NOAEL Studies UV Filter / Sunscreen

TriAsorB NOAEL Studies

INCI: PHENYLENE BIS-DIPHENYLTRIAZINE

CAS: 55514-22-2

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_vision_codex 32 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS_vision_codex NOAEL =48.5 % rat oral 2-week repeated dose toxicity {"dose":"After oral administration of S02771 to Wistar rats at doses of the suspension of 100, 300 and 1000 mg/kg/day, for 13 weeks and a four-week treatment-free recovery period, based on histopathology a NOEL (No Observed Effect Level) could be established for the ground active substance (content 48.5% in the suspension) - at 146 mg/kg/day for males, -...","effect":"ested. In females, absence of effects on thyroid hormones, the absence of effects on the 2-week vaginal oestrus cycles, on sexual organ weights and on sexual and endocrine organ histopathology, allow to conclude the absence of visible endocrine disruptor effects of S02771 with regards to the endocrine parameters tested. After oral administration of S02771 to Wistar rats at doses of the suspension of 100, 300 and 1000 mg/kg/day, for 13 weeks and a four-week treatment-free recovery period, based on histopathology a NOEL (No Observed Effect Level) could be established for the ground active substance (content 48.5% in the suspension) - at 146 mg/kg/day for males, - at 485 mg/kg/day for females. A NOAEL (No Observed Adverse Effect Level) for males could be established at 485 mg/kg/day for the ground active substance. Ref. 64 3.3.5.3 OECD 422 Screening Test A Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test conducted with the non-ground active substance (S02374) according to OECD TG 4","page":36,"pdf":"sccs_o_184.pdf","row_type":"noael_study","study_id":"sccs_o_184_noael_001"}
SCCS_vision_codex NOAEL =485 mg/kg/day rat oral 13 weeks repeated dose toxicity {"dose":"After oral administration of S02771 to Wistar rats at doses of the suspension of 100, 300 and 1000 mg/kg/day, for 13 weeks and a four-week treatment-free recovery period, based on histopathology a NOEL (No Observed Effect Level) could be established for the ground active substance (content 48.5% in the suspension) - at 146 mg/kg/day for males, -...","effect":"pathology, allow to conclude the absence of visible endocrine disruptor effects of S02771 with regards to the endocrine parameters tested. After oral administration of S02771 to Wistar rats at doses of the suspension of 100, 300 and 1000 mg/kg/day, for 13 weeks and a four-week treatment-free recovery period, based on histopathology a NOEL (No Observed Effect Level) could be established for the ground active substance (content 48.5% in the suspension) - at 146 mg/kg/day for males, - at 485 mg/kg/day for females. A NOAEL (No Observed Adverse Effect Level) for males could be established at 485 mg/kg/day for the ground active substance. Ref. 64 3.3.5.3 OECD 422 Screening Test A Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test conducted with the non-ground active substance (S02374) according to OECD TG 422 is described in section 3.3.8.2. The No Observed Effect Level (NOEL) for parental toxicity was considered to be 1000 mg/kg bw/day.","page":36,"pdf":"sccs_o_184.pdf","row_type":"noael_study","study_id":"sccs_o_184_noael_002"}
SCCS_vision_codex NOAEL =1000 mg/kg bw/day - - Developmental repeated dose toxicity {"dose":"tive substance (content 48.5% in the suspension) - at 146 mg/kg/day for males, - at 485 mg/kg/day for females.","effect":"tive substance (content 48.5% in the suspension) - at 146 mg/kg/day for males, - at 485 mg/kg/day for females. A NOAEL (No Observed Adverse Effect Level) for males could be established at 485 mg/kg/day for the ground active substance. Ref. 64 3.3.5.3 OECD 422 Screening Test A Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test conducted with the non-ground active substance (S02374) according to OECD TG 422 is described in section 3.3.8.2. The No Observed Effect Level (NOEL) for parental toxicity was considered to be 1000 mg/kg bw/day.","page":36,"pdf":"sccs_o_184.pdf","row_type":"noael_study","study_id":"sccs_o_184_noael_004"}
SCCS_vision_codex NOAEL =54 mg/kg bw/day - inhalation 14-day NOAEL study {"dose":"86 SCCS comment The LOAEC is 0.63 mg/L and the LOAEL calculated from the inhalation exposure is 115 mg/kg bw/day for the test item corresponding to 0.29 mg/L and 54 mg/kg bw/day for the ground active substance.","effect":"se. There was no evidence of reversal of microscopic findings in the lungs and tracheobronchial lymph node, progressive ongoing reversal of microscopic findings in the nasal cavities and larynx, and almost complete reversal of microscopic findings in the trachea following a 14-day recovery. Ref. 86 SCCS comment The LOAEC is 0.63 mg/L and the LOAEL calculated from the inhalation exposure is 115 mg/kg bw/day for the test item corresponding to 0.29 mg/L and 54 mg/kg bw/day for the ground active substance. A NOAEC or NOAEL value cannot be derived from this study due to the serious effects observed in the respiratory tract, possibly due to a particle overload effect of the test item particles that are barely soluble and persistent. No safe concentration for the use in spray applications can be derived. The concentrations/doses for the RDT inhalation study derived from an acute inhalation toxicity study (used as a pilot study) were too high. The dates of the in-life phase of the study were partly after the date of the animal testing","page":41,"pdf":"sccs_o_184.pdf","row_type":"noael_study","study_id":"sccs_o_184_noael_005"}
SCCS_vision_codex NOAEL =1000 mg/kg/day - - - NOAEL study {"dose":"Conclusion Based on the experimental conditions of this study, - the No Observed Effect Level (NOEL) of the non-ground active substance for parental toxicity was considered to be 1000 mg/kg/day,","effect":"ions There were no effects on live birth, viability and lactation indexes, Functional Observation Battery and motor activity. Amongst the findings noted during the study, none were indicative of a treatment-related effect. Haematology There were no effects on mean haematology parameters. Blood biochemistry and urinalysis There were no toxicological significant effects on mean blood chemistry parameters and urinalysis. Conclusion Based on the experimental conditions of this study, - the No Observed Effect Level (NOEL) of the non-ground active substance for parental toxicity was considered to be 1000 mg/kg/day,","page":50,"pdf":"sccs_o_184.pdf","row_type":"noael_study","study_id":"sccs_o_184_noael_006"}
SCCS_vision_codex NOAEL =464 mg/kg bw/day rat oral prenatal developmental toxicity {"dose":"ic potential on pregnant females up to and including the dose level of 1000 mg/kg bw/day.","effect":"ic potential on pregnant females up to and including the dose level of 1000 mg/kg bw/day. S02771 had no influence on the relevant reproduction data (post-implantation loss and the mean number of foetuses per dam) up to and including the dose level of 1000 mg/kg bw/day. Based on these results, the NOEL (No Observed Effect Level) for both maternal general toxicity and prenatal developmental toxicity was considered to be 1000 mg/kg bw/day, the highest dose used for the test item (suspension). Ref. 71 SCCS comment The NOEL for both maternal general toxicity and prenatal developmental toxicity was 464 mg/kg bw/day for the ground active substance, i.e. the highest dose level in the study. 3.3.9 Toxicokinetics 3.3.9.1 Toxicokinetics in laboratory animals In a satellite study of a screening test according to OECD TG 422 (see section 3.3.8.2), toxicokinetics were investigated with three dose groups of 8 male and 8 female rats per group with the active substance (S02374) applied daily for 2 weeks at oral doses of 100, 300 and 1000 mg/k","page":52,"pdf":"sccs_o_184.pdf","row_type":"noael_study","study_id":"sccs_o_184_noael_009"}
SCCS_vision_codex NOAEL =464 mg/kg bw/d - oral developmental reproductive toxicity {"dose":"NOEL) for parental toxicity and for reproductive performance (mating and fertility) was considered to be 1000 mg/kg/day.","effect":"NOEL) for parental toxicity and for reproductive performance (mating and fertility) was considered to be 1000 mg/kg/day. The NOEL for toxic effects on progeny was considered to be 1000 mg/kg/day. The cosmetic ingredient S02771 was investigated in a developmental toxicity study (OECD 414) at dose levels of 0, 100, 300, 1000 mg/kg bw/day for the test item, corresponding to 0, 46, 139, 464 mg/kg bw/day for the ground active substance. No adverse maternal and foetal effects related to the test item were observed and a NOEL of 464 mg/kg bw/d was derived for maternal and foetal effects. Toxicokinetics In a satellite study of the above OECD 422 Screening test, three groups of eight males and eight females received the non-ground active substance SO2374 by gavage for 2 weeks at dose-levels of 100, 300 or 1000 mg/kg/day for blood plasma concentration measurements.","page":67,"pdf":"sccs_o_184.pdf","row_type":"noael_study","study_id":"sccs_o_184_noael_017"}
SCCS_vision_codex NOAEL =80 mg/kg bw rat dermal 90 day irritation {"dose":"With respect to the precautionary principle, Eumulgin® L is classified as an eye irritant and as a skin irritant. • Eumulgin® L is not considered to be a skin sensitizer. • A NOAEL of 80 mg/kg bw was established in a 90 day study. • No potential for gene mutations was detected in the Ames test with Eumulgin® L.","effect":"SCCS-rejected applicant NOAEL: _____________________________________ 73 Annex Toxicological Evaluation of by-products and impurities Safety evaluation for the solubiliser, Eumulgin L The manufacturer has provided the following safety assessment to the applicant: • Eumulgin® L was not toxic or harmful in an acute toxicity test in the rat. • The dermal penetration is low. With respect to the precautionary principle, Eumulgin® L is classified as an eye irritant and as a skin irritant. • Eumulgin® L is not considered to be a skin sensitizer. • A NOAEL of 80 mg/kg bw was established in a 90 day study. • No potential for gene mutations was detected in the Ames test with Eumulgin® L. Ref. 47 Under these conditions, Eumulgin L could be considered as safe at the maximum concentration of 0.5% on healthy and on altered and irradiated skin, in the general scenario (18g/day). Safety evaluation for the preservative, benzoic acid The SCCP opinion on benzoic acid and sodium benzoate (SCCP/0891/05, dated June 2005) stated that benzoic acid and sodium benzoate are safe for","page":73,"pdf":"sccs_o_184.pdf","row_type":"noael_study","study_id":"sccs_o_184_noael_018"}
SCCS_vision_codex NOAEL =48.5 % rat oral 2-week repeated dose toxicity {"dose":"After oral administration of S02771 to Wistar rats at doses of the suspension of 100, 300 and 1000 mg/kg/day, for 13 weeks and a four-week treatment-free recovery period, based on histopathology a NOEL (No Observed Effect Level) could be established for the ground active substance (content 48.5% in the suspension) - at 146 mg/kg/day for males, -...","effect":"ested. In females, absence of effects on thyroid hormones, the absence of effects on the 2-week vaginal oestrus cycles, on sexual organ weights and on sexual and endocrine organ histopathology, allow to conclude the absence of visible endocrine disruptor effects of S02771 with regards to the endocrine parameters tested. After oral administration of S02771 to Wistar rats at doses of the suspension of 100, 300 and 1000 mg/kg/day, for 13 weeks and a four-week treatment-free recovery period, based on histopathology a NOEL (No Observed Effect Level) could be established for the ground active substance (content 48.5% in the suspension) - at 146 mg/kg/day for males, - at 485 mg/kg/day for females. A NOAEL (No Observed Adverse Effect Level) for males could be established at 485 mg/kg/day for the ground active substance. Ref. 64 3.3.5.3 OECD 422 Screening Test A Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test conducted with the non-ground active substance (S02374) according to OECD TG 4","page":36,"pdf":"sccs_o_184.pdf","row_type":"noael_study","study_id":"sccs_o_184_noael_001"}
SCCS_vision_codex NOAEL =485 mg/kg/day rat oral 13 weeks repeated dose toxicity {"dose":"After oral administration of S02771 to Wistar rats at doses of the suspension of 100, 300 and 1000 mg/kg/day, for 13 weeks and a four-week treatment-free recovery period, based on histopathology a NOEL (No Observed Effect Level) could be established for the ground active substance (content 48.5% in the suspension) - at 146 mg/kg/day for males, -...","effect":"pathology, allow to conclude the absence of visible endocrine disruptor effects of S02771 with regards to the endocrine parameters tested. After oral administration of S02771 to Wistar rats at doses of the suspension of 100, 300 and 1000 mg/kg/day, for 13 weeks and a four-week treatment-free recovery period, based on histopathology a NOEL (No Observed Effect Level) could be established for the ground active substance (content 48.5% in the suspension) - at 146 mg/kg/day for males, - at 485 mg/kg/day for females. A NOAEL (No Observed Adverse Effect Level) for males could be established at 485 mg/kg/day for the ground active substance. Ref. 64 3.3.5.3 OECD 422 Screening Test A Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test conducted with the non-ground active substance (S02374) according to OECD TG 422 is described in section 3.3.8.2. The No Observed Effect Level (NOEL) for parental toxicity was considered to be 1000 mg/kg bw/day.","page":36,"pdf":"sccs_o_184.pdf","row_type":"noael_study","study_id":"sccs_o_184_noael_002"}
SCCS_vision_codex NOAEL =1000 mg/kg bw/day - - Developmental repeated dose toxicity {"dose":"tive substance (content 48.5% in the suspension) - at 146 mg/kg/day for males, - at 485 mg/kg/day for females.","effect":"tive substance (content 48.5% in the suspension) - at 146 mg/kg/day for males, - at 485 mg/kg/day for females. A NOAEL (No Observed Adverse Effect Level) for males could be established at 485 mg/kg/day for the ground active substance. Ref. 64 3.3.5.3 OECD 422 Screening Test A Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test conducted with the non-ground active substance (S02374) according to OECD TG 422 is described in section 3.3.8.2. The No Observed Effect Level (NOEL) for parental toxicity was considered to be 1000 mg/kg bw/day.","page":36,"pdf":"sccs_o_184.pdf","row_type":"noael_study","study_id":"sccs_o_184_noael_004"}
SCCS_vision_codex NOAEL =54 mg/kg bw/day - inhalation 14-day NOAEL study {"dose":"86 SCCS comment The LOAEC is 0.63 mg/L and the LOAEL calculated from the inhalation exposure is 115 mg/kg bw/day for the test item corresponding to 0.29 mg/L and 54 mg/kg bw/day for the ground active substance.","effect":"se. There was no evidence of reversal of microscopic findings in the lungs and tracheobronchial lymph node, progressive ongoing reversal of microscopic findings in the nasal cavities and larynx, and almost complete reversal of microscopic findings in the trachea following a 14-day recovery. Ref. 86 SCCS comment The LOAEC is 0.63 mg/L and the LOAEL calculated from the inhalation exposure is 115 mg/kg bw/day for the test item corresponding to 0.29 mg/L and 54 mg/kg bw/day for the ground active substance. A NOAEC or NOAEL value cannot be derived from this study due to the serious effects observed in the respiratory tract, possibly due to a particle overload effect of the test item particles that are barely soluble and persistent. No safe concentration for the use in spray applications can be derived. The concentrations/doses for the RDT inhalation study derived from an acute inhalation toxicity study (used as a pilot study) were too high. The dates of the in-life phase of the study were partly after the date of the animal testing","page":41,"pdf":"sccs_o_184.pdf","row_type":"noael_study","study_id":"sccs_o_184_noael_005"}
SCCS_vision_codex NOAEL =1000 mg/kg/day - - - NOAEL study {"dose":"Conclusion Based on the experimental conditions of this study, - the No Observed Effect Level (NOEL) of the non-ground active substance for parental toxicity was considered to be 1000 mg/kg/day,","effect":"ions There were no effects on live birth, viability and lactation indexes, Functional Observation Battery and motor activity. Amongst the findings noted during the study, none were indicative of a treatment-related effect. Haematology There were no effects on mean haematology parameters. Blood biochemistry and urinalysis There were no toxicological significant effects on mean blood chemistry parameters and urinalysis. Conclusion Based on the experimental conditions of this study, - the No Observed Effect Level (NOEL) of the non-ground active substance for parental toxicity was considered to be 1000 mg/kg/day,","page":50,"pdf":"sccs_o_184.pdf","row_type":"noael_study","study_id":"sccs_o_184_noael_006"}
SCCS_vision_codex NOAEL =464 mg/kg bw/day rat oral prenatal developmental toxicity {"dose":"ic potential on pregnant females up to and including the dose level of 1000 mg/kg bw/day.","effect":"ic potential on pregnant females up to and including the dose level of 1000 mg/kg bw/day. S02771 had no influence on the relevant reproduction data (post-implantation loss and the mean number of foetuses per dam) up to and including the dose level of 1000 mg/kg bw/day. Based on these results, the NOEL (No Observed Effect Level) for both maternal general toxicity and prenatal developmental toxicity was considered to be 1000 mg/kg bw/day, the highest dose used for the test item (suspension). Ref. 71 SCCS comment The NOEL for both maternal general toxicity and prenatal developmental toxicity was 464 mg/kg bw/day for the ground active substance, i.e. the highest dose level in the study. 3.3.9 Toxicokinetics 3.3.9.1 Toxicokinetics in laboratory animals In a satellite study of a screening test according to OECD TG 422 (see section 3.3.8.2), toxicokinetics were investigated with three dose groups of 8 male and 8 female rats per group with the active substance (S02374) applied daily for 2 weeks at oral doses of 100, 300 and 1000 mg/k","page":52,"pdf":"sccs_o_184.pdf","row_type":"noael_study","study_id":"sccs_o_184_noael_009"}
SCCS_vision_codex NOAEL =464 mg/kg bw/d - oral developmental reproductive toxicity {"dose":"NOEL) for parental toxicity and for reproductive performance (mating and fertility) was considered to be 1000 mg/kg/day.","effect":"NOEL) for parental toxicity and for reproductive performance (mating and fertility) was considered to be 1000 mg/kg/day. The NOEL for toxic effects on progeny was considered to be 1000 mg/kg/day. The cosmetic ingredient S02771 was investigated in a developmental toxicity study (OECD 414) at dose levels of 0, 100, 300, 1000 mg/kg bw/day for the test item, corresponding to 0, 46, 139, 464 mg/kg bw/day for the ground active substance. No adverse maternal and foetal effects related to the test item were observed and a NOEL of 464 mg/kg bw/d was derived for maternal and foetal effects. Toxicokinetics In a satellite study of the above OECD 422 Screening test, three groups of eight males and eight females received the non-ground active substance SO2374 by gavage for 2 weeks at dose-levels of 100, 300 or 1000 mg/kg/day for blood plasma concentration measurements.","page":67,"pdf":"sccs_o_184.pdf","row_type":"noael_study","study_id":"sccs_o_184_noael_017"}
SCCS_vision_codex NOAEL =80 mg/kg bw rat dermal 90 day irritation {"dose":"With respect to the precautionary principle, Eumulgin® L is classified as an eye irritant and as a skin irritant. • Eumulgin® L is not considered to be a skin sensitizer. • A NOAEL of 80 mg/kg bw was established in a 90 day study. • No potential for gene mutations was detected in the Ames test with Eumulgin® L.","effect":"SCCS-rejected applicant NOAEL: _____________________________________ 73 Annex Toxicological Evaluation of by-products and impurities Safety evaluation for the solubiliser, Eumulgin L The manufacturer has provided the following safety assessment to the applicant: • Eumulgin® L was not toxic or harmful in an acute toxicity test in the rat. • The dermal penetration is low. With respect to the precautionary principle, Eumulgin® L is classified as an eye irritant and as a skin irritant. • Eumulgin® L is not considered to be a skin sensitizer. • A NOAEL of 80 mg/kg bw was established in a 90 day study. • No potential for gene mutations was detected in the Ames test with Eumulgin® L. Ref. 47 Under these conditions, Eumulgin L could be considered as safe at the maximum concentration of 0.5% on healthy and on altered and irradiated skin, in the general scenario (18g/day). Safety evaluation for the preservative, benzoic acid The SCCP opinion on benzoic acid and sodium benzoate (SCCP/0891/05, dated June 2005) stated that benzoic acid and sodium benzoate are safe for","page":73,"pdf":"sccs_o_184.pdf","row_type":"noael_study","study_id":"sccs_o_184_noael_018"}
SCCS_vision_codex NOAEL =48.5 % rat oral 2-week repeated dose toxicity {"dose":"After oral administration of S02771 to Wistar rats at doses of the suspension of 100, 300 and 1000 mg/kg/day, for 13 weeks and a four-week treatment-free recovery period, based on histopathology a NOEL (No Observed Effect Level) could be established for the ground active substance (content 48.5% in the suspension) - at 146 mg/kg/day for males, -...","effect":"ested. In females, absence of effects on thyroid hormones, the absence of effects on the 2-week vaginal oestrus cycles, on sexual organ weights and on sexual and endocrine organ histopathology, allow to conclude the absence of visible endocrine disruptor effects of S02771 with regards to the endocrine parameters tested. After oral administration of S02771 to Wistar rats at doses of the suspension of 100, 300 and 1000 mg/kg/day, for 13 weeks and a four-week treatment-free recovery period, based on histopathology a NOEL (No Observed Effect Level) could be established for the ground active substance (content 48.5% in the suspension) - at 146 mg/kg/day for males, - at 485 mg/kg/day for females. A NOAEL (No Observed Adverse Effect Level) for males could be established at 485 mg/kg/day for the ground active substance. Ref. 64 3.3.5.3 OECD 422 Screening Test A Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test conducted with the non-ground active substance (S02374) according to OECD TG 4","page":36,"pdf":"sccs_o_184.pdf","row_type":"noael_study","study_id":"sccs_o_184_noael_001"}
SCCS_vision_codex NOAEL =485 mg/kg/day rat oral 13 weeks repeated dose toxicity {"dose":"After oral administration of S02771 to Wistar rats at doses of the suspension of 100, 300 and 1000 mg/kg/day, for 13 weeks and a four-week treatment-free recovery period, based on histopathology a NOEL (No Observed Effect Level) could be established for the ground active substance (content 48.5% in the suspension) - at 146 mg/kg/day for males, -...","effect":"pathology, allow to conclude the absence of visible endocrine disruptor effects of S02771 with regards to the endocrine parameters tested. After oral administration of S02771 to Wistar rats at doses of the suspension of 100, 300 and 1000 mg/kg/day, for 13 weeks and a four-week treatment-free recovery period, based on histopathology a NOEL (No Observed Effect Level) could be established for the ground active substance (content 48.5% in the suspension) - at 146 mg/kg/day for males, - at 485 mg/kg/day for females. A NOAEL (No Observed Adverse Effect Level) for males could be established at 485 mg/kg/day for the ground active substance. Ref. 64 3.3.5.3 OECD 422 Screening Test A Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test conducted with the non-ground active substance (S02374) according to OECD TG 422 is described in section 3.3.8.2. The No Observed Effect Level (NOEL) for parental toxicity was considered to be 1000 mg/kg bw/day.","page":36,"pdf":"sccs_o_184.pdf","row_type":"noael_study","study_id":"sccs_o_184_noael_002"}
SCCS_vision_codex NOAEL =1000 mg/kg bw/day - - Developmental repeated dose toxicity {"dose":"tive substance (content 48.5% in the suspension) - at 146 mg/kg/day for males, - at 485 mg/kg/day for females.","effect":"tive substance (content 48.5% in the suspension) - at 146 mg/kg/day for males, - at 485 mg/kg/day for females. A NOAEL (No Observed Adverse Effect Level) for males could be established at 485 mg/kg/day for the ground active substance. Ref. 64 3.3.5.3 OECD 422 Screening Test A Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test conducted with the non-ground active substance (S02374) according to OECD TG 422 is described in section 3.3.8.2. The No Observed Effect Level (NOEL) for parental toxicity was considered to be 1000 mg/kg bw/day.","page":36,"pdf":"sccs_o_184.pdf","row_type":"noael_study","study_id":"sccs_o_184_noael_004"}
SCCS_vision_codex NOAEL =54 mg/kg bw/day - inhalation 14-day NOAEL study {"dose":"86 SCCS comment The LOAEC is 0.63 mg/L and the LOAEL calculated from the inhalation exposure is 115 mg/kg bw/day for the test item corresponding to 0.29 mg/L and 54 mg/kg bw/day for the ground active substance.","effect":"se. There was no evidence of reversal of microscopic findings in the lungs and tracheobronchial lymph node, progressive ongoing reversal of microscopic findings in the nasal cavities and larynx, and almost complete reversal of microscopic findings in the trachea following a 14-day recovery. Ref. 86 SCCS comment The LOAEC is 0.63 mg/L and the LOAEL calculated from the inhalation exposure is 115 mg/kg bw/day for the test item corresponding to 0.29 mg/L and 54 mg/kg bw/day for the ground active substance. A NOAEC or NOAEL value cannot be derived from this study due to the serious effects observed in the respiratory tract, possibly due to a particle overload effect of the test item particles that are barely soluble and persistent. No safe concentration for the use in spray applications can be derived. The concentrations/doses for the RDT inhalation study derived from an acute inhalation toxicity study (used as a pilot study) were too high. The dates of the in-life phase of the study were partly after the date of the animal testing","page":41,"pdf":"sccs_o_184.pdf","row_type":"noael_study","study_id":"sccs_o_184_noael_005"}
SCCS_vision_codex NOAEL =1000 mg/kg/day - - - NOAEL study {"dose":"Conclusion Based on the experimental conditions of this study, - the No Observed Effect Level (NOEL) of the non-ground active substance for parental toxicity was considered to be 1000 mg/kg/day,","effect":"ions There were no effects on live birth, viability and lactation indexes, Functional Observation Battery and motor activity. Amongst the findings noted during the study, none were indicative of a treatment-related effect. Haematology There were no effects on mean haematology parameters. Blood biochemistry and urinalysis There were no toxicological significant effects on mean blood chemistry parameters and urinalysis. Conclusion Based on the experimental conditions of this study, - the No Observed Effect Level (NOEL) of the non-ground active substance for parental toxicity was considered to be 1000 mg/kg/day,","page":50,"pdf":"sccs_o_184.pdf","row_type":"noael_study","study_id":"sccs_o_184_noael_006"}
SCCS_vision_codex NOAEL =464 mg/kg bw/day rat oral prenatal developmental toxicity {"dose":"ic potential on pregnant females up to and including the dose level of 1000 mg/kg bw/day.","effect":"ic potential on pregnant females up to and including the dose level of 1000 mg/kg bw/day. S02771 had no influence on the relevant reproduction data (post-implantation loss and the mean number of foetuses per dam) up to and including the dose level of 1000 mg/kg bw/day. Based on these results, the NOEL (No Observed Effect Level) for both maternal general toxicity and prenatal developmental toxicity was considered to be 1000 mg/kg bw/day, the highest dose used for the test item (suspension). Ref. 71 SCCS comment The NOEL for both maternal general toxicity and prenatal developmental toxicity was 464 mg/kg bw/day for the ground active substance, i.e. the highest dose level in the study. 3.3.9 Toxicokinetics 3.3.9.1 Toxicokinetics in laboratory animals In a satellite study of a screening test according to OECD TG 422 (see section 3.3.8.2), toxicokinetics were investigated with three dose groups of 8 male and 8 female rats per group with the active substance (S02374) applied daily for 2 weeks at oral doses of 100, 300 and 1000 mg/k","page":52,"pdf":"sccs_o_184.pdf","row_type":"noael_study","study_id":"sccs_o_184_noael_009"}
SCCS_vision_codex NOAEL =464 mg/kg bw/d - oral developmental reproductive toxicity {"dose":"NOEL) for parental toxicity and for reproductive performance (mating and fertility) was considered to be 1000 mg/kg/day.","effect":"NOEL) for parental toxicity and for reproductive performance (mating and fertility) was considered to be 1000 mg/kg/day. The NOEL for toxic effects on progeny was considered to be 1000 mg/kg/day. The cosmetic ingredient S02771 was investigated in a developmental toxicity study (OECD 414) at dose levels of 0, 100, 300, 1000 mg/kg bw/day for the test item, corresponding to 0, 46, 139, 464 mg/kg bw/day for the ground active substance. No adverse maternal and foetal effects related to the test item were observed and a NOEL of 464 mg/kg bw/d was derived for maternal and foetal effects. Toxicokinetics In a satellite study of the above OECD 422 Screening test, three groups of eight males and eight females received the non-ground active substance SO2374 by gavage for 2 weeks at dose-levels of 100, 300 or 1000 mg/kg/day for blood plasma concentration measurements.","page":67,"pdf":"sccs_o_184.pdf","row_type":"noael_study","study_id":"sccs_o_184_noael_017"}
SCCS_vision_codex NOAEL =80 mg/kg bw rat dermal 90 day irritation {"dose":"With respect to the precautionary principle, Eumulgin® L is classified as an eye irritant and as a skin irritant. • Eumulgin® L is not considered to be a skin sensitizer. • A NOAEL of 80 mg/kg bw was established in a 90 day study. • No potential for gene mutations was detected in the Ames test with Eumulgin® L.","effect":"SCCS-rejected applicant NOAEL: _____________________________________ 73 Annex Toxicological Evaluation of by-products and impurities Safety evaluation for the solubiliser, Eumulgin L The manufacturer has provided the following safety assessment to the applicant: • Eumulgin® L was not toxic or harmful in an acute toxicity test in the rat. • The dermal penetration is low. With respect to the precautionary principle, Eumulgin® L is classified as an eye irritant and as a skin irritant. • Eumulgin® L is not considered to be a skin sensitizer. • A NOAEL of 80 mg/kg bw was established in a 90 day study. • No potential for gene mutations was detected in the Ames test with Eumulgin® L. Ref. 47 Under these conditions, Eumulgin L could be considered as safe at the maximum concentration of 0.5% on healthy and on altered and irradiated skin, in the general scenario (18g/day). Safety evaluation for the preservative, benzoic acid The SCCP opinion on benzoic acid and sodium benzoate (SCCP/0891/05, dated June 2005) stated that benzoic acid and sodium benzoate are safe for","page":73,"pdf":"sccs_o_184.pdf","row_type":"noael_study","study_id":"sccs_o_184_noael_018"}
SCCS_vision_codex NOAEL =48.5 % rat oral 2-week repeated dose toxicity {"dose":"After oral administration of S02771 to Wistar rats at doses of the suspension of 100, 300 and 1000 mg/kg/day, for 13 weeks and a four-week treatment-free recovery period, based on histopathology a NOEL (No Observed Effect Level) could be established for the ground active substance (content 48.5% in the suspension) - at 146 mg/kg/day for males, -...","effect":"ested. In females, absence of effects on thyroid hormones, the absence of effects on the 2-week vaginal oestrus cycles, on sexual organ weights and on sexual and endocrine organ histopathology, allow to conclude the absence of visible endocrine disruptor effects of S02771 with regards to the endocrine parameters tested. After oral administration of S02771 to Wistar rats at doses of the suspension of 100, 300 and 1000 mg/kg/day, for 13 weeks and a four-week treatment-free recovery period, based on histopathology a NOEL (No Observed Effect Level) could be established for the ground active substance (content 48.5% in the suspension) - at 146 mg/kg/day for males, - at 485 mg/kg/day for females. A NOAEL (No Observed Adverse Effect Level) for males could be established at 485 mg/kg/day for the ground active substance. Ref. 64 3.3.5.3 OECD 422 Screening Test A Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test conducted with the non-ground active substance (S02374) according to OECD TG 4","page":36,"pdf":"sccs_o_184.pdf","row_type":"noael_study","study_id":"sccs_o_184_noael_001"}
SCCS_vision_codex NOAEL =485 mg/kg/day rat oral 13 weeks repeated dose toxicity {"dose":"After oral administration of S02771 to Wistar rats at doses of the suspension of 100, 300 and 1000 mg/kg/day, for 13 weeks and a four-week treatment-free recovery period, based on histopathology a NOEL (No Observed Effect Level) could be established for the ground active substance (content 48.5% in the suspension) - at 146 mg/kg/day for males, -...","effect":"pathology, allow to conclude the absence of visible endocrine disruptor effects of S02771 with regards to the endocrine parameters tested. After oral administration of S02771 to Wistar rats at doses of the suspension of 100, 300 and 1000 mg/kg/day, for 13 weeks and a four-week treatment-free recovery period, based on histopathology a NOEL (No Observed Effect Level) could be established for the ground active substance (content 48.5% in the suspension) - at 146 mg/kg/day for males, - at 485 mg/kg/day for females. A NOAEL (No Observed Adverse Effect Level) for males could be established at 485 mg/kg/day for the ground active substance. Ref. 64 3.3.5.3 OECD 422 Screening Test A Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test conducted with the non-ground active substance (S02374) according to OECD TG 422 is described in section 3.3.8.2. The No Observed Effect Level (NOEL) for parental toxicity was considered to be 1000 mg/kg bw/day.","page":36,"pdf":"sccs_o_184.pdf","row_type":"noael_study","study_id":"sccs_o_184_noael_002"}
SCCS_vision_codex NOAEL =1000 mg/kg bw/day - - Developmental repeated dose toxicity {"dose":"tive substance (content 48.5% in the suspension) - at 146 mg/kg/day for males, - at 485 mg/kg/day for females.","effect":"tive substance (content 48.5% in the suspension) - at 146 mg/kg/day for males, - at 485 mg/kg/day for females. A NOAEL (No Observed Adverse Effect Level) for males could be established at 485 mg/kg/day for the ground active substance. Ref. 64 3.3.5.3 OECD 422 Screening Test A Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test conducted with the non-ground active substance (S02374) according to OECD TG 422 is described in section 3.3.8.2. The No Observed Effect Level (NOEL) for parental toxicity was considered to be 1000 mg/kg bw/day.","page":36,"pdf":"sccs_o_184.pdf","row_type":"noael_study","study_id":"sccs_o_184_noael_004"}
SCCS_vision_codex NOAEL =54 mg/kg bw/day - inhalation 14-day NOAEL study {"dose":"86 SCCS comment The LOAEC is 0.63 mg/L and the LOAEL calculated from the inhalation exposure is 115 mg/kg bw/day for the test item corresponding to 0.29 mg/L and 54 mg/kg bw/day for the ground active substance.","effect":"se. There was no evidence of reversal of microscopic findings in the lungs and tracheobronchial lymph node, progressive ongoing reversal of microscopic findings in the nasal cavities and larynx, and almost complete reversal of microscopic findings in the trachea following a 14-day recovery. Ref. 86 SCCS comment The LOAEC is 0.63 mg/L and the LOAEL calculated from the inhalation exposure is 115 mg/kg bw/day for the test item corresponding to 0.29 mg/L and 54 mg/kg bw/day for the ground active substance. A NOAEC or NOAEL value cannot be derived from this study due to the serious effects observed in the respiratory tract, possibly due to a particle overload effect of the test item particles that are barely soluble and persistent. No safe concentration for the use in spray applications can be derived. The concentrations/doses for the RDT inhalation study derived from an acute inhalation toxicity study (used as a pilot study) were too high. The dates of the in-life phase of the study were partly after the date of the animal testing","page":41,"pdf":"sccs_o_184.pdf","row_type":"noael_study","study_id":"sccs_o_184_noael_005"}
SCCS_vision_codex NOAEL =1000 mg/kg/day - - - NOAEL study {"dose":"Conclusion Based on the experimental conditions of this study, - the No Observed Effect Level (NOEL) of the non-ground active substance for parental toxicity was considered to be 1000 mg/kg/day,","effect":"ions There were no effects on live birth, viability and lactation indexes, Functional Observation Battery and motor activity. Amongst the findings noted during the study, none were indicative of a treatment-related effect. Haematology There were no effects on mean haematology parameters. Blood biochemistry and urinalysis There were no toxicological significant effects on mean blood chemistry parameters and urinalysis. Conclusion Based on the experimental conditions of this study, - the No Observed Effect Level (NOEL) of the non-ground active substance for parental toxicity was considered to be 1000 mg/kg/day,","page":50,"pdf":"sccs_o_184.pdf","row_type":"noael_study","study_id":"sccs_o_184_noael_006"}
SCCS_vision_codex NOAEL =464 mg/kg bw/day rat oral prenatal developmental toxicity {"dose":"ic potential on pregnant females up to and including the dose level of 1000 mg/kg bw/day.","effect":"ic potential on pregnant females up to and including the dose level of 1000 mg/kg bw/day. S02771 had no influence on the relevant reproduction data (post-implantation loss and the mean number of foetuses per dam) up to and including the dose level of 1000 mg/kg bw/day. Based on these results, the NOEL (No Observed Effect Level) for both maternal general toxicity and prenatal developmental toxicity was considered to be 1000 mg/kg bw/day, the highest dose used for the test item (suspension). Ref. 71 SCCS comment The NOEL for both maternal general toxicity and prenatal developmental toxicity was 464 mg/kg bw/day for the ground active substance, i.e. the highest dose level in the study. 3.3.9 Toxicokinetics 3.3.9.1 Toxicokinetics in laboratory animals In a satellite study of a screening test according to OECD TG 422 (see section 3.3.8.2), toxicokinetics were investigated with three dose groups of 8 male and 8 female rats per group with the active substance (S02374) applied daily for 2 weeks at oral doses of 100, 300 and 1000 mg/k","page":52,"pdf":"sccs_o_184.pdf","row_type":"noael_study","study_id":"sccs_o_184_noael_009"}
SCCS_vision_codex NOAEL =464 mg/kg bw/d - oral developmental reproductive toxicity {"dose":"NOEL) for parental toxicity and for reproductive performance (mating and fertility) was considered to be 1000 mg/kg/day.","effect":"NOEL) for parental toxicity and for reproductive performance (mating and fertility) was considered to be 1000 mg/kg/day. The NOEL for toxic effects on progeny was considered to be 1000 mg/kg/day. The cosmetic ingredient S02771 was investigated in a developmental toxicity study (OECD 414) at dose levels of 0, 100, 300, 1000 mg/kg bw/day for the test item, corresponding to 0, 46, 139, 464 mg/kg bw/day for the ground active substance. No adverse maternal and foetal effects related to the test item were observed and a NOEL of 464 mg/kg bw/d was derived for maternal and foetal effects. Toxicokinetics In a satellite study of the above OECD 422 Screening test, three groups of eight males and eight females received the non-ground active substance SO2374 by gavage for 2 weeks at dose-levels of 100, 300 or 1000 mg/kg/day for blood plasma concentration measurements.","page":67,"pdf":"sccs_o_184.pdf","row_type":"noael_study","study_id":"sccs_o_184_noael_017"}
SCCS_vision_codex NOAEL =80 mg/kg bw rat dermal 90 day irritation {"dose":"With respect to the precautionary principle, Eumulgin® L is classified as an eye irritant and as a skin irritant. • Eumulgin® L is not considered to be a skin sensitizer. • A NOAEL of 80 mg/kg bw was established in a 90 day study. • No potential for gene mutations was detected in the Ames test with Eumulgin® L.","effect":"SCCS-rejected applicant NOAEL: _____________________________________ 73 Annex Toxicological Evaluation of by-products and impurities Safety evaluation for the solubiliser, Eumulgin L The manufacturer has provided the following safety assessment to the applicant: • Eumulgin® L was not toxic or harmful in an acute toxicity test in the rat. • The dermal penetration is low. With respect to the precautionary principle, Eumulgin® L is classified as an eye irritant and as a skin irritant. • Eumulgin® L is not considered to be a skin sensitizer. • A NOAEL of 80 mg/kg bw was established in a 90 day study. • No potential for gene mutations was detected in the Ames test with Eumulgin® L. Ref. 47 Under these conditions, Eumulgin L could be considered as safe at the maximum concentration of 0.5% on healthy and on altered and irradiated skin, in the general scenario (18g/day). Safety evaluation for the preservative, benzoic acid The SCCP opinion on benzoic acid and sodium benzoate (SCCP/0891/05, dated June 2005) stated that benzoic acid and sodium benzoate are safe for","page":73,"pdf":"sccs_o_184.pdf","row_type":"noael_study","study_id":"sccs_o_184_noael_018"}
ToxValDB_ECHA_IUCLID 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_ECHA_IUCLID NOEL =1000 mg/kg bw/day Rat oral short-term; 5 days short-term QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7cb54e4b0a7c65d225bce; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/6106/7/6/2?documentUUID=4b4753c6-29c3-4692-aadf-22c699e4c870; YEAR=2012; ORIGINAL_YEAR=2012; STUDY_GROUP=ECHA IUCLID:15839320:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_4179f756f5efa114acc49834735cf108
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 18 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 54 mg/kg bw/day - inhalation 14-day - SOURCE_SUBDIR=sccs_o_184; REPORT_TITLE=OPINION ON UV filter S86 Phenylene bis-diphenyltriazine; OPINION_NUMBER=SCCS/1556/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=13 July 2015; VALUE_TEXT=54; DOSE=86 SCCS comment The LOAEC is 0.63 mg/L and the LOAEL calculated from the inhalation exposure is 115 mg/kg bw/day for the test item corresponding to 0.29 mg/L and 54 mg/kg bw/day for the ground active substance.; LOAEL_VALUE=115 mg/kg bw/day; EFFECT=se. There was no evidence of reversal of microscopic findings in the lungs and tracheobronchial lymph node, progressive ongoing reversal of microscopic findings in the nasal cavities and larynx, and almost complete reversal of microscopic findings in the trachea following a 14-day recovery. Ref. 86 SCCS comment The LOAEC is 0.63 mg/L and the LOAEL calculated from the inhalation exposure is 115 mg/kg bw/day for the test item corresponding to 0.29 mg/L and 54 mg/kg bw/day for the ground active substance. A NOAEC or NOAEL value cannot be derived from this study due to the serious effects observed in the respiratory tract, possibly due to a particle overload effect of the test item particles that are barely soluble and persistent. No safe concentration for the use in spray applications can be derived. The concentrations/doses for the RDT inhalation study derived from an acute inhalation toxicity study (used as a pilot study) were too high. The dates of the in-life phase of the study were partly after the date of the animal testing; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"55514-22-2","citation":"","dose":"86 SCCS comment The LOAEC is 0.63 mg/L and the LOAEL calculated from the inhalation exposure is 115 mg/kg bw/day for the test item corresponding to 0.29 mg/L and 54 mg/kg bw/day for the ground active substance.","duration":"14-day","effect":"se. There was no evidence of reversal of microscopic findings in the lungs and tracheobronchial lymph node, progressive ongoing reversal of microscopic findings in the nasal cavities and larynx, and almost complete reversal of microscopic findings in the trachea following a 14-day recovery. Ref. 86 SCCS comment The LOAEC is 0.63 mg/L and the LOAEL calculated from the inhalation exposure is 115 mg/kg bw/day for the test item corresponding to 0.29 mg/L and 54 mg/kg bw/day for the ground active substance. A NOAEC or NOAEL value cannot be derived from this study due to the serious effects observed in the respiratory tract, possibly due to a particle overload effect of the test item particles that are barely soluble and persistent. No safe concentration for the use in spray applications can be derived. The concentrations/doses for the RDT inhalation study derived from an acute inhalation toxicity study (used as a pilot study) were too high. The dates of the in-life phase of the study were partly after the date of the animal testing","endpoint":"","ingredient":"Phenylene bis-diphenyltriazine (CAS n. 55514-22-2) S86 , identified also as S02771,","loael_value":"115 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"54","page":41,"route":"inhalation","species":"","study_id":"sccs_o_184_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 1000 mg/kg/day - - - - SOURCE_SUBDIR=sccs_o_184; REPORT_TITLE=OPINION ON UV filter S86 Phenylene bis-diphenyltriazine; OPINION_NUMBER=SCCS/1556/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=13 July 2015; VALUE_TEXT=1000; DOSE=Conclusion Based on the experimental conditions of this study, - the No Observed Effect Level (NOEL) of the non-ground active substance for parental toxicity was considered to be 1000 mg/kg/day,; EFFECT=ions There were no effects on live birth, viability and lactation indexes, Functional Observation Battery and motor activity. Amongst the findings noted during the study, none were indicative of a treatment-related effect. Haematology There were no effects on mean haematology parameters. Blood biochemistry and urinalysis There were no toxicological significant effects on mean blood chemistry parameters and urinalysis. Conclusion Based on the experimental conditions of this study, - the No Observed Effect Level (NOEL) of the non-ground active substance for parental toxicity was considered to be 1000 mg/kg/day,; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"55514-22-2","citation":"","dose":"Conclusion Based on the experimental conditions of this study, - the No Observed Effect Level (NOEL) of the non-ground active substance for parental toxicity was considered to be 1000 mg/kg/day,","duration":"","effect":"ions There were no effects on live birth, viability and lactation indexes, Functional Observation Battery and motor activity. Amongst the findings noted during the study, none were indicative of a treatment-related effect. Haematology There were no effects on mean haematology parameters. Blood biochemistry and urinalysis There were no toxicological significant effects on mean blood chemistry parameters and urinalysis. Conclusion Based on the experimental conditions of this study, - the No Observed Effect Level (NOEL) of the non-ground active substance for parental toxicity was considered to be 1000 mg/kg/day,","endpoint":"","ingredient":"Phenylene bis-diphenyltriazine (CAS n. 55514-22-2) S86 , identified also as S02771,","loael_value":"","noael_unit":"mg/kg/day","noael_value":"1000","page":50,"route":"","species":"","study_id":"sccs_o_184_noael_006"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 1000 mg/kg/day rat oral 4-week - SOURCE_SUBDIR=sccs_o_184; REPORT_TITLE=OPINION ON UV filter S86 Phenylene bis-diphenyltriazine; OPINION_NUMBER=SCCS/1556/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=13 July 2015; VALUE_TEXT=1000; DOSE=After oral administration of S02771 to Wistar rats at doses of the suspension of 100, 300 and 1000 mg/kg/day, and based on histopathology, a NOEL (No Observed Effect Level) could be established at 300 mg/kg/day for males, at 1000 mg/kg/day for females.; EFFECT=by a 4-week treatment-free period according to OECD 408 was performed on rats with the cosmetic ingredient S02771 containing 48.5% of the ground active substance in the supension. After oral administration of S02771 to Wistar rats at doses of the suspension of 100, 300 and 1000 mg/kg/day, and based on histopathology, a NOEL (No Observed Effect Level) could be established at 300 mg/kg/day for males, at 1000 mg/kg/day for females. The NOAEL of the suspension could be established at 1000 mg/kg/day corresponding to a NOAEL of the ground active substance at 485 mg/kg bw/day, i.e. the highest dose level in the study. One of the objectives of this study was to include parameters to assess possible endocrine disruptor properties of the test item. In the males, absence of effects on thyroid hormones, on sexual organ weights, on sexual and endocrine organ histopathology and on testicular staging allow to conclude the absence of visible endocrine disruptor effects of S02771 with regards to the endocrine parameters tested. In females, absen; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"55514-22-2","citation":"","dose":"After oral administration of S02771 to Wistar rats at doses of the suspension of 100, 300 and 1000 mg/kg/day, and based on histopathology, a NOEL (No Observed Effect Level) could be established at 300 mg/kg/day for males, at 1000 mg/kg/day for females.","duration":"4-week","effect":"by a 4-week treatment-free period according to OECD 408 was performed on rats with the cosmetic ingredient S02771 containing 48.5% of the ground active substance in the supension. After oral administration of S02771 to Wistar rats at doses of the suspension of 100, 300 and 1000 mg/kg/day, and based on histopathology, a NOEL (No Observed Effect Level) could be established at 300 mg/kg/day for males, at 1000 mg/kg/day for females. The NOAEL of the suspension could be established at 1000 mg/kg/day corresponding to a NOAEL of the ground active substance at 485 mg/kg bw/day, i.e. the highest dose level in the study. One of the objectives of this study was to include parameters to assess possible endocrine disruptor properties of the test item. In the males, absence of effects on thyroid hormones, on sexual organ weights, on sexual and endocrine organ histopathology and on testicular staging allow to conclude the absence of visible endocrine disruptor effects of S02771 with regards to the endocrine parameters tested. In females, absen","endpoint":"","ingredient":"Phenylene bis-diphenyltriazine (CAS n. 55514-22-2) S86 , identified also as S02771,","loael_value":"","noael_unit":"mg/kg/day","noael_value":"1000","page":66,"route":"oral","species":"rat","study_id":"sccs_o_184_noael_012"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 1000 mg/kg bw/day - - prenatal developmental toxicity SOURCE_SUBDIR=sccs_o_184; REPORT_TITLE=OPINION ON UV filter S86 Phenylene bis-diphenyltriazine; OPINION_NUMBER=SCCS/1556/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=13 July 2015; VALUE_TEXT=1000; DOSE=SCCS/1556/15 Opinion on UV filter S86 Phenylene Bis Diphenyltriazine ___________________________________________________________________________________________ 52 Conclusion The test item did not show any toxic potential on pregnant females up to and including the dose level of 1000 mg/kg bw/day.; EFFECT=SCCS/1556/15 Opinion on UV filter S86 Phenylene Bis Diphenyltriazine ___________________________________________________________________________________________ 52 Conclusion The test item did not show any toxic potential on pregnant females up to and including the dose level of 1000 mg/kg bw/day. S02771 had no influence on the relevant reproduction data (post-implantation loss and the mean number of foetuses per dam) up to and including the dose level of 1000 mg/kg bw/day. Based on these results, the NOEL (No Observed Effect Level) for both maternal general toxicity and prenatal developmental toxicity was considered to be 1000 mg/kg bw/day, the highest dose used for the test item (suspension). Ref. 71 SCCS comment The NOEL for both maternal general toxicity and prenatal developmental toxicity was 464 mg/kg bw/day for the ground active substance, i.e. the highest dose level in the study. 3.3.9 Toxicokinetics 3.3.9.1 Toxicokinetics in laboratory animals In a satellite study of a screening test according to OECD TG; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"55514-22-2","citation":"","dose":"SCCS/1556/15 Opinion on UV filter S86 Phenylene Bis Diphenyltriazine ___________________________________________________________________________________________ 52 Conclusion The test item did not show any toxic potential on pregnant females up to and including the dose level of 1000 mg/kg bw/day.","duration":"prenatal","effect":"SCCS/1556/15 Opinion on UV filter S86 Phenylene Bis Diphenyltriazine ___________________________________________________________________________________________ 52 Conclusion The test item did not show any toxic potential on pregnant females up to and including the dose level of 1000 mg/kg bw/day. S02771 had no influence on the relevant reproduction data (post-implantation loss and the mean number of foetuses per dam) up to and including the dose level of 1000 mg/kg bw/day. Based on these results, the NOEL (No Observed Effect Level) for both maternal general toxicity and prenatal developmental toxicity was considered to be 1000 mg/kg bw/day, the highest dose used for the test item (suspension). Ref. 71 SCCS comment The NOEL for both maternal general toxicity and prenatal developmental toxicity was 464 mg/kg bw/day for the ground active substance, i.e. the highest dose level in the study. 3.3.9 Toxicokinetics 3.3.9.1 Toxicokinetics in laboratory animals In a satellite study of a screening test according to OECD TG","endpoint":"developmental toxicity","ingredient":"Phenylene bis-diphenyltriazine (CAS n. 55514-22-2) S86 , identified also as S02771,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":52,"route":"","species":"","study_id":"sccs_o_184_noael_008"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 464 mg/kg bw/day rat oral prenatal developmental toxicity SOURCE_SUBDIR=sccs_o_184; REPORT_TITLE=OPINION ON UV filter S86 Phenylene bis-diphenyltriazine; OPINION_NUMBER=SCCS/1556/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=13 July 2015; VALUE_TEXT=464; DOSE=ic potential on pregnant females up to and including the dose level of 1000 mg/kg bw/day.; EFFECT=ic potential on pregnant females up to and including the dose level of 1000 mg/kg bw/day. S02771 had no influence on the relevant reproduction data (post-implantation loss and the mean number of foetuses per dam) up to and including the dose level of 1000 mg/kg bw/day. Based on these results, the NOEL (No Observed Effect Level) for both maternal general toxicity and prenatal developmental toxicity was considered to be 1000 mg/kg bw/day, the highest dose used for the test item (suspension). Ref. 71 SCCS comment The NOEL for both maternal general toxicity and prenatal developmental toxicity was 464 mg/kg bw/day for the ground active substance, i.e. the highest dose level in the study. 3.3.9 Toxicokinetics 3.3.9.1 Toxicokinetics in laboratory animals In a satellite study of a screening test according to OECD TG 422 (see section 3.3.8.2), toxicokinetics were investigated with three dose groups of 8 male and 8 female rats per group with the active substance (S02374) applied daily for 2 weeks at oral doses of 100, 300 and 1000 mg/k; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"55514-22-2","citation":"","dose":"ic potential on pregnant females up to and including the dose level of 1000 mg/kg bw/day.","duration":"prenatal","effect":"ic potential on pregnant females up to and including the dose level of 1000 mg/kg bw/day. S02771 had no influence on the relevant reproduction data (post-implantation loss and the mean number of foetuses per dam) up to and including the dose level of 1000 mg/kg bw/day. Based on these results, the NOEL (No Observed Effect Level) for both maternal general toxicity and prenatal developmental toxicity was considered to be 1000 mg/kg bw/day, the highest dose used for the test item (suspension). Ref. 71 SCCS comment The NOEL for both maternal general toxicity and prenatal developmental toxicity was 464 mg/kg bw/day for the ground active substance, i.e. the highest dose level in the study. 3.3.9 Toxicokinetics 3.3.9.1 Toxicokinetics in laboratory animals In a satellite study of a screening test according to OECD TG 422 (see section 3.3.8.2), toxicokinetics were investigated with three dose groups of 8 male and 8 female rats per group with the active substance (S02374) applied daily for 2 weeks at oral doses of 100, 300 and 1000 mg/k","endpoint":"developmental toxicity","ingredient":"Phenylene bis-diphenyltriazine (CAS n. 55514-22-2) S86 , identified also as S02771,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"464","page":52,"route":"oral","species":"rat","study_id":"sccs_o_184_noael_009"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies irritation 80 mg/kg bw rat dermal 90 day irritation SOURCE_SUBDIR=sccs_o_184; REPORT_TITLE=OPINION ON UV filter S86 Phenylene bis-diphenyltriazine; OPINION_NUMBER=SCCS/1556/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=13 July 2015; VALUE_TEXT=80; DOSE=With respect to the precautionary principle, Eumulgin® L is classified as an eye irritant and as a skin irritant. • Eumulgin® L is not considered to be a skin sensitizer. • A NOAEL of 80 mg/kg bw was established in a 90 day study. • No potential for gene mutations was detected in the Ames test with Eumulgin® L.; EFFECT=SCCS-rejected applicant NOAEL: _____________________________________ 73 Annex Toxicological Evaluation of by-products and impurities Safety evaluation for the solubiliser, Eumulgin L The manufacturer has provided the following safety assessment to the applicant: • Eumulgin® L was not toxic or harmful in an acute toxicity test in the rat. • The dermal penetration is low. With respect to the precautionary principle, Eumulgin® L is classified as an eye irritant and as a skin irritant. • Eumulgin® L is not considered to be a skin sensitizer. • A NOAEL of 80 mg/kg bw was established in a 90 day study. • No potential for gene mutations was detected in the Ames test with Eumulgin® L. Ref. 47 Under these conditions, Eumulgin L could be considered as safe at the maximum concentration of 0.5% on healthy and on altered and irradiated skin, in the general scenario (18g/day). Safety evaluation for the preservative, benzoic acid The SCCP opinion on benzoic acid and sodium benzoate (SCCP/0891/05, dated June 2005) stated that benzoic acid and sodium benzoate are safe for; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"55514-22-2","citation":"","dose":"With respect to the precautionary principle, Eumulgin® L is classified as an eye irritant and as a skin irritant. • Eumulgin® L is not considered to be a skin sensitizer. • A NOAEL of 80 mg/kg bw was established in a 90 day study. • No potential for gene mutations was detected in the Ames test with Eumulgin® L.","duration":"90 day","effect":"SCCS-rejected applicant NOAEL: _____________________________________ 73 Annex Toxicological Evaluation of by-products and impurities Safety evaluation for the solubiliser, Eumulgin L The manufacturer has provided the following safety assessment to the applicant: • Eumulgin® L was not toxic or harmful in an acute toxicity test in the rat. • The dermal penetration is low. With respect to the precautionary principle, Eumulgin® L is classified as an eye irritant and as a skin irritant. • Eumulgin® L is not considered to be a skin sensitizer. • A NOAEL of 80 mg/kg bw was established in a 90 day study. • No potential for gene mutations was detected in the Ames test with Eumulgin® L. Ref. 47 Under these conditions, Eumulgin L could be considered as safe at the maximum concentration of 0.5% on healthy and on altered and irradiated skin, in the general scenario (18g/day). Safety evaluation for the preservative, benzoic acid The SCCP opinion on benzoic acid and sodium benzoate (SCCP/0891/05, dated June 2005) stated that benzoic acid and sodium benzoate are safe for","endpoint":"irritation","ingredient":"Phenylene bis-diphenyltriazine (CAS n. 55514-22-2) S86 , identified also as S02771,","loael_value":"","noael_unit":"mg/kg bw","noael_value":"80","page":73,"route":"dermal","species":"rat","study_id":"sccs_o_184_noael_018"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 48.5 % rat oral 2-week repeated dose toxicity SOURCE_SUBDIR=sccs_o_184; REPORT_TITLE=OPINION ON UV filter S86 Phenylene bis-diphenyltriazine; OPINION_NUMBER=SCCS/1556/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=13 July 2015; VALUE_TEXT=48.5; DOSE=After oral administration of S02771 to Wistar rats at doses of the suspension of 100, 300 and 1000 mg/kg/day, for 13 weeks and a four-week treatment-free recovery period, based on histopathology a NOEL (No Observed Effect Level) could be established for the ground active substance (content 48.5% in the suspension) - at 146 mg/kg/day for males, -...; EFFECT=ested. In females, absence of effects on thyroid hormones, the absence of effects on the 2-week vaginal oestrus cycles, on sexual organ weights and on sexual and endocrine organ histopathology, allow to conclude the absence of visible endocrine disruptor effects of S02771 with regards to the endocrine parameters tested. After oral administration of S02771 to Wistar rats at doses of the suspension of 100, 300 and 1000 mg/kg/day, for 13 weeks and a four-week treatment-free recovery period, based on histopathology a NOEL (No Observed Effect Level) could be established for the ground active substance (content 48.5% in the suspension) - at 146 mg/kg/day for males, - at 485 mg/kg/day for females. A NOAEL (No Observed Adverse Effect Level) for males could be established at 485 mg/kg/day for the ground active substance. Ref. 64 3.3.5.3 OECD 422 Screening Test A Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test conducted with the non-ground active substance (S02374) according to OECD TG 4; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"55514-22-2","citation":"","dose":"After oral administration of S02771 to Wistar rats at doses of the suspension of 100, 300 and 1000 mg/kg/day, for 13 weeks and a four-week treatment-free recovery period, based on histopathology a NOEL (No Observed Effect Level) could be established for the ground active substance (content 48.5% in the suspension) - at 146 mg/kg/day for males, -...","duration":"2-week","effect":"ested. In females, absence of effects on thyroid hormones, the absence of effects on the 2-week vaginal oestrus cycles, on sexual organ weights and on sexual and endocrine organ histopathology, allow to conclude the absence of visible endocrine disruptor effects of S02771 with regards to the endocrine parameters tested. After oral administration of S02771 to Wistar rats at doses of the suspension of 100, 300 and 1000 mg/kg/day, for 13 weeks and a four-week treatment-free recovery period, based on histopathology a NOEL (No Observed Effect Level) could be established for the ground active substance (content 48.5% in the suspension) - at 146 mg/kg/day for males, - at 485 mg/kg/day for females. A NOAEL (No Observed Adverse Effect Level) for males could be established at 485 mg/kg/day for the ground active substance. Ref. 64 3.3.5.3 OECD 422 Screening Test A Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test conducted with the non-ground active substance (S02374) according to OECD TG 4","endpoint":"repeated dose toxicity","ingredient":"Phenylene bis-diphenyltriazine (CAS n. 55514-22-2) S86 , identified also as S02771,","loael_value":"","noael_unit":"%","noael_value":"48.5","page":36,"route":"oral","species":"rat","study_id":"sccs_o_184_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 485 mg/kg/day rat oral 13 weeks repeated dose toxicity SOURCE_SUBDIR=sccs_o_184; REPORT_TITLE=OPINION ON UV filter S86 Phenylene bis-diphenyltriazine; OPINION_NUMBER=SCCS/1556/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=13 July 2015; VALUE_TEXT=485; DOSE=After oral administration of S02771 to Wistar rats at doses of the suspension of 100, 300 and 1000 mg/kg/day, for 13 weeks and a four-week treatment-free recovery period, based on histopathology a NOEL (No Observed Effect Level) could be established for the ground active substance (content 48.5% in the suspension) - at 146 mg/kg/day for males, -...; EFFECT=pathology, allow to conclude the absence of visible endocrine disruptor effects of S02771 with regards to the endocrine parameters tested. After oral administration of S02771 to Wistar rats at doses of the suspension of 100, 300 and 1000 mg/kg/day, for 13 weeks and a four-week treatment-free recovery period, based on histopathology a NOEL (No Observed Effect Level) could be established for the ground active substance (content 48.5% in the suspension) - at 146 mg/kg/day for males, - at 485 mg/kg/day for females. A NOAEL (No Observed Adverse Effect Level) for males could be established at 485 mg/kg/day for the ground active substance. Ref. 64 3.3.5.3 OECD 422 Screening Test A Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test conducted with the non-ground active substance (S02374) according to OECD TG 422 is described in section 3.3.8.2. The No Observed Effect Level (NOEL) for parental toxicity was considered to be 1000 mg/kg bw/day.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"55514-22-2","citation":"","dose":"After oral administration of S02771 to Wistar rats at doses of the suspension of 100, 300 and 1000 mg/kg/day, for 13 weeks and a four-week treatment-free recovery period, based on histopathology a NOEL (No Observed Effect Level) could be established for the ground active substance (content 48.5% in the suspension) - at 146 mg/kg/day for males, -...","duration":"13 weeks","effect":"pathology, allow to conclude the absence of visible endocrine disruptor effects of S02771 with regards to the endocrine parameters tested. After oral administration of S02771 to Wistar rats at doses of the suspension of 100, 300 and 1000 mg/kg/day, for 13 weeks and a four-week treatment-free recovery period, based on histopathology a NOEL (No Observed Effect Level) could be established for the ground active substance (content 48.5% in the suspension) - at 146 mg/kg/day for males, - at 485 mg/kg/day for females. A NOAEL (No Observed Adverse Effect Level) for males could be established at 485 mg/kg/day for the ground active substance. Ref. 64 3.3.5.3 OECD 422 Screening Test A Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test conducted with the non-ground active substance (S02374) according to OECD TG 422 is described in section 3.3.8.2. The No Observed Effect Level (NOEL) for parental toxicity was considered to be 1000 mg/kg bw/day.","endpoint":"repeated dose toxicity","ingredient":"Phenylene bis-diphenyltriazine (CAS n. 55514-22-2) S86 , identified also as S02771,","loael_value":"","noael_unit":"mg/kg/day","noael_value":"485","page":36,"route":"oral","species":"rat","study_id":"sccs_o_184_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 485 mg/kg/day rat oral 13 weeks repeated dose toxicity SOURCE_SUBDIR=sccs_o_184; REPORT_TITLE=OPINION ON UV filter S86 Phenylene bis-diphenyltriazine; OPINION_NUMBER=SCCS/1556/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=13 July 2015; VALUE_TEXT=485; DOSE=After oral administration of S02771 to Wistar rats at doses of the suspension of 100, 300 and 1000 mg/kg/day, for 13 weeks and a four-week treatment-free recovery period, based on histopathology a NOEL (No Observed Effect Level) could be established for the ground active substance (content 48.5% in the suspension) - at 146 mg/kg/day for males, -...; EFFECT=gy, allow to conclude the absence of visible endocrine disruptor effects of S02771 with regards to the endocrine parameters tested. After oral administration of S02771 to Wistar rats at doses of the suspension of 100, 300 and 1000 mg/kg/day, for 13 weeks and a four-week treatment-free recovery period, based on histopathology a NOEL (No Observed Effect Level) could be established for the ground active substance (content 48.5% in the suspension) - at 146 mg/kg/day for males, - at 485 mg/kg/day for females. A NOAEL (No Observed Adverse Effect Level) for males could be established at 485 mg/kg/day for the ground active substance. Ref. 64 3.3.5.3 OECD 422 Screening Test A Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test conducted with the non-ground active substance (S02374) according to OECD TG 422 is described in section 3.3.8.2. The No Observed Effect Level (NOEL) for parental toxicity was considered to be 1000 mg/kg bw/day.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"55514-22-2","citation":"","dose":"After oral administration of S02771 to Wistar rats at doses of the suspension of 100, 300 and 1000 mg/kg/day, for 13 weeks and a four-week treatment-free recovery period, based on histopathology a NOEL (No Observed Effect Level) could be established for the ground active substance (content 48.5% in the suspension) - at 146 mg/kg/day for males, -...","duration":"13 weeks","effect":"gy, allow to conclude the absence of visible endocrine disruptor effects of S02771 with regards to the endocrine parameters tested. After oral administration of S02771 to Wistar rats at doses of the suspension of 100, 300 and 1000 mg/kg/day, for 13 weeks and a four-week treatment-free recovery period, based on histopathology a NOEL (No Observed Effect Level) could be established for the ground active substance (content 48.5% in the suspension) - at 146 mg/kg/day for males, - at 485 mg/kg/day for females. A NOAEL (No Observed Adverse Effect Level) for males could be established at 485 mg/kg/day for the ground active substance. Ref. 64 3.3.5.3 OECD 422 Screening Test A Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test conducted with the non-ground active substance (S02374) according to OECD TG 422 is described in section 3.3.8.2. The No Observed Effect Level (NOEL) for parental toxicity was considered to be 1000 mg/kg bw/day.","endpoint":"repeated dose toxicity","ingredient":"Phenylene bis-diphenyltriazine (CAS n. 55514-22-2) S86 , identified also as S02771,","loael_value":"","noael_unit":"mg/kg/day","noael_value":"485","page":36,"route":"oral","species":"rat","study_id":"sccs_o_184_noael_003"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 1000 mg/kg bw/day - - Developmental repeated dose toxicity SOURCE_SUBDIR=sccs_o_184; REPORT_TITLE=OPINION ON UV filter S86 Phenylene bis-diphenyltriazine; OPINION_NUMBER=SCCS/1556/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=13 July 2015; VALUE_TEXT=1000; DOSE=tive substance (content 48.5% in the suspension) - at 146 mg/kg/day for males, - at 485 mg/kg/day for females.; EFFECT=tive substance (content 48.5% in the suspension) - at 146 mg/kg/day for males, - at 485 mg/kg/day for females. A NOAEL (No Observed Adverse Effect Level) for males could be established at 485 mg/kg/day for the ground active substance. Ref. 64 3.3.5.3 OECD 422 Screening Test A Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test conducted with the non-ground active substance (S02374) according to OECD TG 422 is described in section 3.3.8.2. The No Observed Effect Level (NOEL) for parental toxicity was considered to be 1000 mg/kg bw/day.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"55514-22-2","citation":"","dose":"tive substance (content 48.5% in the suspension) - at 146 mg/kg/day for males, - at 485 mg/kg/day for females.","duration":"Developmental","effect":"tive substance (content 48.5% in the suspension) - at 146 mg/kg/day for males, - at 485 mg/kg/day for females. A NOAEL (No Observed Adverse Effect Level) for males could be established at 485 mg/kg/day for the ground active substance. Ref. 64 3.3.5.3 OECD 422 Screening Test A Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test conducted with the non-ground active substance (S02374) according to OECD TG 422 is described in section 3.3.8.2. The No Observed Effect Level (NOEL) for parental toxicity was considered to be 1000 mg/kg bw/day.","endpoint":"repeated dose toxicity","ingredient":"Phenylene bis-diphenyltriazine (CAS n. 55514-22-2) S86 , identified also as S02771,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":36,"route":"","species":"","study_id":"sccs_o_184_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 1000 mg/kg/day rat oral 13-week repeated dose toxicity SOURCE_SUBDIR=sccs_o_184; REPORT_TITLE=OPINION ON UV filter S86 Phenylene bis-diphenyltriazine; OPINION_NUMBER=SCCS/1556/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=13 July 2015; VALUE_TEXT=1000; DOSE=Repeated dose toxicity A 13-week oral toxicity test followed by a 4-week treatment-free period according to OECD 408 was performed on rats with the cosmetic ingredient S02771 containing 48.5% of the ground active substance in the supension.; EFFECT=alue of 0.33 % dermal absorption (1.8 µg/cm2) from the study on intact human skin can be taken as a worst case for the MoS calculation. Repeated dose toxicity A 13-week oral toxicity test followed by a 4-week treatment-free period according to OECD 408 was performed on rats with the cosmetic ingredient S02771 containing 48.5% of the ground active substance in the supension. After oral administration of S02771 to Wistar rats at doses of the suspension of 100, 300 and 1000 mg/kg/day, and based on histopathology, a NOEL (No Observed Effect Level) could be established at 300 mg/kg/day for males, at 1000 mg/kg/day for females. The NOAEL of the suspension could be established at 1000 mg/kg/day corresponding to a NOAEL of the ground active substance at 485 mg/kg bw/day, i.e. the highest dose level in the study. One of the objectives of this study was to include parameters to assess possible endocrine disruptor properties of the test item. In the males, absence of effects on thyroid hormones, on sexual organ weights, on sexual and end; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"55514-22-2","citation":"","dose":"Repeated dose toxicity A 13-week oral toxicity test followed by a 4-week treatment-free period according to OECD 408 was performed on rats with the cosmetic ingredient S02771 containing 48.5% of the ground active substance in the supension.","duration":"13-week","effect":"alue of 0.33 % dermal absorption (1.8 µg/cm2) from the study on intact human skin can be taken as a worst case for the MoS calculation. Repeated dose toxicity A 13-week oral toxicity test followed by a 4-week treatment-free period according to OECD 408 was performed on rats with the cosmetic ingredient S02771 containing 48.5% of the ground active substance in the supension. After oral administration of S02771 to Wistar rats at doses of the suspension of 100, 300 and 1000 mg/kg/day, and based on histopathology, a NOEL (No Observed Effect Level) could be established at 300 mg/kg/day for males, at 1000 mg/kg/day for females. The NOAEL of the suspension could be established at 1000 mg/kg/day corresponding to a NOAEL of the ground active substance at 485 mg/kg bw/day, i.e. the highest dose level in the study. One of the objectives of this study was to include parameters to assess possible endocrine disruptor properties of the test item. In the males, absence of effects on thyroid hormones, on sexual organ weights, on sexual and end","endpoint":"repeated dose toxicity","ingredient":"Phenylene bis-diphenyltriazine (CAS n. 55514-22-2) S86 , identified also as S02771,","loael_value":"","noael_unit":"mg/kg/day","noael_value":"1000","page":66,"route":"oral","species":"rat","study_id":"sccs_o_184_noael_010"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 1000 mg/kg/day rat oral 13-week repeated dose toxicity SOURCE_SUBDIR=sccs_o_184; REPORT_TITLE=OPINION ON UV filter S86 Phenylene bis-diphenyltriazine; OPINION_NUMBER=SCCS/1556/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=13 July 2015; VALUE_TEXT=1000; DOSE=Repeated dose toxicity A 13-week oral toxicity test followed by a 4-week treatment-free period according to OECD 408 was performed on rats with the cosmetic ingredient S02771 containing 48.5% of the ground active substance in the supension.; EFFECT=he MoS calculation. Repeated dose toxicity A 13-week oral toxicity test followed by a 4-week treatment-free period according to OECD 408 was performed on rats with the cosmetic ingredient S02771 containing 48.5% of the ground active substance in the supension. After oral administration of S02771 to Wistar rats at doses of the suspension of 100, 300 and 1000 mg/kg/day, and based on histopathology, a NOEL (No Observed Effect Level) could be established at 300 mg/kg/day for males, at 1000 mg/kg/day for females. The NOAEL of the suspension could be established at 1000 mg/kg/day corresponding to a NOAEL of the ground active substance at 485 mg/kg bw/day, i.e. the highest dose level in the study. One of the objectives of this study was to include parameters to assess possible endocrine disruptor properties of the test item. In the males, absence of effects on thyroid hormones, on sexual organ weights, on sexual and endocrine organ histopathology and on testicular staging allow to conclude the absence of visible endocrine disruptor ef; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"55514-22-2","citation":"","dose":"Repeated dose toxicity A 13-week oral toxicity test followed by a 4-week treatment-free period according to OECD 408 was performed on rats with the cosmetic ingredient S02771 containing 48.5% of the ground active substance in the supension.","duration":"13-week","effect":"he MoS calculation. Repeated dose toxicity A 13-week oral toxicity test followed by a 4-week treatment-free period according to OECD 408 was performed on rats with the cosmetic ingredient S02771 containing 48.5% of the ground active substance in the supension. After oral administration of S02771 to Wistar rats at doses of the suspension of 100, 300 and 1000 mg/kg/day, and based on histopathology, a NOEL (No Observed Effect Level) could be established at 300 mg/kg/day for males, at 1000 mg/kg/day for females. The NOAEL of the suspension could be established at 1000 mg/kg/day corresponding to a NOAEL of the ground active substance at 485 mg/kg bw/day, i.e. the highest dose level in the study. One of the objectives of this study was to include parameters to assess possible endocrine disruptor properties of the test item. In the males, absence of effects on thyroid hormones, on sexual organ weights, on sexual and endocrine organ histopathology and on testicular staging allow to conclude the absence of visible endocrine disruptor ef","endpoint":"repeated dose toxicity","ingredient":"Phenylene bis-diphenyltriazine (CAS n. 55514-22-2) S86 , identified also as S02771,","loael_value":"","noael_unit":"mg/kg/day","noael_value":"1000","page":66,"route":"oral","species":"rat","study_id":"sccs_o_184_noael_011"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 1000 mg/kg/day rat oral developmental repeated dose toxicity SOURCE_SUBDIR=sccs_o_184; REPORT_TITLE=OPINION ON UV filter S86 Phenylene bis-diphenyltriazine; OPINION_NUMBER=SCCS/1556/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=13 July 2015; VALUE_TEXT=1000; DOSE=Additional supporting repeated dose toxicity data on the non-ground active substance S02374 were obtained from an OECD 422 study (i.e. a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test by oral route (gavage) in rats):; LOAEL_VALUE=115 mg/kg bw/day; EFFECT=exual and endocrine organ histopathology allow to conclude the absence of visible endocrine disruptor effects of S02771 with regards to the endocrine parameters tested. Additional supporting repeated dose toxicity data on the non-ground active substance S02374 were obtained from an OECD 422 study (i.e. a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test by oral route (gavage) in rats): Based on the experimental conditions of this study, the No Observed Effect Level (NOEL) was considered to be 1000 mg/kg/day. A subacute inhalation toxicity study in rats (14 days exposure, nose-only, 4 hours per day) with the cosmetic ingredient SO2771 was performed. The achieved aerosol concentrations of the suspension were 0, 0.63, 1.21 and 2.13 mg/L corresponding to 0, 0.29, 0.55 and 0.98 mg/L for the ground active substance. The LOAEC is 0.63 mg/L and the LOAEL calculated from the inhalation exposure is 115 mg/kg bw/day for the test item corresponding to 0.29 mg/L and 54 mg/kg bw/day for the gr; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"55514-22-2","citation":"","dose":"Additional supporting repeated dose toxicity data on the non-ground active substance S02374 were obtained from an OECD 422 study (i.e. a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test by oral route (gavage) in rats):","duration":"developmental","effect":"exual and endocrine organ histopathology allow to conclude the absence of visible endocrine disruptor effects of S02771 with regards to the endocrine parameters tested. Additional supporting repeated dose toxicity data on the non-ground active substance S02374 were obtained from an OECD 422 study (i.e. a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test by oral route (gavage) in rats): Based on the experimental conditions of this study, the No Observed Effect Level (NOEL) was considered to be 1000 mg/kg/day. A subacute inhalation toxicity study in rats (14 days exposure, nose-only, 4 hours per day) with the cosmetic ingredient SO2771 was performed. The achieved aerosol concentrations of the suspension were 0, 0.63, 1.21 and 2.13 mg/L corresponding to 0, 0.29, 0.55 and 0.98 mg/L for the ground active substance. The LOAEC is 0.63 mg/L and the LOAEL calculated from the inhalation exposure is 115 mg/kg bw/day for the test item corresponding to 0.29 mg/L and 54 mg/kg bw/day for the gr","endpoint":"repeated dose toxicity","ingredient":"Phenylene bis-diphenyltriazine (CAS n. 55514-22-2) S86 , identified also as S02771,","loael_value":"115 mg/kg bw/day","noael_unit":"mg/kg/day","noael_value":"1000","page":66,"route":"oral","species":"rat","study_id":"sccs_o_184_noael_013"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 54 mg/kg bw/day rat inhalation subacute repeated dose toxicity SOURCE_SUBDIR=sccs_o_184; REPORT_TITLE=OPINION ON UV filter S86 Phenylene bis-diphenyltriazine; OPINION_NUMBER=SCCS/1556/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=13 July 2015; VALUE_TEXT=54; DOSE=The LOAEC is 0.63 mg/L and the LOAEL calculated from the inhalation exposure is 115 mg/kg bw/day for the test item corresponding to 0.29 mg/L and 54 mg/kg bw/day for the ground active substance.; LOAEL_VALUE=115 mg/kg bw/day; EFFECT=day. A subacute inhalation toxicity study in rats (14 days exposure, nose-only, 4 hours per day) with the cosmetic ingredient SO2771 was performed. The achieved aerosol concentrations of the suspension were 0, 0.63, 1.21 and 2.13 mg/L corresponding to 0, 0.29, 0.55 and 0.98 mg/L for the ground active substance. The LOAEC is 0.63 mg/L and the LOAEL calculated from the inhalation exposure is 115 mg/kg bw/day for the test item corresponding to 0.29 mg/L and 54 mg/kg bw/day for the ground active substance. A NOAEC or NOAEL value cannot be derived from this study due to the serious effects observed in the respiratory tract, possibly due to a particle overload effect of the test item particles that are barely soluble and persistent. No safe concentration for the use in spray applications can be derived. The concentrations/doses for the repeated dose inhalation study derived from an acute inhalation toxicity study (used as a pilot study) were too high. The dates of the in-life phase of the study were partly after the date of the anim; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"55514-22-2","citation":"","dose":"The LOAEC is 0.63 mg/L and the LOAEL calculated from the inhalation exposure is 115 mg/kg bw/day for the test item corresponding to 0.29 mg/L and 54 mg/kg bw/day for the ground active substance.","duration":"subacute","effect":"day. A subacute inhalation toxicity study in rats (14 days exposure, nose-only, 4 hours per day) with the cosmetic ingredient SO2771 was performed. The achieved aerosol concentrations of the suspension were 0, 0.63, 1.21 and 2.13 mg/L corresponding to 0, 0.29, 0.55 and 0.98 mg/L for the ground active substance. The LOAEC is 0.63 mg/L and the LOAEL calculated from the inhalation exposure is 115 mg/kg bw/day for the test item corresponding to 0.29 mg/L and 54 mg/kg bw/day for the ground active substance. A NOAEC or NOAEL value cannot be derived from this study due to the serious effects observed in the respiratory tract, possibly due to a particle overload effect of the test item particles that are barely soluble and persistent. No safe concentration for the use in spray applications can be derived. The concentrations/doses for the repeated dose inhalation study derived from an acute inhalation toxicity study (used as a pilot study) were too high. The dates of the in-life phase of the study were partly after the date of the anim","endpoint":"repeated dose toxicity","ingredient":"Phenylene bis-diphenyltriazine (CAS n. 55514-22-2) S86 , identified also as S02771,","loael_value":"115 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"54","page":66,"route":"inhalation","species":"rat","study_id":"sccs_o_184_noael_014"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 1000 mg/kg/day rat oral developmental repeated dose toxicity SOURCE_SUBDIR=sccs_o_184; REPORT_TITLE=OPINION ON UV filter S86 Phenylene bis-diphenyltriazine; OPINION_NUMBER=SCCS/1556/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=13 July 2015; VALUE_TEXT=1000; DOSE=Reproductive toxicity An OECD 422 Screening test, i.e., a combined repeated dose toxicity study with the reproduction/developmental toxicity in Sprague-Dawley rats, was conducted with the non- ground active substance SO2374 at doses of 0, 100, 300 or 1000 mg/kg bw/day.; EFFECT=ve a genotoxic potential when used at higher concentrations in the tests. Carcinogenicity No data provided. Reproductive toxicity An OECD 422 Screening test, i.e., a combined repeated dose toxicity study with the reproduction/developmental toxicity in Sprague-Dawley rats, was conducted with the non- ground active substance SO2374 at doses of 0, 100, 300 or 1000 mg/kg bw/day. In a satellite study, toxicokinetics after oral exposure were investigated (see below). Based on this study, the No Observed Effect Level (NOEL) for parental toxicity and for reproductive performance (mating and fertility) was considered to be 1000 mg/kg/day. The NOEL for toxic effects on progeny was considered to be 1000 mg/kg/day. The cosmetic ingredient S02771 was investigated in a developmental toxicity study (OECD 414) at dose levels of 0, 100, 300, 1000 mg/kg bw/day for the test item, corresponding to 0, 46, 139, 464 mg/kg bw/day for the ground active substance. No adverse maternal and foetal effects related to the test item were observed and a NOEL; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"55514-22-2","citation":"","dose":"Reproductive toxicity An OECD 422 Screening test, i.e., a combined repeated dose toxicity study with the reproduction/developmental toxicity in Sprague-Dawley rats, was conducted with the non- ground active substance SO2374 at doses of 0, 100, 300 or 1000 mg/kg bw/day.","duration":"developmental","effect":"ve a genotoxic potential when used at higher concentrations in the tests. Carcinogenicity No data provided. Reproductive toxicity An OECD 422 Screening test, i.e., a combined repeated dose toxicity study with the reproduction/developmental toxicity in Sprague-Dawley rats, was conducted with the non- ground active substance SO2374 at doses of 0, 100, 300 or 1000 mg/kg bw/day. In a satellite study, toxicokinetics after oral exposure were investigated (see below). Based on this study, the No Observed Effect Level (NOEL) for parental toxicity and for reproductive performance (mating and fertility) was considered to be 1000 mg/kg/day. The NOEL for toxic effects on progeny was considered to be 1000 mg/kg/day. The cosmetic ingredient S02771 was investigated in a developmental toxicity study (OECD 414) at dose levels of 0, 100, 300, 1000 mg/kg bw/day for the test item, corresponding to 0, 46, 139, 464 mg/kg bw/day for the ground active substance. No adverse maternal and foetal effects related to the test item were observed and a NOEL","endpoint":"repeated dose toxicity","ingredient":"Phenylene bis-diphenyltriazine (CAS n. 55514-22-2) S86 , identified also as S02771,","loael_value":"","noael_unit":"mg/kg/day","noael_value":"1000","page":67,"route":"oral","species":"rat","study_id":"sccs_o_184_noael_015"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 1000 mg/kg/day rat oral developmental repeated dose toxicity SOURCE_SUBDIR=sccs_o_184; REPORT_TITLE=OPINION ON UV filter S86 Phenylene bis-diphenyltriazine; OPINION_NUMBER=SCCS/1556/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=13 July 2015; VALUE_TEXT=1000; DOSE=oxicity An OECD 422 Screening test, i.e., a combined repeated dose toxicity study with the reproduction/developmental toxicity in Sprague-Dawley rats, was conducted with the non- ground active substance SO2374 at doses of 0, 100, 300 or 1000 mg/kg bw/day.; EFFECT=oxicity An OECD 422 Screening test, i.e., a combined repeated dose toxicity study with the reproduction/developmental toxicity in Sprague-Dawley rats, was conducted with the non- ground active substance SO2374 at doses of 0, 100, 300 or 1000 mg/kg bw/day. In a satellite study, toxicokinetics after oral exposure were investigated (see below). Based on this study, the No Observed Effect Level (NOEL) for parental toxicity and for reproductive performance (mating and fertility) was considered to be 1000 mg/kg/day. The NOEL for toxic effects on progeny was considered to be 1000 mg/kg/day. The cosmetic ingredient S02771 was investigated in a developmental toxicity study (OECD 414) at dose levels of 0, 100, 300, 1000 mg/kg bw/day for the test item, corresponding to 0, 46, 139, 464 mg/kg bw/day for the ground active substance. No adverse maternal and foetal effects related to the test item were observed and a NOEL of 464 mg/kg bw/d was derived for maternal and foetal effects. Toxicokinetics In a satellite study of the above OECD 422 S; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"55514-22-2","citation":"","dose":"oxicity An OECD 422 Screening test, i.e., a combined repeated dose toxicity study with the reproduction/developmental toxicity in Sprague-Dawley rats, was conducted with the non- ground active substance SO2374 at doses of 0, 100, 300 or 1000 mg/kg bw/day.","duration":"developmental","effect":"oxicity An OECD 422 Screening test, i.e., a combined repeated dose toxicity study with the reproduction/developmental toxicity in Sprague-Dawley rats, was conducted with the non- ground active substance SO2374 at doses of 0, 100, 300 or 1000 mg/kg bw/day. In a satellite study, toxicokinetics after oral exposure were investigated (see below). Based on this study, the No Observed Effect Level (NOEL) for parental toxicity and for reproductive performance (mating and fertility) was considered to be 1000 mg/kg/day. The NOEL for toxic effects on progeny was considered to be 1000 mg/kg/day. The cosmetic ingredient S02771 was investigated in a developmental toxicity study (OECD 414) at dose levels of 0, 100, 300, 1000 mg/kg bw/day for the test item, corresponding to 0, 46, 139, 464 mg/kg bw/day for the ground active substance. No adverse maternal and foetal effects related to the test item were observed and a NOEL of 464 mg/kg bw/d was derived for maternal and foetal effects. Toxicokinetics In a satellite study of the above OECD 422 S","endpoint":"repeated dose toxicity","ingredient":"Phenylene bis-diphenyltriazine (CAS n. 55514-22-2) S86 , identified also as S02771,","loael_value":"","noael_unit":"mg/kg/day","noael_value":"1000","page":67,"route":"oral","species":"rat","study_id":"sccs_o_184_noael_016"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 1000 mg/kg/day rat - Developmental reproductive toxicity SOURCE_SUBDIR=sccs_o_184; REPORT_TITLE=OPINION ON UV filter S86 Phenylene bis-diphenyltriazine; OPINION_NUMBER=SCCS/1556/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=13 July 2015; VALUE_TEXT=1000; DOSE=SCCS/1556/15 Opinion on UV filter S86 Phenylene Bis Diphenyltriazine ___________________________________________________________________________________________ 51 - the NOEL of the non-ground, active substance for reproductive performance (mating and fertility) was considered to be 1000 mg/kg/day, - the NOEL of the non-ground, active substance...; EFFECT=SCCS/1556/15 Opinion on UV filter S86 Phenylene Bis Diphenyltriazine ___________________________________________________________________________________________ 51 - the NOEL of the non-ground, active substance for reproductive performance (mating and fertility) was considered to be 1000 mg/kg/day, - the NOEL of the non-ground, active substance for toxic effects on progeny was considered to be 1000 mg/kg/day. Blood plasma levels were around or < 0.500 ng/mL, the limit of quantification. Overall, it was considered that there was no significant systemic exposure to the test item. Ref. 51 3.3.8.3 Developmental Toxicity Cosmetic ingredient S02771 Guideline: OECD 414 Species/strain: Rat; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"55514-22-2","citation":"","dose":"SCCS/1556/15 Opinion on UV filter S86 Phenylene Bis Diphenyltriazine ___________________________________________________________________________________________ 51 - the NOEL of the non-ground, active substance for reproductive performance (mating and fertility) was considered to be 1000 mg/kg/day, - the NOEL of the non-ground, active substance...","duration":"Developmental","effect":"SCCS/1556/15 Opinion on UV filter S86 Phenylene Bis Diphenyltriazine ___________________________________________________________________________________________ 51 - the NOEL of the non-ground, active substance for reproductive performance (mating and fertility) was considered to be 1000 mg/kg/day, - the NOEL of the non-ground, active substance for toxic effects on progeny was considered to be 1000 mg/kg/day. Blood plasma levels were around or < 0.500 ng/mL, the limit of quantification. Overall, it was considered that there was no significant systemic exposure to the test item. Ref. 51 3.3.8.3 Developmental Toxicity Cosmetic ingredient S02771 Guideline: OECD 414 Species/strain: Rat","endpoint":"reproductive toxicity","ingredient":"Phenylene bis-diphenyltriazine (CAS n. 55514-22-2) S86 , identified also as S02771,","loael_value":"","noael_unit":"mg/kg/day","noael_value":"1000","page":51,"route":"","species":"rat","study_id":"sccs_o_184_noael_007"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 464 mg/kg bw/d - oral developmental reproductive toxicity SOURCE_SUBDIR=sccs_o_184; REPORT_TITLE=OPINION ON UV filter S86 Phenylene bis-diphenyltriazine; OPINION_NUMBER=SCCS/1556/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=13 July 2015; VALUE_TEXT=464; DOSE=NOEL) for parental toxicity and for reproductive performance (mating and fertility) was considered to be 1000 mg/kg/day.; EFFECT=NOEL) for parental toxicity and for reproductive performance (mating and fertility) was considered to be 1000 mg/kg/day. The NOEL for toxic effects on progeny was considered to be 1000 mg/kg/day. The cosmetic ingredient S02771 was investigated in a developmental toxicity study (OECD 414) at dose levels of 0, 100, 300, 1000 mg/kg bw/day for the test item, corresponding to 0, 46, 139, 464 mg/kg bw/day for the ground active substance. No adverse maternal and foetal effects related to the test item were observed and a NOEL of 464 mg/kg bw/d was derived for maternal and foetal effects. Toxicokinetics In a satellite study of the above OECD 422 Screening test, three groups of eight males and eight females received the non-ground active substance SO2374 by gavage for 2 weeks at dose-levels of 100, 300 or 1000 mg/kg/day for blood plasma concentration measurements.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"55514-22-2","citation":"","dose":"NOEL) for parental toxicity and for reproductive performance (mating and fertility) was considered to be 1000 mg/kg/day.","duration":"developmental","effect":"NOEL) for parental toxicity and for reproductive performance (mating and fertility) was considered to be 1000 mg/kg/day. The NOEL for toxic effects on progeny was considered to be 1000 mg/kg/day. The cosmetic ingredient S02771 was investigated in a developmental toxicity study (OECD 414) at dose levels of 0, 100, 300, 1000 mg/kg bw/day for the test item, corresponding to 0, 46, 139, 464 mg/kg bw/day for the ground active substance. No adverse maternal and foetal effects related to the test item were observed and a NOEL of 464 mg/kg bw/d was derived for maternal and foetal effects. Toxicokinetics In a satellite study of the above OECD 422 Screening test, three groups of eight males and eight females received the non-ground active substance SO2374 by gavage for 2 weeks at dose-levels of 100, 300 or 1000 mg/kg/day for blood plasma concentration measurements.","endpoint":"reproductive toxicity","ingredient":"Phenylene bis-diphenyltriazine (CAS n. 55514-22-2) S86 , identified also as S02771,","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"464","page":67,"route":"oral","species":"","study_id":"sccs_o_184_noael_017"}