect":"; this finding was not considered to be adverse by the study report authors as it was associated with maternal toxicity and concerned mainly 5th and 6th sternebrae which is a common finding. The foetal ossification level revealed no differences between foetuses from treated and control dams. Conclusion On the basis of the results obtained in the present study, and specifically the effects on maternal body weight, the Lowest Observed Effect level (LOEL) for maternal toxicity was established at 10 mg/kg/day and the NOAEL (No Observed Adverse Effect Level) for foetal and developmental toxicity was established at 30 mg/kg/day. Ref.: 13","page":23,"pdf":"sccs_o_150.pdf","row_type":"noael_study","study_id":"sccs_o_150_noael_003"} |
| SCCS Opinion | NOAEL | =10 | mg/kg bw/day | - | - | Chronic | genotoxicity | {"dose":"Hydroxyethoxy aminopyrazolopyridine HCl (A161) ___________________________________________________________________________________________ 18 SCCS comment As the platelet counts were statistically significantly higher in both intermediate and high- dose females (+33% and +65%, respectively) and relative liver weights were statistically significa...","effect":"Hydroxyethoxy aminopyrazolopyridine HCl (A161) ___________________________________________________________________________________________ 18 SCCS comment As the platelet counts were statistically significantly higher in both intermediate and high- dose females (+33% and +65%, respectively) and relative liver weights were statistically significantly increased in intermediate and high-dose males (relative to body weight: +19% and +29%, respectively), the SCCS considers the intermediate dose level as a LOAEL. The NOAEL is consequently 10 mg/kg bw/day. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted. 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 (1997) Test system: Salmonella typhimurium TA1535, TA1537, TA98, TA100 and TA102 Replicates: triplicates per test concentration Test substance: R0056896C (IMEXINE® FAM) Solvent: purified water Batch: R0056896C 001 P 001 Purity: > 95% pure Concentrations: Experiment I: In the absence","page":18,"pdf":"sccs_o_150.pdf","row_type":"noael_study","study_id":"sccs_o_150_noael_002"} |
| SCCS Opinion | NOAEL | =10 | mg/kg/day | - | - | developmental | developmental toxicity | {"citation":"Ref.: 13","dose":"The foetal ossification level revealed no differences between foetuses from treated and control dams.","effect":"; this finding was not considered to be adverse by the study report authors as it was associated with maternal toxicity and concerned mainly 5th and 6th sternebrae which is a common finding. The foetal ossification level revealed no differences between foetuses from treated and control dams. Conclusion On the basis of the results obtained in the present study, and specifically the effects on maternal body weight, the Lowest Observed Effect level (LOEL) for maternal toxicity was established at 10 mg/kg/day and the NOAEL (No Observed Adverse Effect Level) for foetal and developmental toxicity was established at 30 mg/kg/day. Ref.: 13","page":23,"pdf":"sccs_o_150.pdf","row_type":"noael_study","study_id":"sccs_o_150_noael_003"} |
| SCCS Opinion | NOAEL | =30 | mg/kg bw/day | rat | oral | 90-day | developmental toxicity | {"dose":"General toxicity The maximal non-lethal dose in rats by the oral and the dermal routes was higher than 500 mg/kg bw.","effect":"rted. General toxicity The maximal non-lethal dose in rats by the oral and the dermal routes was higher than 500 mg/kg bw. In a 90-day oral (gavage) study in rats, the NOAEL was 10 mg/kg bw/day based on statistically significantly higher platelet counts in females and statistically significantly increased relative liver weights in males at the higher dose levels (30 and 100 mg/kg bw/day). In a prenatal developmental oral (gavage) toxicity study in rats, the LOAEL was 10 mg/kg bw/day for maternal toxicity and the NOAEL was 30 mg/kg bw/day for foetal and developmental toxicity. The LOAEL of 10 mg/kg bw/day for maternal toxicity in the prenatal developmental toxicity study is used for the calculation of the MoS. No two-generation reproduction study was submitted. Irritation / sensitisation Under the conditions of an in vitro Primary Cutaneous Tolerance study, hydroxyethoxy aminopyrazolopyridine HCl at 2% was considered to be well tolerated after dermal application. It was non-irritating to rabbit eyes when tested at 10% solution","page":25,"pdf":"sccs_o_150.pdf","row_type":"noael_study","study_id":"sccs_o_150_noael_009"} |
| SCCS Opinion | NOAEL | =30 | mg/kg bw/day | rat | oral | 90-day | developmental toxicity | {"dose":"General toxicity The maximal non-lethal dose in rats by the oral and the dermal routes was higher than 500 mg/kg bw.","effect":"rted. General toxicity The maximal non-lethal dose in rats by the oral and the dermal routes was higher than 500 mg/kg bw. In a 90-day oral (gavage) study in rats, the NOAEL was 10 mg/kg bw/day based on statistically significantly higher platelet counts in females and statistically significantly increased relative liver weights in males at the higher dose levels (30 and 100 mg/kg bw/day). In a prenatal developmental oral (gavage) toxicity study in rats, the LOAEL was 10 mg/kg bw/day for maternal toxicity and the NOAEL was 30 mg/kg bw/day for foetal and developmental toxicity. The LOAEL of 10 mg/kg bw/day for maternal toxicity in the prenatal developmental toxicity study is used for the calculation of the MoS. No two-generation reproduction study was submitted. Irritation / sensitisation Under the conditions of an in vitro Primary Cutaneous Tolerance study, hydroxyethoxy aminopyrazolopyridine HCl at 2% was considered to be well tolerated after dermal application. It was non-irritating to rabbit eyes when tested at 10% solution","page":25,"pdf":"sccs_o_150.pdf","row_type":"noael_study","study_id":"sccs_o_150_noael_009"} |
| SCCS Opinion | NOAEL | =30 | mg/kg bw/day | rat | oral | 90-day | developmental toxicity | {"dose":"General toxicity The maximal non-lethal dose in rats by the oral and the dermal routes was higher than 500 mg/kg bw.","effect":"rted. General toxicity The maximal non-lethal dose in rats by the oral and the dermal routes was higher than 500 mg/kg bw. In a 90-day oral (gavage) study in rats, the NOAEL was 10 mg/kg bw/day based on statistically significantly higher platelet counts in females and statistically significantly increased relative liver weights in males at the higher dose levels (30 and 100 mg/kg bw/day). In a prenatal developmental oral (gavage) toxicity study in rats, the LOAEL was 10 mg/kg bw/day for maternal toxicity and the NOAEL was 30 mg/kg bw/day for foetal and developmental toxicity. The LOAEL of 10 mg/kg bw/day for maternal toxicity in the prenatal developmental toxicity study is used for the calculation of the MoS. No two-generation reproduction study was submitted. Irritation / sensitisation Under the conditions of an in vitro Primary Cutaneous Tolerance study, hydroxyethoxy aminopyrazolopyridine HCl at 2% was considered to be well tolerated after dermal application. It was non-irritating to rabbit eyes when tested at 10% solution","page":25,"pdf":"sccs_o_150.pdf","row_type":"noael_study","study_id":"sccs_o_150_noael_009"} |
| SCCS Opinion | NOAEL | =30 | mg/kg bw/day | rat | oral | 90-day | developmental toxicity | {"dose":"General toxicity The maximal non-lethal dose in rats by the oral and the dermal routes was higher than 500 mg/kg bw.","effect":"rted. General toxicity The maximal non-lethal dose in rats by the oral and the dermal routes was higher than 500 mg/kg bw. In a 90-day oral (gavage) study in rats, the NOAEL was 10 mg/kg bw/day based on statistically significantly higher platelet counts in females and statistically significantly increased relative liver weights in males at the higher dose levels (30 and 100 mg/kg bw/day). In a prenatal developmental oral (gavage) toxicity study in rats, the LOAEL was 10 mg/kg bw/day for maternal toxicity and the NOAEL was 30 mg/kg bw/day for foetal and developmental toxicity. The LOAEL of 10 mg/kg bw/day for maternal toxicity in the prenatal developmental toxicity study is used for the calculation of the MoS. No two-generation reproduction study was submitted. Irritation / sensitisation Under the conditions of an in vitro Primary Cutaneous Tolerance study, hydroxyethoxy aminopyrazolopyridine HCl at 2% was considered to be well tolerated after dermal application. It was non-irritating to rabbit eyes when tested at 10% solution","page":25,"pdf":"sccs_o_150.pdf","row_type":"noael_study","study_id":"sccs_o_150_noael_009"} |
| SCCS Opinion | NOAEL | =100 | mg/kg bw/day | rat | - | - | NOAEL study | {"citation":"Ref.: 12","dose":"cept for the following findings which occurred at a slightly higher incidence in the high-dose group compared to the control group:","effect":"cept for the following findings which occurred at a slightly higher incidence in the high-dose group compared to the control group: Kidney bilateral or unilateral slight diffuse vacuolar or swelling cell or tubular degeneration (both sexes), bilateral and unilateral tubular proteinaceous material in the kidneys (both sexes), and slight swelling cell degeneration or vacuolar degeneration in the liver (both sexes). Conclusion On the basis of the adverse kidney changes observed at 100 mg/kg bw/day in this study, the NOAEL was established at 30 mg/kg bw/day for both male and female Wistar rats. Ref.: 12","page":17,"pdf":"sccs_o_150.pdf","row_type":"noael_study","study_id":"sccs_o_150_noael_001"} |
| SCCS Opinion | NOAEL | =100 | mg/kg bw/day | rat | - | - | NOAEL study | {"citation":"Ref.: 12","dose":"cept for the following findings which occurred at a slightly higher incidence in the high-dose group compared to the control group:","effect":"cept for the following findings which occurred at a slightly higher incidence in the high-dose group compared to the control group: Kidney bilateral or unilateral slight diffuse vacuolar or swelling cell or tubular degeneration (both sexes), bilateral and unilateral tubular proteinaceous material in the kidneys (both sexes), and slight swelling cell degeneration or vacuolar degeneration in the liver (both sexes). Conclusion On the basis of the adverse kidney changes observed at 100 mg/kg bw/day in this study, the NOAEL was established at 30 mg/kg bw/day for both male and female Wistar rats. Ref.: 12","page":17,"pdf":"sccs_o_150.pdf","row_type":"noael_study","study_id":"sccs_o_150_noael_001"} |
| SCCS Opinion | NOAEL | =100 | mg/kg bw/day | rat | - | - | NOAEL study | {"citation":"Ref.: 12","dose":"cept for the following findings which occurred at a slightly higher incidence in the high-dose group compared to the control group:","effect":"cept for the following findings which occurred at a slightly higher incidence in the high-dose group compared to the control group: Kidney bilateral or unilateral slight diffuse vacuolar or swelling cell or tubular degeneration (both sexes), bilateral and unilateral tubular proteinaceous material in the kidneys (both sexes), and slight swelling cell degeneration or vacuolar degeneration in the liver (both sexes). Conclusion On the basis of the adverse kidney changes observed at 100 mg/kg bw/day in this study, the NOAEL was established at 30 mg/kg bw/day for both male and female Wistar rats. Ref.: 12","page":17,"pdf":"sccs_o_150.pdf","row_type":"noael_study","study_id":"sccs_o_150_noael_001"} |
| SCCS Opinion | NOAEL | =100 | mg/kg bw/day | rat | - | - | NOAEL study | {"citation":"Ref.: 12","dose":"cept for the following findings which occurred at a slightly higher incidence in the high-dose group compared to the control group:","effect":"cept for the following findings which occurred at a slightly higher incidence in the high-dose group compared to the control group: Kidney bilateral or unilateral slight diffuse vacuolar or swelling cell or tubular degeneration (both sexes), bilateral and unilateral tubular proteinaceous material in the kidneys (both sexes), and slight swelling cell degeneration or vacuolar degeneration in the liver (both sexes). Conclusion On the basis of the adverse kidney changes observed at 100 mg/kg bw/day in this study, the NOAEL was established at 30 mg/kg bw/day for both male and female Wistar rats. Ref.: 12","page":17,"pdf":"sccs_o_150.pdf","row_type":"noael_study","study_id":"sccs_o_150_noael_001"} |
ECHA 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ECHA | NOAEL | =30 | mg/kg bw/day | Rat | oral | subchronic; 13 weeks | subchronic | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaccce4b0a7c65d1c0e1d; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/5635?documentUUID=f8f19aa2-0938-4cfc-b1b4-f291d972f227; YEAR=2006; ORIGINAL_YEAR=2006; STUDY_GROUP=ECHA IUCLID:15841896: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_f1a298213527a681bc0011059e98e8de |
Regulatory source 9 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| Regulatory source | - | 100 | mg/kg bw/day | rat | - | - | - | SOURCE_SUBDIR=sccs_o_150; REPORT_TITLE=OPINION ON Hydroxyethoxy aminopyrazolopyridine HCl COLIPA n° A161; OPINION_NUMBER=SCCS/1530/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2014; VALUE_TEXT=100; DOSE=cept for the following findings which occurred at a slightly higher incidence in the high-dose group compared to the control group:; EFFECT=cept for the following findings which occurred at a slightly higher incidence in the high-dose group compared to the control group: Kidney bilateral or unilateral slight diffuse vacuolar or swelling cell or tubular degeneration (both sexes), bilateral and unilateral tubular proteinaceous material in the kidneys (both sexes), and slight swelling cell degeneration or vacuolar degeneration in the liver (both sexes). Conclusion On the basis of the adverse kidney changes observed at 100 mg/kg bw/day in this study, the NOAEL was established at 30 mg/kg bw/day for both male and female Wistar rats. Ref.: 12; CITATION=Ref.: 12; CITATION_NUMBERS=[12]; REFERENCE=Ref.: 12; DETAILS_JSON={"cas_number":"1079221-49-0","citation":"Ref.: 12","dose":"cept for the following findings which occurred at a slightly higher incidence in the high-dose group compared to the control group:","duration":"","effect":"cept for the following findings which occurred at a slightly higher incidence in the high-dose group compared to the control group: Kidney bilateral or unilateral slight diffuse vacuolar or swelling cell or tubular degeneration (both sexes), bilateral and unilateral tubular proteinaceous material in the kidneys (both sexes), and slight swelling cell degeneration or vacuolar degeneration in the liver (both sexes). Conclusion On the basis of the adverse kidney changes observed at 100 mg/kg bw/day in this study, the NOAEL was established at 30 mg/kg bw/day for both male and female Wistar rats. Ref.: 12","endpoint":"","ingredient":"codes........................................7","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"100","page":17,"route":"","species":"rat","study_id":"sccs_o_150_noael_001"} |
| Regulatory source | dermal absorption | 10 | mg/kg bw/day | human | dermal | - | dermal absorption | SOURCE_SUBDIR=sccs_o_150; REPORT_TITLE=OPINION ON Hydroxyethoxy aminopyrazolopyridine HCl COLIPA n° A161; OPINION_NUMBER=SCCS/1530/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2014; VALUE_TEXT=10; DOSE=e opinion on Hydroxyethoxy aminopyrazolopyridine HCl (A161) ___________________________________________________________________________________________ 24 SCCS comment As the corrected maternal body weight gain was statistically significantly lower in all the treated groups (-28%, -42% and -56%, respectively) and showed a dose-response relations...; EFFECT=e opinion on Hydroxyethoxy aminopyrazolopyridine HCl (A161) ___________________________________________________________________________________________ 24 SCCS comment As the corrected maternal body weight gain was statistically significantly lower in all the treated groups (-28%, -42% and -56%, respectively) and showed a dose-response relationship, and as the magnitude of the decrease was considerable also at the lowest dose level (-28%), the SCCS considers the lowest dose level of 10 mg/kg bw/day as a LOAEL. A NOAEL for maternal toxicity could not be established based on this study. 3.3.9. Toxicokinetics No data submitted. 3.3.10. Photo-induced toxicity No data submitted. 3.3.11. Human data No data submitted. 3.3.12. Special investigations No data submitted. 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (under oxidative conditions) Absorption through the skin A = 0.60 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"1079221-49-0","citation":"","dose":"e opinion on Hydroxyethoxy aminopyrazolopyridine HCl (A161) ___________________________________________________________________________________________ 24 SCCS comment As the corrected maternal body weight gain was statistically significantly lower in all the treated groups (-28%, -42% and -56%, respectively) and showed a dose-response relations...","duration":"","effect":"e opinion on Hydroxyethoxy aminopyrazolopyridine HCl (A161) ___________________________________________________________________________________________ 24 SCCS comment As the corrected maternal body weight gain was statistically significantly lower in all the treated groups (-28%, -42% and -56%, respectively) and showed a dose-response relationship, and as the magnitude of the decrease was considerable also at the lowest dose level (-28%), the SCCS considers the lowest dose level of 10 mg/kg bw/day as a LOAEL. A NOAEL for maternal toxicity could not be established based on this study. 3.3.9. Toxicokinetics No data submitted. 3.3.10. Photo-induced toxicity No data submitted. 3.3.11. Human data No data submitted. 3.3.12. Special investigations No data submitted. 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (under oxidative conditions) Absorption through the skin A = 0.60 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.","endpoint":"dermal absorption","ingredient":"codes........................................7","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"10","page":24,"route":"dermal","species":"human","study_id":"sccs_o_150_noael_005"} |
| Regulatory source | developmental toxicity | =1.67 | mg/kg bw/d | human | oral | prenatal | developmental toxicity | SOURCE_SUBDIR=sccs_o_150; REPORT_TITLE=OPINION ON Hydroxyethoxy aminopyrazolopyridine HCl COLIPA n° A161; OPINION_NUMBER=SCCS/1530/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2014; VALUE_TEXT== 1.67; DOSE=(under oxidative conditions) Absorption through the skin A = 0.60 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.35 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0058 mg/kg bw Lowest observed adverse effect level LOAEL = 10 mg/kg bw/d (maternal toxicity in...; LOAEL_VALUE=10 mg/kg bw/d; EFFECT=(under oxidative conditions) Absorption through the skin A = 0.60 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.35 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0058 mg/kg bw Lowest observed adverse effect level LOAEL = 10 mg/kg bw/d (maternal toxicity in prenatal oral developmental toxicity study) Assessment factor of 3 for LOAEL to NOAEL = 3.33 mg/kg bw/d Bioavailability 50%* = 1.67 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 287 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"1079221-49-0","citation":"","dose":"(under oxidative conditions) Absorption through the skin A = 0.60 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.35 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0058 mg/kg bw Lowest observed adverse effect level LOAEL = 10 mg/kg bw/d (maternal toxicity in...","duration":"prenatal","effect":"(under oxidative conditions) Absorption through the skin A = 0.60 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.35 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0058 mg/kg bw Lowest observed adverse effect level LOAEL = 10 mg/kg bw/d (maternal toxicity in prenatal oral developmental toxicity study) Assessment factor of 3 for LOAEL to NOAEL = 3.33 mg/kg bw/d Bioavailability 50%* = 1.67 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 287 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation.","endpoint":"developmental toxicity","ingredient":"codes........................................7","loael_value":"10 mg/kg bw/d","noael_unit":"mg/kg bw/d","noael_value":"= 1.67","page":24,"route":"oral","species":"human","study_id":"sccs_o_150_noael_007"} |
| Regulatory source | developmental toxicity | =3.33 | mg/kg bw/d | human | oral | prenatal | developmental toxicity | SOURCE_SUBDIR=sccs_o_150; REPORT_TITLE=OPINION ON Hydroxyethoxy aminopyrazolopyridine HCl COLIPA n° A161; OPINION_NUMBER=SCCS/1530/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2014; VALUE_TEXT== 3.33; DOSE=afety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (under oxidative conditions) Absorption through the skin A = 0.60 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.35 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0058 mg...; LOAEL_VALUE=10 mg/kg bw/d; EFFECT=afety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (under oxidative conditions) Absorption through the skin A = 0.60 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.35 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0058 mg/kg bw Lowest observed adverse effect level LOAEL = 10 mg/kg bw/d (maternal toxicity in prenatal oral developmental toxicity study) Assessment factor of 3 for LOAEL to NOAEL = 3.33 mg/kg bw/d Bioavailability 50%* = 1.67 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 287 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"1079221-49-0","citation":"","dose":"afety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (under oxidative conditions) Absorption through the skin A = 0.60 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.35 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0058 mg...","duration":"prenatal","effect":"afety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (under oxidative conditions) Absorption through the skin A = 0.60 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.35 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0058 mg/kg bw Lowest observed adverse effect level LOAEL = 10 mg/kg bw/d (maternal toxicity in prenatal oral developmental toxicity study) Assessment factor of 3 for LOAEL to NOAEL = 3.33 mg/kg bw/d Bioavailability 50%* = 1.67 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 287 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation.","endpoint":"developmental toxicity","ingredient":"codes........................................7","loael_value":"10 mg/kg bw/d","noael_unit":"mg/kg bw/d","noael_value":"= 3.33","page":24,"route":"oral","species":"human","study_id":"sccs_o_150_noael_006"} |
| Regulatory source | developmental toxicity | 10 | mg/kg/day | - | - | developmental | developmental toxicity | SOURCE_SUBDIR=sccs_o_150; REPORT_TITLE=OPINION ON Hydroxyethoxy aminopyrazolopyridine HCl COLIPA n° A161; OPINION_NUMBER=SCCS/1530/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2014; VALUE_TEXT=10; DOSE=The foetal ossification level revealed no differences between foetuses from treated and control dams.; EFFECT=; this finding was not considered to be adverse by the study report authors as it was associated with maternal toxicity and concerned mainly 5th and 6th sternebrae which is a common finding. The foetal ossification level revealed no differences between foetuses from treated and control dams. Conclusion On the basis of the results obtained in the present study, and specifically the effects on maternal body weight, the Lowest Observed Effect level (LOEL) for maternal toxicity was established at 10 mg/kg/day and the NOAEL (No Observed Adverse Effect Level) for foetal and developmental toxicity was established at 30 mg/kg/day. Ref.: 13; CITATION=Ref.: 13; CITATION_NUMBERS=[13]; REFERENCE=Ref.: 13; DETAILS_JSON={"cas_number":"1079221-49-0","citation":"Ref.: 13","dose":"The foetal ossification level revealed no differences between foetuses from treated and control dams.","duration":"developmental","effect":"; this finding was not considered to be adverse by the study report authors as it was associated with maternal toxicity and concerned mainly 5th and 6th sternebrae which is a common finding. The foetal ossification level revealed no differences between foetuses from treated and control dams. Conclusion On the basis of the results obtained in the present study, and specifically the effects on maternal body weight, the Lowest Observed Effect level (LOEL) for maternal toxicity was established at 10 mg/kg/day and the NOAEL (No Observed Adverse Effect Level) for foetal and developmental toxicity was established at 30 mg/kg/day. Ref.: 13","endpoint":"developmental toxicity","ingredient":"codes........................................7","loael_value":"","noael_unit":"mg/kg/day","noael_value":"10","page":23,"route":"","species":"","study_id":"sccs_o_150_noael_003"} |
| Regulatory source | developmental toxicity | 10 | mg/kg/day | - | - | developmental | developmental toxicity | SOURCE_SUBDIR=sccs_o_150; REPORT_TITLE=OPINION ON Hydroxyethoxy aminopyrazolopyridine HCl COLIPA n° A161; OPINION_NUMBER=SCCS/1530/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2014; VALUE_TEXT=10; DOSE=The foetal ossification level revealed no differences between foetuses from treated and control dams.; EFFECT=finding was not considered to be adverse by the study report authors as it was associated with maternal toxicity and concerned mainly 5th and 6th sternebrae which is a common finding. The foetal ossification level revealed no differences between foetuses from treated and control dams. Conclusion On the basis of the results obtained in the present study, and specifically the effects on maternal body weight, the Lowest Observed Effect level (LOEL) for maternal toxicity was established at 10 mg/kg/day and the NOAEL (No Observed Adverse Effect Level) for foetal and developmental toxicity was established at 30 mg/kg/day. Ref.: 13; CITATION=Ref.: 13; CITATION_NUMBERS=[13]; REFERENCE=Ref.: 13; DETAILS_JSON={"cas_number":"1079221-49-0","citation":"Ref.: 13","dose":"The foetal ossification level revealed no differences between foetuses from treated and control dams.","duration":"developmental","effect":"finding was not considered to be adverse by the study report authors as it was associated with maternal toxicity and concerned mainly 5th and 6th sternebrae which is a common finding. The foetal ossification level revealed no differences between foetuses from treated and control dams. Conclusion On the basis of the results obtained in the present study, and specifically the effects on maternal body weight, the Lowest Observed Effect level (LOEL) for maternal toxicity was established at 10 mg/kg/day and the NOAEL (No Observed Adverse Effect Level) for foetal and developmental toxicity was established at 30 mg/kg/day. Ref.: 13","endpoint":"developmental toxicity","ingredient":"codes........................................7","loael_value":"","noael_unit":"mg/kg/day","noael_value":"10","page":23,"route":"","species":"","study_id":"sccs_o_150_noael_004"} |
| Regulatory source | developmental toxicity | 10 | mg/kg bw/day | rat | oral | 90-day | developmental toxicity | SOURCE_SUBDIR=sccs_o_150; REPORT_TITLE=OPINION ON Hydroxyethoxy aminopyrazolopyridine HCl COLIPA n° A161; OPINION_NUMBER=SCCS/1530/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2014; VALUE_TEXT=10; DOSE=General toxicity The maximal non-lethal dose in rats by the oral and the dermal routes was higher than 500 mg/kg bw.; LOAEL_VALUE=10 mg/kg bw/day; EFFECT=n of 4%, which after mixing typically in a ratio of 1:1 with hydrogen peroxide prior to use, corresponds to a concentration of 2% upon application (final, on-head concentration). EC No. of hydroxyethoxy aminopyrazolopyridine HCl was not reported. The stability of hydroxyethoxy aminopyrazolopyridine HCl in typical hair dye formulations was not reported. General toxicity The maximal non-lethal dose in rats by the oral and the dermal routes was higher than 500 mg/kg bw. In a 90-day oral (gavage) study in rats, the NOAEL was 10 mg/kg bw/day based on statistically significantly higher platelet counts in females and statistically significantly increased relative liver weights in males at the higher dose levels (30 and 100 mg/kg bw/day). In a prenatal developmental oral (gavage) toxicity study in rats, the LOAEL was 10 mg/kg bw/day for maternal toxicity and the NOAEL was 30 mg/kg bw/day for foetal and developmental toxicity. The LOAEL of 10 mg/kg bw/day for maternal toxicity in the prenatal developmental toxicity study is used for th; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"1079221-49-0","citation":"","dose":"General toxicity The maximal non-lethal dose in rats by the oral and the dermal routes was higher than 500 mg/kg bw.","duration":"90-day","effect":"n of 4%, which after mixing typically in a ratio of 1:1 with hydrogen peroxide prior to use, corresponds to a concentration of 2% upon application (final, on-head concentration). EC No. of hydroxyethoxy aminopyrazolopyridine HCl was not reported. The stability of hydroxyethoxy aminopyrazolopyridine HCl in typical hair dye formulations was not reported. General toxicity The maximal non-lethal dose in rats by the oral and the dermal routes was higher than 500 mg/kg bw. In a 90-day oral (gavage) study in rats, the NOAEL was 10 mg/kg bw/day based on statistically significantly higher platelet counts in females and statistically significantly increased relative liver weights in males at the higher dose levels (30 and 100 mg/kg bw/day). In a prenatal developmental oral (gavage) toxicity study in rats, the LOAEL was 10 mg/kg bw/day for maternal toxicity and the NOAEL was 30 mg/kg bw/day for foetal and developmental toxicity. The LOAEL of 10 mg/kg bw/day for maternal toxicity in the prenatal developmental toxicity study is used for th","endpoint":"developmental toxicity","ingredient":"codes........................................7","loael_value":"10 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"10","page":25,"route":"oral","species":"rat","study_id":"sccs_o_150_noael_008"} |
| Regulatory source | developmental toxicity | 30 | mg/kg bw/day | rat | oral | 90-day | developmental toxicity | SOURCE_SUBDIR=sccs_o_150; REPORT_TITLE=OPINION ON Hydroxyethoxy aminopyrazolopyridine HCl COLIPA n° A161; OPINION_NUMBER=SCCS/1530/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2014; VALUE_TEXT=30; DOSE=General toxicity The maximal non-lethal dose in rats by the oral and the dermal routes was higher than 500 mg/kg bw.; LOAEL_VALUE=10 mg/kg bw/day; EFFECT=rted. General toxicity The maximal non-lethal dose in rats by the oral and the dermal routes was higher than 500 mg/kg bw. In a 90-day oral (gavage) study in rats, the NOAEL was 10 mg/kg bw/day based on statistically significantly higher platelet counts in females and statistically significantly increased relative liver weights in males at the higher dose levels (30 and 100 mg/kg bw/day). In a prenatal developmental oral (gavage) toxicity study in rats, the LOAEL was 10 mg/kg bw/day for maternal toxicity and the NOAEL was 30 mg/kg bw/day for foetal and developmental toxicity. The LOAEL of 10 mg/kg bw/day for maternal toxicity in the prenatal developmental toxicity study is used for the calculation of the MoS. No two-generation reproduction study was submitted. Irritation / sensitisation Under the conditions of an in vitro Primary Cutaneous Tolerance study, hydroxyethoxy aminopyrazolopyridine HCl at 2% was considered to be well tolerated after dermal application. It was non-irritating to rabbit eyes when tested at 10% solution; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"1079221-49-0","citation":"","dose":"General toxicity The maximal non-lethal dose in rats by the oral and the dermal routes was higher than 500 mg/kg bw.","duration":"90-day","effect":"rted. General toxicity The maximal non-lethal dose in rats by the oral and the dermal routes was higher than 500 mg/kg bw. In a 90-day oral (gavage) study in rats, the NOAEL was 10 mg/kg bw/day based on statistically significantly higher platelet counts in females and statistically significantly increased relative liver weights in males at the higher dose levels (30 and 100 mg/kg bw/day). In a prenatal developmental oral (gavage) toxicity study in rats, the LOAEL was 10 mg/kg bw/day for maternal toxicity and the NOAEL was 30 mg/kg bw/day for foetal and developmental toxicity. The LOAEL of 10 mg/kg bw/day for maternal toxicity in the prenatal developmental toxicity study is used for the calculation of the MoS. No two-generation reproduction study was submitted. Irritation / sensitisation Under the conditions of an in vitro Primary Cutaneous Tolerance study, hydroxyethoxy aminopyrazolopyridine HCl at 2% was considered to be well tolerated after dermal application. It was non-irritating to rabbit eyes when tested at 10% solution","endpoint":"developmental toxicity","ingredient":"codes........................................7","loael_value":"10 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"30","page":25,"route":"oral","species":"rat","study_id":"sccs_o_150_noael_009"} |
| Regulatory source | genotoxicity | 10 | mg/kg bw/day | - | - | Chronic | genotoxicity | SOURCE_SUBDIR=sccs_o_150; REPORT_TITLE=OPINION ON Hydroxyethoxy aminopyrazolopyridine HCl COLIPA n° A161; OPINION_NUMBER=SCCS/1530/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2014; VALUE_TEXT=10; DOSE=Hydroxyethoxy aminopyrazolopyridine HCl (A161) ___________________________________________________________________________________________ 18 SCCS comment As the platelet counts were statistically significantly higher in both intermediate and high- dose females (+33% and +65%, respectively) and relative liver weights were statistically significa...; LOAEL_VALUE=10 mg/kg bw/day; EFFECT=Hydroxyethoxy aminopyrazolopyridine HCl (A161) ___________________________________________________________________________________________ 18 SCCS comment As the platelet counts were statistically significantly higher in both intermediate and high- dose females (+33% and +65%, respectively) and relative liver weights were statistically significantly increased in intermediate and high-dose males (relative to body weight: +19% and +29%, respectively), the SCCS considers the intermediate dose level as a LOAEL. The NOAEL is consequently 10 mg/kg bw/day. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted. 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 (1997) Test system: Salmonella typhimurium TA1535, TA1537, TA98, TA100 and TA102 Replicates: triplicates per test concentration Test substance: R0056896C (IMEXINE® FAM) Solvent: purified water Batch: R0056896C 001 P 001 Purity: > 95% pure Concentrations: Experiment I: In the absence; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"1079221-49-0","citation":"","dose":"Hydroxyethoxy aminopyrazolopyridine HCl (A161) ___________________________________________________________________________________________ 18 SCCS comment As the platelet counts were statistically significantly higher in both intermediate and high- dose females (+33% and +65%, respectively) and relative liver weights were statistically significa...","duration":"Chronic","effect":"Hydroxyethoxy aminopyrazolopyridine HCl (A161) ___________________________________________________________________________________________ 18 SCCS comment As the platelet counts were statistically significantly higher in both intermediate and high- dose females (+33% and +65%, respectively) and relative liver weights were statistically significantly increased in intermediate and high-dose males (relative to body weight: +19% and +29%, respectively), the SCCS considers the intermediate dose level as a LOAEL. The NOAEL is consequently 10 mg/kg bw/day. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted. 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 (1997) Test system: Salmonella typhimurium TA1535, TA1537, TA98, TA100 and TA102 Replicates: triplicates per test concentration Test substance: R0056896C (IMEXINE® FAM) Solvent: purified water Batch: R0056896C 001 P 001 Purity: > 95% pure Concentrations: Experiment I: In the absence","endpoint":"genotoxicity","ingredient":"codes........................................7","loael_value":"10 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"10","page":18,"route":"","species":"","study_id":"sccs_o_150_noael_002"} |