NOAEL Studies Cosmetic Ingredient

Bis(Butylbenzoate) Diaminotriazine Aminopropyltrisiloxane NOAEL Studies

INCI: BIS(BUTYLBENZOATE) DIAMINOTRIAZINE AMINOPROPYLTRISILOXANE

CAS: 207562-42-3

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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SCCS Opinion 36 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS Opinion NOAEL =1 % human oral - NOAEL study {"citation":"Ref.: 8 Comment The range-finder experiment was performed without UV irradiation","dose":"Safety evaluation For the calculation of a MoS, the SED (systemic exposure dose) is compared to the No- observed-adverse effect-level (NOAEL).","effect":"data were analysed at the 1% level using Dunnett’s test. Conclusion From the results of the study it can be concluded that the test substance is not phototoxic or photo-mutagenic in this assay system. Ref.: 8 Comment The range-finder experiment was performed without UV irradiation. 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation For the calculation of a MoS, the SED (systemic exposure dose) is compared to the No- observed-adverse effect-level (NOAEL). This means that an internal dose (the SED) is compared to an external dose (the NOAEL). The assessment approach taken for most cosmetic ingredients involves a route-to-route extrapolation for the MoS calculation, comparing the SED calculated for the dermal route to the NOAEL from an oral study. The direct comparison of the dermal SED to an oral NOAEL implicitly assumes full oral bioavailability. In cases where there are indications that oral bioavailability is low, the NOAEL from the oral toxicity study needs to","page":28,"pdf":"sccs_o_055.pdf","row_type":"noael_study","study_id":"sccs_o_055_noael_006"}
SCCS Opinion NOAEL =1 % human oral - NOAEL study {"citation":"Ref.: 8 Comment The range-finder experiment was performed without UV irradiation","dose":"Safety evaluation For the calculation of a MoS, the SED (systemic exposure dose) is compared to the No- observed-adverse effect-level (NOAEL).","effect":"data were analysed at the 1% level using Dunnett’s test. Conclusion From the results of the study it can be concluded that the test substance is not phototoxic or photo-mutagenic in this assay system. Ref.: 8 Comment The range-finder experiment was performed without UV irradiation. 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation For the calculation of a MoS, the SED (systemic exposure dose) is compared to the No- observed-adverse effect-level (NOAEL). This means that an internal dose (the SED) is compared to an external dose (the NOAEL). The assessment approach taken for most cosmetic ingredients involves a route-to-route extrapolation for the MoS calculation, comparing the SED calculated for the dermal route to the NOAEL from an oral study. The direct comparison of the dermal SED to an oral NOAEL implicitly assumes full oral bioavailability. In cases where there are indications that oral bioavailability is low, the NOAEL from the oral toxicity study needs to","page":28,"pdf":"sccs_o_055.pdf","row_type":"noael_study","study_id":"sccs_o_055_noael_006"}
SCCS Opinion NOAEL =1 % human oral - NOAEL study {"citation":"Ref.: 8 Comment The range-finder experiment was performed without UV irradiation","dose":"Safety evaluation For the calculation of a MoS, the SED (systemic exposure dose) is compared to the No- observed-adverse effect-level (NOAEL).","effect":"data were analysed at the 1% level using Dunnett’s test. Conclusion From the results of the study it can be concluded that the test substance is not phototoxic or photo-mutagenic in this assay system. Ref.: 8 Comment The range-finder experiment was performed without UV irradiation. 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation For the calculation of a MoS, the SED (systemic exposure dose) is compared to the No- observed-adverse effect-level (NOAEL). This means that an internal dose (the SED) is compared to an external dose (the NOAEL). The assessment approach taken for most cosmetic ingredients involves a route-to-route extrapolation for the MoS calculation, comparing the SED calculated for the dermal route to the NOAEL from an oral study. The direct comparison of the dermal SED to an oral NOAEL implicitly assumes full oral bioavailability. In cases where there are indications that oral bioavailability is low, the NOAEL from the oral toxicity study needs to","page":28,"pdf":"sccs_o_055.pdf","row_type":"noael_study","study_id":"sccs_o_055_noael_006"}
SCCS Opinion NOAEL =1 % human oral - NOAEL study {"citation":"Ref.: 8 Comment The range-finder experiment was performed without UV irradiation","dose":"Safety evaluation For the calculation of a MoS, the SED (systemic exposure dose) is compared to the No- observed-adverse effect-level (NOAEL).","effect":"data were analysed at the 1% level using Dunnett’s test. Conclusion From the results of the study it can be concluded that the test substance is not phototoxic or photo-mutagenic in this assay system. Ref.: 8 Comment The range-finder experiment was performed without UV irradiation. 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation For the calculation of a MoS, the SED (systemic exposure dose) is compared to the No- observed-adverse effect-level (NOAEL). This means that an internal dose (the SED) is compared to an external dose (the NOAEL). The assessment approach taken for most cosmetic ingredients involves a route-to-route extrapolation for the MoS calculation, comparing the SED calculated for the dermal route to the NOAEL from an oral study. The direct comparison of the dermal SED to an oral NOAEL implicitly assumes full oral bioavailability. In cases where there are indications that oral bioavailability is low, the NOAEL from the oral toxicity study needs to","page":28,"pdf":"sccs_o_055.pdf","row_type":"noael_study","study_id":"sccs_o_055_noael_006"}
SCCS Opinion NOAEL =1.34 mg/kg bw/day rat oral 13 week NOAEL study {"dose":"dient in finished product C = 10% Typical body weight of human = 60 kg Systemic exposure dose (SED) (A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60) = 1.34 mg/kg bw/d No adverse observed effect level NOAEL = 1000 mg/kg bw/d (13 week oral rat study) MOS = NOAEL/SED The uncorrected NOAEL (assuming 100 % absorption) is 1000 mg/kg bw/d.","effect":"dient in finished product C = 10% Typical body weight of human = 60 kg Systemic exposure dose (SED) (A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60) = 1.34 mg/kg bw/d No adverse observed effect level NOAEL = 1000 mg/kg bw/d (13 week oral rat study) MOS = NOAEL/SED The uncorrected NOAEL (assuming 100 % absorption) is 1000 mg/kg bw/d. The expected SED from the use of bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane in sun protection products is 1.34 mg/kg bw/day. To achieve a MoS of 100, the NOAEL corrected for oral availability therefore needs to be at least 134 mg/kg bw/day. Using an assessment approach based on route-to-route extrapolation, a sufficient high MoS would only be obtained if oral bioavailability of ≥ 13.4% could be demonstrated. A calculation of the MoS based on route-to-route extrapolation requires quantification of the oral availability of bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane. Ideally this could have been investigated more thoroughly in the oral in vivo studies perfor","page":29,"pdf":"sccs_o_055.pdf","row_type":"noael_study","study_id":"sccs_o_055_noael_016"}
SCCS Opinion NOAEL =1.34 mg/kg bw/day rat oral 13 week NOAEL study {"dose":"dient in finished product C = 10% Typical body weight of human = 60 kg Systemic exposure dose (SED) (A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60) = 1.34 mg/kg bw/d No adverse observed effect level NOAEL = 1000 mg/kg bw/d (13 week oral rat study) MOS = NOAEL/SED The uncorrected NOAEL (assuming 100 % absorption) is 1000 mg/kg bw/d.","effect":"dient in finished product C = 10% Typical body weight of human = 60 kg Systemic exposure dose (SED) (A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60) = 1.34 mg/kg bw/d No adverse observed effect level NOAEL = 1000 mg/kg bw/d (13 week oral rat study) MOS = NOAEL/SED The uncorrected NOAEL (assuming 100 % absorption) is 1000 mg/kg bw/d. The expected SED from the use of bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane in sun protection products is 1.34 mg/kg bw/day. To achieve a MoS of 100, the NOAEL corrected for oral availability therefore needs to be at least 134 mg/kg bw/day. Using an assessment approach based on route-to-route extrapolation, a sufficient high MoS would only be obtained if oral bioavailability of ≥ 13.4% could be demonstrated. A calculation of the MoS based on route-to-route extrapolation requires quantification of the oral availability of bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane. Ideally this could have been investigated more thoroughly in the oral in vivo studies perfor","page":29,"pdf":"sccs_o_055.pdf","row_type":"noael_study","study_id":"sccs_o_055_noael_016"}
SCCS Opinion NOAEL =1.34 mg/kg bw/day rat oral 13 week NOAEL study {"dose":"dient in finished product C = 10% Typical body weight of human = 60 kg Systemic exposure dose (SED) (A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60) = 1.34 mg/kg bw/d No adverse observed effect level NOAEL = 1000 mg/kg bw/d (13 week oral rat study) MOS = NOAEL/SED The uncorrected NOAEL (assuming 100 % absorption) is 1000 mg/kg bw/d.","effect":"dient in finished product C = 10% Typical body weight of human = 60 kg Systemic exposure dose (SED) (A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60) = 1.34 mg/kg bw/d No adverse observed effect level NOAEL = 1000 mg/kg bw/d (13 week oral rat study) MOS = NOAEL/SED The uncorrected NOAEL (assuming 100 % absorption) is 1000 mg/kg bw/d. The expected SED from the use of bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane in sun protection products is 1.34 mg/kg bw/day. To achieve a MoS of 100, the NOAEL corrected for oral availability therefore needs to be at least 134 mg/kg bw/day. Using an assessment approach based on route-to-route extrapolation, a sufficient high MoS would only be obtained if oral bioavailability of ≥ 13.4% could be demonstrated. A calculation of the MoS based on route-to-route extrapolation requires quantification of the oral availability of bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane. Ideally this could have been investigated more thoroughly in the oral in vivo studies perfor","page":29,"pdf":"sccs_o_055.pdf","row_type":"noael_study","study_id":"sccs_o_055_noael_016"}
SCCS Opinion NOAEL =1.34 mg/kg bw/day rat oral 13 week NOAEL study {"dose":"dient in finished product C = 10% Typical body weight of human = 60 kg Systemic exposure dose (SED) (A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60) = 1.34 mg/kg bw/d No adverse observed effect level NOAEL = 1000 mg/kg bw/d (13 week oral rat study) MOS = NOAEL/SED The uncorrected NOAEL (assuming 100 % absorption) is 1000 mg/kg bw/d.","effect":"dient in finished product C = 10% Typical body weight of human = 60 kg Systemic exposure dose (SED) (A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60) = 1.34 mg/kg bw/d No adverse observed effect level NOAEL = 1000 mg/kg bw/d (13 week oral rat study) MOS = NOAEL/SED The uncorrected NOAEL (assuming 100 % absorption) is 1000 mg/kg bw/d. The expected SED from the use of bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane in sun protection products is 1.34 mg/kg bw/day. To achieve a MoS of 100, the NOAEL corrected for oral availability therefore needs to be at least 134 mg/kg bw/day. Using an assessment approach based on route-to-route extrapolation, a sufficient high MoS would only be obtained if oral bioavailability of ≥ 13.4% could be demonstrated. A calculation of the MoS based on route-to-route extrapolation requires quantification of the oral availability of bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane. Ideally this could have been investigated more thoroughly in the oral in vivo studies perfor","page":29,"pdf":"sccs_o_055.pdf","row_type":"noael_study","study_id":"sccs_o_055_noael_016"}
SCCS Opinion NOAEL =3.3 - human oral - NOAEL study {"dose":"Safety evaluation For the calculation of a MoS, the SED (systemic exposure dose) is compared to the No- observed-adverse effect-level (NOAEL).","effect":"ation. 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation For the calculation of a MoS, the SED (systemic exposure dose) is compared to the No- observed-adverse effect-level (NOAEL). This means that an internal dose (the SED) is compared to an external dose (the NOAEL). The assessment approach taken for most cosmetic ingredients involves a route-to-route extrapolation for the MoS calculation, comparing the SED calculated for the dermal route to the NOAEL from an oral study. The direct comparison of the dermal SED to an oral NOAEL implicitly assumes full oral bioavailability. In cases where there are indications that oral bioavailability is low, the NOAEL from the oral toxicity study needs to be corrected by the percentage of oral bioavailability in order to perform an adequate route-to-route extrapolation. This requires information on the extent of oral bioavailability. In the case of bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane, an oral NOAEL of 100","page":28,"pdf":"sccs_o_055.pdf","row_type":"noael_study","study_id":"sccs_o_055_noael_008"}
SCCS Opinion NOAEL =3.3 - human oral - NOAEL study {"dose":"Safety evaluation For the calculation of a MoS, the SED (systemic exposure dose) is compared to the No- observed-adverse effect-level (NOAEL).","effect":"ation. 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation For the calculation of a MoS, the SED (systemic exposure dose) is compared to the No- observed-adverse effect-level (NOAEL). This means that an internal dose (the SED) is compared to an external dose (the NOAEL). The assessment approach taken for most cosmetic ingredients involves a route-to-route extrapolation for the MoS calculation, comparing the SED calculated for the dermal route to the NOAEL from an oral study. The direct comparison of the dermal SED to an oral NOAEL implicitly assumes full oral bioavailability. In cases where there are indications that oral bioavailability is low, the NOAEL from the oral toxicity study needs to be corrected by the percentage of oral bioavailability in order to perform an adequate route-to-route extrapolation. This requires information on the extent of oral bioavailability. In the case of bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane, an oral NOAEL of 100","page":28,"pdf":"sccs_o_055.pdf","row_type":"noael_study","study_id":"sccs_o_055_noael_008"}
SCCS Opinion NOAEL =3.3 - human oral - NOAEL study {"dose":"Safety evaluation For the calculation of a MoS, the SED (systemic exposure dose) is compared to the No- observed-adverse effect-level (NOAEL).","effect":"ation. 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation For the calculation of a MoS, the SED (systemic exposure dose) is compared to the No- observed-adverse effect-level (NOAEL). This means that an internal dose (the SED) is compared to an external dose (the NOAEL). The assessment approach taken for most cosmetic ingredients involves a route-to-route extrapolation for the MoS calculation, comparing the SED calculated for the dermal route to the NOAEL from an oral study. The direct comparison of the dermal SED to an oral NOAEL implicitly assumes full oral bioavailability. In cases where there are indications that oral bioavailability is low, the NOAEL from the oral toxicity study needs to be corrected by the percentage of oral bioavailability in order to perform an adequate route-to-route extrapolation. This requires information on the extent of oral bioavailability. In the case of bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane, an oral NOAEL of 100","page":28,"pdf":"sccs_o_055.pdf","row_type":"noael_study","study_id":"sccs_o_055_noael_008"}
SCCS Opinion NOAEL =3.3 - human oral - NOAEL study {"dose":"Safety evaluation For the calculation of a MoS, the SED (systemic exposure dose) is compared to the No- observed-adverse effect-level (NOAEL).","effect":"ation. 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation For the calculation of a MoS, the SED (systemic exposure dose) is compared to the No- observed-adverse effect-level (NOAEL). This means that an internal dose (the SED) is compared to an external dose (the NOAEL). The assessment approach taken for most cosmetic ingredients involves a route-to-route extrapolation for the MoS calculation, comparing the SED calculated for the dermal route to the NOAEL from an oral study. The direct comparison of the dermal SED to an oral NOAEL implicitly assumes full oral bioavailability. In cases where there are indications that oral bioavailability is low, the NOAEL from the oral toxicity study needs to be corrected by the percentage of oral bioavailability in order to perform an adequate route-to-route extrapolation. This requires information on the extent of oral bioavailability. In the case of bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane, an oral NOAEL of 100","page":28,"pdf":"sccs_o_055.pdf","row_type":"noael_study","study_id":"sccs_o_055_noael_008"}
SCCS Opinion NOAEL =4.46 % human oral - NOAEL study {"dose":"Absorption through the skin DAp = 4.46% Amount of cosmetic product applied daily A = 18 g/d Concentration of ingredient in finished product C = 10% Typical body weight of human = 60 kg Systemic exposure dose (SED) (A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100","effect":"SCCS-rejected applicant NOAEL: utylbenzoate) diaminotriazine aminopropyltrisiloxane __________________________________________________________________________________ 29 The available data point towards a very low oral bioavailability of S85, albeit they are insufficient to quantify the extent of oral absorption. While low systemic availability might be a favourable property of substances being intended to be used as UV filters, the SCCS is of the opinion that the submitted data are not appropriate for the calculation of a MoS based on an oral NOAEL, as an appropriate correction factor for the limited oral bioavailability cannot be derived. To determine the percentage of oral absorption which would enable the safe use of the substance, a calculation has been done based on the available information. Absorption through the skin DAp = 4.46% Amount of cosmetic product applied daily A = 18 g/d Concentration of ingredient in finished product C = 10% Typical body weight of human = 60 kg Systemic exposure dose (SED) (A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100","page":29,"pdf":"sccs_o_055.pdf","row_type":"noael_study","study_id":"sccs_o_055_noael_012"}
SCCS Opinion NOAEL =4.46 % human oral - NOAEL study {"dose":"Absorption through the skin DAp = 4.46% Amount of cosmetic product applied daily A = 18 g/d Concentration of ingredient in finished product C = 10% Typical body weight of human = 60 kg Systemic exposure dose (SED) (A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100","effect":"SCCS-rejected applicant NOAEL: utylbenzoate) diaminotriazine aminopropyltrisiloxane __________________________________________________________________________________ 29 The available data point towards a very low oral bioavailability of S85, albeit they are insufficient to quantify the extent of oral absorption. While low systemic availability might be a favourable property of substances being intended to be used as UV filters, the SCCS is of the opinion that the submitted data are not appropriate for the calculation of a MoS based on an oral NOAEL, as an appropriate correction factor for the limited oral bioavailability cannot be derived. To determine the percentage of oral absorption which would enable the safe use of the substance, a calculation has been done based on the available information. Absorption through the skin DAp = 4.46% Amount of cosmetic product applied daily A = 18 g/d Concentration of ingredient in finished product C = 10% Typical body weight of human = 60 kg Systemic exposure dose (SED) (A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100","page":29,"pdf":"sccs_o_055.pdf","row_type":"noael_study","study_id":"sccs_o_055_noael_012"}
SCCS Opinion NOAEL =4.46 % human oral - NOAEL study {"dose":"Absorption through the skin DAp = 4.46% Amount of cosmetic product applied daily A = 18 g/d Concentration of ingredient in finished product C = 10% Typical body weight of human = 60 kg Systemic exposure dose (SED) (A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100","effect":"SCCS-rejected applicant NOAEL: utylbenzoate) diaminotriazine aminopropyltrisiloxane __________________________________________________________________________________ 29 The available data point towards a very low oral bioavailability of S85, albeit they are insufficient to quantify the extent of oral absorption. While low systemic availability might be a favourable property of substances being intended to be used as UV filters, the SCCS is of the opinion that the submitted data are not appropriate for the calculation of a MoS based on an oral NOAEL, as an appropriate correction factor for the limited oral bioavailability cannot be derived. To determine the percentage of oral absorption which would enable the safe use of the substance, a calculation has been done based on the available information. Absorption through the skin DAp = 4.46% Amount of cosmetic product applied daily A = 18 g/d Concentration of ingredient in finished product C = 10% Typical body weight of human = 60 kg Systemic exposure dose (SED) (A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100","page":29,"pdf":"sccs_o_055.pdf","row_type":"noael_study","study_id":"sccs_o_055_noael_012"}
SCCS Opinion NOAEL =4.46 % human oral - NOAEL study {"dose":"Absorption through the skin DAp = 4.46% Amount of cosmetic product applied daily A = 18 g/d Concentration of ingredient in finished product C = 10% Typical body weight of human = 60 kg Systemic exposure dose (SED) (A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100","effect":"SCCS-rejected applicant NOAEL: utylbenzoate) diaminotriazine aminopropyltrisiloxane __________________________________________________________________________________ 29 The available data point towards a very low oral bioavailability of S85, albeit they are insufficient to quantify the extent of oral absorption. While low systemic availability might be a favourable property of substances being intended to be used as UV filters, the SCCS is of the opinion that the submitted data are not appropriate for the calculation of a MoS based on an oral NOAEL, as an appropriate correction factor for the limited oral bioavailability cannot be derived. To determine the percentage of oral absorption which would enable the safe use of the substance, a calculation has been done based on the available information. Absorption through the skin DAp = 4.46% Amount of cosmetic product applied daily A = 18 g/d Concentration of ingredient in finished product C = 10% Typical body weight of human = 60 kg Systemic exposure dose (SED) (A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100","page":29,"pdf":"sccs_o_055.pdf","row_type":"noael_study","study_id":"sccs_o_055_noael_012"}
SCCS Opinion NOAEL =8 - human oral - NOAEL study {"citation":"Ref.: 8 Comment The range-finder experiment was performed without UV irradiation","dose":"Safety evaluation For the calculation of a MoS, the SED (systemic exposure dose) is compared to the No- observed-adverse effect-level (NOAEL).","effect":"the study it can be concluded that the test substance is not phototoxic or photo-mutagenic in this assay system. Ref.: 8 Comment The range-finder experiment was performed without UV irradiation. 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation For the calculation of a MoS, the SED (systemic exposure dose) is compared to the No- observed-adverse effect-level (NOAEL). This means that an internal dose (the SED) is compared to an external dose (the NOAEL). The assessment approach taken for most cosmetic ingredients involves a route-to-route extrapolation for the MoS calculation, comparing the SED calculated for the dermal route to the NOAEL from an oral study. The direct comparison of the dermal SED to an oral NOAEL implicitly assumes full oral bioavailability. In cases where there are indications that oral bioavailability is low, the NOAEL from the oral toxicity study needs to be corrected by the percentage of oral bioavailability in order to perform an adequate","page":28,"pdf":"sccs_o_055.pdf","row_type":"noael_study","study_id":"sccs_o_055_noael_007"}
SCCS Opinion NOAEL =8 - human oral - NOAEL study {"citation":"Ref.: 8 Comment The range-finder experiment was performed without UV irradiation","dose":"Safety evaluation For the calculation of a MoS, the SED (systemic exposure dose) is compared to the No- observed-adverse effect-level (NOAEL).","effect":"the study it can be concluded that the test substance is not phototoxic or photo-mutagenic in this assay system. Ref.: 8 Comment The range-finder experiment was performed without UV irradiation. 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation For the calculation of a MoS, the SED (systemic exposure dose) is compared to the No- observed-adverse effect-level (NOAEL). This means that an internal dose (the SED) is compared to an external dose (the NOAEL). The assessment approach taken for most cosmetic ingredients involves a route-to-route extrapolation for the MoS calculation, comparing the SED calculated for the dermal route to the NOAEL from an oral study. The direct comparison of the dermal SED to an oral NOAEL implicitly assumes full oral bioavailability. In cases where there are indications that oral bioavailability is low, the NOAEL from the oral toxicity study needs to be corrected by the percentage of oral bioavailability in order to perform an adequate","page":28,"pdf":"sccs_o_055.pdf","row_type":"noael_study","study_id":"sccs_o_055_noael_007"}
SCCS Opinion NOAEL =8 - human oral - NOAEL study {"citation":"Ref.: 8 Comment The range-finder experiment was performed without UV irradiation","dose":"Safety evaluation For the calculation of a MoS, the SED (systemic exposure dose) is compared to the No- observed-adverse effect-level (NOAEL).","effect":"the study it can be concluded that the test substance is not phototoxic or photo-mutagenic in this assay system. Ref.: 8 Comment The range-finder experiment was performed without UV irradiation. 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation For the calculation of a MoS, the SED (systemic exposure dose) is compared to the No- observed-adverse effect-level (NOAEL). This means that an internal dose (the SED) is compared to an external dose (the NOAEL). The assessment approach taken for most cosmetic ingredients involves a route-to-route extrapolation for the MoS calculation, comparing the SED calculated for the dermal route to the NOAEL from an oral study. The direct comparison of the dermal SED to an oral NOAEL implicitly assumes full oral bioavailability. In cases where there are indications that oral bioavailability is low, the NOAEL from the oral toxicity study needs to be corrected by the percentage of oral bioavailability in order to perform an adequate","page":28,"pdf":"sccs_o_055.pdf","row_type":"noael_study","study_id":"sccs_o_055_noael_007"}
SCCS Opinion NOAEL =8 - human oral - NOAEL study {"citation":"Ref.: 8 Comment The range-finder experiment was performed without UV irradiation","dose":"Safety evaluation For the calculation of a MoS, the SED (systemic exposure dose) is compared to the No- observed-adverse effect-level (NOAEL).","effect":"the study it can be concluded that the test substance is not phototoxic or photo-mutagenic in this assay system. Ref.: 8 Comment The range-finder experiment was performed without UV irradiation. 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation For the calculation of a MoS, the SED (systemic exposure dose) is compared to the No- observed-adverse effect-level (NOAEL). This means that an internal dose (the SED) is compared to an external dose (the NOAEL). The assessment approach taken for most cosmetic ingredients involves a route-to-route extrapolation for the MoS calculation, comparing the SED calculated for the dermal route to the NOAEL from an oral study. The direct comparison of the dermal SED to an oral NOAEL implicitly assumes full oral bioavailability. In cases where there are indications that oral bioavailability is low, the NOAEL from the oral toxicity study needs to be corrected by the percentage of oral bioavailability in order to perform an adequate","page":28,"pdf":"sccs_o_055.pdf","row_type":"noael_study","study_id":"sccs_o_055_noael_007"}
SCCS Opinion NOAEL =10 - - oral 10 months NOAEL study {"citation":"Ref.: 9 Comment As the physico-chemical properties of bis(butylbenzoate) diaminotriazine aminopropyl- trisiloxane point towards a limited bioavailability, reliable data on toxicokinetics","dose":"It indicates that (at least) a small fraction of the administered dose of R0027603A becomes systemically bioavailable after oral administration, however, a quantification of bioavailability is not possible.","effect":"sis were performed up to 10 months after sampling), the toxicokinetic parameters were not determined. The overall conclusion by the study authors from these plasma profiles was that the test item could be detected in plasma of animals, thus showing systemic exposure. Ref.: 9 Comment As the physico-chemical properties of bis(butylbenzoate) diaminotriazine aminopropyl- trisiloxane point towards a limited bioavailability, reliable data on toxicokinetics are considered essential for a risk assessment based on an oral NOAEL. The submitted study is of limited value for the assessment of oral bioavailability. It indicates that (at least) a small fraction of the administered dose of R0027603A becomes systemically bioavailable after oral administration, however, a quantification of bioavailability is not possible. Only the parent compound has been analyzed and no conclusions can be drawn with respect to probable breakdown products/metabolites. Further, the reliability of the data obtained is questionable: analyses were performed 10 month","page":25,"pdf":"sccs_o_055.pdf","row_type":"noael_study","study_id":"sccs_o_055_noael_005"}
SCCS Opinion NOAEL =10 - - oral 10 months NOAEL study {"citation":"Ref.: 9 Comment As the physico-chemical properties of bis(butylbenzoate) diaminotriazine aminopropyl- trisiloxane point towards a limited bioavailability, reliable data on toxicokinetics","dose":"It indicates that (at least) a small fraction of the administered dose of R0027603A becomes systemically bioavailable after oral administration, however, a quantification of bioavailability is not possible.","effect":"sis were performed up to 10 months after sampling), the toxicokinetic parameters were not determined. The overall conclusion by the study authors from these plasma profiles was that the test item could be detected in plasma of animals, thus showing systemic exposure. Ref.: 9 Comment As the physico-chemical properties of bis(butylbenzoate) diaminotriazine aminopropyl- trisiloxane point towards a limited bioavailability, reliable data on toxicokinetics are considered essential for a risk assessment based on an oral NOAEL. The submitted study is of limited value for the assessment of oral bioavailability. It indicates that (at least) a small fraction of the administered dose of R0027603A becomes systemically bioavailable after oral administration, however, a quantification of bioavailability is not possible. Only the parent compound has been analyzed and no conclusions can be drawn with respect to probable breakdown products/metabolites. Further, the reliability of the data obtained is questionable: analyses were performed 10 month","page":25,"pdf":"sccs_o_055.pdf","row_type":"noael_study","study_id":"sccs_o_055_noael_005"}
SCCS Opinion NOAEL =10 - - oral 10 months NOAEL study {"citation":"Ref.: 9 Comment As the physico-chemical properties of bis(butylbenzoate) diaminotriazine aminopropyl- trisiloxane point towards a limited bioavailability, reliable data on toxicokinetics","dose":"It indicates that (at least) a small fraction of the administered dose of R0027603A becomes systemically bioavailable after oral administration, however, a quantification of bioavailability is not possible.","effect":"sis were performed up to 10 months after sampling), the toxicokinetic parameters were not determined. The overall conclusion by the study authors from these plasma profiles was that the test item could be detected in plasma of animals, thus showing systemic exposure. Ref.: 9 Comment As the physico-chemical properties of bis(butylbenzoate) diaminotriazine aminopropyl- trisiloxane point towards a limited bioavailability, reliable data on toxicokinetics are considered essential for a risk assessment based on an oral NOAEL. The submitted study is of limited value for the assessment of oral bioavailability. It indicates that (at least) a small fraction of the administered dose of R0027603A becomes systemically bioavailable after oral administration, however, a quantification of bioavailability is not possible. Only the parent compound has been analyzed and no conclusions can be drawn with respect to probable breakdown products/metabolites. Further, the reliability of the data obtained is questionable: analyses were performed 10 month","page":25,"pdf":"sccs_o_055.pdf","row_type":"noael_study","study_id":"sccs_o_055_noael_005"}
SCCS Opinion NOAEL =10 - - oral 10 months NOAEL study {"citation":"Ref.: 9 Comment As the physico-chemical properties of bis(butylbenzoate) diaminotriazine aminopropyl- trisiloxane point towards a limited bioavailability, reliable data on toxicokinetics","dose":"It indicates that (at least) a small fraction of the administered dose of R0027603A becomes systemically bioavailable after oral administration, however, a quantification of bioavailability is not possible.","effect":"sis were performed up to 10 months after sampling), the toxicokinetic parameters were not determined. The overall conclusion by the study authors from these plasma profiles was that the test item could be detected in plasma of animals, thus showing systemic exposure. Ref.: 9 Comment As the physico-chemical properties of bis(butylbenzoate) diaminotriazine aminopropyl- trisiloxane point towards a limited bioavailability, reliable data on toxicokinetics are considered essential for a risk assessment based on an oral NOAEL. The submitted study is of limited value for the assessment of oral bioavailability. It indicates that (at least) a small fraction of the administered dose of R0027603A becomes systemically bioavailable after oral administration, however, a quantification of bioavailability is not possible. Only the parent compound has been analyzed and no conclusions can be drawn with respect to probable breakdown products/metabolites. Further, the reliability of the data obtained is questionable: analyses were performed 10 month","page":25,"pdf":"sccs_o_055.pdf","row_type":"noael_study","study_id":"sccs_o_055_noael_005"}
SCCS Opinion NOAEL =100 % rat oral 13 week NOAEL study {"dose":"Absorption through the skin DAp = 4.46% Amount of cosmetic product applied daily A = 18 g/d Concentration of ingredient in finished product C = 10% Typical body weight of human = 60 kg Systemic exposure dose (SED) (A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60) = 1.34 mg/kg bw/d No adverse observed effect level NOAEL = 1000 mg/kg bw/d (13 we...","effect":"of oral absorption which would enable the safe use of the substance, a calculation has been done based on the available information. Absorption through the skin DAp = 4.46% Amount of cosmetic product applied daily A = 18 g/d Concentration of ingredient in finished product C = 10% Typical body weight of human = 60 kg Systemic exposure dose (SED) (A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60) = 1.34 mg/kg bw/d No adverse observed effect level NOAEL = 1000 mg/kg bw/d (13 week oral rat study) MOS = NOAEL/SED The uncorrected NOAEL (assuming 100 % absorption) is 1000 mg/kg bw/d. The expected SED from the use of bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane in sun protection products is 1.34 mg/kg bw/day. To achieve a MoS of 100, the NOAEL corrected for oral availability therefore needs to be at least 134 mg/kg bw/day. Using an assessment approach based on route-to-route extrapolation, a sufficient high MoS would only be obtained if oral bioavailability of ≥ 13.4% could be demonstrated. A calculation of","page":29,"pdf":"sccs_o_055.pdf","row_type":"noael_study","study_id":"sccs_o_055_noael_014"}
SCCS Opinion NOAEL =100 % rat oral 13 week NOAEL study {"dose":"Absorption through the skin DAp = 4.46% Amount of cosmetic product applied daily A = 18 g/d Concentration of ingredient in finished product C = 10% Typical body weight of human = 60 kg Systemic exposure dose (SED) (A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60) = 1.34 mg/kg bw/d No adverse observed effect level NOAEL = 1000 mg/kg bw/d (13 we...","effect":"of oral absorption which would enable the safe use of the substance, a calculation has been done based on the available information. Absorption through the skin DAp = 4.46% Amount of cosmetic product applied daily A = 18 g/d Concentration of ingredient in finished product C = 10% Typical body weight of human = 60 kg Systemic exposure dose (SED) (A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60) = 1.34 mg/kg bw/d No adverse observed effect level NOAEL = 1000 mg/kg bw/d (13 week oral rat study) MOS = NOAEL/SED The uncorrected NOAEL (assuming 100 % absorption) is 1000 mg/kg bw/d. The expected SED from the use of bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane in sun protection products is 1.34 mg/kg bw/day. To achieve a MoS of 100, the NOAEL corrected for oral availability therefore needs to be at least 134 mg/kg bw/day. Using an assessment approach based on route-to-route extrapolation, a sufficient high MoS would only be obtained if oral bioavailability of ≥ 13.4% could be demonstrated. A calculation of","page":29,"pdf":"sccs_o_055.pdf","row_type":"noael_study","study_id":"sccs_o_055_noael_014"}
SCCS Opinion NOAEL =100 % rat oral 13 week NOAEL study {"dose":"Absorption through the skin DAp = 4.46% Amount of cosmetic product applied daily A = 18 g/d Concentration of ingredient in finished product C = 10% Typical body weight of human = 60 kg Systemic exposure dose (SED) (A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60) = 1.34 mg/kg bw/d No adverse observed effect level NOAEL = 1000 mg/kg bw/d (13 we...","effect":"of oral absorption which would enable the safe use of the substance, a calculation has been done based on the available information. Absorption through the skin DAp = 4.46% Amount of cosmetic product applied daily A = 18 g/d Concentration of ingredient in finished product C = 10% Typical body weight of human = 60 kg Systemic exposure dose (SED) (A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60) = 1.34 mg/kg bw/d No adverse observed effect level NOAEL = 1000 mg/kg bw/d (13 week oral rat study) MOS = NOAEL/SED The uncorrected NOAEL (assuming 100 % absorption) is 1000 mg/kg bw/d. The expected SED from the use of bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane in sun protection products is 1.34 mg/kg bw/day. To achieve a MoS of 100, the NOAEL corrected for oral availability therefore needs to be at least 134 mg/kg bw/day. Using an assessment approach based on route-to-route extrapolation, a sufficient high MoS would only be obtained if oral bioavailability of ≥ 13.4% could be demonstrated. A calculation of","page":29,"pdf":"sccs_o_055.pdf","row_type":"noael_study","study_id":"sccs_o_055_noael_014"}
SCCS Opinion NOAEL =100 % rat oral 13 week NOAEL study {"dose":"Absorption through the skin DAp = 4.46% Amount of cosmetic product applied daily A = 18 g/d Concentration of ingredient in finished product C = 10% Typical body weight of human = 60 kg Systemic exposure dose (SED) (A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60) = 1.34 mg/kg bw/d No adverse observed effect level NOAEL = 1000 mg/kg bw/d (13 we...","effect":"of oral absorption which would enable the safe use of the substance, a calculation has been done based on the available information. Absorption through the skin DAp = 4.46% Amount of cosmetic product applied daily A = 18 g/d Concentration of ingredient in finished product C = 10% Typical body weight of human = 60 kg Systemic exposure dose (SED) (A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60) = 1.34 mg/kg bw/d No adverse observed effect level NOAEL = 1000 mg/kg bw/d (13 week oral rat study) MOS = NOAEL/SED The uncorrected NOAEL (assuming 100 % absorption) is 1000 mg/kg bw/d. The expected SED from the use of bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane in sun protection products is 1.34 mg/kg bw/day. To achieve a MoS of 100, the NOAEL corrected for oral availability therefore needs to be at least 134 mg/kg bw/day. Using an assessment approach based on route-to-route extrapolation, a sufficient high MoS would only be obtained if oral bioavailability of ≥ 13.4% could be demonstrated. A calculation of","page":29,"pdf":"sccs_o_055.pdf","row_type":"noael_study","study_id":"sccs_o_055_noael_014"}
SCCS Opinion NOAEL =1000 mg/kg bw/day rat oral Sub-chronic repeated dose toxicity {"citation":"Ref.: 24 3","dose":"SCCS/1335/10 Opinion on bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane __________________________________________________________________________________ 17 Conclusion Under the experimental conditions of the study, the No Observed Adverse Effect Level (NOAEL) was considered to be 1000 mg/kg bw/day in males and females.","effect":"SCCS/1335/10 Opinion on bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane __________________________________________________________________________________ 17 Conclusion Under the experimental conditions of the study, the No Observed Adverse Effect Level (NOAEL) was considered to be 1000 mg/kg bw/day in males and females. A NOEL could not be derived. Ref.: 24 3.3.5.2. Sub-chronic (90 days) oral toxicity Guideline: OECD TG 408 Species/strain: Rat, Sprague-Dawley; RjHan:SD Group size: 10 male and 10 female animals per dose group Test substance: R0027603A Batch: Pilote 2 Purity: 98.2% Dose levels: 100, 300 and 1000 mg/kg bw/d Route: oral (gavage) Vehicle: 0.5% carboxymethylcellulose, aqueous solution Dosing schedule: daily oral doses (gavage) for 91 days Dosage vol","page":17,"pdf":"sccs_o_055.pdf","row_type":"noael_study","study_id":"sccs_o_055_noael_001"}
SCCS Opinion NOAEL =1000 mg/kg bw/d - oral 28 day genotoxicity {"citation":"Ref.: 9 Comment No explanation was given by the study authors why substance-related (non adverse) effects as observed in the oral 28 day repeat-dose study were not seen in the oral 90 da","dose":"Slight changes in organ weight of test-item-treated animals (e.g. statistically significantly increased kidney weights of high-dose males) were observed.","effect":"ared to control mean values at the end of the treatment period. Slight changes in organ weight of test-item-treated animals (e.g. statistically significantly increased kidney weights of high-dose males) were observed. However, these changes were of low magnitude, not dose-related and partially of opposing trend between groups and sexes and thus not considered to be treatment-related. No treatment-related macroscopic and microscopic findings were noted. Conclusion Under the experimental conditions of this study, a No Observed Adverse Effect Level (NOAEL) of 1000 mg/kg bw/d was derived. Ref.: 9 Comment No explanation was given by the study authors why substance-related (non adverse) effects as observed in the oral 28 day repeat-dose study were not seen in the oral 90 day repeat- dose study. 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 gene mutation assay Guideline: OECD TG 471 / EC B.13/14 Species/strain: Salmonella typhimurium TA 1535, TA 1537, T","page":18,"pdf":"sccs_o_055.pdf","row_type":"noael_study","study_id":"sccs_o_055_noael_002"}
SCCS Opinion NOAEL =1000 mg/kg bw/day rat oral Sub-chronic repeated dose toxicity {"citation":"Ref.: 24 3","dose":"SCCS/1335/10 Opinion on bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane __________________________________________________________________________________ 17 Conclusion Under the experimental conditions of the study, the No Observed Adverse Effect Level (NOAEL) was considered to be 1000 mg/kg bw/day in males and females.","effect":"SCCS/1335/10 Opinion on bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane __________________________________________________________________________________ 17 Conclusion Under the experimental conditions of the study, the No Observed Adverse Effect Level (NOAEL) was considered to be 1000 mg/kg bw/day in males and females. A NOEL could not be derived. Ref.: 24 3.3.5.2. Sub-chronic (90 days) oral toxicity Guideline: OECD TG 408 Species/strain: Rat, Sprague-Dawley; RjHan:SD Group size: 10 male and 10 female animals per dose group Test substance: R0027603A Batch: Pilote 2 Purity: 98.2% Dose levels: 100, 300 and 1000 mg/kg bw/d Route: oral (gavage) Vehicle: 0.5% carboxymethylcellulose, aqueous solution Dosing schedule: daily oral doses (gavage) for 91 days Dosage vol","page":17,"pdf":"sccs_o_055.pdf","row_type":"noael_study","study_id":"sccs_o_055_noael_001"}
SCCS Opinion NOAEL =1000 mg/kg bw/d - oral 28 day genotoxicity {"citation":"Ref.: 9 Comment No explanation was given by the study authors why substance-related (non adverse) effects as observed in the oral 28 day repeat-dose study were not seen in the oral 90 da","dose":"Slight changes in organ weight of test-item-treated animals (e.g. statistically significantly increased kidney weights of high-dose males) were observed.","effect":"ared to control mean values at the end of the treatment period. Slight changes in organ weight of test-item-treated animals (e.g. statistically significantly increased kidney weights of high-dose males) were observed. However, these changes were of low magnitude, not dose-related and partially of opposing trend between groups and sexes and thus not considered to be treatment-related. No treatment-related macroscopic and microscopic findings were noted. Conclusion Under the experimental conditions of this study, a No Observed Adverse Effect Level (NOAEL) of 1000 mg/kg bw/d was derived. Ref.: 9 Comment No explanation was given by the study authors why substance-related (non adverse) effects as observed in the oral 28 day repeat-dose study were not seen in the oral 90 day repeat- dose study. 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 gene mutation assay Guideline: OECD TG 471 / EC B.13/14 Species/strain: Salmonella typhimurium TA 1535, TA 1537, T","page":18,"pdf":"sccs_o_055.pdf","row_type":"noael_study","study_id":"sccs_o_055_noael_002"}
SCCS Opinion NOAEL =1000 mg/kg bw/day rat oral Sub-chronic repeated dose toxicity {"citation":"Ref.: 24 3","dose":"SCCS/1335/10 Opinion on bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane __________________________________________________________________________________ 17 Conclusion Under the experimental conditions of the study, the No Observed Adverse Effect Level (NOAEL) was considered to be 1000 mg/kg bw/day in males and females.","effect":"SCCS/1335/10 Opinion on bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane __________________________________________________________________________________ 17 Conclusion Under the experimental conditions of the study, the No Observed Adverse Effect Level (NOAEL) was considered to be 1000 mg/kg bw/day in males and females. A NOEL could not be derived. Ref.: 24 3.3.5.2. Sub-chronic (90 days) oral toxicity Guideline: OECD TG 408 Species/strain: Rat, Sprague-Dawley; RjHan:SD Group size: 10 male and 10 female animals per dose group Test substance: R0027603A Batch: Pilote 2 Purity: 98.2% Dose levels: 100, 300 and 1000 mg/kg bw/d Route: oral (gavage) Vehicle: 0.5% carboxymethylcellulose, aqueous solution Dosing schedule: daily oral doses (gavage) for 91 days Dosage vol","page":17,"pdf":"sccs_o_055.pdf","row_type":"noael_study","study_id":"sccs_o_055_noael_001"}
SCCS Opinion NOAEL =1000 mg/kg bw/d - oral 28 day genotoxicity {"citation":"Ref.: 9 Comment No explanation was given by the study authors why substance-related (non adverse) effects as observed in the oral 28 day repeat-dose study were not seen in the oral 90 da","dose":"Slight changes in organ weight of test-item-treated animals (e.g. statistically significantly increased kidney weights of high-dose males) were observed.","effect":"ared to control mean values at the end of the treatment period. Slight changes in organ weight of test-item-treated animals (e.g. statistically significantly increased kidney weights of high-dose males) were observed. However, these changes were of low magnitude, not dose-related and partially of opposing trend between groups and sexes and thus not considered to be treatment-related. No treatment-related macroscopic and microscopic findings were noted. Conclusion Under the experimental conditions of this study, a No Observed Adverse Effect Level (NOAEL) of 1000 mg/kg bw/d was derived. Ref.: 9 Comment No explanation was given by the study authors why substance-related (non adverse) effects as observed in the oral 28 day repeat-dose study were not seen in the oral 90 day repeat- dose study. 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 gene mutation assay Guideline: OECD TG 471 / EC B.13/14 Species/strain: Salmonella typhimurium TA 1535, TA 1537, T","page":18,"pdf":"sccs_o_055.pdf","row_type":"noael_study","study_id":"sccs_o_055_noael_002"}
SCCS Opinion NOAEL =1000 mg/kg bw/day rat oral Sub-chronic repeated dose toxicity {"citation":"Ref.: 24 3","dose":"SCCS/1335/10 Opinion on bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane __________________________________________________________________________________ 17 Conclusion Under the experimental conditions of the study, the No Observed Adverse Effect Level (NOAEL) was considered to be 1000 mg/kg bw/day in males and females.","effect":"SCCS/1335/10 Opinion on bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane __________________________________________________________________________________ 17 Conclusion Under the experimental conditions of the study, the No Observed Adverse Effect Level (NOAEL) was considered to be 1000 mg/kg bw/day in males and females. A NOEL could not be derived. Ref.: 24 3.3.5.2. Sub-chronic (90 days) oral toxicity Guideline: OECD TG 408 Species/strain: Rat, Sprague-Dawley; RjHan:SD Group size: 10 male and 10 female animals per dose group Test substance: R0027603A Batch: Pilote 2 Purity: 98.2% Dose levels: 100, 300 and 1000 mg/kg bw/d Route: oral (gavage) Vehicle: 0.5% carboxymethylcellulose, aqueous solution Dosing schedule: daily oral doses (gavage) for 91 days Dosage vol","page":17,"pdf":"sccs_o_055.pdf","row_type":"noael_study","study_id":"sccs_o_055_noael_001"}
SCCS Opinion NOAEL =1000 mg/kg bw/d - oral 28 day genotoxicity {"citation":"Ref.: 9 Comment No explanation was given by the study authors why substance-related (non adverse) effects as observed in the oral 28 day repeat-dose study were not seen in the oral 90 da","dose":"Slight changes in organ weight of test-item-treated animals (e.g. statistically significantly increased kidney weights of high-dose males) were observed.","effect":"ared to control mean values at the end of the treatment period. Slight changes in organ weight of test-item-treated animals (e.g. statistically significantly increased kidney weights of high-dose males) were observed. However, these changes were of low magnitude, not dose-related and partially of opposing trend between groups and sexes and thus not considered to be treatment-related. No treatment-related macroscopic and microscopic findings were noted. Conclusion Under the experimental conditions of this study, a No Observed Adverse Effect Level (NOAEL) of 1000 mg/kg bw/d was derived. Ref.: 9 Comment No explanation was given by the study authors why substance-related (non adverse) effects as observed in the oral 28 day repeat-dose study were not seen in the oral 90 day repeat- dose study. 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 gene mutation assay Guideline: OECD TG 471 / EC B.13/14 Species/strain: Salmonella typhimurium TA 1535, TA 1537, T","page":18,"pdf":"sccs_o_055.pdf","row_type":"noael_study","study_id":"sccs_o_055_noael_002"}
Regulatory source 19 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
Regulatory source - 1 % human oral - - SOURCE_SUBDIR=sccs_o_055; REPORT_TITLE=OPINION ON Bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane COLIPA n° S85; OPINION_NUMBER=SCCS/1335/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 March 2011; VALUE_TEXT=1; DOSE=Safety evaluation For the calculation of a MoS, the SED (systemic exposure dose) is compared to the No- observed-adverse effect-level (NOAEL).; EFFECT=data were analysed at the 1% level using Dunnett’s test. Conclusion From the results of the study it can be concluded that the test substance is not phototoxic or photo-mutagenic in this assay system. Ref.: 8 Comment The range-finder experiment was performed without UV irradiation. 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation For the calculation of a MoS, the SED (systemic exposure dose) is compared to the No- observed-adverse effect-level (NOAEL). This means that an internal dose (the SED) is compared to an external dose (the NOAEL). The assessment approach taken for most cosmetic ingredients involves a route-to-route extrapolation for the MoS calculation, comparing the SED calculated for the dermal route to the NOAEL from an oral study. The direct comparison of the dermal SED to an oral NOAEL implicitly assumes full oral bioavailability. In cases where there are indications that oral bioavailability is low, the NOAEL from the oral toxicity study needs to; CITATION=Ref.: 8 Comment The range-finder experiment was performed without UV irradiation; CITATION_NUMBERS=[8]; REFERENCE=Ref.: 8 Comment The range-finder experiment was performed without UV irradiation; DETAILS_JSON={"cas_number":"207562-42-3","citation":"Ref.: 8 Comment The range-finder experiment was performed without UV irradiation","dose":"Safety evaluation For the calculation of a MoS, the SED (systemic exposure dose) is compared to the No- observed-adverse effect-level (NOAEL).","duration":"","effect":"data were analysed at the 1% level using Dunnett’s test. Conclusion From the results of the study it can be concluded that the test substance is not phototoxic or photo-mutagenic in this assay system. Ref.: 8 Comment The range-finder experiment was performed without UV irradiation. 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation For the calculation of a MoS, the SED (systemic exposure dose) is compared to the No- observed-adverse effect-level (NOAEL). This means that an internal dose (the SED) is compared to an external dose (the NOAEL). The assessment approach taken for most cosmetic ingredients involves a route-to-route extrapolation for the MoS calculation, comparing the SED calculated for the dermal route to the NOAEL from an oral study. The direct comparison of the dermal SED to an oral NOAEL implicitly assumes full oral bioavailability. In cases where there are indications that oral bioavailability is low, the NOAEL from the oral toxicity study needs to","endpoint":"","ingredient":"Bis(butylbenzoate)","loael_value":"","noael_unit":"%","noael_value":"1","page":28,"route":"oral","species":"human","study_id":"sccs_o_055_noael_006"}
Regulatory source - 1.34 mg/kg bw/day rat oral 13 week - SOURCE_SUBDIR=sccs_o_055; REPORT_TITLE=OPINION ON Bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane COLIPA n° S85; OPINION_NUMBER=SCCS/1335/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 March 2011; VALUE_TEXT=1.34; DOSE=dient in finished product C = 10% Typical body weight of human = 60 kg Systemic exposure dose (SED) (A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60) = 1.34 mg/kg bw/d No adverse observed effect level NOAEL = 1000 mg/kg bw/d (13 week oral rat study) MOS = NOAEL/SED The uncorrected NOAEL (assuming 100 % absorption) is 1000 mg/kg bw/d.; EFFECT=dient in finished product C = 10% Typical body weight of human = 60 kg Systemic exposure dose (SED) (A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60) = 1.34 mg/kg bw/d No adverse observed effect level NOAEL = 1000 mg/kg bw/d (13 week oral rat study) MOS = NOAEL/SED The uncorrected NOAEL (assuming 100 % absorption) is 1000 mg/kg bw/d. The expected SED from the use of bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane in sun protection products is 1.34 mg/kg bw/day. To achieve a MoS of 100, the NOAEL corrected for oral availability therefore needs to be at least 134 mg/kg bw/day. Using an assessment approach based on route-to-route extrapolation, a sufficient high MoS would only be obtained if oral bioavailability of ≥ 13.4% could be demonstrated. A calculation of the MoS based on route-to-route extrapolation requires quantification of the oral availability of bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane. Ideally this could have been investigated more thoroughly in the oral in vivo studies perfor; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"207562-42-3","citation":"","dose":"dient in finished product C = 10% Typical body weight of human = 60 kg Systemic exposure dose (SED) (A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60) = 1.34 mg/kg bw/d No adverse observed effect level NOAEL = 1000 mg/kg bw/d (13 week oral rat study) MOS = NOAEL/SED The uncorrected NOAEL (assuming 100 % absorption) is 1000 mg/kg bw/d.","duration":"13 week","effect":"dient in finished product C = 10% Typical body weight of human = 60 kg Systemic exposure dose (SED) (A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60) = 1.34 mg/kg bw/d No adverse observed effect level NOAEL = 1000 mg/kg bw/d (13 week oral rat study) MOS = NOAEL/SED The uncorrected NOAEL (assuming 100 % absorption) is 1000 mg/kg bw/d. The expected SED from the use of bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane in sun protection products is 1.34 mg/kg bw/day. To achieve a MoS of 100, the NOAEL corrected for oral availability therefore needs to be at least 134 mg/kg bw/day. Using an assessment approach based on route-to-route extrapolation, a sufficient high MoS would only be obtained if oral bioavailability of ≥ 13.4% could be demonstrated. A calculation of the MoS based on route-to-route extrapolation requires quantification of the oral availability of bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane. Ideally this could have been investigated more thoroughly in the oral in vivo studies perfor","endpoint":"","ingredient":"Bis(butylbenzoate)","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1.34","page":29,"route":"oral","species":"rat","study_id":"sccs_o_055_noael_016"}
Regulatory source - 3.3 - human oral - - SOURCE_SUBDIR=sccs_o_055; REPORT_TITLE=OPINION ON Bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane COLIPA n° S85; OPINION_NUMBER=SCCS/1335/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 March 2011; VALUE_TEXT=unclear:ation. 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation For the calculation of a MoS, the SED (systemic exposure dose) is compared to the No- observed-adverse effect-level (NOAEL). This means that an internal dose (the SED) is compared to an external dose (the NOAEL). The assessment approach taken for most cosmetic ingredients involves a route-to-route extrapolation for the MoS calculation, comparing the SED calculated for the dermal route to the NOAEL from an oral study. The direct comparison of the dermal SED to an oral NOAEL implicitly assumes full oral bioavailability. In cases where there are indications that oral bioavailability is low, the NOAEL from the oral toxicity study needs to be corrected by the percentage of oral bioavailability in order to perform an adequate route-to-route extrapolation. This requires information on the extent of oral bioavailability. In the case of bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane, an oral NOAEL of 100; DOSE=Safety evaluation For the calculation of a MoS, the SED (systemic exposure dose) is compared to the No- observed-adverse effect-level (NOAEL).; EFFECT=ation. 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation For the calculation of a MoS, the SED (systemic exposure dose) is compared to the No- observed-adverse effect-level (NOAEL). This means that an internal dose (the SED) is compared to an external dose (the NOAEL). The assessment approach taken for most cosmetic ingredients involves a route-to-route extrapolation for the MoS calculation, comparing the SED calculated for the dermal route to the NOAEL from an oral study. The direct comparison of the dermal SED to an oral NOAEL implicitly assumes full oral bioavailability. In cases where there are indications that oral bioavailability is low, the NOAEL from the oral toxicity study needs to be corrected by the percentage of oral bioavailability in order to perform an adequate route-to-route extrapolation. This requires information on the extent of oral bioavailability. In the case of bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane, an oral NOAEL of 100; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"207562-42-3","citation":"","dose":"Safety evaluation For the calculation of a MoS, the SED (systemic exposure dose) is compared to the No- observed-adverse effect-level (NOAEL).","duration":"","effect":"ation. 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation For the calculation of a MoS, the SED (systemic exposure dose) is compared to the No- observed-adverse effect-level (NOAEL). This means that an internal dose (the SED) is compared to an external dose (the NOAEL). The assessment approach taken for most cosmetic ingredients involves a route-to-route extrapolation for the MoS calculation, comparing the SED calculated for the dermal route to the NOAEL from an oral study. The direct comparison of the dermal SED to an oral NOAEL implicitly assumes full oral bioavailability. In cases where there are indications that oral bioavailability is low, the NOAEL from the oral toxicity study needs to be corrected by the percentage of oral bioavailability in order to perform an adequate route-to-route extrapolation. This requires information on the extent of oral bioavailability. In the case of bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane, an oral NOAEL of 100","endpoint":"","ingredient":"Bis(butylbenzoate)","loael_value":"","noael_unit":"","noael_value":"unclear:ation. 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation For the calculation of a MoS, the SED (systemic exposure dose) is compared to the No- observed-adverse effect-level (NOAEL). This means that an internal dose (the SED) is compared to an external dose (the NOAEL). The assessment approach taken for most cosmetic ingredients involves a route-to-route extrapolation for the MoS calculation, comparing the SED calculated for the dermal route to the NOAEL from an oral study. The direct comparison of the dermal SED to an oral NOAEL implicitly assumes full oral bioavailability. In cases where there are indications that oral bioavailability is low, the NOAEL from the oral toxicity study needs to be corrected by the percentage of oral bioavailability in order to perform an adequate route-to-route extrapolation. This requires information on the extent of oral bioavailability. In the case of bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane, an oral NOAEL of 100","page":28,"route":"oral","species":"human","study_id":"sccs_o_055_noael_008"}
Regulatory source - =4.46 % human oral - - SOURCE_SUBDIR=sccs_o_055; REPORT_TITLE=OPINION ON Bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane COLIPA n° S85; OPINION_NUMBER=SCCS/1335/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 March 2011; VALUE_TEXT== 4.46; DOSE=Absorption through the skin DAp = 4.46% Amount of cosmetic product applied daily A = 18 g/d Concentration of ingredient in finished product C = 10% Typical body weight of human = 60 kg Systemic exposure dose (SED) (A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100; EFFECT=SCCS-rejected applicant NOAEL: utylbenzoate) diaminotriazine aminopropyltrisiloxane __________________________________________________________________________________ 29 The available data point towards a very low oral bioavailability of S85, albeit they are insufficient to quantify the extent of oral absorption. While low systemic availability might be a favourable property of substances being intended to be used as UV filters, the SCCS is of the opinion that the submitted data are not appropriate for the calculation of a MoS based on an oral NOAEL, as an appropriate correction factor for the limited oral bioavailability cannot be derived. To determine the percentage of oral absorption which would enable the safe use of the substance, a calculation has been done based on the available information. Absorption through the skin DAp = 4.46% Amount of cosmetic product applied daily A = 18 g/d Concentration of ingredient in finished product C = 10% Typical body weight of human = 60 kg Systemic exposure dose (SED) (A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"207562-42-3","citation":"","dose":"Absorption through the skin DAp = 4.46% Amount of cosmetic product applied daily A = 18 g/d Concentration of ingredient in finished product C = 10% Typical body weight of human = 60 kg Systemic exposure dose (SED) (A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100","duration":"","effect":"SCCS-rejected applicant NOAEL: utylbenzoate) diaminotriazine aminopropyltrisiloxane __________________________________________________________________________________ 29 The available data point towards a very low oral bioavailability of S85, albeit they are insufficient to quantify the extent of oral absorption. While low systemic availability might be a favourable property of substances being intended to be used as UV filters, the SCCS is of the opinion that the submitted data are not appropriate for the calculation of a MoS based on an oral NOAEL, as an appropriate correction factor for the limited oral bioavailability cannot be derived. To determine the percentage of oral absorption which would enable the safe use of the substance, a calculation has been done based on the available information. Absorption through the skin DAp = 4.46% Amount of cosmetic product applied daily A = 18 g/d Concentration of ingredient in finished product C = 10% Typical body weight of human = 60 kg Systemic exposure dose (SED) (A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100","endpoint":"","ingredient":"Bis(butylbenzoate)","loael_value":"","noael_unit":"%","noael_value":"= 4.46","page":29,"route":"oral","species":"human","study_id":"sccs_o_055_noael_012"}
Regulatory source - 8 - human oral - - SOURCE_SUBDIR=sccs_o_055; REPORT_TITLE=OPINION ON Bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane COLIPA n° S85; OPINION_NUMBER=SCCS/1335/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 March 2011; VALUE_TEXT=unclear:the study it can be concluded that the test substance is not phototoxic or photo-mutagenic in this assay system. Ref.: 8 Comment The range-finder experiment was performed without UV irradiation. 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation For the calculation of a MoS, the SED (systemic exposure dose) is compared to the No- observed-adverse effect-level (NOAEL). This means that an internal dose (the SED) is compared to an external dose (the NOAEL). The assessment approach taken for most cosmetic ingredients involves a route-to-route extrapolation for the MoS calculation, comparing the SED calculated for the dermal route to the NOAEL from an oral study. The direct comparison of the dermal SED to an oral NOAEL implicitly assumes full oral bioavailability. In cases where there are indications that oral bioavailability is low, the NOAEL from the oral toxicity study needs to be corrected by the percentage of oral bioavailability in order to perform an adequate; DOSE=Safety evaluation For the calculation of a MoS, the SED (systemic exposure dose) is compared to the No- observed-adverse effect-level (NOAEL).; EFFECT=the study it can be concluded that the test substance is not phototoxic or photo-mutagenic in this assay system. Ref.: 8 Comment The range-finder experiment was performed without UV irradiation. 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation For the calculation of a MoS, the SED (systemic exposure dose) is compared to the No- observed-adverse effect-level (NOAEL). This means that an internal dose (the SED) is compared to an external dose (the NOAEL). The assessment approach taken for most cosmetic ingredients involves a route-to-route extrapolation for the MoS calculation, comparing the SED calculated for the dermal route to the NOAEL from an oral study. The direct comparison of the dermal SED to an oral NOAEL implicitly assumes full oral bioavailability. In cases where there are indications that oral bioavailability is low, the NOAEL from the oral toxicity study needs to be corrected by the percentage of oral bioavailability in order to perform an adequate; CITATION=Ref.: 8 Comment The range-finder experiment was performed without UV irradiation; CITATION_NUMBERS=[8]; REFERENCE=Ref.: 8 Comment The range-finder experiment was performed without UV irradiation; DETAILS_JSON={"cas_number":"207562-42-3","citation":"Ref.: 8 Comment The range-finder experiment was performed without UV irradiation","dose":"Safety evaluation For the calculation of a MoS, the SED (systemic exposure dose) is compared to the No- observed-adverse effect-level (NOAEL).","duration":"","effect":"the study it can be concluded that the test substance is not phototoxic or photo-mutagenic in this assay system. Ref.: 8 Comment The range-finder experiment was performed without UV irradiation. 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation For the calculation of a MoS, the SED (systemic exposure dose) is compared to the No- observed-adverse effect-level (NOAEL). This means that an internal dose (the SED) is compared to an external dose (the NOAEL). The assessment approach taken for most cosmetic ingredients involves a route-to-route extrapolation for the MoS calculation, comparing the SED calculated for the dermal route to the NOAEL from an oral study. The direct comparison of the dermal SED to an oral NOAEL implicitly assumes full oral bioavailability. In cases where there are indications that oral bioavailability is low, the NOAEL from the oral toxicity study needs to be corrected by the percentage of oral bioavailability in order to perform an adequate","endpoint":"","ingredient":"Bis(butylbenzoate)","loael_value":"","noael_unit":"","noael_value":"unclear:the study it can be concluded that the test substance is not phototoxic or photo-mutagenic in this assay system. Ref.: 8 Comment The range-finder experiment was performed without UV irradiation. 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation For the calculation of a MoS, the SED (systemic exposure dose) is compared to the No- observed-adverse effect-level (NOAEL). This means that an internal dose (the SED) is compared to an external dose (the NOAEL). The assessment approach taken for most cosmetic ingredients involves a route-to-route extrapolation for the MoS calculation, comparing the SED calculated for the dermal route to the NOAEL from an oral study. The direct comparison of the dermal SED to an oral NOAEL implicitly assumes full oral bioavailability. In cases where there are indications that oral bioavailability is low, the NOAEL from the oral toxicity study needs to be corrected by the percentage of oral bioavailability in order to perform an adequate","page":28,"route":"oral","species":"human","study_id":"sccs_o_055_noael_007"}
Regulatory source - 10 - - oral 10 months - SOURCE_SUBDIR=sccs_o_055; REPORT_TITLE=OPINION ON Bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane COLIPA n° S85; OPINION_NUMBER=SCCS/1335/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 March 2011; VALUE_TEXT=unclear:sis were performed up to 10 months after sampling), the toxicokinetic parameters were not determined. The overall conclusion by the study authors from these plasma profiles was that the test item could be detected in plasma of animals, thus showing systemic exposure. Ref.: 9 Comment As the physico-chemical properties of bis(butylbenzoate) diaminotriazine aminopropyl- trisiloxane point towards a limited bioavailability, reliable data on toxicokinetics are considered essential for a risk assessment based on an oral NOAEL. The submitted study is of limited value for the assessment of oral bioavailability. It indicates that (at least) a small fraction of the administered dose of R0027603A becomes systemically bioavailable after oral administration, however, a quantification of bioavailability is not possible. Only the parent compound has been analyzed and no conclusions can be drawn with respect to probable breakdown products/metabolites. Further, the reliability of the data obtained is questionable: analyses were performed 10 month; DOSE=It indicates that (at least) a small fraction of the administered dose of R0027603A becomes systemically bioavailable after oral administration, however, a quantification of bioavailability is not possible.; EFFECT=sis were performed up to 10 months after sampling), the toxicokinetic parameters were not determined. The overall conclusion by the study authors from these plasma profiles was that the test item could be detected in plasma of animals, thus showing systemic exposure. Ref.: 9 Comment As the physico-chemical properties of bis(butylbenzoate) diaminotriazine aminopropyl- trisiloxane point towards a limited bioavailability, reliable data on toxicokinetics are considered essential for a risk assessment based on an oral NOAEL. The submitted study is of limited value for the assessment of oral bioavailability. It indicates that (at least) a small fraction of the administered dose of R0027603A becomes systemically bioavailable after oral administration, however, a quantification of bioavailability is not possible. Only the parent compound has been analyzed and no conclusions can be drawn with respect to probable breakdown products/metabolites. Further, the reliability of the data obtained is questionable: analyses were performed 10 month; CITATION=Ref.: 9 Comment As the physico-chemical properties of bis(butylbenzoate) diaminotriazine aminopropyl- trisiloxane point towards a limited bioavailability, reliable data on toxicokinetics; CITATION_NUMBERS=[9]; REFERENCE=Ref.: 9 Comment As the physico-chemical properties of bis(butylbenzoate) diaminotriazine aminopropyl- trisiloxane point towards a limited bioavailability, reliable data on toxicokinetics; DETAILS_JSON={"cas_number":"207562-42-3","citation":"Ref.: 9 Comment As the physico-chemical properties of bis(butylbenzoate) diaminotriazine aminopropyl- trisiloxane point towards a limited bioavailability, reliable data on toxicokinetics","dose":"It indicates that (at least) a small fraction of the administered dose of R0027603A becomes systemically bioavailable after oral administration, however, a quantification of bioavailability is not possible.","duration":"10 months","effect":"sis were performed up to 10 months after sampling), the toxicokinetic parameters were not determined. The overall conclusion by the study authors from these plasma profiles was that the test item could be detected in plasma of animals, thus showing systemic exposure. Ref.: 9 Comment As the physico-chemical properties of bis(butylbenzoate) diaminotriazine aminopropyl- trisiloxane point towards a limited bioavailability, reliable data on toxicokinetics are considered essential for a risk assessment based on an oral NOAEL. The submitted study is of limited value for the assessment of oral bioavailability. It indicates that (at least) a small fraction of the administered dose of R0027603A becomes systemically bioavailable after oral administration, however, a quantification of bioavailability is not possible. Only the parent compound has been analyzed and no conclusions can be drawn with respect to probable breakdown products/metabolites. Further, the reliability of the data obtained is questionable: analyses were performed 10 month","endpoint":"","ingredient":"Bis(butylbenzoate)","loael_value":"","noael_unit":"","noael_value":"unclear:sis were performed up to 10 months after sampling), the toxicokinetic parameters were not determined. The overall conclusion by the study authors from these plasma profiles was that the test item could be detected in plasma of animals, thus showing systemic exposure. Ref.: 9 Comment As the physico-chemical properties of bis(butylbenzoate) diaminotriazine aminopropyl- trisiloxane point towards a limited bioavailability, reliable data on toxicokinetics are considered essential for a risk assessment based on an oral NOAEL. The submitted study is of limited value for the assessment of oral bioavailability. It indicates that (at least) a small fraction of the administered dose of R0027603A becomes systemically bioavailable after oral administration, however, a quantification of bioavailability is not possible. Only the parent compound has been analyzed and no conclusions can be drawn with respect to probable breakdown products/metabolites. Further, the reliability of the data obtained is questionable: analyses were performed 10 month","page":25,"route":"oral","species":"","study_id":"sccs_o_055_noael_005"}
Regulatory source - 10 % - oral 90-day - SOURCE_SUBDIR=sccs_o_055; REPORT_TITLE=OPINION ON Bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane COLIPA n° S85; OPINION_NUMBER=SCCS/1335/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 March 2011; VALUE_TEXT=10.0; EFFECT=tagenic. Thus, under the assay conditions used in the respective test, bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane was neither phototoxic nor photomutagenic. 4. CONCLUSION The SCCS considers that the safe use of Bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane as an UV-filter in cosmetic products in a concentration up to maximum 10.0% cannot be assessed based on the available data. As low oral bioavailability of the substance is anticipated, a quantitative risk assessment based on the oral NOAEL cannot be performed in the absence of adequate information on the extent of internal exposure. In order to properly assess the safety of Bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane additional data such as a 90-day dermal toxicity study or sound data on oral bioavailability are required. However, the SCCS is aware that such studies are no longer permitted in the European Union. Further recommendation The SCCS already addresses the issue of limited bioavailability in the revisions of its Notes of Gu; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"207562-42-3","citation":"","dose":"","duration":"90-day","effect":"tagenic. Thus, under the assay conditions used in the respective test, bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane was neither phototoxic nor photomutagenic. 4. CONCLUSION The SCCS considers that the safe use of Bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane as an UV-filter in cosmetic products in a concentration up to maximum 10.0% cannot be assessed based on the available data. As low oral bioavailability of the substance is anticipated, a quantitative risk assessment based on the oral NOAEL cannot be performed in the absence of adequate information on the extent of internal exposure. In order to properly assess the safety of Bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane additional data such as a 90-day dermal toxicity study or sound data on oral bioavailability are required. However, the SCCS is aware that such studies are no longer permitted in the European Union. Further recommendation The SCCS already addresses the issue of limited bioavailability in the revisions of its Notes of Gu","endpoint":"","ingredient":"Bis(butylbenzoate)","loael_value":"","noael_unit":"%","noael_value":"10.0","page":31,"route":"oral","species":"","study_id":"sccs_o_055_noael_019"}
Regulatory source - 100 % rat oral 13 week - SOURCE_SUBDIR=sccs_o_055; REPORT_TITLE=OPINION ON Bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane COLIPA n° S85; OPINION_NUMBER=SCCS/1335/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 March 2011; VALUE_TEXT=100; DOSE=Absorption through the skin DAp = 4.46% Amount of cosmetic product applied daily A = 18 g/d Concentration of ingredient in finished product C = 10% Typical body weight of human = 60 kg Systemic exposure dose (SED) (A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60) = 1.34 mg/kg bw/d No adverse observed effect level NOAEL = 1000 mg/kg bw/d (13 we...; EFFECT=of oral absorption which would enable the safe use of the substance, a calculation has been done based on the available information. Absorption through the skin DAp = 4.46% Amount of cosmetic product applied daily A = 18 g/d Concentration of ingredient in finished product C = 10% Typical body weight of human = 60 kg Systemic exposure dose (SED) (A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60) = 1.34 mg/kg bw/d No adverse observed effect level NOAEL = 1000 mg/kg bw/d (13 week oral rat study) MOS = NOAEL/SED The uncorrected NOAEL (assuming 100 % absorption) is 1000 mg/kg bw/d. The expected SED from the use of bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane in sun protection products is 1.34 mg/kg bw/day. To achieve a MoS of 100, the NOAEL corrected for oral availability therefore needs to be at least 134 mg/kg bw/day. Using an assessment approach based on route-to-route extrapolation, a sufficient high MoS would only be obtained if oral bioavailability of ≥ 13.4% could be demonstrated. A calculation of; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"207562-42-3","citation":"","dose":"Absorption through the skin DAp = 4.46% Amount of cosmetic product applied daily A = 18 g/d Concentration of ingredient in finished product C = 10% Typical body weight of human = 60 kg Systemic exposure dose (SED) (A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60) = 1.34 mg/kg bw/d No adverse observed effect level NOAEL = 1000 mg/kg bw/d (13 we...","duration":"13 week","effect":"of oral absorption which would enable the safe use of the substance, a calculation has been done based on the available information. Absorption through the skin DAp = 4.46% Amount of cosmetic product applied daily A = 18 g/d Concentration of ingredient in finished product C = 10% Typical body weight of human = 60 kg Systemic exposure dose (SED) (A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60) = 1.34 mg/kg bw/d No adverse observed effect level NOAEL = 1000 mg/kg bw/d (13 week oral rat study) MOS = NOAEL/SED The uncorrected NOAEL (assuming 100 % absorption) is 1000 mg/kg bw/d. The expected SED from the use of bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane in sun protection products is 1.34 mg/kg bw/day. To achieve a MoS of 100, the NOAEL corrected for oral availability therefore needs to be at least 134 mg/kg bw/day. Using an assessment approach based on route-to-route extrapolation, a sufficient high MoS would only be obtained if oral bioavailability of ≥ 13.4% could be demonstrated. A calculation of","endpoint":"","ingredient":"Bis(butylbenzoate)","loael_value":"","noael_unit":"%","noael_value":"100","page":29,"route":"oral","species":"rat","study_id":"sccs_o_055_noael_014"}
Regulatory source - 100 % rat oral 13 week - SOURCE_SUBDIR=sccs_o_055; REPORT_TITLE=OPINION ON Bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane COLIPA n° S85; OPINION_NUMBER=SCCS/1335/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 March 2011; VALUE_TEXT=100; DOSE=Absorption through the skin DAp = 4.46% Amount of cosmetic product applied daily A = 18 g/d Concentration of ingredient in finished product C = 10% Typical body weight of human = 60 kg Systemic exposure dose (SED) (A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60) = 1.34 mg/kg bw/d No adverse observed effect level NOAEL = 1000 mg/kg bw/d (13 we...; EFFECT=uld enable the safe use of the substance, a calculation has been done based on the available information. Absorption through the skin DAp = 4.46% Amount of cosmetic product applied daily A = 18 g/d Concentration of ingredient in finished product C = 10% Typical body weight of human = 60 kg Systemic exposure dose (SED) (A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60) = 1.34 mg/kg bw/d No adverse observed effect level NOAEL = 1000 mg/kg bw/d (13 week oral rat study) MOS = NOAEL/SED The uncorrected NOAEL (assuming 100 % absorption) is 1000 mg/kg bw/d. The expected SED from the use of bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane in sun protection products is 1.34 mg/kg bw/day. To achieve a MoS of 100, the NOAEL corrected for oral availability therefore needs to be at least 134 mg/kg bw/day. Using an assessment approach based on route-to-route extrapolation, a sufficient high MoS would only be obtained if oral bioavailability of ≥ 13.4% could be demonstrated. A calculation of the MoS based on route-to-; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"207562-42-3","citation":"","dose":"Absorption through the skin DAp = 4.46% Amount of cosmetic product applied daily A = 18 g/d Concentration of ingredient in finished product C = 10% Typical body weight of human = 60 kg Systemic exposure dose (SED) (A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60) = 1.34 mg/kg bw/d No adverse observed effect level NOAEL = 1000 mg/kg bw/d (13 we...","duration":"13 week","effect":"uld enable the safe use of the substance, a calculation has been done based on the available information. Absorption through the skin DAp = 4.46% Amount of cosmetic product applied daily A = 18 g/d Concentration of ingredient in finished product C = 10% Typical body weight of human = 60 kg Systemic exposure dose (SED) (A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60) = 1.34 mg/kg bw/d No adverse observed effect level NOAEL = 1000 mg/kg bw/d (13 week oral rat study) MOS = NOAEL/SED The uncorrected NOAEL (assuming 100 % absorption) is 1000 mg/kg bw/d. The expected SED from the use of bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane in sun protection products is 1.34 mg/kg bw/day. To achieve a MoS of 100, the NOAEL corrected for oral availability therefore needs to be at least 134 mg/kg bw/day. Using an assessment approach based on route-to-route extrapolation, a sufficient high MoS would only be obtained if oral bioavailability of ≥ 13.4% could be demonstrated. A calculation of the MoS based on route-to-","endpoint":"","ingredient":"Bis(butylbenzoate)","loael_value":"","noael_unit":"%","noael_value":"100","page":29,"route":"oral","species":"rat","study_id":"sccs_o_055_noael_015"}
Regulatory source - 1000 mg/kg bw/d - oral - - SOURCE_SUBDIR=sccs_o_055; REPORT_TITLE=OPINION ON Bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane COLIPA n° S85; OPINION_NUMBER=SCCS/1335/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 March 2011; VALUE_TEXT=1000; DOSE=Safety evaluation For the calculation of a MoS, the SED (systemic exposure dose) is compared to the No- observed-adverse effect-level (NOAEL).; EFFECT=No data submitted 3.3.13. Safety evaluation For the calculation of a MoS, the SED (systemic exposure dose) is compared to the No- observed-adverse effect-level (NOAEL). This means that an internal dose (the SED) is compared to an external dose (the NOAEL). The assessment approach taken for most cosmetic ingredients involves a route-to-route extrapolation for the MoS calculation, comparing the SED calculated for the dermal route to the NOAEL from an oral study. The direct comparison of the dermal SED to an oral NOAEL implicitly assumes full oral bioavailability. In cases where there are indications that oral bioavailability is low, the NOAEL from the oral toxicity study needs to be corrected by the percentage of oral bioavailability in order to perform an adequate route-to-route extrapolation. This requires information on the extent of oral bioavailability. In the case of bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane, an oral NOAEL of 1000 mg/kg bw/d is available for MoS calculation. To a limited extent, conclusio; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"207562-42-3","citation":"","dose":"Safety evaluation For the calculation of a MoS, the SED (systemic exposure dose) is compared to the No- observed-adverse effect-level (NOAEL).","duration":"","effect":"No data submitted 3.3.13. Safety evaluation For the calculation of a MoS, the SED (systemic exposure dose) is compared to the No- observed-adverse effect-level (NOAEL). This means that an internal dose (the SED) is compared to an external dose (the NOAEL). The assessment approach taken for most cosmetic ingredients involves a route-to-route extrapolation for the MoS calculation, comparing the SED calculated for the dermal route to the NOAEL from an oral study. The direct comparison of the dermal SED to an oral NOAEL implicitly assumes full oral bioavailability. In cases where there are indications that oral bioavailability is low, the NOAEL from the oral toxicity study needs to be corrected by the percentage of oral bioavailability in order to perform an adequate route-to-route extrapolation. This requires information on the extent of oral bioavailability. In the case of bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane, an oral NOAEL of 1000 mg/kg bw/d is available for MoS calculation. To a limited extent, conclusio","endpoint":"","ingredient":"Bis(butylbenzoate)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"1000","page":28,"route":"oral","species":"","study_id":"sccs_o_055_noael_009"}
Regulatory source - 1000 mg/kg bw/d - oral - - SOURCE_SUBDIR=sccs_o_055; REPORT_TITLE=OPINION ON Bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane COLIPA n° S85; OPINION_NUMBER=SCCS/1335/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 March 2011; VALUE_TEXT=1000; DOSE=This means that an internal dose (the SED) is compared to an external dose (the NOAEL).; EFFECT=he No- observed-adverse effect-level (NOAEL). This means that an internal dose (the SED) is compared to an external dose (the NOAEL). The assessment approach taken for most cosmetic ingredients involves a route-to-route extrapolation for the MoS calculation, comparing the SED calculated for the dermal route to the NOAEL from an oral study. The direct comparison of the dermal SED to an oral NOAEL implicitly assumes full oral bioavailability. In cases where there are indications that oral bioavailability is low, the NOAEL from the oral toxicity study needs to be corrected by the percentage of oral bioavailability in order to perform an adequate route-to-route extrapolation. This requires information on the extent of oral bioavailability. In the case of bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane, an oral NOAEL of 1000 mg/kg bw/d is available for MoS calculation. To a limited extent, conclusions on bioavailability and oral absorption of bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane can be drawn from its ph; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"207562-42-3","citation":"","dose":"This means that an internal dose (the SED) is compared to an external dose (the NOAEL).","duration":"","effect":"he No- observed-adverse effect-level (NOAEL). This means that an internal dose (the SED) is compared to an external dose (the NOAEL). The assessment approach taken for most cosmetic ingredients involves a route-to-route extrapolation for the MoS calculation, comparing the SED calculated for the dermal route to the NOAEL from an oral study. The direct comparison of the dermal SED to an oral NOAEL implicitly assumes full oral bioavailability. In cases where there are indications that oral bioavailability is low, the NOAEL from the oral toxicity study needs to be corrected by the percentage of oral bioavailability in order to perform an adequate route-to-route extrapolation. This requires information on the extent of oral bioavailability. In the case of bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane, an oral NOAEL of 1000 mg/kg bw/d is available for MoS calculation. To a limited extent, conclusions on bioavailability and oral absorption of bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane can be drawn from its ph","endpoint":"","ingredient":"Bis(butylbenzoate)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"1000","page":28,"route":"oral","species":"","study_id":"sccs_o_055_noael_010"}
Regulatory source - 1000 mg/kg bw/d - oral 90 day - SOURCE_SUBDIR=sccs_o_055; REPORT_TITLE=OPINION ON Bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane COLIPA n° S85; OPINION_NUMBER=SCCS/1335/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 March 2011; VALUE_TEXT=1000; DOSE=In the case of bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane, an oral NOAEL of 1000 mg/kg bw/d is available for MoS calculation.; EFFECT=to the NOAEL from an oral study. The direct comparison of the dermal SED to an oral NOAEL implicitly assumes full oral bioavailability. In cases where there are indications that oral bioavailability is low, the NOAEL from the oral toxicity study needs to be corrected by the percentage of oral bioavailability in order to perform an adequate route-to-route extrapolation. This requires information on the extent of oral bioavailability. In the case of bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane, an oral NOAEL of 1000 mg/kg bw/d is available for MoS calculation. To a limited extent, conclusions on bioavailability and oral absorption of bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane can be drawn from its physico-chemical properties and from the 90 day oral toxicity study, where plasma levels of the substance have been determined in a satellite group. The very low water solubility of 0.0001 mg/l, the high molecular weight of 741.12 g/mol and the high log Pow value of 9.4 indicate that the substance has low bioa; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"207562-42-3","citation":"","dose":"In the case of bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane, an oral NOAEL of 1000 mg/kg bw/d is available for MoS calculation.","duration":"90 day","effect":"to the NOAEL from an oral study. The direct comparison of the dermal SED to an oral NOAEL implicitly assumes full oral bioavailability. In cases where there are indications that oral bioavailability is low, the NOAEL from the oral toxicity study needs to be corrected by the percentage of oral bioavailability in order to perform an adequate route-to-route extrapolation. This requires information on the extent of oral bioavailability. In the case of bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane, an oral NOAEL of 1000 mg/kg bw/d is available for MoS calculation. To a limited extent, conclusions on bioavailability and oral absorption of bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane can be drawn from its physico-chemical properties and from the 90 day oral toxicity study, where plasma levels of the substance have been determined in a satellite group. The very low water solubility of 0.0001 mg/l, the high molecular weight of 741.12 g/mol and the high log Pow value of 9.4 indicate that the substance has low bioa","endpoint":"","ingredient":"Bis(butylbenzoate)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"1000","page":28,"route":"oral","species":"","study_id":"sccs_o_055_noael_011"}
Regulatory source - =1000 mg/kg bw/d rat oral 13 week - SOURCE_SUBDIR=sccs_o_055; REPORT_TITLE=OPINION ON Bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane COLIPA n° S85; OPINION_NUMBER=SCCS/1335/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 March 2011; VALUE_TEXT== 1000; DOSE=Absorption through the skin DAp = 4.46% Amount of cosmetic product applied daily A = 18 g/d Concentration of ingredient in finished product C = 10% Typical body weight of human = 60 kg Systemic exposure dose (SED) (A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60) = 1.34 mg/kg bw/d No adverse observed effect level NOAEL = 1000 mg/kg bw/d (13 we...; EFFECT=l bioavailability cannot be derived. To determine the percentage of oral absorption which would enable the safe use of the substance, a calculation has been done based on the available information. Absorption through the skin DAp = 4.46% Amount of cosmetic product applied daily A = 18 g/d Concentration of ingredient in finished product C = 10% Typical body weight of human = 60 kg Systemic exposure dose (SED) (A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60) = 1.34 mg/kg bw/d No adverse observed effect level NOAEL = 1000 mg/kg bw/d (13 week oral rat study) MOS = NOAEL/SED The uncorrected NOAEL (assuming 100 % absorption) is 1000 mg/kg bw/d. The expected SED from the use of bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane in sun protection products is 1.34 mg/kg bw/day. To achieve a MoS of 100, the NOAEL corrected for oral availability therefore needs to be at least 134 mg/kg bw/day. Using an assessment approach based on route-to-route extrapolation, a sufficient high MoS would only be obtained if oral b; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"207562-42-3","citation":"","dose":"Absorption through the skin DAp = 4.46% Amount of cosmetic product applied daily A = 18 g/d Concentration of ingredient in finished product C = 10% Typical body weight of human = 60 kg Systemic exposure dose (SED) (A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60) = 1.34 mg/kg bw/d No adverse observed effect level NOAEL = 1000 mg/kg bw/d (13 we...","duration":"13 week","effect":"l bioavailability cannot be derived. To determine the percentage of oral absorption which would enable the safe use of the substance, a calculation has been done based on the available information. Absorption through the skin DAp = 4.46% Amount of cosmetic product applied daily A = 18 g/d Concentration of ingredient in finished product C = 10% Typical body weight of human = 60 kg Systemic exposure dose (SED) (A (g/d) x 1000 mg/g x C (%)/100 x Dap (%)/100 /60) = 1.34 mg/kg bw/d No adverse observed effect level NOAEL = 1000 mg/kg bw/d (13 week oral rat study) MOS = NOAEL/SED The uncorrected NOAEL (assuming 100 % absorption) is 1000 mg/kg bw/d. The expected SED from the use of bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane in sun protection products is 1.34 mg/kg bw/day. To achieve a MoS of 100, the NOAEL corrected for oral availability therefore needs to be at least 134 mg/kg bw/day. Using an assessment approach based on route-to-route extrapolation, a sufficient high MoS would only be obtained if oral b","endpoint":"","ingredient":"Bis(butylbenzoate)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 1000","page":29,"route":"oral","species":"rat","study_id":"sccs_o_055_noael_013"}
Regulatory source developmental toxicity 1000 mg/kg bw/day - - developmental developmental toxicity SOURCE_SUBDIR=sccs_o_055; REPORT_TITLE=OPINION ON Bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane COLIPA n° S85; OPINION_NUMBER=SCCS/1335/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 March 2011; VALUE_TEXT=1000; DOSE=Dilated ureter was also observed in one of the animals having shown dilated renal pelvis at 1000 mg/kg bw/day.; EFFECT=Dilated ureter was also observed in one of the animals having shown dilated renal pelvis at 1000 mg/kg bw/day. As the incidences of these soft-tissue findings were low, they were not ascribed to substance treatment. Skeletal malformations and variations – if present- were observed at low incidences did not reach statistically significant level and remained within the historical control ranges. Under the experimental conditions of this study, 1000 mg/kg bw/day was identified as the No Observed Effect Adverse Level (NOAEL) for maternal and foetal developmental toxicity. Ref.: 14 Comment Mean foetal body weight was increased in the groups given 100 or 1000 mg/kg bw/day and reached a statistically significant level when compared to the control group. Since the difference from the mean control value was only +3% (6.02 g in the 100 and 1000 mg/kg bw/day groups vs. 5.82 g in the control group) and no dose-relationship was noted, the applicant considered mean foetal body weights to be unaffected by the test item treatment. 3.3.9. Toxic; CITATION=Ref.: 14 Comment Mean foetal body weight was increased in the groups given 100 or 1000 mg/kg bw/day and reached a statistically significant level when compared to the control group; CITATION_NUMBERS=[14,100,1000]; REFERENCE=Ref.: 14 Comment Mean foetal body weight was increased in the groups given 100 or 1000 mg/kg bw/day and reached a statistically significant level when compared to the control group; DETAILS_JSON={"cas_number":"207562-42-3","citation":"Ref.: 14 Comment Mean foetal body weight was increased in the groups given 100 or 1000 mg/kg bw/day and reached a statistically significant level when compared to the control group","dose":"Dilated ureter was also observed in one of the animals having shown dilated renal pelvis at 1000 mg/kg bw/day.","duration":"developmental","effect":"Dilated ureter was also observed in one of the animals having shown dilated renal pelvis at 1000 mg/kg bw/day. As the incidences of these soft-tissue findings were low, they were not ascribed to substance treatment. Skeletal malformations and variations – if present- were observed at low incidences did not reach statistically significant level and remained within the historical control ranges. Under the experimental conditions of this study, 1000 mg/kg bw/day was identified as the No Observed Effect Adverse Level (NOAEL) for maternal and foetal developmental toxicity. Ref.: 14 Comment Mean foetal body weight was increased in the groups given 100 or 1000 mg/kg bw/day and reached a statistically significant level when compared to the control group. Since the difference from the mean control value was only +3% (6.02 g in the 100 and 1000 mg/kg bw/day groups vs. 5.82 g in the control group) and no dose-relationship was noted, the applicant considered mean foetal body weights to be unaffected by the test item treatment. 3.3.9. Toxic","endpoint":"developmental toxicity","ingredient":"Bis(butylbenzoate)","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":24,"route":"","species":"","study_id":"sccs_o_055_noael_004"}
Regulatory source genotoxicity 1000 mg/kg bw/d - oral 28 day genotoxicity SOURCE_SUBDIR=sccs_o_055; REPORT_TITLE=OPINION ON Bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane COLIPA n° S85; OPINION_NUMBER=SCCS/1335/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 March 2011; VALUE_TEXT=1000; DOSE=Slight changes in organ weight of test-item-treated animals (e.g. statistically significantly increased kidney weights of high-dose males) were observed.; EFFECT=ared to control mean values at the end of the treatment period. Slight changes in organ weight of test-item-treated animals (e.g. statistically significantly increased kidney weights of high-dose males) were observed. However, these changes were of low magnitude, not dose-related and partially of opposing trend between groups and sexes and thus not considered to be treatment-related. No treatment-related macroscopic and microscopic findings were noted. Conclusion Under the experimental conditions of this study, a No Observed Adverse Effect Level (NOAEL) of 1000 mg/kg bw/d was derived. Ref.: 9 Comment No explanation was given by the study authors why substance-related (non adverse) effects as observed in the oral 28 day repeat-dose study were not seen in the oral 90 day repeat- dose study. 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 gene mutation assay Guideline: OECD TG 471 / EC B.13/14 Species/strain: Salmonella typhimurium TA 1535, TA 1537, T; CITATION=Ref.: 9 Comment No explanation was given by the study authors why substance-related (non adverse) effects as observed in the oral 28 day repeat-dose study were not seen in the oral 90 da; CITATION_NUMBERS=[9,28,90]; REFERENCE=Ref.: 9 Comment No explanation was given by the study authors why substance-related (non adverse) effects as observed in the oral 28 day repeat-dose study were not seen in the oral 90 da; DETAILS_JSON={"cas_number":"207562-42-3","citation":"Ref.: 9 Comment No explanation was given by the study authors why substance-related (non adverse) effects as observed in the oral 28 day repeat-dose study were not seen in the oral 90 da","dose":"Slight changes in organ weight of test-item-treated animals (e.g. statistically significantly increased kidney weights of high-dose males) were observed.","duration":"28 day","effect":"ared to control mean values at the end of the treatment period. Slight changes in organ weight of test-item-treated animals (e.g. statistically significantly increased kidney weights of high-dose males) were observed. However, these changes were of low magnitude, not dose-related and partially of opposing trend between groups and sexes and thus not considered to be treatment-related. No treatment-related macroscopic and microscopic findings were noted. Conclusion Under the experimental conditions of this study, a No Observed Adverse Effect Level (NOAEL) of 1000 mg/kg bw/d was derived. Ref.: 9 Comment No explanation was given by the study authors why substance-related (non adverse) effects as observed in the oral 28 day repeat-dose study were not seen in the oral 90 day repeat- dose study. 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 gene mutation assay Guideline: OECD TG 471 / EC B.13/14 Species/strain: Salmonella typhimurium TA 1535, TA 1537, T","endpoint":"genotoxicity","ingredient":"Bis(butylbenzoate)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"1000","page":18,"route":"oral","species":"","study_id":"sccs_o_055_noael_002"}
Regulatory source genotoxicity 1000 mg/kg bw/d - oral 28 day genotoxicity SOURCE_SUBDIR=sccs_o_055; REPORT_TITLE=OPINION ON Bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane COLIPA n° S85; OPINION_NUMBER=SCCS/1335/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 March 2011; VALUE_TEXT=1000; DOSE=Slight changes in organ weight of test-item-treated animals (e.g. statistically significantly increased kidney weights of high-dose males) were observed.; EFFECT=end of the treatment period. Slight changes in organ weight of test-item-treated animals (e.g. statistically significantly increased kidney weights of high-dose males) were observed. However, these changes were of low magnitude, not dose-related and partially of opposing trend between groups and sexes and thus not considered to be treatment-related. No treatment-related macroscopic and microscopic findings were noted. Conclusion Under the experimental conditions of this study, a No Observed Adverse Effect Level (NOAEL) of 1000 mg/kg bw/d was derived. Ref.: 9 Comment No explanation was given by the study authors why substance-related (non adverse) effects as observed in the oral 28 day repeat-dose study were not seen in the oral 90 day repeat- dose study. 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 gene mutation assay Guideline: OECD TG 471 / EC B.13/14 Species/strain: Salmonella typhimurium TA 1535, TA 1537, TA 98, T; CITATION=Ref.: 9 Comment No explanation was given by the study authors why substance-related (non adverse) effects as observed in the oral 28 day repeat-dose study were not seen in the oral 90 da; CITATION_NUMBERS=[9,28,90]; REFERENCE=Ref.: 9 Comment No explanation was given by the study authors why substance-related (non adverse) effects as observed in the oral 28 day repeat-dose study were not seen in the oral 90 da; DETAILS_JSON={"cas_number":"207562-42-3","citation":"Ref.: 9 Comment No explanation was given by the study authors why substance-related (non adverse) effects as observed in the oral 28 day repeat-dose study were not seen in the oral 90 da","dose":"Slight changes in organ weight of test-item-treated animals (e.g. statistically significantly increased kidney weights of high-dose males) were observed.","duration":"28 day","effect":"end of the treatment period. Slight changes in organ weight of test-item-treated animals (e.g. statistically significantly increased kidney weights of high-dose males) were observed. However, these changes were of low magnitude, not dose-related and partially of opposing trend between groups and sexes and thus not considered to be treatment-related. No treatment-related macroscopic and microscopic findings were noted. Conclusion Under the experimental conditions of this study, a No Observed Adverse Effect Level (NOAEL) of 1000 mg/kg bw/d was derived. Ref.: 9 Comment No explanation was given by the study authors why substance-related (non adverse) effects as observed in the oral 28 day repeat-dose study were not seen in the oral 90 day repeat- dose study. 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 gene mutation assay Guideline: OECD TG 471 / EC B.13/14 Species/strain: Salmonella typhimurium TA 1535, TA 1537, TA 98, T","endpoint":"genotoxicity","ingredient":"Bis(butylbenzoate)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"1000","page":18,"route":"oral","species":"","study_id":"sccs_o_055_noael_003"}
Regulatory source genotoxicity 1000 mg/kg bw/d mouse oral 4 week genotoxicity SOURCE_SUBDIR=sccs_o_055; REPORT_TITLE=OPINION ON Bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane COLIPA n° S85; OPINION_NUMBER=SCCS/1335/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 March 2011; VALUE_TEXT=1000; DOSE=increased number of lipophilic vacuoles in the glandular epithelium of the mammary gland in males treated at 1000 mg/kg bw/day.; EFFECT=increased number of lipophilic vacuoles in the glandular epithelium of the mammary gland in males treated at 1000 mg/kg bw/day. These effects were all considered non-adverse by the study authors. The effects seen in the 4 week study were not confirmed by the 13-week study, where no adverse effects up to a dose level of 1000 mg/kg bw/d were observed. In particular, substance- related effects on thyroid parameters and on male mammary gland were not seen after 13 week treatment. Thus, 1000 mg/kg bw/d was selected as NOAEL from the oral 13 week study. Mutagenicity/Genotoxicity Four in vitro assays (a bacterial gene mutation assay using different strains of Salmonella typhimurium, a photomutagenicity assay using different strains of salmonella typhimurium in the presence and absence of irradiation, an in vitro mammalian cell gene mutation test using L5178Y tk+/- mouse lymphoma cells and an in vitro micronucleus test using L5178Y tk+/- mouse lymphoma cells) are available. All these in vitro test were negative, however, the use of hig; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"207562-42-3","citation":"","dose":"increased number of lipophilic vacuoles in the glandular epithelium of the mammary gland in males treated at 1000 mg/kg bw/day.","duration":"4 week","effect":"increased number of lipophilic vacuoles in the glandular epithelium of the mammary gland in males treated at 1000 mg/kg bw/day. These effects were all considered non-adverse by the study authors. The effects seen in the 4 week study were not confirmed by the 13-week study, where no adverse effects up to a dose level of 1000 mg/kg bw/d were observed. In particular, substance- related effects on thyroid parameters and on male mammary gland were not seen after 13 week treatment. Thus, 1000 mg/kg bw/d was selected as NOAEL from the oral 13 week study. Mutagenicity/Genotoxicity Four in vitro assays (a bacterial gene mutation assay using different strains of Salmonella typhimurium, a photomutagenicity assay using different strains of salmonella typhimurium in the presence and absence of irradiation, an in vitro mammalian cell gene mutation test using L5178Y tk+/- mouse lymphoma cells and an in vitro micronucleus test using L5178Y tk+/- mouse lymphoma cells) are available. All these in vitro test were negative, however, the use of hig","endpoint":"genotoxicity","ingredient":"Bis(butylbenzoate)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"1000","page":30,"route":"oral","species":"mouse","study_id":"sccs_o_055_noael_017"}
Regulatory source repeated dose toxicity 1000 mg/kg bw/day rat oral Sub-chronic repeated dose toxicity SOURCE_SUBDIR=sccs_o_055; REPORT_TITLE=OPINION ON Bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane COLIPA n° S85; OPINION_NUMBER=SCCS/1335/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 March 2011; VALUE_TEXT=1000; DOSE=SCCS/1335/10 Opinion on bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane __________________________________________________________________________________ 17 Conclusion Under the experimental conditions of the study, the No Observed Adverse Effect Level (NOAEL) was considered to be 1000 mg/kg bw/day in males and females.; EFFECT=SCCS/1335/10 Opinion on bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane __________________________________________________________________________________ 17 Conclusion Under the experimental conditions of the study, the No Observed Adverse Effect Level (NOAEL) was considered to be 1000 mg/kg bw/day in males and females. A NOEL could not be derived. Ref.: 24 3.3.5.2. Sub-chronic (90 days) oral toxicity Guideline: OECD TG 408 Species/strain: Rat, Sprague-Dawley; RjHan:SD Group size: 10 male and 10 female animals per dose group Test substance: R0027603A Batch: Pilote 2 Purity: 98.2% Dose levels: 100, 300 and 1000 mg/kg bw/d Route: oral (gavage) Vehicle: 0.5% carboxymethylcellulose, aqueous solution Dosing schedule: daily oral doses (gavage) for 91 days Dosage vol; CITATION=Ref.: 24 3; CITATION_NUMBERS=[24,3]; REFERENCE=Ref.: 24 3; DETAILS_JSON={"cas_number":"207562-42-3","citation":"Ref.: 24 3","dose":"SCCS/1335/10 Opinion on bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane __________________________________________________________________________________ 17 Conclusion Under the experimental conditions of the study, the No Observed Adverse Effect Level (NOAEL) was considered to be 1000 mg/kg bw/day in males and females.","duration":"Sub-chronic","effect":"SCCS/1335/10 Opinion on bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane __________________________________________________________________________________ 17 Conclusion Under the experimental conditions of the study, the No Observed Adverse Effect Level (NOAEL) was considered to be 1000 mg/kg bw/day in males and females. A NOEL could not be derived. Ref.: 24 3.3.5.2. Sub-chronic (90 days) oral toxicity Guideline: OECD TG 408 Species/strain: Rat, Sprague-Dawley; RjHan:SD Group size: 10 male and 10 female animals per dose group Test substance: R0027603A Batch: Pilote 2 Purity: 98.2% Dose levels: 100, 300 and 1000 mg/kg bw/d Route: oral (gavage) Vehicle: 0.5% carboxymethylcellulose, aqueous solution Dosing schedule: daily oral doses (gavage) for 91 days Dosage vol","endpoint":"repeated dose toxicity","ingredient":"Bis(butylbenzoate)","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":17,"route":"oral","species":"rat","study_id":"sccs_o_055_noael_001"}
Regulatory source reproductive toxicity 1000 mg/kg bw/d - oral 90 day reproductive toxicity SOURCE_SUBDIR=sccs_o_055; REPORT_TITLE=OPINION ON Bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane COLIPA n° S85; OPINION_NUMBER=SCCS/1335/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 March 2011; VALUE_TEXT=1000; DOSE=SCCS/1335/10 Opinion on bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane __________________________________________________________________________________ 31 mg/kg bw/d.; EFFECT=SCCS/1335/10 Opinion on bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane __________________________________________________________________________________ 31 mg/kg bw/d. No test-item related adverse maternal and foetal effects were observed and a NOAEL of 1000 mg/kg bw/d was derived for maternal and foetal effects. It should be noted, however, that this study does not allow drawing firm conclusions on male and female fertility. Thus, no conclusions on probable adverse effects of R0027603A on fertility can be drawn when discussing its reprotoxic effects. Toxicokinetics To a limited extent, conclusions on toxicokinetics of bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane can be drawn from its physico-chemical properties and from the 90 day oral toxicity; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"207562-42-3","citation":"","dose":"SCCS/1335/10 Opinion on bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane __________________________________________________________________________________ 31 mg/kg bw/d.","duration":"90 day","effect":"SCCS/1335/10 Opinion on bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane __________________________________________________________________________________ 31 mg/kg bw/d. No test-item related adverse maternal and foetal effects were observed and a NOAEL of 1000 mg/kg bw/d was derived for maternal and foetal effects. It should be noted, however, that this study does not allow drawing firm conclusions on male and female fertility. Thus, no conclusions on probable adverse effects of R0027603A on fertility can be drawn when discussing its reprotoxic effects. Toxicokinetics To a limited extent, conclusions on toxicokinetics of bis(butylbenzoate) diaminotriazine aminopropyltrisiloxane can be drawn from its physico-chemical properties and from the 90 day oral toxicity","endpoint":"reproductive toxicity","ingredient":"Bis(butylbenzoate)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"1000","page":31,"route":"oral","species":"","study_id":"sccs_o_055_noael_018"}
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier 50I65NU3DV UNII - - - chemical {"approval_status":null,"molecular_formula":"C35H56N6O6Si3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"50I65NU3DV"}
openFDA substances FDA UNII substance identifier 50I65NU3DV UNII - - - chemical {"approval_status":null,"molecular_formula":"C35H56N6O6Si3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"50I65NU3DV"}
openFDA substances FDA UNII substance identifier 50I65NU3DV UNII - - - chemical {"approval_status":null,"molecular_formula":"C35H56N6O6Si3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"50I65NU3DV"}
openFDA substances FDA UNII substance identifier 50I65NU3DV UNII - - - chemical {"approval_status":null,"molecular_formula":"C35H56N6O6Si3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"50I65NU3DV"}