NOAEL Studies Active Ingredient

Ensulizole NOAEL Studies

INCI: PHENYLBENZIMIDAZOLE SULFONIC ACID

CAS: 27503-81-7

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

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COSMOS_DB 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
COSMOS_DB NOAEL 1000 mg/kg bw/day rat oral 91 day Subchronic SCCP; E.Bomhard et al. (Bayer AG, Institute of Toxicology):'Novantisolsaeure – Subchronic Toxicity Study in Rats'. Report no. 7780. 06-09-78
SCCS_vision_codex 24 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS_vision_codex NOAEL =0.125 mg/kg rat oral 90-day dermal absorption {"dose":"200 mg/kg bw (highest concentration tested) is a NO(A)EL for oestrogenic effects.","effect":"for the absence of an oestrogenic potential Neo Heliopan Hydro sodium salt. 200 mg/kg bw (highest concentration tested) is a NO(A)EL for oestrogenic effects. 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 0.416 µg/cm2 Skin area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 7.488 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.125 mg/kg No observed adverse effect level NOAEL = 40 mg/kg bw (rat, oral, 90-day: 1000 mg/kg bw, 4% absorption) Margin of Safety NOAEL/SED = 320 3.3.14. Discussion Physico-chemical specifications Several batches were used without a proper physico-chemical characterisation. General toxicity The LD50 i.p. rat is in the range 1000 – 1500 mg/kg bw. The LD50 dermal rat is >3000 mg/kg bw. The NO(A)EL was set at 1000 mg/kg bw/day (13 week oral study in rats). In a teratogenicity study, the NO(A)EL was set at 1000 mg/kg bw for the dams and foetuses. The","page":29,"pdf":"sccp_o_079.pdf","row_type":"noael_study","study_id":"sccp_o_079_noael_004"}
SCCS_vision_codex NOAEL =0.125 mg/kg rat oral 90-day dermal absorption {"dose":"200 mg/kg bw (highest concentration tested) is a NO(A)EL for oestrogenic effects.","effect":"for the absence of an oestrogenic potential Neo Heliopan Hydro sodium salt. 200 mg/kg bw (highest concentration tested) is a NO(A)EL for oestrogenic effects. 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 0.416 µg/cm2 Skin area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 7.488 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.125 mg/kg No observed adverse effect level NOAEL = 40 mg/kg bw (rat, oral, 90-day: 1000 mg/kg bw, 4% absorption) Margin of Safety NOAEL/SED = 320 3.3.14. Discussion Physico-chemical specifications Several batches were used without a proper physico-chemical characterisation. General toxicity The LD50 i.p. rat is in the range 1000 – 1500 mg/kg bw. The LD50 dermal rat is >3000 mg/kg bw. The NO(A)EL was set at 1000 mg/kg bw/day (13 week oral study in rats). In a teratogenicity study, the NO(A)EL was set at 1000 mg/kg bw for the dams and foetuses. The","page":29,"pdf":"sccp_o_079.pdf","row_type":"noael_study","study_id":"sccp_o_079_noael_004"}
SCCS_vision_codex NOAEL =0.125 mg/kg rat oral 90-day dermal absorption {"dose":"200 mg/kg bw (highest concentration tested) is a NO(A)EL for oestrogenic effects.","effect":"for the absence of an oestrogenic potential Neo Heliopan Hydro sodium salt. 200 mg/kg bw (highest concentration tested) is a NO(A)EL for oestrogenic effects. 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 0.416 µg/cm2 Skin area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 7.488 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.125 mg/kg No observed adverse effect level NOAEL = 40 mg/kg bw (rat, oral, 90-day: 1000 mg/kg bw, 4% absorption) Margin of Safety NOAEL/SED = 320 3.3.14. Discussion Physico-chemical specifications Several batches were used without a proper physico-chemical characterisation. General toxicity The LD50 i.p. rat is in the range 1000 – 1500 mg/kg bw. The LD50 dermal rat is >3000 mg/kg bw. The NO(A)EL was set at 1000 mg/kg bw/day (13 week oral study in rats). In a teratogenicity study, the NO(A)EL was set at 1000 mg/kg bw for the dams and foetuses. The","page":29,"pdf":"sccp_o_079.pdf","row_type":"noael_study","study_id":"sccp_o_079_noael_004"}
SCCS_vision_codex NOAEL =0.125 mg/kg rat oral 90-day dermal absorption {"dose":"200 mg/kg bw (highest concentration tested) is a NO(A)EL for oestrogenic effects.","effect":"for the absence of an oestrogenic potential Neo Heliopan Hydro sodium salt. 200 mg/kg bw (highest concentration tested) is a NO(A)EL for oestrogenic effects. 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 0.416 µg/cm2 Skin area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 7.488 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.125 mg/kg No observed adverse effect level NOAEL = 40 mg/kg bw (rat, oral, 90-day: 1000 mg/kg bw, 4% absorption) Margin of Safety NOAEL/SED = 320 3.3.14. Discussion Physico-chemical specifications Several batches were used without a proper physico-chemical characterisation. General toxicity The LD50 i.p. rat is in the range 1000 – 1500 mg/kg bw. The LD50 dermal rat is >3000 mg/kg bw. The NO(A)EL was set at 1000 mg/kg bw/day (13 week oral study in rats). In a teratogenicity study, the NO(A)EL was set at 1000 mg/kg bw for the dams and foetuses. The","page":29,"pdf":"sccp_o_079.pdf","row_type":"noael_study","study_id":"sccp_o_079_noael_004"}
SCCS_vision_codex NOAEL =4 % rat oral 90-day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 0.416 µg/cm2 Skin area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 7.488 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.125 mg/k...","effect":"a NO(A)EL for oestrogenic effects. 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 0.416 µg/cm2 Skin area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 7.488 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.125 mg/kg No observed adverse effect level NOAEL = 40 mg/kg bw (rat, oral, 90-day: 1000 mg/kg bw, 4% absorption) Margin of Safety NOAEL/SED = 320 3.3.14. Discussion Physico-chemical specifications Several batches were used without a proper physico-chemical characterisation. General toxicity The LD50 i.p. rat is in the range 1000 – 1500 mg/kg bw. The LD50 dermal rat is >3000 mg/kg bw. The NO(A)EL was set at 1000 mg/kg bw/day (13 week oral study in rats). In a teratogenicity study, the NO(A)EL was set at 1000 mg/kg bw for the dams and foetuses. The submitted studies produce evidence for the absence of an oestrogenic potential. 200 mg/kg bw (hi","page":29,"pdf":"sccp_o_079.pdf","row_type":"noael_study","study_id":"sccp_o_079_noael_006"}
SCCS_vision_codex NOAEL =4 % rat oral 90-day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 0.416 µg/cm2 Skin area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 7.488 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.125 mg/k...","effect":"a NO(A)EL for oestrogenic effects. 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 0.416 µg/cm2 Skin area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 7.488 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.125 mg/kg No observed adverse effect level NOAEL = 40 mg/kg bw (rat, oral, 90-day: 1000 mg/kg bw, 4% absorption) Margin of Safety NOAEL/SED = 320 3.3.14. Discussion Physico-chemical specifications Several batches were used without a proper physico-chemical characterisation. General toxicity The LD50 i.p. rat is in the range 1000 – 1500 mg/kg bw. The LD50 dermal rat is >3000 mg/kg bw. The NO(A)EL was set at 1000 mg/kg bw/day (13 week oral study in rats). In a teratogenicity study, the NO(A)EL was set at 1000 mg/kg bw for the dams and foetuses. The submitted studies produce evidence for the absence of an oestrogenic potential. 200 mg/kg bw (hi","page":29,"pdf":"sccp_o_079.pdf","row_type":"noael_study","study_id":"sccp_o_079_noael_006"}
SCCS_vision_codex NOAEL =4 % rat oral 90-day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 0.416 µg/cm2 Skin area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 7.488 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.125 mg/k...","effect":"a NO(A)EL for oestrogenic effects. 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 0.416 µg/cm2 Skin area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 7.488 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.125 mg/kg No observed adverse effect level NOAEL = 40 mg/kg bw (rat, oral, 90-day: 1000 mg/kg bw, 4% absorption) Margin of Safety NOAEL/SED = 320 3.3.14. Discussion Physico-chemical specifications Several batches were used without a proper physico-chemical characterisation. General toxicity The LD50 i.p. rat is in the range 1000 – 1500 mg/kg bw. The LD50 dermal rat is >3000 mg/kg bw. The NO(A)EL was set at 1000 mg/kg bw/day (13 week oral study in rats). In a teratogenicity study, the NO(A)EL was set at 1000 mg/kg bw for the dams and foetuses. The submitted studies produce evidence for the absence of an oestrogenic potential. 200 mg/kg bw (hi","page":29,"pdf":"sccp_o_079.pdf","row_type":"noael_study","study_id":"sccp_o_079_noael_006"}
SCCS_vision_codex NOAEL =4 % rat oral 90-day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 0.416 µg/cm2 Skin area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 7.488 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.125 mg/k...","effect":"a NO(A)EL for oestrogenic effects. 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 0.416 µg/cm2 Skin area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 7.488 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.125 mg/kg No observed adverse effect level NOAEL = 40 mg/kg bw (rat, oral, 90-day: 1000 mg/kg bw, 4% absorption) Margin of Safety NOAEL/SED = 320 3.3.14. Discussion Physico-chemical specifications Several batches were used without a proper physico-chemical characterisation. General toxicity The LD50 i.p. rat is in the range 1000 – 1500 mg/kg bw. The LD50 dermal rat is >3000 mg/kg bw. The NO(A)EL was set at 1000 mg/kg bw/day (13 week oral study in rats). In a teratogenicity study, the NO(A)EL was set at 1000 mg/kg bw for the dams and foetuses. The submitted studies produce evidence for the absence of an oestrogenic potential. 200 mg/kg bw (hi","page":29,"pdf":"sccp_o_079.pdf","row_type":"noael_study","study_id":"sccp_o_079_noael_006"}
SCCS_vision_codex NOAEL =40 mg/kg bw rat oral 90-day dermal absorption {"dose":"200 mg/kg bw (highest concentration tested) is a NO(A)EL for oestrogenic effects.","effect":"c potential Neo Heliopan Hydro sodium salt. 200 mg/kg bw (highest concentration tested) is a NO(A)EL for oestrogenic effects. 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 0.416 µg/cm2 Skin area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 7.488 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.125 mg/kg No observed adverse effect level NOAEL = 40 mg/kg bw (rat, oral, 90-day: 1000 mg/kg bw, 4% absorption) Margin of Safety NOAEL/SED = 320 3.3.14. Discussion Physico-chemical specifications Several batches were used without a proper physico-chemical characterisation. General toxicity The LD50 i.p. rat is in the range 1000 – 1500 mg/kg bw. The LD50 dermal rat is >3000 mg/kg bw. The NO(A)EL was set at 1000 mg/kg bw/day (13 week oral study in rats). In a teratogenicity study, the NO(A)EL was set at 1000 mg/kg bw for the dams and foetuses. The submit","page":29,"pdf":"sccp_o_079.pdf","row_type":"noael_study","study_id":"sccp_o_079_noael_005"}
SCCS_vision_codex NOAEL =40 mg/kg bw rat oral 90-day dermal absorption {"dose":"200 mg/kg bw (highest concentration tested) is a NO(A)EL for oestrogenic effects.","effect":"c potential Neo Heliopan Hydro sodium salt. 200 mg/kg bw (highest concentration tested) is a NO(A)EL for oestrogenic effects. 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 0.416 µg/cm2 Skin area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 7.488 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.125 mg/kg No observed adverse effect level NOAEL = 40 mg/kg bw (rat, oral, 90-day: 1000 mg/kg bw, 4% absorption) Margin of Safety NOAEL/SED = 320 3.3.14. Discussion Physico-chemical specifications Several batches were used without a proper physico-chemical characterisation. General toxicity The LD50 i.p. rat is in the range 1000 – 1500 mg/kg bw. The LD50 dermal rat is >3000 mg/kg bw. The NO(A)EL was set at 1000 mg/kg bw/day (13 week oral study in rats). In a teratogenicity study, the NO(A)EL was set at 1000 mg/kg bw for the dams and foetuses. The submit","page":29,"pdf":"sccp_o_079.pdf","row_type":"noael_study","study_id":"sccp_o_079_noael_005"}
SCCS_vision_codex NOAEL =40 mg/kg bw rat oral 90-day dermal absorption {"dose":"200 mg/kg bw (highest concentration tested) is a NO(A)EL for oestrogenic effects.","effect":"c potential Neo Heliopan Hydro sodium salt. 200 mg/kg bw (highest concentration tested) is a NO(A)EL for oestrogenic effects. 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 0.416 µg/cm2 Skin area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 7.488 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.125 mg/kg No observed adverse effect level NOAEL = 40 mg/kg bw (rat, oral, 90-day: 1000 mg/kg bw, 4% absorption) Margin of Safety NOAEL/SED = 320 3.3.14. Discussion Physico-chemical specifications Several batches were used without a proper physico-chemical characterisation. General toxicity The LD50 i.p. rat is in the range 1000 – 1500 mg/kg bw. The LD50 dermal rat is >3000 mg/kg bw. The NO(A)EL was set at 1000 mg/kg bw/day (13 week oral study in rats). In a teratogenicity study, the NO(A)EL was set at 1000 mg/kg bw for the dams and foetuses. The submit","page":29,"pdf":"sccp_o_079.pdf","row_type":"noael_study","study_id":"sccp_o_079_noael_005"}
SCCS_vision_codex NOAEL =40 mg/kg bw rat oral 90-day dermal absorption {"dose":"200 mg/kg bw (highest concentration tested) is a NO(A)EL for oestrogenic effects.","effect":"c potential Neo Heliopan Hydro sodium salt. 200 mg/kg bw (highest concentration tested) is a NO(A)EL for oestrogenic effects. 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 0.416 µg/cm2 Skin area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 7.488 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.125 mg/kg No observed adverse effect level NOAEL = 40 mg/kg bw (rat, oral, 90-day: 1000 mg/kg bw, 4% absorption) Margin of Safety NOAEL/SED = 320 3.3.14. Discussion Physico-chemical specifications Several batches were used without a proper physico-chemical characterisation. General toxicity The LD50 i.p. rat is in the range 1000 – 1500 mg/kg bw. The LD50 dermal rat is >3000 mg/kg bw. The NO(A)EL was set at 1000 mg/kg bw/day (13 week oral study in rats). In a teratogenicity study, the NO(A)EL was set at 1000 mg/kg bw for the dams and foetuses. The submit","page":29,"pdf":"sccp_o_079.pdf","row_type":"noael_study","study_id":"sccp_o_079_noael_005"}
SCCS_vision_codex NOAEL =200 mg/kg bw rat oral 90-day dermal absorption {"citation":"Ref.: 21 These studies produce evidence for the absence of an oestrogenic potential Neo Heliopan Hydro sodium salt","dose":"200 mg/kg bw (highest concentration tested) is a NO(A)EL for oestrogenic effects.","effect":"SCCP/1056/06 OPINION ON PHENYLBENZIMIDAZOLE SULFONIC ACID AND ITS SALTS 29 There were no clinical signs of toxicity throughout the dosing period. Food consumption and body weight development was the same in test and control groups. At necropsy no gross pathological findings except enlargement of uteri in positive controls became manifest. Ref.: 21 These studies produce evidence for the absence of an oestrogenic potential Neo Heliopan Hydro sodium salt. 200 mg/kg bw (highest concentration tested) is a NO(A)EL for oestrogenic effects. 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 0.416 µg/cm2 Skin area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 7.488 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.125 mg/kg No observed adverse effect level NOAEL = 40 mg/kg bw (rat, oral, 90-day: 1000 mg/kg bw, 4% absorption) Margin of Safety NOAEL/SED","page":29,"pdf":"sccp_o_079.pdf","row_type":"noael_study","study_id":"sccp_o_079_noael_003"}
SCCS_vision_codex NOAEL =200 mg/kg bw rat oral 90-day dermal absorption {"citation":"Ref.: 21 These studies produce evidence for the absence of an oestrogenic potential Neo Heliopan Hydro sodium salt","dose":"200 mg/kg bw (highest concentration tested) is a NO(A)EL for oestrogenic effects.","effect":"SCCP/1056/06 OPINION ON PHENYLBENZIMIDAZOLE SULFONIC ACID AND ITS SALTS 29 There were no clinical signs of toxicity throughout the dosing period. Food consumption and body weight development was the same in test and control groups. At necropsy no gross pathological findings except enlargement of uteri in positive controls became manifest. Ref.: 21 These studies produce evidence for the absence of an oestrogenic potential Neo Heliopan Hydro sodium salt. 200 mg/kg bw (highest concentration tested) is a NO(A)EL for oestrogenic effects. 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 0.416 µg/cm2 Skin area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 7.488 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.125 mg/kg No observed adverse effect level NOAEL = 40 mg/kg bw (rat, oral, 90-day: 1000 mg/kg bw, 4% absorption) Margin of Safety NOAEL/SED","page":29,"pdf":"sccp_o_079.pdf","row_type":"noael_study","study_id":"sccp_o_079_noael_003"}
SCCS_vision_codex NOAEL =200 mg/kg bw rat oral 90-day dermal absorption {"citation":"Ref.: 21 These studies produce evidence for the absence of an oestrogenic potential Neo Heliopan Hydro sodium salt","dose":"200 mg/kg bw (highest concentration tested) is a NO(A)EL for oestrogenic effects.","effect":"SCCP/1056/06 OPINION ON PHENYLBENZIMIDAZOLE SULFONIC ACID AND ITS SALTS 29 There were no clinical signs of toxicity throughout the dosing period. Food consumption and body weight development was the same in test and control groups. At necropsy no gross pathological findings except enlargement of uteri in positive controls became manifest. Ref.: 21 These studies produce evidence for the absence of an oestrogenic potential Neo Heliopan Hydro sodium salt. 200 mg/kg bw (highest concentration tested) is a NO(A)EL for oestrogenic effects. 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 0.416 µg/cm2 Skin area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 7.488 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.125 mg/kg No observed adverse effect level NOAEL = 40 mg/kg bw (rat, oral, 90-day: 1000 mg/kg bw, 4% absorption) Margin of Safety NOAEL/SED","page":29,"pdf":"sccp_o_079.pdf","row_type":"noael_study","study_id":"sccp_o_079_noael_003"}
SCCS_vision_codex NOAEL =200 mg/kg bw rat oral 90-day dermal absorption {"citation":"Ref.: 21 These studies produce evidence for the absence of an oestrogenic potential Neo Heliopan Hydro sodium salt","dose":"200 mg/kg bw (highest concentration tested) is a NO(A)EL for oestrogenic effects.","effect":"SCCP/1056/06 OPINION ON PHENYLBENZIMIDAZOLE SULFONIC ACID AND ITS SALTS 29 There were no clinical signs of toxicity throughout the dosing period. Food consumption and body weight development was the same in test and control groups. At necropsy no gross pathological findings except enlargement of uteri in positive controls became manifest. Ref.: 21 These studies produce evidence for the absence of an oestrogenic potential Neo Heliopan Hydro sodium salt. 200 mg/kg bw (highest concentration tested) is a NO(A)EL for oestrogenic effects. 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 0.416 µg/cm2 Skin area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 7.488 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.125 mg/kg No observed adverse effect level NOAEL = 40 mg/kg bw (rat, oral, 90-day: 1000 mg/kg bw, 4% absorption) Margin of Safety NOAEL/SED","page":29,"pdf":"sccp_o_079.pdf","row_type":"noael_study","study_id":"sccp_o_079_noael_003"}
SCCS_vision_codex NOAEL =1000 mg/kg bw/day - - Chronic genotoxicity {"citation":"Ref.: 13 3","dose":"Differences in organ weights, if observable at all (e.g. spleen in ♀'s), were small and not dose dependent.","effect":"d was therefore not considered substance related. Anatomical pathology: Necropsy-findings in the animals which had died intercurrently, revealed no pathological changes attributable to the test substance. Neither did the animals which were sacrificed pursuant to protocol at the end of the study exhibit any such changes. Differences in organ weights, if observable at all (e.g. spleen in ♀'s), were small and not dose dependent. Histopathology did not reveal any organ change or –damage in any one of the dose groups. NO(A)EL: 1000 mg/kg bw/day Ref.: 13 3.3.5.3. Chronic (> 12 months) toxicity / 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assays Guideline: EEC guideline in Annex V of Directive 67/548/EEC Species/strain: Salmonella typhimurium (TA100, TA1535, TA98, TA1537, TA1538) Escherichia coli (WP2, WP2 uvrA) Replicates: Test substance: Eusolex 232 (2-Phenylbenzimidazole-5-sulfonic acid) Solvent: DMSO Batch: G-196572, article n° 1/05372-6 Purity: 99.7% Concentration","page":18,"pdf":"sccp_o_079.pdf","row_type":"noael_study","study_id":"sccp_o_079_noael_001"}
SCCS_vision_codex NOAEL =1000 mg/kg bw rat oral - NOAEL study {"citation":"Ref.: 17 3","dose":"Therefore, 1000 mg/kg bw is a NO(A)EL for dams and foetuses.","effect":"3 5.3 49.7** 92 3.8 41.6** *) relative to number of implantations (avg. of individual dams) **) relative to number of live foetuses (avg. of individual dams) Foetuses were weighed, inspected macroscopically for external malformations and prepared for inspection for visceral and skeletal malformations (by transverse section and double staining respectively). They did not show any such malformations. Skeletal variations were the same (nature and frequency) in test- and control group. Therefore, 1000 mg/kg bw is a NO(A)EL for dams and foetuses. The study was conducted as a limit test and conformed to OECD 414 and method B.31 of Annex V to Directive 67/548/EEC although not stated in the report. Ref.: 17 3.3.8.2. Teratogenicity / 3.3.9. Toxicokinetics Rat screening experiment, in vivo stability and excretory pathways Guideline: / Species/strain: male Chbb:THOM (Wistar) rat Group size: 4 (oral and intra-venous, 2 animals each) Test substance: Eusolex 232 sodium salt [2-14C] Batch: / Purity: / Dose: single dose of 0.378 MBq/anima","page":21,"pdf":"sccp_o_079.pdf","row_type":"noael_study","study_id":"sccp_o_079_noael_002"}
SCCS_vision_codex NOAEL =1000 mg/kg bw/day - - Chronic genotoxicity {"citation":"Ref.: 13 3","dose":"Differences in organ weights, if observable at all (e.g. spleen in ♀'s), were small and not dose dependent.","effect":"d was therefore not considered substance related. Anatomical pathology: Necropsy-findings in the animals which had died intercurrently, revealed no pathological changes attributable to the test substance. Neither did the animals which were sacrificed pursuant to protocol at the end of the study exhibit any such changes. Differences in organ weights, if observable at all (e.g. spleen in ♀'s), were small and not dose dependent. Histopathology did not reveal any organ change or –damage in any one of the dose groups. NO(A)EL: 1000 mg/kg bw/day Ref.: 13 3.3.5.3. Chronic (> 12 months) toxicity / 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assays Guideline: EEC guideline in Annex V of Directive 67/548/EEC Species/strain: Salmonella typhimurium (TA100, TA1535, TA98, TA1537, TA1538) Escherichia coli (WP2, WP2 uvrA) Replicates: Test substance: Eusolex 232 (2-Phenylbenzimidazole-5-sulfonic acid) Solvent: DMSO Batch: G-196572, article n° 1/05372-6 Purity: 99.7% Concentration","page":18,"pdf":"sccp_o_079.pdf","row_type":"noael_study","study_id":"sccp_o_079_noael_001"}
SCCS_vision_codex NOAEL =1000 mg/kg bw rat oral - NOAEL study {"citation":"Ref.: 17 3","dose":"Therefore, 1000 mg/kg bw is a NO(A)EL for dams and foetuses.","effect":"3 5.3 49.7** 92 3.8 41.6** *) relative to number of implantations (avg. of individual dams) **) relative to number of live foetuses (avg. of individual dams) Foetuses were weighed, inspected macroscopically for external malformations and prepared for inspection for visceral and skeletal malformations (by transverse section and double staining respectively). They did not show any such malformations. Skeletal variations were the same (nature and frequency) in test- and control group. Therefore, 1000 mg/kg bw is a NO(A)EL for dams and foetuses. The study was conducted as a limit test and conformed to OECD 414 and method B.31 of Annex V to Directive 67/548/EEC although not stated in the report. Ref.: 17 3.3.8.2. Teratogenicity / 3.3.9. Toxicokinetics Rat screening experiment, in vivo stability and excretory pathways Guideline: / Species/strain: male Chbb:THOM (Wistar) rat Group size: 4 (oral and intra-venous, 2 animals each) Test substance: Eusolex 232 sodium salt [2-14C] Batch: / Purity: / Dose: single dose of 0.378 MBq/anima","page":21,"pdf":"sccp_o_079.pdf","row_type":"noael_study","study_id":"sccp_o_079_noael_002"}
SCCS_vision_codex NOAEL =1000 mg/kg bw/day - - Chronic genotoxicity {"citation":"Ref.: 13 3","dose":"Differences in organ weights, if observable at all (e.g. spleen in ♀'s), were small and not dose dependent.","effect":"d was therefore not considered substance related. Anatomical pathology: Necropsy-findings in the animals which had died intercurrently, revealed no pathological changes attributable to the test substance. Neither did the animals which were sacrificed pursuant to protocol at the end of the study exhibit any such changes. Differences in organ weights, if observable at all (e.g. spleen in ♀'s), were small and not dose dependent. Histopathology did not reveal any organ change or –damage in any one of the dose groups. NO(A)EL: 1000 mg/kg bw/day Ref.: 13 3.3.5.3. Chronic (> 12 months) toxicity / 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assays Guideline: EEC guideline in Annex V of Directive 67/548/EEC Species/strain: Salmonella typhimurium (TA100, TA1535, TA98, TA1537, TA1538) Escherichia coli (WP2, WP2 uvrA) Replicates: Test substance: Eusolex 232 (2-Phenylbenzimidazole-5-sulfonic acid) Solvent: DMSO Batch: G-196572, article n° 1/05372-6 Purity: 99.7% Concentration","page":18,"pdf":"sccp_o_079.pdf","row_type":"noael_study","study_id":"sccp_o_079_noael_001"}
SCCS_vision_codex NOAEL =1000 mg/kg bw rat oral - NOAEL study {"citation":"Ref.: 17 3","dose":"Therefore, 1000 mg/kg bw is a NO(A)EL for dams and foetuses.","effect":"3 5.3 49.7** 92 3.8 41.6** *) relative to number of implantations (avg. of individual dams) **) relative to number of live foetuses (avg. of individual dams) Foetuses were weighed, inspected macroscopically for external malformations and prepared for inspection for visceral and skeletal malformations (by transverse section and double staining respectively). They did not show any such malformations. Skeletal variations were the same (nature and frequency) in test- and control group. Therefore, 1000 mg/kg bw is a NO(A)EL for dams and foetuses. The study was conducted as a limit test and conformed to OECD 414 and method B.31 of Annex V to Directive 67/548/EEC although not stated in the report. Ref.: 17 3.3.8.2. Teratogenicity / 3.3.9. Toxicokinetics Rat screening experiment, in vivo stability and excretory pathways Guideline: / Species/strain: male Chbb:THOM (Wistar) rat Group size: 4 (oral and intra-venous, 2 animals each) Test substance: Eusolex 232 sodium salt [2-14C] Batch: / Purity: / Dose: single dose of 0.378 MBq/anima","page":21,"pdf":"sccp_o_079.pdf","row_type":"noael_study","study_id":"sccp_o_079_noael_002"}
SCCS_vision_codex NOAEL =1000 mg/kg bw/day - - Chronic genotoxicity {"citation":"Ref.: 13 3","dose":"Differences in organ weights, if observable at all (e.g. spleen in ♀'s), were small and not dose dependent.","effect":"d was therefore not considered substance related. Anatomical pathology: Necropsy-findings in the animals which had died intercurrently, revealed no pathological changes attributable to the test substance. Neither did the animals which were sacrificed pursuant to protocol at the end of the study exhibit any such changes. Differences in organ weights, if observable at all (e.g. spleen in ♀'s), were small and not dose dependent. Histopathology did not reveal any organ change or –damage in any one of the dose groups. NO(A)EL: 1000 mg/kg bw/day Ref.: 13 3.3.5.3. Chronic (> 12 months) toxicity / 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assays Guideline: EEC guideline in Annex V of Directive 67/548/EEC Species/strain: Salmonella typhimurium (TA100, TA1535, TA98, TA1537, TA1538) Escherichia coli (WP2, WP2 uvrA) Replicates: Test substance: Eusolex 232 (2-Phenylbenzimidazole-5-sulfonic acid) Solvent: DMSO Batch: G-196572, article n° 1/05372-6 Purity: 99.7% Concentration","page":18,"pdf":"sccp_o_079.pdf","row_type":"noael_study","study_id":"sccp_o_079_noael_001"}
SCCS_vision_codex NOAEL =1000 mg/kg bw rat oral - NOAEL study {"citation":"Ref.: 17 3","dose":"Therefore, 1000 mg/kg bw is a NO(A)EL for dams and foetuses.","effect":"3 5.3 49.7** 92 3.8 41.6** *) relative to number of implantations (avg. of individual dams) **) relative to number of live foetuses (avg. of individual dams) Foetuses were weighed, inspected macroscopically for external malformations and prepared for inspection for visceral and skeletal malformations (by transverse section and double staining respectively). They did not show any such malformations. Skeletal variations were the same (nature and frequency) in test- and control group. Therefore, 1000 mg/kg bw is a NO(A)EL for dams and foetuses. The study was conducted as a limit test and conformed to OECD 414 and method B.31 of Annex V to Directive 67/548/EEC although not stated in the report. Ref.: 17 3.3.8.2. Teratogenicity / 3.3.9. Toxicokinetics Rat screening experiment, in vivo stability and excretory pathways Guideline: / Species/strain: male Chbb:THOM (Wistar) rat Group size: 4 (oral and intra-venous, 2 animals each) Test substance: Eusolex 232 sodium salt [2-14C] Batch: / Purity: / Dose: single dose of 0.378 MBq/anima","page":21,"pdf":"sccp_o_079.pdf","row_type":"noael_study","study_id":"sccp_o_079_noael_002"}
ToxValDB_GESTIS_DNEL 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_GESTIS_DNEL DNEL systemic =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:15634079:-:--; 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_ef0426372325e7c97762b2bd6dfcd78a
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 9 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 200 mg/kg bw rat oral 13 week - SOURCE_SUBDIR=sccp_o_079; REPORT_TITLE=OPINION ON PHENYLBENZIMIDAZOLE SUFONIC ACID AND ITS SALTS COLIPA S45; OPINION_NUMBER=SCCP/1056/06; COMMITTEE=SCCP; REPORT_DATE=19 December 2006; VALUE_TEXT=200; DOSE=General toxicity The LD50 i.p. rat is in the range 1000 – 1500 mg/kg bw.; EFFECT=Physico-chemical specifications Several batches were used without a proper physico-chemical characterisation. General toxicity The LD50 i.p. rat is in the range 1000 – 1500 mg/kg bw. The LD50 dermal rat is >3000 mg/kg bw. The NO(A)EL was set at 1000 mg/kg bw/day (13 week oral study in rats). In a teratogenicity study, the NO(A)EL was set at 1000 mg/kg bw for the dams and foetuses. The submitted studies produce evidence for the absence of an oestrogenic potential. 200 mg/kg bw (highest concentration tested) is a NO(A)EL for oestrogenic effects. Absorption, distribution and excretion An absorption, distribution and excretion study in pregnant rats showed that there was no indication for accumulation in any of the organs investigated (both routes); trace amounts of radioactivity are found in brain and foetuses after i.v. application; nothing is found in these organs in the oral experiment. This indicates that both blood/brain- and placental barriers are not passed; elimination of radioactivity from the body is virtually complete b; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"27503-81-7","citation":"","dose":"General toxicity The LD50 i.p. rat is in the range 1000 – 1500 mg/kg bw.","duration":"13 week","effect":"Physico-chemical specifications Several batches were used without a proper physico-chemical characterisation. General toxicity The LD50 i.p. rat is in the range 1000 – 1500 mg/kg bw. The LD50 dermal rat is >3000 mg/kg bw. The NO(A)EL was set at 1000 mg/kg bw/day (13 week oral study in rats). In a teratogenicity study, the NO(A)EL was set at 1000 mg/kg bw for the dams and foetuses. The submitted studies produce evidence for the absence of an oestrogenic potential. 200 mg/kg bw (highest concentration tested) is a NO(A)EL for oestrogenic effects. Absorption, distribution and excretion An absorption, distribution and excretion study in pregnant rats showed that there was no indication for accumulation in any of the organs investigated (both routes); trace amounts of radioactivity are found in brain and foetuses after i.v. application; nothing is found in these organs in the oral experiment. This indicates that both blood/brain- and placental barriers are not passed; elimination of radioactivity from the body is virtually complete b","endpoint":"","ingredient":"Phenylbenzimidazole Sulfonic Acid (INCI)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"200","page":29,"route":"oral","species":"rat","study_id":"sccp_o_079_noael_009"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 1000 mg/kg bw rat oral - - SOURCE_SUBDIR=sccp_o_079; REPORT_TITLE=OPINION ON PHENYLBENZIMIDAZOLE SUFONIC ACID AND ITS SALTS COLIPA S45; OPINION_NUMBER=SCCP/1056/06; COMMITTEE=SCCP; REPORT_DATE=19 December 2006; VALUE_TEXT=1000; DOSE=Therefore, 1000 mg/kg bw is a NO(A)EL for dams and foetuses.; EFFECT=3 5.3 49.7** 92 3.8 41.6** *) relative to number of implantations (avg. of individual dams) **) relative to number of live foetuses (avg. of individual dams) Foetuses were weighed, inspected macroscopically for external malformations and prepared for inspection for visceral and skeletal malformations (by transverse section and double staining respectively). They did not show any such malformations. Skeletal variations were the same (nature and frequency) in test- and control group. Therefore, 1000 mg/kg bw is a NO(A)EL for dams and foetuses. The study was conducted as a limit test and conformed to OECD 414 and method B.31 of Annex V to Directive 67/548/EEC although not stated in the report. Ref.: 17 3.3.8.2. Teratogenicity / 3.3.9. Toxicokinetics Rat screening experiment, in vivo stability and excretory pathways Guideline: / Species/strain: male Chbb:THOM (Wistar) rat Group size: 4 (oral and intra-venous, 2 animals each) Test substance: Eusolex 232 sodium salt [2-14C] Batch: / Purity: / Dose: single dose of 0.378 MBq/anima; CITATION=Ref.: 17 3; CITATION_NUMBERS=[17,3]; REFERENCE=Ref.: 17 3; DETAILS_JSON={"cas_number":"27503-81-7","citation":"Ref.: 17 3","dose":"Therefore, 1000 mg/kg bw is a NO(A)EL for dams and foetuses.","duration":"","effect":"3 5.3 49.7** 92 3.8 41.6** *) relative to number of implantations (avg. of individual dams) **) relative to number of live foetuses (avg. of individual dams) Foetuses were weighed, inspected macroscopically for external malformations and prepared for inspection for visceral and skeletal malformations (by transverse section and double staining respectively). They did not show any such malformations. Skeletal variations were the same (nature and frequency) in test- and control group. Therefore, 1000 mg/kg bw is a NO(A)EL for dams and foetuses. The study was conducted as a limit test and conformed to OECD 414 and method B.31 of Annex V to Directive 67/548/EEC although not stated in the report. Ref.: 17 3.3.8.2. Teratogenicity / 3.3.9. Toxicokinetics Rat screening experiment, in vivo stability and excretory pathways Guideline: / Species/strain: male Chbb:THOM (Wistar) rat Group size: 4 (oral and intra-venous, 2 animals each) Test substance: Eusolex 232 sodium salt [2-14C] Batch: / Purity: / Dose: single dose of 0.378 MBq/anima","endpoint":"","ingredient":"Phenylbenzimidazole Sulfonic Acid (INCI)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"1000","page":21,"route":"oral","species":"rat","study_id":"sccp_o_079_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 1000 mg/kg bw/day rat oral 90-day - SOURCE_SUBDIR=sccp_o_079; REPORT_TITLE=OPINION ON PHENYLBENZIMIDAZOLE SUFONIC ACID AND ITS SALTS COLIPA S45; OPINION_NUMBER=SCCP/1056/06; COMMITTEE=SCCP; REPORT_DATE=19 December 2006; VALUE_TEXT=1000; DOSE=nt SAS x A x 0.001 = 7.488 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.125 mg/kg No observed adverse effect level NOAEL = 40 mg/kg bw (rat, oral, 90-day:; EFFECT=nt SAS x A x 0.001 = 7.488 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.125 mg/kg No observed adverse effect level NOAEL = 40 mg/kg bw (rat, oral, 90-day: 1000 mg/kg bw, 4% absorption) Margin of Safety NOAEL/SED = 320 3.3.14. Discussion Physico-chemical specifications Several batches were used without a proper physico-chemical characterisation. General toxicity The LD50 i.p. rat is in the range 1000 – 1500 mg/kg bw. The LD50 dermal rat is >3000 mg/kg bw. The NO(A)EL was set at 1000 mg/kg bw/day (13 week oral study in rats). In a teratogenicity study, the NO(A)EL was set at 1000 mg/kg bw for the dams and foetuses. The submitted studies produce evidence for the absence of an oestrogenic potential. 200 mg/kg bw (highest concentration tested) is a NO(A)EL for oestrogenic effects. Absorption, distribution and excretion An absorption, distribution and excretion study in pregnant rats showed that there was no indication for accumulation in any of the organs investigated (both route; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"27503-81-7","citation":"","dose":"nt SAS x A x 0.001 = 7.488 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.125 mg/kg No observed adverse effect level NOAEL = 40 mg/kg bw (rat, oral, 90-day:","duration":"90-day","effect":"nt SAS x A x 0.001 = 7.488 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.125 mg/kg No observed adverse effect level NOAEL = 40 mg/kg bw (rat, oral, 90-day: 1000 mg/kg bw, 4% absorption) Margin of Safety NOAEL/SED = 320 3.3.14. Discussion Physico-chemical specifications Several batches were used without a proper physico-chemical characterisation. General toxicity The LD50 i.p. rat is in the range 1000 – 1500 mg/kg bw. The LD50 dermal rat is >3000 mg/kg bw. The NO(A)EL was set at 1000 mg/kg bw/day (13 week oral study in rats). In a teratogenicity study, the NO(A)EL was set at 1000 mg/kg bw for the dams and foetuses. The submitted studies produce evidence for the absence of an oestrogenic potential. 200 mg/kg bw (highest concentration tested) is a NO(A)EL for oestrogenic effects. Absorption, distribution and excretion An absorption, distribution and excretion study in pregnant rats showed that there was no indication for accumulation in any of the organs investigated (both route","endpoint":"","ingredient":"Phenylbenzimidazole Sulfonic Acid (INCI)","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":29,"route":"oral","species":"rat","study_id":"sccp_o_079_noael_007"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 1000 mg/kg bw rat oral 90-day - SOURCE_SUBDIR=sccp_o_079; REPORT_TITLE=OPINION ON PHENYLBENZIMIDAZOLE SUFONIC ACID AND ITS SALTS COLIPA S45; OPINION_NUMBER=SCCP/1056/06; COMMITTEE=SCCP; REPORT_DATE=19 December 2006; VALUE_TEXT=1000; DOSE=AS x A x 0.001/60 = 0.125 mg/kg No observed adverse effect level NOAEL = 40 mg/kg bw (rat, oral, 90-day:; EFFECT=AS x A x 0.001/60 = 0.125 mg/kg No observed adverse effect level NOAEL = 40 mg/kg bw (rat, oral, 90-day: 1000 mg/kg bw, 4% absorption) Margin of Safety NOAEL/SED = 320 3.3.14. Discussion Physico-chemical specifications Several batches were used without a proper physico-chemical characterisation. General toxicity The LD50 i.p. rat is in the range 1000 – 1500 mg/kg bw. The LD50 dermal rat is >3000 mg/kg bw. The NO(A)EL was set at 1000 mg/kg bw/day (13 week oral study in rats). In a teratogenicity study, the NO(A)EL was set at 1000 mg/kg bw for the dams and foetuses. The submitted studies produce evidence for the absence of an oestrogenic potential. 200 mg/kg bw (highest concentration tested) is a NO(A)EL for oestrogenic effects. Absorption, distribution and excretion An absorption, distribution and excretion study in pregnant rats showed that there was no indication for accumulation in any of the organs investigated (both routes); trace amounts of radioactivity are found in brain and foetuses after i.v. application; nothing; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"27503-81-7","citation":"","dose":"AS x A x 0.001/60 = 0.125 mg/kg No observed adverse effect level NOAEL = 40 mg/kg bw (rat, oral, 90-day:","duration":"90-day","effect":"AS x A x 0.001/60 = 0.125 mg/kg No observed adverse effect level NOAEL = 40 mg/kg bw (rat, oral, 90-day: 1000 mg/kg bw, 4% absorption) Margin of Safety NOAEL/SED = 320 3.3.14. Discussion Physico-chemical specifications Several batches were used without a proper physico-chemical characterisation. General toxicity The LD50 i.p. rat is in the range 1000 – 1500 mg/kg bw. The LD50 dermal rat is >3000 mg/kg bw. The NO(A)EL was set at 1000 mg/kg bw/day (13 week oral study in rats). In a teratogenicity study, the NO(A)EL was set at 1000 mg/kg bw for the dams and foetuses. The submitted studies produce evidence for the absence of an oestrogenic potential. 200 mg/kg bw (highest concentration tested) is a NO(A)EL for oestrogenic effects. Absorption, distribution and excretion An absorption, distribution and excretion study in pregnant rats showed that there was no indication for accumulation in any of the organs investigated (both routes); trace amounts of radioactivity are found in brain and foetuses after i.v. application; nothing","endpoint":"","ingredient":"Phenylbenzimidazole Sulfonic Acid (INCI)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"1000","page":29,"route":"oral","species":"rat","study_id":"sccp_o_079_noael_008"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =0.125 mg/kg rat oral 90-day dermal absorption SOURCE_SUBDIR=sccp_o_079; REPORT_TITLE=OPINION ON PHENYLBENZIMIDAZOLE SUFONIC ACID AND ITS SALTS COLIPA S45; OPINION_NUMBER=SCCP/1056/06; COMMITTEE=SCCP; REPORT_DATE=19 December 2006; VALUE_TEXT== 0.125; DOSE=200 mg/kg bw (highest concentration tested) is a NO(A)EL for oestrogenic effects.; EFFECT=for the absence of an oestrogenic potential Neo Heliopan Hydro sodium salt. 200 mg/kg bw (highest concentration tested) is a NO(A)EL for oestrogenic effects. 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 0.416 µg/cm2 Skin area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 7.488 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.125 mg/kg No observed adverse effect level NOAEL = 40 mg/kg bw (rat, oral, 90-day: 1000 mg/kg bw, 4% absorption) Margin of Safety NOAEL/SED = 320 3.3.14. Discussion Physico-chemical specifications Several batches were used without a proper physico-chemical characterisation. General toxicity The LD50 i.p. rat is in the range 1000 – 1500 mg/kg bw. The LD50 dermal rat is >3000 mg/kg bw. The NO(A)EL was set at 1000 mg/kg bw/day (13 week oral study in rats). In a teratogenicity study, the NO(A)EL was set at 1000 mg/kg bw for the dams and foetuses. The; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"27503-81-7","citation":"","dose":"200 mg/kg bw (highest concentration tested) is a NO(A)EL for oestrogenic effects.","duration":"90-day","effect":"for the absence of an oestrogenic potential Neo Heliopan Hydro sodium salt. 200 mg/kg bw (highest concentration tested) is a NO(A)EL for oestrogenic effects. 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 0.416 µg/cm2 Skin area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 7.488 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.125 mg/kg No observed adverse effect level NOAEL = 40 mg/kg bw (rat, oral, 90-day: 1000 mg/kg bw, 4% absorption) Margin of Safety NOAEL/SED = 320 3.3.14. Discussion Physico-chemical specifications Several batches were used without a proper physico-chemical characterisation. General toxicity The LD50 i.p. rat is in the range 1000 – 1500 mg/kg bw. The LD50 dermal rat is >3000 mg/kg bw. The NO(A)EL was set at 1000 mg/kg bw/day (13 week oral study in rats). In a teratogenicity study, the NO(A)EL was set at 1000 mg/kg bw for the dams and foetuses. The","endpoint":"dermal absorption","ingredient":"Phenylbenzimidazole Sulfonic Acid (INCI)","loael_value":"","noael_unit":"mg/kg","noael_value":"= 0.125","page":29,"route":"oral","species":"rat","study_id":"sccp_o_079_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption 4 % rat oral 90-day dermal absorption SOURCE_SUBDIR=sccp_o_079; REPORT_TITLE=OPINION ON PHENYLBENZIMIDAZOLE SUFONIC ACID AND ITS SALTS COLIPA S45; OPINION_NUMBER=SCCP/1056/06; COMMITTEE=SCCP; REPORT_DATE=19 December 2006; VALUE_TEXT=4; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 0.416 µg/cm2 Skin area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 7.488 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.125 mg/k...; EFFECT=a NO(A)EL for oestrogenic effects. 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 0.416 µg/cm2 Skin area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 7.488 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.125 mg/kg No observed adverse effect level NOAEL = 40 mg/kg bw (rat, oral, 90-day: 1000 mg/kg bw, 4% absorption) Margin of Safety NOAEL/SED = 320 3.3.14. Discussion Physico-chemical specifications Several batches were used without a proper physico-chemical characterisation. General toxicity The LD50 i.p. rat is in the range 1000 – 1500 mg/kg bw. The LD50 dermal rat is >3000 mg/kg bw. The NO(A)EL was set at 1000 mg/kg bw/day (13 week oral study in rats). In a teratogenicity study, the NO(A)EL was set at 1000 mg/kg bw for the dams and foetuses. The submitted studies produce evidence for the absence of an oestrogenic potential. 200 mg/kg bw (hi; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"27503-81-7","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 0.416 µg/cm2 Skin area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 7.488 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.125 mg/k...","duration":"90-day","effect":"a NO(A)EL for oestrogenic effects. 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 0.416 µg/cm2 Skin area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 7.488 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.125 mg/kg No observed adverse effect level NOAEL = 40 mg/kg bw (rat, oral, 90-day: 1000 mg/kg bw, 4% absorption) Margin of Safety NOAEL/SED = 320 3.3.14. Discussion Physico-chemical specifications Several batches were used without a proper physico-chemical characterisation. General toxicity The LD50 i.p. rat is in the range 1000 – 1500 mg/kg bw. The LD50 dermal rat is >3000 mg/kg bw. The NO(A)EL was set at 1000 mg/kg bw/day (13 week oral study in rats). In a teratogenicity study, the NO(A)EL was set at 1000 mg/kg bw for the dams and foetuses. The submitted studies produce evidence for the absence of an oestrogenic potential. 200 mg/kg bw (hi","endpoint":"dermal absorption","ingredient":"Phenylbenzimidazole Sulfonic Acid (INCI)","loael_value":"","noael_unit":"%","noael_value":"4","page":29,"route":"oral","species":"rat","study_id":"sccp_o_079_noael_006"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =40 mg/kg bw rat oral 90-day dermal absorption SOURCE_SUBDIR=sccp_o_079; REPORT_TITLE=OPINION ON PHENYLBENZIMIDAZOLE SUFONIC ACID AND ITS SALTS COLIPA S45; OPINION_NUMBER=SCCP/1056/06; COMMITTEE=SCCP; REPORT_DATE=19 December 2006; VALUE_TEXT== 40; DOSE=200 mg/kg bw (highest concentration tested) is a NO(A)EL for oestrogenic effects.; EFFECT=c potential Neo Heliopan Hydro sodium salt. 200 mg/kg bw (highest concentration tested) is a NO(A)EL for oestrogenic effects. 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 0.416 µg/cm2 Skin area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 7.488 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.125 mg/kg No observed adverse effect level NOAEL = 40 mg/kg bw (rat, oral, 90-day: 1000 mg/kg bw, 4% absorption) Margin of Safety NOAEL/SED = 320 3.3.14. Discussion Physico-chemical specifications Several batches were used without a proper physico-chemical characterisation. General toxicity The LD50 i.p. rat is in the range 1000 – 1500 mg/kg bw. The LD50 dermal rat is >3000 mg/kg bw. The NO(A)EL was set at 1000 mg/kg bw/day (13 week oral study in rats). In a teratogenicity study, the NO(A)EL was set at 1000 mg/kg bw for the dams and foetuses. The submit; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"27503-81-7","citation":"","dose":"200 mg/kg bw (highest concentration tested) is a NO(A)EL for oestrogenic effects.","duration":"90-day","effect":"c potential Neo Heliopan Hydro sodium salt. 200 mg/kg bw (highest concentration tested) is a NO(A)EL for oestrogenic effects. 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 0.416 µg/cm2 Skin area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 7.488 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.125 mg/kg No observed adverse effect level NOAEL = 40 mg/kg bw (rat, oral, 90-day: 1000 mg/kg bw, 4% absorption) Margin of Safety NOAEL/SED = 320 3.3.14. Discussion Physico-chemical specifications Several batches were used without a proper physico-chemical characterisation. General toxicity The LD50 i.p. rat is in the range 1000 – 1500 mg/kg bw. The LD50 dermal rat is >3000 mg/kg bw. The NO(A)EL was set at 1000 mg/kg bw/day (13 week oral study in rats). In a teratogenicity study, the NO(A)EL was set at 1000 mg/kg bw for the dams and foetuses. The submit","endpoint":"dermal absorption","ingredient":"Phenylbenzimidazole Sulfonic Acid (INCI)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 40","page":29,"route":"oral","species":"rat","study_id":"sccp_o_079_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption 200 mg/kg bw rat oral 90-day dermal absorption SOURCE_SUBDIR=sccp_o_079; REPORT_TITLE=OPINION ON PHENYLBENZIMIDAZOLE SUFONIC ACID AND ITS SALTS COLIPA S45; OPINION_NUMBER=SCCP/1056/06; COMMITTEE=SCCP; REPORT_DATE=19 December 2006; VALUE_TEXT=200; DOSE=200 mg/kg bw (highest concentration tested) is a NO(A)EL for oestrogenic effects.; EFFECT=SCCP/1056/06 OPINION ON PHENYLBENZIMIDAZOLE SULFONIC ACID AND ITS SALTS 29 There were no clinical signs of toxicity throughout the dosing period. Food consumption and body weight development was the same in test and control groups. At necropsy no gross pathological findings except enlargement of uteri in positive controls became manifest. Ref.: 21 These studies produce evidence for the absence of an oestrogenic potential Neo Heliopan Hydro sodium salt. 200 mg/kg bw (highest concentration tested) is a NO(A)EL for oestrogenic effects. 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 0.416 µg/cm2 Skin area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 7.488 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.125 mg/kg No observed adverse effect level NOAEL = 40 mg/kg bw (rat, oral, 90-day: 1000 mg/kg bw, 4% absorption) Margin of Safety NOAEL/SED; CITATION=Ref.: 21 These studies produce evidence for the absence of an oestrogenic potential Neo Heliopan Hydro sodium salt; CITATION_NUMBERS=[21]; REFERENCE=Ref.: 21 These studies produce evidence for the absence of an oestrogenic potential Neo Heliopan Hydro sodium salt; DETAILS_JSON={"cas_number":"27503-81-7","citation":"Ref.: 21 These studies produce evidence for the absence of an oestrogenic potential Neo Heliopan Hydro sodium salt","dose":"200 mg/kg bw (highest concentration tested) is a NO(A)EL for oestrogenic effects.","duration":"90-day","effect":"SCCP/1056/06 OPINION ON PHENYLBENZIMIDAZOLE SULFONIC ACID AND ITS SALTS 29 There were no clinical signs of toxicity throughout the dosing period. Food consumption and body weight development was the same in test and control groups. At necropsy no gross pathological findings except enlargement of uteri in positive controls became manifest. Ref.: 21 These studies produce evidence for the absence of an oestrogenic potential Neo Heliopan Hydro sodium salt. 200 mg/kg bw (highest concentration tested) is a NO(A)EL for oestrogenic effects. 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 0.416 µg/cm2 Skin area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 7.488 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.125 mg/kg No observed adverse effect level NOAEL = 40 mg/kg bw (rat, oral, 90-day: 1000 mg/kg bw, 4% absorption) Margin of Safety NOAEL/SED","endpoint":"dermal absorption","ingredient":"Phenylbenzimidazole Sulfonic Acid (INCI)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"200","page":29,"route":"oral","species":"rat","study_id":"sccp_o_079_noael_003"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies genotoxicity 1000 mg/kg bw/day - - Chronic genotoxicity SOURCE_SUBDIR=sccp_o_079; REPORT_TITLE=OPINION ON PHENYLBENZIMIDAZOLE SUFONIC ACID AND ITS SALTS COLIPA S45; OPINION_NUMBER=SCCP/1056/06; COMMITTEE=SCCP; REPORT_DATE=19 December 2006; VALUE_TEXT=1000; DOSE=Differences in organ weights, if observable at all (e.g. spleen in ♀'s), were small and not dose dependent.; EFFECT=d was therefore not considered substance related. Anatomical pathology: Necropsy-findings in the animals which had died intercurrently, revealed no pathological changes attributable to the test substance. Neither did the animals which were sacrificed pursuant to protocol at the end of the study exhibit any such changes. Differences in organ weights, if observable at all (e.g. spleen in ♀'s), were small and not dose dependent. Histopathology did not reveal any organ change or –damage in any one of the dose groups. NO(A)EL: 1000 mg/kg bw/day Ref.: 13 3.3.5.3. Chronic (> 12 months) toxicity / 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assays Guideline: EEC guideline in Annex V of Directive 67/548/EEC Species/strain: Salmonella typhimurium (TA100, TA1535, TA98, TA1537, TA1538) Escherichia coli (WP2, WP2 uvrA) Replicates: Test substance: Eusolex 232 (2-Phenylbenzimidazole-5-sulfonic acid) Solvent: DMSO Batch: G-196572, article n° 1/05372-6 Purity: 99.7% Concentration; CITATION=Ref.: 13 3; CITATION_NUMBERS=[13,3]; REFERENCE=Ref.: 13 3; DETAILS_JSON={"cas_number":"27503-81-7","citation":"Ref.: 13 3","dose":"Differences in organ weights, if observable at all (e.g. spleen in ♀'s), were small and not dose dependent.","duration":"Chronic","effect":"d was therefore not considered substance related. Anatomical pathology: Necropsy-findings in the animals which had died intercurrently, revealed no pathological changes attributable to the test substance. Neither did the animals which were sacrificed pursuant to protocol at the end of the study exhibit any such changes. Differences in organ weights, if observable at all (e.g. spleen in ♀'s), were small and not dose dependent. Histopathology did not reveal any organ change or –damage in any one of the dose groups. NO(A)EL: 1000 mg/kg bw/day Ref.: 13 3.3.5.3. Chronic (> 12 months) toxicity / 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assays Guideline: EEC guideline in Annex V of Directive 67/548/EEC Species/strain: Salmonella typhimurium (TA100, TA1535, TA98, TA1537, TA1538) Escherichia coli (WP2, WP2 uvrA) Replicates: Test substance: Eusolex 232 (2-Phenylbenzimidazole-5-sulfonic acid) Solvent: DMSO Batch: G-196572, article n° 1/05372-6 Purity: 99.7% Concentration","endpoint":"genotoxicity","ingredient":"Phenylbenzimidazole Sulfonic Acid (INCI)","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":18,"route":"","species":"","study_id":"sccp_o_079_noael_001"}
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier 9YQ9DI1W42 UNII - - - chemical {"approval_status":null,"molecular_formula":"C13H10N2O3S","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"9YQ9DI1W42"}
openFDA substances FDA UNII substance identifier 9YQ9DI1W42 UNII - - - chemical {"approval_status":null,"molecular_formula":"C13H10N2O3S","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"9YQ9DI1W42"}
openFDA substances FDA UNII substance identifier 9YQ9DI1W42 UNII - - - chemical {"approval_status":null,"molecular_formula":"C13H10N2O3S","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"9YQ9DI1W42"}
openFDA substances FDA UNII substance identifier 9YQ9DI1W42 UNII - - - chemical {"approval_status":null,"molecular_formula":"C13H10N2O3S","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"9YQ9DI1W42"}