NOAEL Studies Cosmetic Ingredient

Trimethylbenzoyl Diphenylphosphine Oxide (TPO) NOAEL Studies

INCI: TRIMETHYLBENZOYL DIPHENYLPHOSPHINE OXIDE

CAS: 75980-60-8

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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CIR_vision_codex 20 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
CIR_vision_codex	NOAEL	=50	mg/kg bw/d	rat	oral	Subchronic	repeated dose toxicity	{"citation":"4; 1; 3","dose":"The acute oral LD50 was determined to be > 5000 mg/kg.","effect":"and piloerection 4-h post-dosing. All animals appeared normal after day 1 of treatment. No abnormalities were noted at necropsy. The acute oral LD50 was determined to be > 5000 mg/kg. Short-Term and Subchronic Toxicity Studies Details on the repeated dose oral toxicity studies summarized below can be found in Table 3. A 28-d oral toxicity study was performed using Sprague-Dawley rats (5/sex/group) given up to 750 mg/kg bw/d Trimethylbenzoyl Diphenylphosphine Oxide (purity 99%) in arachis oil via gavage.3,2,14 The no-observed-adverse-effect-level (NOAEL) was determined to be 50 mg/kg bw/d due to abnormalities observed at higher concentrations (decreased body weight gain, increased liver and kidney weights, testicular atrophy, and blood/urine abnormalities indicative of hepatic and renal injury). Conversely, no adverse effects were observed in a 28-d toxicity study in which male Wistar rats (number of animals not stated) were given Trimethylbenzoyl Diphenylphosphine Oxide (purity 99.3%; 1000 mg/kg bw/d) suspended in","page":5,"pdf":"SLR_TrimethylbenzoylDiphenylphosphineOxide_122024.pdf","row_type":"noael_study","study_id":"SLR_TrimethylbenzoylDiphenylphosphineOxide_122024_noael_001"}
CIR_vision_codex	NOAEL	=100	mg/kg bw/d	rat	oral	90-d	repeated dose toxicity	{"citation":"0; 5; 3","dose":"0.5% aqueous carboxymethylcellulose via gavage.3 An NOAEL of 100 mg/kg bw/d was determined in a 90-d toxicity study in which Wistar rats (10/sex/group) were given Trimethylbenzoyl Diphenylphosphine Oxide (purity 94.8%;","effect":"0.5% aqueous carboxymethylcellulose via gavage.3 An NOAEL of 100 mg/kg bw/d was determined in a 90-d toxicity study in which Wistar rats (10/sex/group) were given Trimethylbenzoyl Diphenylphosphine Oxide (purity 94.8%; 100, 300, or 1000 mg/kg bw/d) in 0.5% aqueous carboxymethylcellulose via gavage.2,3 Some of the adverse effects observed in this study include body weight reduction, abnormalities in clinical chemistry, increased liver, kidney, brain, adrenal gland, and testes weight, and marked diffuse atrophy of the testicular parenchyma (compared to controls; these effects were observed in the mid- and high-dose groups). Testicular atrophy, decreased mean testes weight, and decreased mea","page":6,"pdf":"SLR_TrimethylbenzoylDiphenylphosphineOxide_122024.pdf","row_type":"noael_study","study_id":"SLR_TrimethylbenzoylDiphenylphosphineOxide_122024_noael_002"}
CIR_vision_codex	NOAEL	=150	mg/kg bw/d	rat	oral	90-d	repeated dose toxicity	{"citation":"90; (10; 99","dose":"d- and high-dose groups).","effect":"d- and high-dose groups). Testicular atrophy, decreased mean testes weight, and decreased mean body weights (compared to controls) were also observed in a different 90-d assay performed in male Wistar rats (10/group) given Trimethylbenzoyl Diphenylphosphine Oxide (purity 99.3%; 1000 mg/kg bw/d) in a 0.5% carboxymethylcellulose aqueous solution via gavage. DEVELOPMENTAL AND REPRODUCTIVE TOXICITY STUDIES Details on the oral developmental and reproductive toxicity studies summarized below can be found in Table 4. The NOAEL for maternal and developmental toxicity was determined to be 150 mg/kg bw/d in a study in which female Wistar rats (22 females/group) were given Trimethylbenzoyl Diphenylphosphine Oxide in 1% aqueous carboxymethylcellulose at doses of up to 500 mg/kg bw/d via gavage on days 6 – 20 post-coitum.2 Adverse effects in both dams (e.g., decreased body weight gain) and fetuses (e.g., increased incidence of fetuses with bent limb bones) were observed at 500 mg/kg bw/d. An overall reproductive toxicity NOAEL of 60 mg/kg bw/d was established in a one-generation reproductive t...","page":6,"pdf":"SLR_TrimethylbenzoylDiphenylphosphineOxide_122024.pdf","row_type":"noael_study","study_id":"SLR_TrimethylbenzoylDiphenylphosphineOxide_122024_noael_003"}
CIR_vision_codex	NOAEL	=60	mg/kg bw/d	rat	oral	20 d	developmental toxicity	{"citation":"4; 150; (22","dose":"The NOAEL for maternal and developmental toxicity was determined to be 150 mg/kg bw/d in a study in which female Wistar rats (22 females/group) were given Trimethylbenzoyl Diphenylphosphine Oxide in 1% aqueous carboxymethylcellulose at doses of up to 500 mg/kg bw/d via gavage on days 6 – 20 post-coitum.2 Adverse effects in both dams (e.g., decreased body...","effect":"in Table 4. The NOAEL for maternal and developmental toxicity was determined to be 150 mg/kg bw/d in a study in which female Wistar rats (22 females/group) were given Trimethylbenzoyl Diphenylphosphine Oxide in 1% aqueous carboxymethylcellulose at doses of up to 500 mg/kg bw/d via gavage on days 6 – 20 post-coitum.2 Adverse effects in both dams (e.g., decreased body weight gain) and fetuses (e.g., increased incidence of fetuses with bent limb bones) were observed at 500 mg/kg bw/d. An overall reproductive toxicity NOAEL of 60 mg/kg bw/d was established in a one-generation reproductive toxicity assay performed in Wistar Han rats (5/sex/group) given up to 600 mg/kg bw/d Trimethylbenzoyl Diphenylphosphine Oxide (purity 99.3%) in 1% aqueous carboxymethylcellulose (parental males treated prior to mating and during mating; parental females treated prior to mating up until at least 20 d after delivery). Fertility indices were 100, 90, 100 and 0% for the control, 60, 200, and 600 mg/kg groups, respectively. Testicular abnormalities were observed in mid- and high-dosed paternal males. No t...","page":6,"pdf":"SLR_TrimethylbenzoylDiphenylphosphineOxide_122024.pdf","row_type":"noael_study","study_id":"SLR_TrimethylbenzoylDiphenylphosphineOxide_122024_noael_004"}
CIR_vision_codex	NOAEL	=200	mg/kg bw/d	-	-	-	developmental toxicity	{"citation":"200; 600; 1","dose":"ease in hypertrophy of the follicular epithelium of the thyroid glands was noted in males at 200 and 600 mg/kg and in females at 600 mg/kg (considered non-adverse at current severity and in absence of any other pathological finding).","effect":"ease in hypertrophy of the follicular epithelium of the thyroid glands was noted in males at 200 and 600 mg/kg and in females at 600 mg/kg (considered non-adverse at current severity and in absence of any other pathological finding). No treatment-related clinical signs or adverse gross pathological findings were observed in pups. Live birth indices (number of live offspring on PND 1 as percentage of total number of offspring born) were 97% for the control and 99% for the 60 and 200 mg/kg groups. Parental toxicity NOAEL: 200 mg/kg bw/d. Developmental toxicity NOAEL: 200 mg/kg bw/d. Overall reproductive toxicity NOAEL: 60 mg/kg bw/d.","page":14,"pdf":"SLR_TrimethylbenzoylDiphenylphosphineOxide_122024.pdf","row_type":"noael_study","study_id":"SLR_TrimethylbenzoylDiphenylphosphineOxide_122024_noael_006"}
CIR_vision_codex	NOAEL	=50	mg/kg bw/d	rat	oral	Subchronic	repeated dose toxicity	{"citation":"4; 1; 3","dose":"The acute oral LD50 was determined to be > 5000 mg/kg.","effect":"and piloerection 4-h post-dosing. All animals appeared normal after day 1 of treatment. No abnormalities were noted at necropsy. The acute oral LD50 was determined to be > 5000 mg/kg. Short-Term and Subchronic Toxicity Studies Details on the repeated dose oral toxicity studies summarized below can be found in Table 3. A 28-d oral toxicity study was performed using Sprague-Dawley rats (5/sex/group) given up to 750 mg/kg bw/d Trimethylbenzoyl Diphenylphosphine Oxide (purity 99%) in arachis oil via gavage.3,2,14 The no-observed-adverse-effect-level (NOAEL) was determined to be 50 mg/kg bw/d due to abnormalities observed at higher concentrations (decreased body weight gain, increased liver and kidney weights, testicular atrophy, and blood/urine abnormalities indicative of hepatic and renal injury). Conversely, no adverse effects were observed in a 28-d toxicity study in which male Wistar rats (number of animals not stated) were given Trimethylbenzoyl Diphenylphosphine Oxide (purity 99.3%; 1000 mg/kg bw/d) suspended in","page":5,"pdf":"SLR_TrimethylbenzoylDiphenylphosphineOxide_122024.pdf","row_type":"noael_study","study_id":"SLR_TrimethylbenzoylDiphenylphosphineOxide_122024_noael_001"}
CIR_vision_codex	NOAEL	=100	mg/kg bw/d	rat	oral	90-d	repeated dose toxicity	{"citation":"0; 5; 3","dose":"0.5% aqueous carboxymethylcellulose via gavage.3 An NOAEL of 100 mg/kg bw/d was determined in a 90-d toxicity study in which Wistar rats (10/sex/group) were given Trimethylbenzoyl Diphenylphosphine Oxide (purity 94.8%;","effect":"0.5% aqueous carboxymethylcellulose via gavage.3 An NOAEL of 100 mg/kg bw/d was determined in a 90-d toxicity study in which Wistar rats (10/sex/group) were given Trimethylbenzoyl Diphenylphosphine Oxide (purity 94.8%; 100, 300, or 1000 mg/kg bw/d) in 0.5% aqueous carboxymethylcellulose via gavage.2,3 Some of the adverse effects observed in this study include body weight reduction, abnormalities in clinical chemistry, increased liver, kidney, brain, adrenal gland, and testes weight, and marked diffuse atrophy of the testicular parenchyma (compared to controls; these effects were observed in the mid- and high-dose groups). Testicular atrophy, decreased mean testes weight, and decreased mea","page":6,"pdf":"SLR_TrimethylbenzoylDiphenylphosphineOxide_122024.pdf","row_type":"noael_study","study_id":"SLR_TrimethylbenzoylDiphenylphosphineOxide_122024_noael_002"}
CIR_vision_codex	NOAEL	=150	mg/kg bw/d	rat	oral	90-d	repeated dose toxicity	{"citation":"90; (10; 99","dose":"d- and high-dose groups).","effect":"d- and high-dose groups). Testicular atrophy, decreased mean testes weight, and decreased mean body weights (compared to controls) were also observed in a different 90-d assay performed in male Wistar rats (10/group) given Trimethylbenzoyl Diphenylphosphine Oxide (purity 99.3%; 1000 mg/kg bw/d) in a 0.5% carboxymethylcellulose aqueous solution via gavage. DEVELOPMENTAL AND REPRODUCTIVE TOXICITY STUDIES Details on the oral developmental and reproductive toxicity studies summarized below can be found in Table 4. The NOAEL for maternal and developmental toxicity was determined to be 150 mg/kg bw/d in a study in which female Wistar rats (22 females/group) were given Trimethylbenzoyl Diphenylphosphine Oxide in 1% aqueous carboxymethylcellulose at doses of up to 500 mg/kg bw/d via gavage on days 6 – 20 post-coitum.2 Adverse effects in both dams (e.g., decreased body weight gain) and fetuses (e.g., increased incidence of fetuses with bent limb bones) were observed at 500 mg/kg bw/d. An overall reproductive toxicity NOAEL of 60 mg/kg bw/d was established in a one-generation reproductive t...","page":6,"pdf":"SLR_TrimethylbenzoylDiphenylphosphineOxide_122024.pdf","row_type":"noael_study","study_id":"SLR_TrimethylbenzoylDiphenylphosphineOxide_122024_noael_003"}
CIR_vision_codex	NOAEL	=60	mg/kg bw/d	rat	oral	20 d	developmental toxicity	{"citation":"4; 150; (22","dose":"The NOAEL for maternal and developmental toxicity was determined to be 150 mg/kg bw/d in a study in which female Wistar rats (22 females/group) were given Trimethylbenzoyl Diphenylphosphine Oxide in 1% aqueous carboxymethylcellulose at doses of up to 500 mg/kg bw/d via gavage on days 6 – 20 post-coitum.2 Adverse effects in both dams (e.g., decreased body...","effect":"in Table 4. The NOAEL for maternal and developmental toxicity was determined to be 150 mg/kg bw/d in a study in which female Wistar rats (22 females/group) were given Trimethylbenzoyl Diphenylphosphine Oxide in 1% aqueous carboxymethylcellulose at doses of up to 500 mg/kg bw/d via gavage on days 6 – 20 post-coitum.2 Adverse effects in both dams (e.g., decreased body weight gain) and fetuses (e.g., increased incidence of fetuses with bent limb bones) were observed at 500 mg/kg bw/d. An overall reproductive toxicity NOAEL of 60 mg/kg bw/d was established in a one-generation reproductive toxicity assay performed in Wistar Han rats (5/sex/group) given up to 600 mg/kg bw/d Trimethylbenzoyl Diphenylphosphine Oxide (purity 99.3%) in 1% aqueous carboxymethylcellulose (parental males treated prior to mating and during mating; parental females treated prior to mating up until at least 20 d after delivery). Fertility indices were 100, 90, 100 and 0% for the control, 60, 200, and 600 mg/kg groups, respectively. Testicular abnormalities were observed in mid- and high-dosed paternal males. No t...","page":6,"pdf":"SLR_TrimethylbenzoylDiphenylphosphineOxide_122024.pdf","row_type":"noael_study","study_id":"SLR_TrimethylbenzoylDiphenylphosphineOxide_122024_noael_004"}
CIR_vision_codex	NOAEL	=200	mg/kg bw/d	-	-	-	developmental toxicity	{"citation":"200; 600; 1","dose":"ease in hypertrophy of the follicular epithelium of the thyroid glands was noted in males at 200 and 600 mg/kg and in females at 600 mg/kg (considered non-adverse at current severity and in absence of any other pathological finding).","effect":"ease in hypertrophy of the follicular epithelium of the thyroid glands was noted in males at 200 and 600 mg/kg and in females at 600 mg/kg (considered non-adverse at current severity and in absence of any other pathological finding). No treatment-related clinical signs or adverse gross pathological findings were observed in pups. Live birth indices (number of live offspring on PND 1 as percentage of total number of offspring born) were 97% for the control and 99% for the 60 and 200 mg/kg groups. Parental toxicity NOAEL: 200 mg/kg bw/d. Developmental toxicity NOAEL: 200 mg/kg bw/d. Overall reproductive toxicity NOAEL: 60 mg/kg bw/d.","page":14,"pdf":"SLR_TrimethylbenzoylDiphenylphosphineOxide_122024.pdf","row_type":"noael_study","study_id":"SLR_TrimethylbenzoylDiphenylphosphineOxide_122024_noael_006"}
CIR_vision_codex	NOAEL	=50	mg/kg bw/d	rat	oral	Subchronic	repeated dose toxicity	{"citation":"4; 1; 3","dose":"The acute oral LD50 was determined to be > 5000 mg/kg.","effect":"and piloerection 4-h post-dosing. All animals appeared normal after day 1 of treatment. No abnormalities were noted at necropsy. The acute oral LD50 was determined to be > 5000 mg/kg. Short-Term and Subchronic Toxicity Studies Details on the repeated dose oral toxicity studies summarized below can be found in Table 3. A 28-d oral toxicity study was performed using Sprague-Dawley rats (5/sex/group) given up to 750 mg/kg bw/d Trimethylbenzoyl Diphenylphosphine Oxide (purity 99%) in arachis oil via gavage.3,2,14 The no-observed-adverse-effect-level (NOAEL) was determined to be 50 mg/kg bw/d due to abnormalities observed at higher concentrations (decreased body weight gain, increased liver and kidney weights, testicular atrophy, and blood/urine abnormalities indicative of hepatic and renal injury). Conversely, no adverse effects were observed in a 28-d toxicity study in which male Wistar rats (number of animals not stated) were given Trimethylbenzoyl Diphenylphosphine Oxide (purity 99.3%; 1000 mg/kg bw/d) suspended in","page":5,"pdf":"SLR_TrimethylbenzoylDiphenylphosphineOxide_122024.pdf","row_type":"noael_study","study_id":"SLR_TrimethylbenzoylDiphenylphosphineOxide_122024_noael_001"}
CIR_vision_codex	NOAEL	=100	mg/kg bw/d	rat	oral	90-d	repeated dose toxicity	{"citation":"0; 5; 3","dose":"0.5% aqueous carboxymethylcellulose via gavage.3 An NOAEL of 100 mg/kg bw/d was determined in a 90-d toxicity study in which Wistar rats (10/sex/group) were given Trimethylbenzoyl Diphenylphosphine Oxide (purity 94.8%;","effect":"0.5% aqueous carboxymethylcellulose via gavage.3 An NOAEL of 100 mg/kg bw/d was determined in a 90-d toxicity study in which Wistar rats (10/sex/group) were given Trimethylbenzoyl Diphenylphosphine Oxide (purity 94.8%; 100, 300, or 1000 mg/kg bw/d) in 0.5% aqueous carboxymethylcellulose via gavage.2,3 Some of the adverse effects observed in this study include body weight reduction, abnormalities in clinical chemistry, increased liver, kidney, brain, adrenal gland, and testes weight, and marked diffuse atrophy of the testicular parenchyma (compared to controls; these effects were observed in the mid- and high-dose groups). Testicular atrophy, decreased mean testes weight, and decreased mea","page":6,"pdf":"SLR_TrimethylbenzoylDiphenylphosphineOxide_122024.pdf","row_type":"noael_study","study_id":"SLR_TrimethylbenzoylDiphenylphosphineOxide_122024_noael_002"}
CIR_vision_codex	NOAEL	=150	mg/kg bw/d	rat	oral	90-d	repeated dose toxicity	{"citation":"90; (10; 99","dose":"d- and high-dose groups).","effect":"d- and high-dose groups). Testicular atrophy, decreased mean testes weight, and decreased mean body weights (compared to controls) were also observed in a different 90-d assay performed in male Wistar rats (10/group) given Trimethylbenzoyl Diphenylphosphine Oxide (purity 99.3%; 1000 mg/kg bw/d) in a 0.5% carboxymethylcellulose aqueous solution via gavage. DEVELOPMENTAL AND REPRODUCTIVE TOXICITY STUDIES Details on the oral developmental and reproductive toxicity studies summarized below can be found in Table 4. The NOAEL for maternal and developmental toxicity was determined to be 150 mg/kg bw/d in a study in which female Wistar rats (22 females/group) were given Trimethylbenzoyl Diphenylphosphine Oxide in 1% aqueous carboxymethylcellulose at doses of up to 500 mg/kg bw/d via gavage on days 6 – 20 post-coitum.2 Adverse effects in both dams (e.g., decreased body weight gain) and fetuses (e.g., increased incidence of fetuses with bent limb bones) were observed at 500 mg/kg bw/d. An overall reproductive toxicity NOAEL of 60 mg/kg bw/d was established in a one-generation reproductive t...","page":6,"pdf":"SLR_TrimethylbenzoylDiphenylphosphineOxide_122024.pdf","row_type":"noael_study","study_id":"SLR_TrimethylbenzoylDiphenylphosphineOxide_122024_noael_003"}
CIR_vision_codex	NOAEL	=60	mg/kg bw/d	rat	oral	20 d	developmental toxicity	{"citation":"4; 150; (22","dose":"The NOAEL for maternal and developmental toxicity was determined to be 150 mg/kg bw/d in a study in which female Wistar rats (22 females/group) were given Trimethylbenzoyl Diphenylphosphine Oxide in 1% aqueous carboxymethylcellulose at doses of up to 500 mg/kg bw/d via gavage on days 6 – 20 post-coitum.2 Adverse effects in both dams (e.g., decreased body...","effect":"in Table 4. The NOAEL for maternal and developmental toxicity was determined to be 150 mg/kg bw/d in a study in which female Wistar rats (22 females/group) were given Trimethylbenzoyl Diphenylphosphine Oxide in 1% aqueous carboxymethylcellulose at doses of up to 500 mg/kg bw/d via gavage on days 6 – 20 post-coitum.2 Adverse effects in both dams (e.g., decreased body weight gain) and fetuses (e.g., increased incidence of fetuses with bent limb bones) were observed at 500 mg/kg bw/d. An overall reproductive toxicity NOAEL of 60 mg/kg bw/d was established in a one-generation reproductive toxicity assay performed in Wistar Han rats (5/sex/group) given up to 600 mg/kg bw/d Trimethylbenzoyl Diphenylphosphine Oxide (purity 99.3%) in 1% aqueous carboxymethylcellulose (parental males treated prior to mating and during mating; parental females treated prior to mating up until at least 20 d after delivery). Fertility indices were 100, 90, 100 and 0% for the control, 60, 200, and 600 mg/kg groups, respectively. Testicular abnormalities were observed in mid- and high-dosed paternal males. No t...","page":6,"pdf":"SLR_TrimethylbenzoylDiphenylphosphineOxide_122024.pdf","row_type":"noael_study","study_id":"SLR_TrimethylbenzoylDiphenylphosphineOxide_122024_noael_004"}
CIR_vision_codex	NOAEL	=200	mg/kg bw/d	-	-	-	developmental toxicity	{"citation":"200; 600; 1","dose":"ease in hypertrophy of the follicular epithelium of the thyroid glands was noted in males at 200 and 600 mg/kg and in females at 600 mg/kg (considered non-adverse at current severity and in absence of any other pathological finding).","effect":"ease in hypertrophy of the follicular epithelium of the thyroid glands was noted in males at 200 and 600 mg/kg and in females at 600 mg/kg (considered non-adverse at current severity and in absence of any other pathological finding). No treatment-related clinical signs or adverse gross pathological findings were observed in pups. Live birth indices (number of live offspring on PND 1 as percentage of total number of offspring born) were 97% for the control and 99% for the 60 and 200 mg/kg groups. Parental toxicity NOAEL: 200 mg/kg bw/d. Developmental toxicity NOAEL: 200 mg/kg bw/d. Overall reproductive toxicity NOAEL: 60 mg/kg bw/d.","page":14,"pdf":"SLR_TrimethylbenzoylDiphenylphosphineOxide_122024.pdf","row_type":"noael_study","study_id":"SLR_TrimethylbenzoylDiphenylphosphineOxide_122024_noael_006"}
CIR_vision_codex	NOAEL	=50	mg/kg bw/d	rat	oral	Subchronic	repeated dose toxicity	{"citation":"4; 1; 3","dose":"The acute oral LD50 was determined to be > 5000 mg/kg.","effect":"and piloerection 4-h post-dosing. All animals appeared normal after day 1 of treatment. No abnormalities were noted at necropsy. The acute oral LD50 was determined to be > 5000 mg/kg. Short-Term and Subchronic Toxicity Studies Details on the repeated dose oral toxicity studies summarized below can be found in Table 3. A 28-d oral toxicity study was performed using Sprague-Dawley rats (5/sex/group) given up to 750 mg/kg bw/d Trimethylbenzoyl Diphenylphosphine Oxide (purity 99%) in arachis oil via gavage.3,2,14 The no-observed-adverse-effect-level (NOAEL) was determined to be 50 mg/kg bw/d due to abnormalities observed at higher concentrations (decreased body weight gain, increased liver and kidney weights, testicular atrophy, and blood/urine abnormalities indicative of hepatic and renal injury). Conversely, no adverse effects were observed in a 28-d toxicity study in which male Wistar rats (number of animals not stated) were given Trimethylbenzoyl Diphenylphosphine Oxide (purity 99.3%; 1000 mg/kg bw/d) suspended in","page":5,"pdf":"SLR_TrimethylbenzoylDiphenylphosphineOxide_122024.pdf","row_type":"noael_study","study_id":"SLR_TrimethylbenzoylDiphenylphosphineOxide_122024_noael_001"}
CIR_vision_codex	NOAEL	=100	mg/kg bw/d	rat	oral	90-d	repeated dose toxicity	{"citation":"0; 5; 3","dose":"0.5% aqueous carboxymethylcellulose via gavage.3 An NOAEL of 100 mg/kg bw/d was determined in a 90-d toxicity study in which Wistar rats (10/sex/group) were given Trimethylbenzoyl Diphenylphosphine Oxide (purity 94.8%;","effect":"0.5% aqueous carboxymethylcellulose via gavage.3 An NOAEL of 100 mg/kg bw/d was determined in a 90-d toxicity study in which Wistar rats (10/sex/group) were given Trimethylbenzoyl Diphenylphosphine Oxide (purity 94.8%; 100, 300, or 1000 mg/kg bw/d) in 0.5% aqueous carboxymethylcellulose via gavage.2,3 Some of the adverse effects observed in this study include body weight reduction, abnormalities in clinical chemistry, increased liver, kidney, brain, adrenal gland, and testes weight, and marked diffuse atrophy of the testicular parenchyma (compared to controls; these effects were observed in the mid- and high-dose groups). Testicular atrophy, decreased mean testes weight, and decreased mea","page":6,"pdf":"SLR_TrimethylbenzoylDiphenylphosphineOxide_122024.pdf","row_type":"noael_study","study_id":"SLR_TrimethylbenzoylDiphenylphosphineOxide_122024_noael_002"}
CIR_vision_codex	NOAEL	=150	mg/kg bw/d	rat	oral	90-d	repeated dose toxicity	{"citation":"90; (10; 99","dose":"d- and high-dose groups).","effect":"d- and high-dose groups). Testicular atrophy, decreased mean testes weight, and decreased mean body weights (compared to controls) were also observed in a different 90-d assay performed in male Wistar rats (10/group) given Trimethylbenzoyl Diphenylphosphine Oxide (purity 99.3%; 1000 mg/kg bw/d) in a 0.5% carboxymethylcellulose aqueous solution via gavage. DEVELOPMENTAL AND REPRODUCTIVE TOXICITY STUDIES Details on the oral developmental and reproductive toxicity studies summarized below can be found in Table 4. The NOAEL for maternal and developmental toxicity was determined to be 150 mg/kg bw/d in a study in which female Wistar rats (22 females/group) were given Trimethylbenzoyl Diphenylphosphine Oxide in 1% aqueous carboxymethylcellulose at doses of up to 500 mg/kg bw/d via gavage on days 6 – 20 post-coitum.2 Adverse effects in both dams (e.g., decreased body weight gain) and fetuses (e.g., increased incidence of fetuses with bent limb bones) were observed at 500 mg/kg bw/d. An overall reproductive toxicity NOAEL of 60 mg/kg bw/d was established in a one-generation reproductive t...","page":6,"pdf":"SLR_TrimethylbenzoylDiphenylphosphineOxide_122024.pdf","row_type":"noael_study","study_id":"SLR_TrimethylbenzoylDiphenylphosphineOxide_122024_noael_003"}
CIR_vision_codex	NOAEL	=60	mg/kg bw/d	rat	oral	20 d	developmental toxicity	{"citation":"4; 150; (22","dose":"The NOAEL for maternal and developmental toxicity was determined to be 150 mg/kg bw/d in a study in which female Wistar rats (22 females/group) were given Trimethylbenzoyl Diphenylphosphine Oxide in 1% aqueous carboxymethylcellulose at doses of up to 500 mg/kg bw/d via gavage on days 6 – 20 post-coitum.2 Adverse effects in both dams (e.g., decreased body...","effect":"in Table 4. The NOAEL for maternal and developmental toxicity was determined to be 150 mg/kg bw/d in a study in which female Wistar rats (22 females/group) were given Trimethylbenzoyl Diphenylphosphine Oxide in 1% aqueous carboxymethylcellulose at doses of up to 500 mg/kg bw/d via gavage on days 6 – 20 post-coitum.2 Adverse effects in both dams (e.g., decreased body weight gain) and fetuses (e.g., increased incidence of fetuses with bent limb bones) were observed at 500 mg/kg bw/d. An overall reproductive toxicity NOAEL of 60 mg/kg bw/d was established in a one-generation reproductive toxicity assay performed in Wistar Han rats (5/sex/group) given up to 600 mg/kg bw/d Trimethylbenzoyl Diphenylphosphine Oxide (purity 99.3%) in 1% aqueous carboxymethylcellulose (parental males treated prior to mating and during mating; parental females treated prior to mating up until at least 20 d after delivery). Fertility indices were 100, 90, 100 and 0% for the control, 60, 200, and 600 mg/kg groups, respectively. Testicular abnormalities were observed in mid- and high-dosed paternal males. No t...","page":6,"pdf":"SLR_TrimethylbenzoylDiphenylphosphineOxide_122024.pdf","row_type":"noael_study","study_id":"SLR_TrimethylbenzoylDiphenylphosphineOxide_122024_noael_004"}
CIR_vision_codex	NOAEL	=200	mg/kg bw/d	-	-	-	developmental toxicity	{"citation":"200; 600; 1","dose":"ease in hypertrophy of the follicular epithelium of the thyroid glands was noted in males at 200 and 600 mg/kg and in females at 600 mg/kg (considered non-adverse at current severity and in absence of any other pathological finding).","effect":"ease in hypertrophy of the follicular epithelium of the thyroid glands was noted in males at 200 and 600 mg/kg and in females at 600 mg/kg (considered non-adverse at current severity and in absence of any other pathological finding). No treatment-related clinical signs or adverse gross pathological findings were observed in pups. Live birth indices (number of live offspring on PND 1 as percentage of total number of offspring born) were 97% for the control and 99% for the 60 and 200 mg/kg groups. Parental toxicity NOAEL: 200 mg/kg bw/d. Developmental toxicity NOAEL: 200 mg/kg bw/d. Overall reproductive toxicity NOAEL: 60 mg/kg bw/d.","page":14,"pdf":"SLR_TrimethylbenzoylDiphenylphosphineOxide_122024.pdf","row_type":"noael_study","study_id":"SLR_TrimethylbenzoylDiphenylphosphineOxide_122024_noael_006"}

NTP_ICE_acute_oral 1 endpoint

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
NTP_ICE_acute_oral	LD50	>5000	mg/kg bw	Rat	oral	acute	Rat Acute Oral Toxicity	record_id=acute_oral_11345; row=7977; data_type=In Vivo; mixture=Chemical; chemical_name=Diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide; preferred_name=Diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide; dtxsid=DTXSID4052502; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID4052502; source_file=acute_oral.xlsx

SCCS_vision_codex 12 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
SCCS_vision_codex	NOAEL	=50	mg/kg bw/day	rat	oral	28-day	repeated dose toxicity	{"dose":"to determine the dose levels for the definitive 28-day repeated dose toxicity study.","effect":"to determine the dose levels for the definitive 28-day repeated dose toxicity study. The test substance was administered by gavage to Sprague-Dawley rats (3/sex/dose) for 14 consecutive days, at dose levels of 0, 50, 250, 500, 750 and 1000 mg/kg bw/day in arachis oil (B. P.). The highest dose was lethal and adverse effects in form of clinical symptoms and reduced body weight gains were noted at 500 and 750 mg/kg bw/day. Minor clinical signs were observed at 250 mg/kg bw/day. The low dose of 50 mg/kg bw/day was the No observed adverse effect level in this range finding study. Consequently, dose levels of 0, 50, 250 and 750 mg/kg bw/day were selected for the main study. In the main study, dose levels of 50, 250 and 750 mg/kg bw/day were administered orally by gavage to groups each made up of five male and five female Sprague-Dawley rats for twenty-eight consecutive days. A control group of five males and five females was dosed with the vehicle arachis oil (B. P.) alone. Recovery groups, each made up of five males and five females, were treated with the high","page":13,"pdf":"sccs_o_149.pdf","row_type":"noael_study","study_id":"sccs_o_149_noael_001"}
SCCS_vision_codex	NOAEL	=100	mg/kg bw/day	rat	-	-	NOAEL study	{"dose":", 300 and 1000 mg/kg bw/day led to substance related findings at 300 and 1000 mg/kg bw/day in form of reduced body weights, impaired clinical chemistry and indications for inflammation in females, while the males showed testicular atrophy.","effect":", 300 and 1000 mg/kg bw/day led to substance related findings at 300 and 1000 mg/kg bw/day in form of reduced body weights, impaired clinical chemistry and indications for inflammation in females, while the males showed testicular atrophy. In any case and in contrast to the distinct general toxicity at doses at ≥300 mg/kg bw/day, the testing for neurotoxic effects according to the \"Functional Observational Battery\" revealed no functional defects of any kind or any other signs of neurotoxicity during the study. The NOAEL for male and female Wistar rats derived from this study was 100 mg/kg bw/day.","page":18,"pdf":"sccs_o_149.pdf","row_type":"noael_study","study_id":"sccs_o_149_noael_004"}
SCCS_vision_codex	NOAEL	=0.033	mg/kg bw/day	rat	oral	90 day	repeated dose toxicity	{"dose":"3.33 mg/kg bw Assumed residue:","effect":"remains as residue, of which 100% becomes systemically available via the human nail (see Discussion). CALCULATION OF THE MARGIN OF SAFETY Trimethylbenzoyl-diphenylphosphine oxide (TPO) Amount of the gel applied: 4 g Concentration of TPO in the gel: 5% Total amount of TPO applied: 200 mg Default human body weight: 60 kg Amount of TPO applied/kg human b.w.: 3.33 mg/kg bw Assumed residue: 1% Assumed absorption through the nail plate: 100% Systemic exposure dose (SED): 3.33 mg/kg bw * 0.01 = 0.033 mg/kg bw/day No Observed Adverse Effect Level (NOAEL) 100 mg/kg bw/day (90 day repeated dose oral toxicity, rat) Corrected NOAEL for 50% bioavailability: 50 mg/kg bw/day Margin of Safety adjusted NOAEL/SED = 1515 Standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14. Discussion Physico-chemical properties, function and use TPO is a yellow powder which is sparingly soluble in water but readily soluble in various organic solvents and typical monomers of use. TPO is used a","page":26,"pdf":"sccs_o_149.pdf","row_type":"noael_study","study_id":"sccs_o_149_noael_005"}
SCCS_vision_codex	NOAEL	=50	mg/kg bw/day	rat	oral	28-day	repeated dose toxicity	{"dose":"to determine the dose levels for the definitive 28-day repeated dose toxicity study.","effect":"to determine the dose levels for the definitive 28-day repeated dose toxicity study. The test substance was administered by gavage to Sprague-Dawley rats (3/sex/dose) for 14 consecutive days, at dose levels of 0, 50, 250, 500, 750 and 1000 mg/kg bw/day in arachis oil (B. P.). The highest dose was lethal and adverse effects in form of clinical symptoms and reduced body weight gains were noted at 500 and 750 mg/kg bw/day. Minor clinical signs were observed at 250 mg/kg bw/day. The low dose of 50 mg/kg bw/day was the No observed adverse effect level in this range finding study. Consequently, dose levels of 0, 50, 250 and 750 mg/kg bw/day were selected for the main study. In the main study, dose levels of 50, 250 and 750 mg/kg bw/day were administered orally by gavage to groups each made up of five male and five female Sprague-Dawley rats for twenty-eight consecutive days. A control group of five males and five females was dosed with the vehicle arachis oil (B. P.) alone. Recovery groups, each made up of five males and five females, were treated with the high","page":13,"pdf":"sccs_o_149.pdf","row_type":"noael_study","study_id":"sccs_o_149_noael_001"}
SCCS_vision_codex	NOAEL	=100	mg/kg bw/day	rat	-	-	NOAEL study	{"dose":", 300 and 1000 mg/kg bw/day led to substance related findings at 300 and 1000 mg/kg bw/day in form of reduced body weights, impaired clinical chemistry and indications for inflammation in females, while the males showed testicular atrophy.","effect":", 300 and 1000 mg/kg bw/day led to substance related findings at 300 and 1000 mg/kg bw/day in form of reduced body weights, impaired clinical chemistry and indications for inflammation in females, while the males showed testicular atrophy. In any case and in contrast to the distinct general toxicity at doses at ≥300 mg/kg bw/day, the testing for neurotoxic effects according to the \"Functional Observational Battery\" revealed no functional defects of any kind or any other signs of neurotoxicity during the study. The NOAEL for male and female Wistar rats derived from this study was 100 mg/kg bw/day.","page":18,"pdf":"sccs_o_149.pdf","row_type":"noael_study","study_id":"sccs_o_149_noael_004"}
SCCS_vision_codex	NOAEL	=0.033	mg/kg bw/day	rat	oral	90 day	repeated dose toxicity	{"dose":"3.33 mg/kg bw Assumed residue:","effect":"remains as residue, of which 100% becomes systemically available via the human nail (see Discussion). CALCULATION OF THE MARGIN OF SAFETY Trimethylbenzoyl-diphenylphosphine oxide (TPO) Amount of the gel applied: 4 g Concentration of TPO in the gel: 5% Total amount of TPO applied: 200 mg Default human body weight: 60 kg Amount of TPO applied/kg human b.w.: 3.33 mg/kg bw Assumed residue: 1% Assumed absorption through the nail plate: 100% Systemic exposure dose (SED): 3.33 mg/kg bw * 0.01 = 0.033 mg/kg bw/day No Observed Adverse Effect Level (NOAEL) 100 mg/kg bw/day (90 day repeated dose oral toxicity, rat) Corrected NOAEL for 50% bioavailability: 50 mg/kg bw/day Margin of Safety adjusted NOAEL/SED = 1515 Standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14. Discussion Physico-chemical properties, function and use TPO is a yellow powder which is sparingly soluble in water but readily soluble in various organic solvents and typical monomers of use. TPO is used a","page":26,"pdf":"sccs_o_149.pdf","row_type":"noael_study","study_id":"sccs_o_149_noael_005"}
SCCS_vision_codex	NOAEL	=50	mg/kg bw/day	rat	oral	28-day	repeated dose toxicity	{"dose":"to determine the dose levels for the definitive 28-day repeated dose toxicity study.","effect":"to determine the dose levels for the definitive 28-day repeated dose toxicity study. The test substance was administered by gavage to Sprague-Dawley rats (3/sex/dose) for 14 consecutive days, at dose levels of 0, 50, 250, 500, 750 and 1000 mg/kg bw/day in arachis oil (B. P.). The highest dose was lethal and adverse effects in form of clinical symptoms and reduced body weight gains were noted at 500 and 750 mg/kg bw/day. Minor clinical signs were observed at 250 mg/kg bw/day. The low dose of 50 mg/kg bw/day was the No observed adverse effect level in this range finding study. Consequently, dose levels of 0, 50, 250 and 750 mg/kg bw/day were selected for the main study. In the main study, dose levels of 50, 250 and 750 mg/kg bw/day were administered orally by gavage to groups each made up of five male and five female Sprague-Dawley rats for twenty-eight consecutive days. A control group of five males and five females was dosed with the vehicle arachis oil (B. P.) alone. Recovery groups, each made up of five males and five females, were treated with the high","page":13,"pdf":"sccs_o_149.pdf","row_type":"noael_study","study_id":"sccs_o_149_noael_001"}
SCCS_vision_codex	NOAEL	=100	mg/kg bw/day	rat	-	-	NOAEL study	{"dose":", 300 and 1000 mg/kg bw/day led to substance related findings at 300 and 1000 mg/kg bw/day in form of reduced body weights, impaired clinical chemistry and indications for inflammation in females, while the males showed testicular atrophy.","effect":", 300 and 1000 mg/kg bw/day led to substance related findings at 300 and 1000 mg/kg bw/day in form of reduced body weights, impaired clinical chemistry and indications for inflammation in females, while the males showed testicular atrophy. In any case and in contrast to the distinct general toxicity at doses at ≥300 mg/kg bw/day, the testing for neurotoxic effects according to the \"Functional Observational Battery\" revealed no functional defects of any kind or any other signs of neurotoxicity during the study. The NOAEL for male and female Wistar rats derived from this study was 100 mg/kg bw/day.","page":18,"pdf":"sccs_o_149.pdf","row_type":"noael_study","study_id":"sccs_o_149_noael_004"}
SCCS_vision_codex	NOAEL	=0.033	mg/kg bw/day	rat	oral	90 day	repeated dose toxicity	{"dose":"3.33 mg/kg bw Assumed residue:","effect":"remains as residue, of which 100% becomes systemically available via the human nail (see Discussion). CALCULATION OF THE MARGIN OF SAFETY Trimethylbenzoyl-diphenylphosphine oxide (TPO) Amount of the gel applied: 4 g Concentration of TPO in the gel: 5% Total amount of TPO applied: 200 mg Default human body weight: 60 kg Amount of TPO applied/kg human b.w.: 3.33 mg/kg bw Assumed residue: 1% Assumed absorption through the nail plate: 100% Systemic exposure dose (SED): 3.33 mg/kg bw * 0.01 = 0.033 mg/kg bw/day No Observed Adverse Effect Level (NOAEL) 100 mg/kg bw/day (90 day repeated dose oral toxicity, rat) Corrected NOAEL for 50% bioavailability: 50 mg/kg bw/day Margin of Safety adjusted NOAEL/SED = 1515 Standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14. Discussion Physico-chemical properties, function and use TPO is a yellow powder which is sparingly soluble in water but readily soluble in various organic solvents and typical monomers of use. TPO is used a","page":26,"pdf":"sccs_o_149.pdf","row_type":"noael_study","study_id":"sccs_o_149_noael_005"}
SCCS_vision_codex	NOAEL	=50	mg/kg bw/day	rat	oral	28-day	repeated dose toxicity	{"dose":"to determine the dose levels for the definitive 28-day repeated dose toxicity study.","effect":"to determine the dose levels for the definitive 28-day repeated dose toxicity study. The test substance was administered by gavage to Sprague-Dawley rats (3/sex/dose) for 14 consecutive days, at dose levels of 0, 50, 250, 500, 750 and 1000 mg/kg bw/day in arachis oil (B. P.). The highest dose was lethal and adverse effects in form of clinical symptoms and reduced body weight gains were noted at 500 and 750 mg/kg bw/day. Minor clinical signs were observed at 250 mg/kg bw/day. The low dose of 50 mg/kg bw/day was the No observed adverse effect level in this range finding study. Consequently, dose levels of 0, 50, 250 and 750 mg/kg bw/day were selected for the main study. In the main study, dose levels of 50, 250 and 750 mg/kg bw/day were administered orally by gavage to groups each made up of five male and five female Sprague-Dawley rats for twenty-eight consecutive days. A control group of five males and five females was dosed with the vehicle arachis oil (B. P.) alone. Recovery groups, each made up of five males and five females, were treated with the high","page":13,"pdf":"sccs_o_149.pdf","row_type":"noael_study","study_id":"sccs_o_149_noael_001"}
SCCS_vision_codex	NOAEL	=100	mg/kg bw/day	rat	-	-	NOAEL study	{"dose":", 300 and 1000 mg/kg bw/day led to substance related findings at 300 and 1000 mg/kg bw/day in form of reduced body weights, impaired clinical chemistry and indications for inflammation in females, while the males showed testicular atrophy.","effect":", 300 and 1000 mg/kg bw/day led to substance related findings at 300 and 1000 mg/kg bw/day in form of reduced body weights, impaired clinical chemistry and indications for inflammation in females, while the males showed testicular atrophy. In any case and in contrast to the distinct general toxicity at doses at ≥300 mg/kg bw/day, the testing for neurotoxic effects according to the \"Functional Observational Battery\" revealed no functional defects of any kind or any other signs of neurotoxicity during the study. The NOAEL for male and female Wistar rats derived from this study was 100 mg/kg bw/day.","page":18,"pdf":"sccs_o_149.pdf","row_type":"noael_study","study_id":"sccs_o_149_noael_004"}
SCCS_vision_codex	NOAEL	=0.033	mg/kg bw/day	rat	oral	90 day	repeated dose toxicity	{"dose":"3.33 mg/kg bw Assumed residue:","effect":"remains as residue, of which 100% becomes systemically available via the human nail (see Discussion). CALCULATION OF THE MARGIN OF SAFETY Trimethylbenzoyl-diphenylphosphine oxide (TPO) Amount of the gel applied: 4 g Concentration of TPO in the gel: 5% Total amount of TPO applied: 200 mg Default human body weight: 60 kg Amount of TPO applied/kg human b.w.: 3.33 mg/kg bw Assumed residue: 1% Assumed absorption through the nail plate: 100% Systemic exposure dose (SED): 3.33 mg/kg bw * 0.01 = 0.033 mg/kg bw/day No Observed Adverse Effect Level (NOAEL) 100 mg/kg bw/day (90 day repeated dose oral toxicity, rat) Corrected NOAEL for 50% bioavailability: 50 mg/kg bw/day Margin of Safety adjusted NOAEL/SED = 1515 Standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14. Discussion Physico-chemical properties, function and use TPO is a yellow powder which is sparingly soluble in water but readily soluble in various organic solvents and typical monomers of use. TPO is used a","page":26,"pdf":"sccs_o_149.pdf","row_type":"noael_study","study_id":"sccs_o_149_noael_005"}

ToxValDB_EPA_TSCA_8e 1 endpoint

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
ToxValDB_EPA_TSCA_8e	LEL	=500	mg/kg bw/day	Rat	oral	short-term (developmental); 15 days	reproduction developmental	STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/68c96d15e4b02565fc7d3269; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://chemview.epa.gov; SUBSOURCE_URL=https://chemview.epa.gov/chemview/proxy?filename=090225268023f445_8EHQ-16-20230_Section 8 (e)_N_2075 No Confidentiality Letter CDX.pdf; TOXICOLOGICAL_EFFECT=P0: decreased body weight; STUDY_GROUP=EPA TSCA 8e:15957445:F:--; QC_CATEGORY=Manually extracted from unstructured data source; Source overall passed QC, and this record was manually checked; QC_STATUS=pass; SOURCE_HASH=ToxValhc_82e5987ccc21599ba8ba8a7516788d98

ToxValDB_GESTIS_DNEL 1 endpoint

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
ToxValDB_GESTIS_DNEL	DNEL systemic	=0.822	mg/m3	Human	inhalation	-	Toxicity Value	STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6543dd69e4b045b9ff7cd87e; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.dguv.de/ifa/gestis/gestis-dnel-liste/index-2.jsp; STUDY_GROUP=GESTIS DNEL:15631554:-:--; 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_798c61a3798dbdbb148f0aec7291f219

UnifiedCodex:CIR:beta.noael_studies 6 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
UnifiedCodex:CIR:beta.noael_studies	developmental toxicity	60	mg/kg bw/d	rat	oral	20 d	developmental toxicity	SOURCE_SUBDIR=SLR_TrimethylbenzoylDiphenylphosphineOxide_122024; REPORT_TITLE=Safety Assessment of Trimethylbenzoyl Diphenylphosphine Oxide as Used in Cosmetics Status: Scientific Literature Review for Public Comment Release Date:; OPINION_NUMBER=SLR_TrimethylbenzoylDiphenylphosphineOxide_122024; COMMITTEE=Expert Panel for Cosmetic Ingredient Safety; REPORT_DATE=November 2024; VALUE_TEXT=60; DOSE=The NOAEL for maternal and developmental toxicity was determined to be 150 mg/kg bw/d in a study in which female Wistar rats (22 females/group) were given Trimethylbenzoyl Diphenylphosphine Oxide in 1% aqueous carboxymethylcellulose at doses of up to 500 mg/kg bw/d via gavage on days 6 – 20 post-coitum.2 Adverse effects in both dams (e.g., decreased body...; EFFECT=in Table 4. The NOAEL for maternal and developmental toxicity was determined to be 150 mg/kg bw/d in a study in which female Wistar rats (22 females/group) were given Trimethylbenzoyl Diphenylphosphine Oxide in 1% aqueous carboxymethylcellulose at doses of up to 500 mg/kg bw/d via gavage on days 6 – 20 post-coitum.2 Adverse effects in both dams (e.g., decreased body weight gain) and fetuses (e.g., increased incidence of fetuses with bent limb bones) were observed at 500 mg/kg bw/d. An overall reproductive toxicity NOAEL of 60 mg/kg bw/d was established in a one-generation reproductive toxicity assay performed in Wistar Han rats (5/sex/group) given up to 600 mg/kg bw/d Trimethylbenzoyl Diphenylphosphine Oxide (purity 99.3%) in 1% aqueous carboxymethylcellulose (parental males treated prior to mating and during mating; parental females treated prior to mating up until at least 20 d after delivery). Fertility indices were 100, 90, 100 and 0% for the control, 60, 200, and 600 mg/kg groups, respectively. Testicular abnormalities were observed in mid- and high-dosed paternal males. No t...; CITATION=4; 150; (22; CITATION_NUMBERS=[4,150,22]; REFERENCE=4; 150; (22; DETAILS_JSON={"cas_number":"75980-60-8","citation":"4; 150; (22","dose":"The NOAEL for maternal and developmental toxicity was determined to be 150 mg/kg bw/d in a study in which female Wistar rats (22 females/group) were given Trimethylbenzoyl Diphenylphosphine Oxide in 1% aqueous carboxymethylcellulose at doses of up to 500 mg/kg bw/d via gavage on days 6 – 20 post-coitum.2 Adverse effects in both dams (e.g., decreased body...","duration":"20 d","effect":"in Table 4. The NOAEL for maternal and developmental toxicity was determined to be 150 mg/kg bw/d in a study in which female Wistar rats (22 females/group) were given Trimethylbenzoyl Diphenylphosphine Oxide in 1% aqueous carboxymethylcellulose at doses of up to 500 mg/kg bw/d via gavage on days 6 – 20 post-coitum.2 Adverse effects in both dams (e.g., decreased body weight gain) and fetuses (e.g., increased incidence of fetuses with bent limb bones) were observed at 500 mg/kg bw/d. An overall reproductive toxicity NOAEL of 60 mg/kg bw/d was established in a one-generation reproductive toxicity assay performed in Wistar Han rats (5/sex/group) given up to 600 mg/kg bw/d Trimethylbenzoyl Diphenylphosphine Oxide (purity 99.3%) in 1% aqueous carboxymethylcellulose (parental males treated prior to mating and during mating; parental females treated prior to mating up until at least 20 d after delivery). Fertility indices were 100, 90, 100 and 0% for the control, 60, 200, and 600 mg/kg groups, respectively. Testicular abnormalities were observed in mid- and high-dosed paternal males. No t...","endpoint":"developmental toxicity","ingredient":"Trimethylbenzoyl Diphenylphosphine Oxide","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"60","page":6,"route":"oral","species":"rat","study_id":"SLR_TrimethylbenzoylDiphenylphosphineOxide_122024_noael_004"}
UnifiedCodex:CIR:beta.noael_studies	developmental toxicity	>100	mg/kg bw/d	rabbit	oral	20 d	developmental toxicity	SOURCE_SUBDIR=SLR_TrimethylbenzoylDiphenylphosphineOxide_122024; REPORT_TITLE=Safety Assessment of Trimethylbenzoyl Diphenylphosphine Oxide as Used in Cosmetics Status: Scientific Literature Review for Public Comment Release Date:; OPINION_NUMBER=SLR_TrimethylbenzoylDiphenylphosphineOxide_122024; COMMITTEE=Expert Panel for Cosmetic Ingredient Safety; REPORT_DATE=November 2024; VALUE_TEXT=> 100; DOSE=Fertility indices were 100, 90, 100 and 0% for the control, 60, 200, and 600 mg/kg groups, respectively.; EFFECT=phosphine Oxide (purity 99.3%) in 1% aqueous carboxymethylcellulose (parental males treated prior to mating and during mating; parental females treated prior to mating up until at least 20 d after delivery). Fertility indices were 100, 90, 100 and 0% for the control, 60, 200, and 600 mg/kg groups, respectively. Testicular abnormalities were observed in mid- and high-dosed paternal males. No treatment-related clinical signs or adverse gross pathological findings were observed in pups. The maternal and developmental NOAEL was determined to be >100 mg/kg bw/d in a study performed using New Zealand White rabbits (22 females/group) given Trimethylbenzoyl Diphenylphosphine Oxide (purity 99.3%) in 1% aqueous carboxymethylcellulose at doses of up to 100 mg/kg via gavage on days 6 – 28 post-coitum. No clinical signs of toxicity, treatment-related mortality, body weight changes, or gross pathological abnormalities were observed in dams. No dose- dependent adverse effects were observed in fetuses; however, a statistically significant increase in the incidence of misaligned vertebrae was obse...; CITATION=99; 3; 1; CITATION_NUMBERS=[99,3,1]; REFERENCE=99; 3; 1; DETAILS_JSON={"cas_number":"75980-60-8","citation":"99; 3; 1","dose":"Fertility indices were 100, 90, 100 and 0% for the control, 60, 200, and 600 mg/kg groups, respectively.","duration":"20 d","effect":"phosphine Oxide (purity 99.3%) in 1% aqueous carboxymethylcellulose (parental males treated prior to mating and during mating; parental females treated prior to mating up until at least 20 d after delivery). Fertility indices were 100, 90, 100 and 0% for the control, 60, 200, and 600 mg/kg groups, respectively. Testicular abnormalities were observed in mid- and high-dosed paternal males. No treatment-related clinical signs or adverse gross pathological findings were observed in pups. The maternal and developmental NOAEL was determined to be >100 mg/kg bw/d in a study performed using New Zealand White rabbits (22 females/group) given Trimethylbenzoyl Diphenylphosphine Oxide (purity 99.3%) in 1% aqueous carboxymethylcellulose at doses of up to 100 mg/kg via gavage on days 6 – 28 post-coitum. No clinical signs of toxicity, treatment-related mortality, body weight changes, or gross pathological abnormalities were observed in dams. No dose- dependent adverse effects were observed in fetuses; however, a statistically significant increase in the incidence of misaligned vertebrae was obse...","endpoint":"developmental toxicity","ingredient":"Trimethylbenzoyl Diphenylphosphine Oxide","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"> 100","page":6,"route":"oral","species":"rabbit","study_id":"SLR_TrimethylbenzoylDiphenylphosphineOxide_122024_noael_005"}
UnifiedCodex:CIR:beta.noael_studies	developmental toxicity	200	mg/kg bw/d	-	-	-	developmental toxicity	SOURCE_SUBDIR=SLR_TrimethylbenzoylDiphenylphosphineOxide_122024; REPORT_TITLE=Safety Assessment of Trimethylbenzoyl Diphenylphosphine Oxide as Used in Cosmetics Status: Scientific Literature Review for Public Comment Release Date:; OPINION_NUMBER=SLR_TrimethylbenzoylDiphenylphosphineOxide_122024; COMMITTEE=Expert Panel for Cosmetic Ingredient Safety; REPORT_DATE=November 2024; VALUE_TEXT=200; DOSE=ease in hypertrophy of the follicular epithelium of the thyroid glands was noted in males at 200 and 600 mg/kg and in females at 600 mg/kg (considered non-adverse at current severity and in absence of any other pathological finding).; EFFECT=ease in hypertrophy of the follicular epithelium of the thyroid glands was noted in males at 200 and 600 mg/kg and in females at 600 mg/kg (considered non-adverse at current severity and in absence of any other pathological finding). No treatment-related clinical signs or adverse gross pathological findings were observed in pups. Live birth indices (number of live offspring on PND 1 as percentage of total number of offspring born) were 97% for the control and 99% for the 60 and 200 mg/kg groups. Parental toxicity NOAEL: 200 mg/kg bw/d. Developmental toxicity NOAEL: 200 mg/kg bw/d. Overall reproductive toxicity NOAEL: 60 mg/kg bw/d.; CITATION=200; 600; 1; CITATION_NUMBERS=[200,600,1]; REFERENCE=200; 600; 1; DETAILS_JSON={"cas_number":"75980-60-8","citation":"200; 600; 1","dose":"ease in hypertrophy of the follicular epithelium of the thyroid glands was noted in males at 200 and 600 mg/kg and in females at 600 mg/kg (considered non-adverse at current severity and in absence of any other pathological finding).","duration":"","effect":"ease in hypertrophy of the follicular epithelium of the thyroid glands was noted in males at 200 and 600 mg/kg and in females at 600 mg/kg (considered non-adverse at current severity and in absence of any other pathological finding). No treatment-related clinical signs or adverse gross pathological findings were observed in pups. Live birth indices (number of live offspring on PND 1 as percentage of total number of offspring born) were 97% for the control and 99% for the 60 and 200 mg/kg groups. Parental toxicity NOAEL: 200 mg/kg bw/d. Developmental toxicity NOAEL: 200 mg/kg bw/d. Overall reproductive toxicity NOAEL: 60 mg/kg bw/d.","endpoint":"developmental toxicity","ingredient":"Trimethylbenzoyl Diphenylphosphine Oxide","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"200","page":14,"route":"","species":"","study_id":"SLR_TrimethylbenzoylDiphenylphosphineOxide_122024_noael_006"}
UnifiedCodex:CIR:beta.noael_studies	repeated dose toxicity	50	mg/kg bw/d	rat	oral	Subchronic	repeated dose toxicity	SOURCE_SUBDIR=SLR_TrimethylbenzoylDiphenylphosphineOxide_122024; REPORT_TITLE=Safety Assessment of Trimethylbenzoyl Diphenylphosphine Oxide as Used in Cosmetics Status: Scientific Literature Review for Public Comment Release Date:; OPINION_NUMBER=SLR_TrimethylbenzoylDiphenylphosphineOxide_122024; COMMITTEE=Expert Panel for Cosmetic Ingredient Safety; REPORT_DATE=November 2024; VALUE_TEXT=50; DOSE=The acute oral LD50 was determined to be > 5000 mg/kg.; EFFECT=and piloerection 4-h post-dosing. All animals appeared normal after day 1 of treatment. No abnormalities were noted at necropsy. The acute oral LD50 was determined to be > 5000 mg/kg. Short-Term and Subchronic Toxicity Studies Details on the repeated dose oral toxicity studies summarized below can be found in Table 3. A 28-d oral toxicity study was performed using Sprague-Dawley rats (5/sex/group) given up to 750 mg/kg bw/d Trimethylbenzoyl Diphenylphosphine Oxide (purity 99%) in arachis oil via gavage.3,2,14 The no-observed-adverse-effect-level (NOAEL) was determined to be 50 mg/kg bw/d due to abnormalities observed at higher concentrations (decreased body weight gain, increased liver and kidney weights, testicular atrophy, and blood/urine abnormalities indicative of hepatic and renal injury). Conversely, no adverse effects were observed in a 28-d toxicity study in which male Wistar rats (number of animals not stated) were given Trimethylbenzoyl Diphenylphosphine Oxide (purity 99.3%; 1000 mg/kg bw/d) suspended in; CITATION=4; 1; 3; CITATION_NUMBERS=[4,1,3]; REFERENCE=4; 1; 3; DETAILS_JSON={"cas_number":"75980-60-8","citation":"4; 1; 3","dose":"The acute oral LD50 was determined to be > 5000 mg/kg.","duration":"Subchronic","effect":"and piloerection 4-h post-dosing. All animals appeared normal after day 1 of treatment. No abnormalities were noted at necropsy. The acute oral LD50 was determined to be > 5000 mg/kg. Short-Term and Subchronic Toxicity Studies Details on the repeated dose oral toxicity studies summarized below can be found in Table 3. A 28-d oral toxicity study was performed using Sprague-Dawley rats (5/sex/group) given up to 750 mg/kg bw/d Trimethylbenzoyl Diphenylphosphine Oxide (purity 99%) in arachis oil via gavage.3,2,14 The no-observed-adverse-effect-level (NOAEL) was determined to be 50 mg/kg bw/d due to abnormalities observed at higher concentrations (decreased body weight gain, increased liver and kidney weights, testicular atrophy, and blood/urine abnormalities indicative of hepatic and renal injury). Conversely, no adverse effects were observed in a 28-d toxicity study in which male Wistar rats (number of animals not stated) were given Trimethylbenzoyl Diphenylphosphine Oxide (purity 99.3%; 1000 mg/kg bw/d) suspended in","endpoint":"repeated dose toxicity","ingredient":"Trimethylbenzoyl Diphenylphosphine Oxide","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"50","page":5,"route":"oral","species":"rat","study_id":"SLR_TrimethylbenzoylDiphenylphosphineOxide_122024_noael_001"}
UnifiedCodex:CIR:beta.noael_studies	repeated dose toxicity	100	mg/kg bw/d	rat	oral	90-d	repeated dose toxicity	SOURCE_SUBDIR=SLR_TrimethylbenzoylDiphenylphosphineOxide_122024; REPORT_TITLE=Safety Assessment of Trimethylbenzoyl Diphenylphosphine Oxide as Used in Cosmetics Status: Scientific Literature Review for Public Comment Release Date:; OPINION_NUMBER=SLR_TrimethylbenzoylDiphenylphosphineOxide_122024; COMMITTEE=Expert Panel for Cosmetic Ingredient Safety; REPORT_DATE=November 2024; VALUE_TEXT=100; DOSE=0.5% aqueous carboxymethylcellulose via gavage.3 An NOAEL of 100 mg/kg bw/d was determined in a 90-d toxicity study in which Wistar rats (10/sex/group) were given Trimethylbenzoyl Diphenylphosphine Oxide (purity 94.8%;; EFFECT=0.5% aqueous carboxymethylcellulose via gavage.3 An NOAEL of 100 mg/kg bw/d was determined in a 90-d toxicity study in which Wistar rats (10/sex/group) were given Trimethylbenzoyl Diphenylphosphine Oxide (purity 94.8%; 100, 300, or 1000 mg/kg bw/d) in 0.5% aqueous carboxymethylcellulose via gavage.2,3 Some of the adverse effects observed in this study include body weight reduction, abnormalities in clinical chemistry, increased liver, kidney, brain, adrenal gland, and testes weight, and marked diffuse atrophy of the testicular parenchyma (compared to controls; these effects were observed in the mid- and high-dose groups). Testicular atrophy, decreased mean testes weight, and decreased mea; CITATION=0; 5; 3; CITATION_NUMBERS=[5,3]; REFERENCE=0; 5; 3; DETAILS_JSON={"cas_number":"75980-60-8","citation":"0; 5; 3","dose":"0.5% aqueous carboxymethylcellulose via gavage.3 An NOAEL of 100 mg/kg bw/d was determined in a 90-d toxicity study in which Wistar rats (10/sex/group) were given Trimethylbenzoyl Diphenylphosphine Oxide (purity 94.8%;","duration":"90-d","effect":"0.5% aqueous carboxymethylcellulose via gavage.3 An NOAEL of 100 mg/kg bw/d was determined in a 90-d toxicity study in which Wistar rats (10/sex/group) were given Trimethylbenzoyl Diphenylphosphine Oxide (purity 94.8%; 100, 300, or 1000 mg/kg bw/d) in 0.5% aqueous carboxymethylcellulose via gavage.2,3 Some of the adverse effects observed in this study include body weight reduction, abnormalities in clinical chemistry, increased liver, kidney, brain, adrenal gland, and testes weight, and marked diffuse atrophy of the testicular parenchyma (compared to controls; these effects were observed in the mid- and high-dose groups). Testicular atrophy, decreased mean testes weight, and decreased mea","endpoint":"repeated dose toxicity","ingredient":"Trimethylbenzoyl Diphenylphosphine Oxide","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"100","page":6,"route":"oral","species":"rat","study_id":"SLR_TrimethylbenzoylDiphenylphosphineOxide_122024_noael_002"}
UnifiedCodex:CIR:beta.noael_studies	repeated dose toxicity	150	mg/kg bw/d	rat	oral	90-d	repeated dose toxicity	SOURCE_SUBDIR=SLR_TrimethylbenzoylDiphenylphosphineOxide_122024; REPORT_TITLE=Safety Assessment of Trimethylbenzoyl Diphenylphosphine Oxide as Used in Cosmetics Status: Scientific Literature Review for Public Comment Release Date:; OPINION_NUMBER=SLR_TrimethylbenzoylDiphenylphosphineOxide_122024; COMMITTEE=Expert Panel for Cosmetic Ingredient Safety; REPORT_DATE=November 2024; VALUE_TEXT=150; DOSE=d- and high-dose groups).; EFFECT=d- and high-dose groups). Testicular atrophy, decreased mean testes weight, and decreased mean body weights (compared to controls) were also observed in a different 90-d assay performed in male Wistar rats (10/group) given Trimethylbenzoyl Diphenylphosphine Oxide (purity 99.3%; 1000 mg/kg bw/d) in a 0.5% carboxymethylcellulose aqueous solution via gavage. DEVELOPMENTAL AND REPRODUCTIVE TOXICITY STUDIES Details on the oral developmental and reproductive toxicity studies summarized below can be found in Table 4. The NOAEL for maternal and developmental toxicity was determined to be 150 mg/kg bw/d in a study in which female Wistar rats (22 females/group) were given Trimethylbenzoyl Diphenylphosphine Oxide in 1% aqueous carboxymethylcellulose at doses of up to 500 mg/kg bw/d via gavage on days 6 – 20 post-coitum.2 Adverse effects in both dams (e.g., decreased body weight gain) and fetuses (e.g., increased incidence of fetuses with bent limb bones) were observed at 500 mg/kg bw/d. An overall reproductive toxicity NOAEL of 60 mg/kg bw/d was established in a one-generation reproductive t...; CITATION=90; (10; 99; CITATION_NUMBERS=[90,10,99]; REFERENCE=90; (10; 99; DETAILS_JSON={"cas_number":"75980-60-8","citation":"90; (10; 99","dose":"d- and high-dose groups).","duration":"90-d","effect":"d- and high-dose groups). Testicular atrophy, decreased mean testes weight, and decreased mean body weights (compared to controls) were also observed in a different 90-d assay performed in male Wistar rats (10/group) given Trimethylbenzoyl Diphenylphosphine Oxide (purity 99.3%; 1000 mg/kg bw/d) in a 0.5% carboxymethylcellulose aqueous solution via gavage. DEVELOPMENTAL AND REPRODUCTIVE TOXICITY STUDIES Details on the oral developmental and reproductive toxicity studies summarized below can be found in Table 4. The NOAEL for maternal and developmental toxicity was determined to be 150 mg/kg bw/d in a study in which female Wistar rats (22 females/group) were given Trimethylbenzoyl Diphenylphosphine Oxide in 1% aqueous carboxymethylcellulose at doses of up to 500 mg/kg bw/d via gavage on days 6 – 20 post-coitum.2 Adverse effects in both dams (e.g., decreased body weight gain) and fetuses (e.g., increased incidence of fetuses with bent limb bones) were observed at 500 mg/kg bw/d. An overall reproductive toxicity NOAEL of 60 mg/kg bw/d was established in a one-generation reproductive t...","endpoint":"repeated dose toxicity","ingredient":"Trimethylbenzoyl Diphenylphosphine Oxide","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"150","page":6,"route":"oral","species":"rat","study_id":"SLR_TrimethylbenzoylDiphenylphosphineOxide_122024_noael_003"}

UnifiedCodex:SCCS_SHADOW:beta.noael_studies 15 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	100	mg/kg bw/day	rat	-	-	-	SOURCE_SUBDIR=sccs_o_149; REPORT_TITLE=OPINION ON Trimethylbenzoyl diphenylphosphine oxide (TPO); OPINION_NUMBER=SCCS/1528/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=27 March 2014; VALUE_TEXT=100; DOSE=, 300 and 1000 mg/kg bw/day led to substance related findings at 300 and 1000 mg/kg bw/day in form of reduced body weights, impaired clinical chemistry and indications for inflammation in females, while the males showed testicular atrophy.; EFFECT=, 300 and 1000 mg/kg bw/day led to substance related findings at 300 and 1000 mg/kg bw/day in form of reduced body weights, impaired clinical chemistry and indications for inflammation in females, while the males showed testicular atrophy. In any case and in contrast to the distinct general toxicity at doses at ≥300 mg/kg bw/day, the testing for neurotoxic effects according to the "Functional Observational Battery" revealed no functional defects of any kind or any other signs of neurotoxicity during the study. The NOAEL for male and female Wistar rats derived from this study was 100 mg/kg bw/day.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"75980-60-8","citation":"","dose":", 300 and 1000 mg/kg bw/day led to substance related findings at 300 and 1000 mg/kg bw/day in form of reduced body weights, impaired clinical chemistry and indications for inflammation in females, while the males showed testicular atrophy.","duration":"","effect":", 300 and 1000 mg/kg bw/day led to substance related findings at 300 and 1000 mg/kg bw/day in form of reduced body weights, impaired clinical chemistry and indications for inflammation in females, while the males showed testicular atrophy. In any case and in contrast to the distinct general toxicity at doses at ≥300 mg/kg bw/day, the testing for neurotoxic effects according to the \"Functional Observational Battery\" revealed no functional defects of any kind or any other signs of neurotoxicity during the study. The NOAEL for male and female Wistar rats derived from this study was 100 mg/kg bw/day.","endpoint":"","ingredient":"codes........................................7","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"100","page":18,"route":"","species":"rat","study_id":"sccs_o_149_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	100	mg/kg bw/day	rat	-	91 days	-	SOURCE_SUBDIR=sccs_o_149; REPORT_TITLE=OPINION ON Trimethylbenzoyl diphenylphosphine oxide (TPO); OPINION_NUMBER=SCCS/1528/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=27 March 2014; VALUE_TEXT=100; DOSE=ronic administration of TPO to Wistar rats for 90/91 days at dose levels of 0, 100, 300 and 1000 mg/kg bw/day led to substance-related findings at 300 and 1000 mg/kg bw/day in the form of reduced body weights, increased absolute and relative kidney and liver weights, impaired clinical chemistry and indications for inflammation in females, while...; EFFECT=ronic administration of TPO to Wistar rats for 90/91 days at dose levels of 0, 100, 300 and 1000 mg/kg bw/day led to substance-related findings at 300 and 1000 mg/kg bw/day in the form of reduced body weights, increased absolute and relative kidney and liver weights, impaired clinical chemistry and indications for inflammation in females, while the males showed testicular atrophy. The testing for neurotoxic effects revealed no functional defects of any kind or any other signs of neurotoxicity during the study. The NOAEL obtained in this study was 100 mg/kg bw/day. Finally, it can be concluded that in general, comparable effects are noted in the 28-day and 90-day studies. Especially no increase in severity of the organ damages at almost identical dose levels occurred with increased exposure time (28- versus 90-day). The most susceptible organs were the testes. A clear NOAEL was obtained for testicular atrophy in both studies. The NOAEL in the 28-day study was 50 mg/kg bw/day and the NOAEL in the 90-day study was 100 mg/kg bw/day.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"75980-60-8","citation":"","dose":"ronic administration of TPO to Wistar rats for 90/91 days at dose levels of 0, 100, 300 and 1000 mg/kg bw/day led to substance-related findings at 300 and 1000 mg/kg bw/day in the form of reduced body weights, increased absolute and relative kidney and liver weights, impaired clinical chemistry and indications for inflammation in females, while...","duration":"91 days","effect":"ronic administration of TPO to Wistar rats for 90/91 days at dose levels of 0, 100, 300 and 1000 mg/kg bw/day led to substance-related findings at 300 and 1000 mg/kg bw/day in the form of reduced body weights, increased absolute and relative kidney and liver weights, impaired clinical chemistry and indications for inflammation in females, while the males showed testicular atrophy. The testing for neurotoxic effects revealed no functional defects of any kind or any other signs of neurotoxicity during the study. The NOAEL obtained in this study was 100 mg/kg bw/day. Finally, it can be concluded that in general, comparable effects are noted in the 28-day and 90-day studies. Especially no increase in severity of the organ damages at almost identical dose levels occurred with increased exposure time (28- versus 90-day). The most susceptible organs were the testes. A clear NOAEL was obtained for testicular atrophy in both studies. The NOAEL in the 28-day study was 50 mg/kg bw/day and the NOAEL in the 90-day study was 100 mg/kg bw/day.","endpoint":"","ingredient":"codes........................................7","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"100","page":27,"route":"","species":"rat","study_id":"sccs_o_149_noael_010"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	repeated dose toxicity	50	mg/kg bw/day	rat	oral	28-day	repeated dose toxicity	SOURCE_SUBDIR=sccs_o_149; REPORT_TITLE=OPINION ON Trimethylbenzoyl diphenylphosphine oxide (TPO); OPINION_NUMBER=SCCS/1528/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=27 March 2014; VALUE_TEXT=50; DOSE=to determine the dose levels for the definitive 28-day repeated dose toxicity study.; EFFECT=to determine the dose levels for the definitive 28-day repeated dose toxicity study. The test substance was administered by gavage to Sprague-Dawley rats (3/sex/dose) for 14 consecutive days, at dose levels of 0, 50, 250, 500, 750 and 1000 mg/kg bw/day in arachis oil (B. P.). The highest dose was lethal and adverse effects in form of clinical symptoms and reduced body weight gains were noted at 500 and 750 mg/kg bw/day. Minor clinical signs were observed at 250 mg/kg bw/day. The low dose of 50 mg/kg bw/day was the No observed adverse effect level in this range finding study. Consequently, dose levels of 0, 50, 250 and 750 mg/kg bw/day were selected for the main study. In the main study, dose levels of 50, 250 and 750 mg/kg bw/day were administered orally by gavage to groups each made up of five male and five female Sprague-Dawley rats for twenty-eight consecutive days. A control group of five males and five females was dosed with the vehicle arachis oil (B. P.) alone. Recovery groups, each made up of five males and five females, were treated with the high; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"75980-60-8","citation":"","dose":"to determine the dose levels for the definitive 28-day repeated dose toxicity study.","duration":"28-day","effect":"to determine the dose levels for the definitive 28-day repeated dose toxicity study. The test substance was administered by gavage to Sprague-Dawley rats (3/sex/dose) for 14 consecutive days, at dose levels of 0, 50, 250, 500, 750 and 1000 mg/kg bw/day in arachis oil (B. P.). The highest dose was lethal and adverse effects in form of clinical symptoms and reduced body weight gains were noted at 500 and 750 mg/kg bw/day. Minor clinical signs were observed at 250 mg/kg bw/day. The low dose of 50 mg/kg bw/day was the No observed adverse effect level in this range finding study. Consequently, dose levels of 0, 50, 250 and 750 mg/kg bw/day were selected for the main study. In the main study, dose levels of 50, 250 and 750 mg/kg bw/day were administered orally by gavage to groups each made up of five male and five female Sprague-Dawley rats for twenty-eight consecutive days. A control group of five males and five females was dosed with the vehicle arachis oil (B. P.) alone. Recovery groups, each made up of five males and five females, were treated with the high","endpoint":"repeated dose toxicity","ingredient":"codes........................................7","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"50","page":13,"route":"oral","species":"rat","study_id":"sccs_o_149_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	repeated dose toxicity	50	mg/kg bw/day	rat	oral	28 days	repeated dose toxicity	SOURCE_SUBDIR=sccs_o_149; REPORT_TITLE=OPINION ON Trimethylbenzoyl diphenylphosphine oxide (TPO); OPINION_NUMBER=SCCS/1528/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=27 March 2014; VALUE_TEXT=50; DOSE=k for 28 days at dose levels of 0, 50, 250 and 750 mg/kg bw/day led to toxicologically relevant effects in both sexes at 250 and 750 mg/kg bw/day in the form of impaired general state of health, reduced body weight parameters and functional as well as morphological findings indicative for kidney and liver damage.; EFFECT=k for 28 days at dose levels of 0, 50, 250 and 750 mg/kg bw/day led to toxicologically relevant effects in both sexes at 250 and 750 mg/kg bw/day in the form of impaired general state of health, reduced body weight parameters and functional as well as morphological findings indicative for kidney and liver damage. In addition, the males at 750 mg/kg bw/day showed testicular atrophy. With the exception of the testes and liver finding, most of the findings improved or disappeared during the recovery period. Thus, the No Observed Adverse Effect Level (NOAEL) for male and female Sprague-Dawley rats was 50 mg/kg bw/day. Ref. 32 SCCS comment No analytical evidence for the purity of the test substance was provided in the study report. 2) A subsequently performed oral (gavage) 28-day repeated dose toxicity study (non-GLP, conducted in March-April 2000, study report Jan 2001) in another strain of male rats, designed specifically to investigate testicular effects, did not confirm the above findings. Three male Wistar rats received another batch of TPO with higher p; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"75980-60-8","citation":"","dose":"k for 28 days at dose levels of 0, 50, 250 and 750 mg/kg bw/day led to toxicologically relevant effects in both sexes at 250 and 750 mg/kg bw/day in the form of impaired general state of health, reduced body weight parameters and functional as well as morphological findings indicative for kidney and liver damage.","duration":"28 days","effect":"k for 28 days at dose levels of 0, 50, 250 and 750 mg/kg bw/day led to toxicologically relevant effects in both sexes at 250 and 750 mg/kg bw/day in the form of impaired general state of health, reduced body weight parameters and functional as well as morphological findings indicative for kidney and liver damage. In addition, the males at 750 mg/kg bw/day showed testicular atrophy. With the exception of the testes and liver finding, most of the findings improved or disappeared during the recovery period. Thus, the No Observed Adverse Effect Level (NOAEL) for male and female Sprague-Dawley rats was 50 mg/kg bw/day. Ref. 32 SCCS comment No analytical evidence for the purity of the test substance was provided in the study report. 2) A subsequently performed oral (gavage) 28-day repeated dose toxicity study (non-GLP, conducted in March-April 2000, study report Jan 2001) in another strain of male rats, designed specifically to investigate testicular effects, did not confirm the above findings. Three male Wistar rats received another batch of TPO with higher p","endpoint":"repeated dose toxicity","ingredient":"codes........................................7","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"50","page":14,"route":"oral","species":"rat","study_id":"sccs_o_149_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	repeated dose toxicity	50	mg/kg bw/day	rat	oral	28-day	repeated dose toxicity	SOURCE_SUBDIR=sccs_o_149; REPORT_TITLE=OPINION ON Trimethylbenzoyl diphenylphosphine oxide (TPO); OPINION_NUMBER=SCCS/1528/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=27 March 2014; VALUE_TEXT=50; DOSE=50, 250 and 750 mg/kg bw/day led to toxicologically relevant effects in both sexes at 250 and 750 mg/kg bw/day in the form of impaired general state of health, reduced body weight parameters and functional as well as morphological findings indicative for kidney and liver damage.; EFFECT=50, 250 and 750 mg/kg bw/day led to toxicologically relevant effects in both sexes at 250 and 750 mg/kg bw/day in the form of impaired general state of health, reduced body weight parameters and functional as well as morphological findings indicative for kidney and liver damage. In addition, the males at 750 mg/kg bw/day showed testicular atrophy. With the exception of the testes and liver finding, most of the findings improved or disappeared during the recovery period. Thus, the No Observed Adverse Effect Level (NOAEL) for male and female Sprague-Dawley rats was 50 mg/kg bw/day. Ref. 32 SCCS comment No analytical evidence for the purity of the test substance was provided in the study report. 2) A subsequently performed oral (gavage) 28-day repeated dose toxicity study (non-GLP, conducted in March-April 2000, study report Jan 2001) in another strain of male rats, designed specifically to investigate testicular effects, did not confirm the above findings. Three male Wistar rats received another batch of TPO with higher purity (; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"75980-60-8","citation":"","dose":"50, 250 and 750 mg/kg bw/day led to toxicologically relevant effects in both sexes at 250 and 750 mg/kg bw/day in the form of impaired general state of health, reduced body weight parameters and functional as well as morphological findings indicative for kidney and liver damage.","duration":"28-day","effect":"50, 250 and 750 mg/kg bw/day led to toxicologically relevant effects in both sexes at 250 and 750 mg/kg bw/day in the form of impaired general state of health, reduced body weight parameters and functional as well as morphological findings indicative for kidney and liver damage. In addition, the males at 750 mg/kg bw/day showed testicular atrophy. With the exception of the testes and liver finding, most of the findings improved or disappeared during the recovery period. Thus, the No Observed Adverse Effect Level (NOAEL) for male and female Sprague-Dawley rats was 50 mg/kg bw/day. Ref. 32 SCCS comment No analytical evidence for the purity of the test substance was provided in the study report. 2) A subsequently performed oral (gavage) 28-day repeated dose toxicity study (non-GLP, conducted in March-April 2000, study report Jan 2001) in another strain of male rats, designed specifically to investigate testicular effects, did not confirm the above findings. Three male Wistar rats received another batch of TPO with higher purity (","endpoint":"repeated dose toxicity","ingredient":"codes........................................7","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"50","page":14,"route":"oral","species":"rat","study_id":"sccs_o_149_noael_003"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	repeated dose toxicity	=0.033	mg/kg bw/day	rat	oral	90 day	repeated dose toxicity	SOURCE_SUBDIR=sccs_o_149; REPORT_TITLE=OPINION ON Trimethylbenzoyl diphenylphosphine oxide (TPO); OPINION_NUMBER=SCCS/1528/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=27 March 2014; VALUE_TEXT== 0.033; DOSE=3.33 mg/kg bw Assumed residue:; EFFECT=remains as residue, of which 100% becomes systemically available via the human nail (see Discussion). CALCULATION OF THE MARGIN OF SAFETY Trimethylbenzoyl-diphenylphosphine oxide (TPO) Amount of the gel applied: 4 g Concentration of TPO in the gel: 5% Total amount of TPO applied: 200 mg Default human body weight: 60 kg Amount of TPO applied/kg human b.w.: 3.33 mg/kg bw Assumed residue: 1% Assumed absorption through the nail plate: 100% Systemic exposure dose (SED): 3.33 mg/kg bw * 0.01 = 0.033 mg/kg bw/day No Observed Adverse Effect Level (NOAEL) 100 mg/kg bw/day (90 day repeated dose oral toxicity, rat) Corrected NOAEL for 50% bioavailability: 50 mg/kg bw/day Margin of Safety adjusted NOAEL/SED = 1515 Standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14. Discussion Physico-chemical properties, function and use TPO is a yellow powder which is sparingly soluble in water but readily soluble in various organic solvents and typical monomers of use. TPO is used a; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"75980-60-8","citation":"","dose":"3.33 mg/kg bw Assumed residue:","duration":"90 day","effect":"remains as residue, of which 100% becomes systemically available via the human nail (see Discussion). CALCULATION OF THE MARGIN OF SAFETY Trimethylbenzoyl-diphenylphosphine oxide (TPO) Amount of the gel applied: 4 g Concentration of TPO in the gel: 5% Total amount of TPO applied: 200 mg Default human body weight: 60 kg Amount of TPO applied/kg human b.w.: 3.33 mg/kg bw Assumed residue: 1% Assumed absorption through the nail plate: 100% Systemic exposure dose (SED): 3.33 mg/kg bw * 0.01 = 0.033 mg/kg bw/day No Observed Adverse Effect Level (NOAEL) 100 mg/kg bw/day (90 day repeated dose oral toxicity, rat) Corrected NOAEL for 50% bioavailability: 50 mg/kg bw/day Margin of Safety adjusted NOAEL/SED = 1515 Standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14. Discussion Physico-chemical properties, function and use TPO is a yellow powder which is sparingly soluble in water but readily soluble in various organic solvents and typical monomers of use. TPO is used a","endpoint":"repeated dose toxicity","ingredient":"codes........................................7","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"= 0.033","page":26,"route":"oral","species":"rat","study_id":"sccs_o_149_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	repeated dose toxicity	100	mg/kg bw/day	rat	oral	90 day	repeated dose toxicity	SOURCE_SUBDIR=sccs_o_149; REPORT_TITLE=OPINION ON Trimethylbenzoyl diphenylphosphine oxide (TPO); OPINION_NUMBER=SCCS/1528/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=27 March 2014; VALUE_TEXT=100; DOSE=3.33 mg/kg bw Assumed residue:; EFFECT=becomes systemically available via the human nail (see Discussion). CALCULATION OF THE MARGIN OF SAFETY Trimethylbenzoyl-diphenylphosphine oxide (TPO) Amount of the gel applied: 4 g Concentration of TPO in the gel: 5% Total amount of TPO applied: 200 mg Default human body weight: 60 kg Amount of TPO applied/kg human b.w.: 3.33 mg/kg bw Assumed residue: 1% Assumed absorption through the nail plate: 100% Systemic exposure dose (SED): 3.33 mg/kg bw * 0.01 = 0.033 mg/kg bw/day No Observed Adverse Effect Level (NOAEL) 100 mg/kg bw/day (90 day repeated dose oral toxicity, rat) Corrected NOAEL for 50% bioavailability: 50 mg/kg bw/day Margin of Safety adjusted NOAEL/SED = 1515 Standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14. Discussion Physico-chemical properties, function and use TPO is a yellow powder which is sparingly soluble in water but readily soluble in various organic solvents and typical monomers of use. TPO is used as a key; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"75980-60-8","citation":"","dose":"3.33 mg/kg bw Assumed residue:","duration":"90 day","effect":"becomes systemically available via the human nail (see Discussion). CALCULATION OF THE MARGIN OF SAFETY Trimethylbenzoyl-diphenylphosphine oxide (TPO) Amount of the gel applied: 4 g Concentration of TPO in the gel: 5% Total amount of TPO applied: 200 mg Default human body weight: 60 kg Amount of TPO applied/kg human b.w.: 3.33 mg/kg bw Assumed residue: 1% Assumed absorption through the nail plate: 100% Systemic exposure dose (SED): 3.33 mg/kg bw * 0.01 = 0.033 mg/kg bw/day No Observed Adverse Effect Level (NOAEL) 100 mg/kg bw/day (90 day repeated dose oral toxicity, rat) Corrected NOAEL for 50% bioavailability: 50 mg/kg bw/day Margin of Safety adjusted NOAEL/SED = 1515 Standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14. Discussion Physico-chemical properties, function and use TPO is a yellow powder which is sparingly soluble in water but readily soluble in various organic solvents and typical monomers of use. TPO is used as a key","endpoint":"repeated dose toxicity","ingredient":"codes........................................7","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"100","page":26,"route":"oral","species":"rat","study_id":"sccs_o_149_noael_006"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	repeated dose toxicity	50	%	rat	oral	90 day	repeated dose toxicity	SOURCE_SUBDIR=sccs_o_149; REPORT_TITLE=OPINION ON Trimethylbenzoyl diphenylphosphine oxide (TPO); OPINION_NUMBER=SCCS/1528/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=27 March 2014; VALUE_TEXT=50; DOSE=3.33 mg/kg bw Assumed residue:; EFFECT=TION OF THE MARGIN OF SAFETY Trimethylbenzoyl-diphenylphosphine oxide (TPO) Amount of the gel applied: 4 g Concentration of TPO in the gel: 5% Total amount of TPO applied: 200 mg Default human body weight: 60 kg Amount of TPO applied/kg human b.w.: 3.33 mg/kg bw Assumed residue: 1% Assumed absorption through the nail plate: 100% Systemic exposure dose (SED): 3.33 mg/kg bw * 0.01 = 0.033 mg/kg bw/day No Observed Adverse Effect Level (NOAEL) 100 mg/kg bw/day (90 day repeated dose oral toxicity, rat) Corrected NOAEL for 50% bioavailability: 50 mg/kg bw/day Margin of Safety adjusted NOAEL/SED = 1515 Standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14. Discussion Physico-chemical properties, function and use TPO is a yellow powder which is sparingly soluble in water but readily soluble in various organic solvents and typical monomers of use. TPO is used as a key processing aid in form of a chemical photo-initiator for polymerisation in; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"75980-60-8","citation":"","dose":"3.33 mg/kg bw Assumed residue:","duration":"90 day","effect":"TION OF THE MARGIN OF SAFETY Trimethylbenzoyl-diphenylphosphine oxide (TPO) Amount of the gel applied: 4 g Concentration of TPO in the gel: 5% Total amount of TPO applied: 200 mg Default human body weight: 60 kg Amount of TPO applied/kg human b.w.: 3.33 mg/kg bw Assumed residue: 1% Assumed absorption through the nail plate: 100% Systemic exposure dose (SED): 3.33 mg/kg bw * 0.01 = 0.033 mg/kg bw/day No Observed Adverse Effect Level (NOAEL) 100 mg/kg bw/day (90 day repeated dose oral toxicity, rat) Corrected NOAEL for 50% bioavailability: 50 mg/kg bw/day Margin of Safety adjusted NOAEL/SED = 1515 Standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14. Discussion Physico-chemical properties, function and use TPO is a yellow powder which is sparingly soluble in water but readily soluble in various organic solvents and typical monomers of use. TPO is used as a key processing aid in form of a chemical photo-initiator for polymerisation in","endpoint":"repeated dose toxicity","ingredient":"codes........................................7","loael_value":"","noael_unit":"%","noael_value":"50","page":26,"route":"oral","species":"rat","study_id":"sccs_o_149_noael_007"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	repeated dose toxicity	50	mg/kg bw/day	rat	oral	90 day	repeated dose toxicity	SOURCE_SUBDIR=sccs_o_149; REPORT_TITLE=OPINION ON Trimethylbenzoyl diphenylphosphine oxide (TPO); OPINION_NUMBER=SCCS/1528/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=27 March 2014; VALUE_TEXT=50; DOSE=3.33 mg/kg bw Assumed residue:; EFFECT=) Amount of the gel applied: 4 g Concentration of TPO in the gel: 5% Total amount of TPO applied: 200 mg Default human body weight: 60 kg Amount of TPO applied/kg human b.w.: 3.33 mg/kg bw Assumed residue: 1% Assumed absorption through the nail plate: 100% Systemic exposure dose (SED): 3.33 mg/kg bw * 0.01 = 0.033 mg/kg bw/day No Observed Adverse Effect Level (NOAEL) 100 mg/kg bw/day (90 day repeated dose oral toxicity, rat) Corrected NOAEL for 50% bioavailability: 50 mg/kg bw/day Margin of Safety adjusted NOAEL/SED = 1515 Standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14. Discussion Physico-chemical properties, function and use TPO is a yellow powder which is sparingly soluble in water but readily soluble in various organic solvents and typical monomers of use. TPO is used as a key processing aid in form of a chemical photo-initiator for polymerisation in artificial nail systems, primarily in UV-curable one-component gel systems.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"75980-60-8","citation":"","dose":"3.33 mg/kg bw Assumed residue:","duration":"90 day","effect":") Amount of the gel applied: 4 g Concentration of TPO in the gel: 5% Total amount of TPO applied: 200 mg Default human body weight: 60 kg Amount of TPO applied/kg human b.w.: 3.33 mg/kg bw Assumed residue: 1% Assumed absorption through the nail plate: 100% Systemic exposure dose (SED): 3.33 mg/kg bw * 0.01 = 0.033 mg/kg bw/day No Observed Adverse Effect Level (NOAEL) 100 mg/kg bw/day (90 day repeated dose oral toxicity, rat) Corrected NOAEL for 50% bioavailability: 50 mg/kg bw/day Margin of Safety adjusted NOAEL/SED = 1515 Standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14. Discussion Physico-chemical properties, function and use TPO is a yellow powder which is sparingly soluble in water but readily soluble in various organic solvents and typical monomers of use. TPO is used as a key processing aid in form of a chemical photo-initiator for polymerisation in artificial nail systems, primarily in UV-curable one-component gel systems.","endpoint":"repeated dose toxicity","ingredient":"codes........................................7","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"50","page":26,"route":"oral","species":"rat","study_id":"sccs_o_149_noael_008"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	repeated dose toxicity	50	mg/kg bw/day	rat	oral	28-day	repeated dose toxicity	SOURCE_SUBDIR=sccs_o_149; REPORT_TITLE=OPINION ON Trimethylbenzoyl diphenylphosphine oxide (TPO); OPINION_NUMBER=SCCS/1528/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=27 March 2014; VALUE_TEXT=50; DOSE=In addition, the males at 750 mg/kg bw/day showed testicular atrophy.; EFFECT=SCCS/1528/14 Opinion on the safety of Trimethylbenzoyl diphenylphosphine oxide (TPO) ___________________________________________________________________________________________ 27 reduced body weight parameters and functional as well as morphological findings indicative for kidney and liver damage. In addition, the males at 750 mg/kg bw/day showed testicular atrophy. With the exception of the testes and liver findings, the findings disappeared during the recovery period. The NOAEL obtained in this study was 50 mg/kg bw/day. A subsequently performed oral (gavage) 28-day repeated dose toxicity study in male Wistar rats (non-GLP), designed specifically to investigate testicular effects, did not confirm the above findings as the animals treated at the single dose of 1000 mg/kg bw/day did not show any clinical findings and especially no testicular atrophy. An additional 90-day repeated dose toxicity study in male Wistar rats (non-GLP) with a dose level of 1000 mg/kg bw/day confirmed the findings; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"75980-60-8","citation":"","dose":"In addition, the males at 750 mg/kg bw/day showed testicular atrophy.","duration":"28-day","effect":"SCCS/1528/14 Opinion on the safety of Trimethylbenzoyl diphenylphosphine oxide (TPO) ___________________________________________________________________________________________ 27 reduced body weight parameters and functional as well as morphological findings indicative for kidney and liver damage. In addition, the males at 750 mg/kg bw/day showed testicular atrophy. With the exception of the testes and liver findings, the findings disappeared during the recovery period. The NOAEL obtained in this study was 50 mg/kg bw/day. A subsequently performed oral (gavage) 28-day repeated dose toxicity study in male Wistar rats (non-GLP), designed specifically to investigate testicular effects, did not confirm the above findings as the animals treated at the single dose of 1000 mg/kg bw/day did not show any clinical findings and especially no testicular atrophy. An additional 90-day repeated dose toxicity study in male Wistar rats (non-GLP) with a dose level of 1000 mg/kg bw/day confirmed the findings","endpoint":"repeated dose toxicity","ingredient":"codes........................................7","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"50","page":27,"route":"oral","species":"rat","study_id":"sccs_o_149_noael_009"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	repeated dose toxicity	50	mg/kg bw/day	rabbit	oral	28-day	repeated dose toxicity	SOURCE_SUBDIR=sccs_o_149; REPORT_TITLE=OPINION ON Trimethylbenzoyl diphenylphosphine oxide (TPO); OPINION_NUMBER=SCCS/1528/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=27 March 2014; VALUE_TEXT=50; DOSE=The NOAEL obtained in this study was 100 mg/kg bw/day.; EFFECT=wed testicular atrophy. The testing for neurotoxic effects revealed no functional defects of any kind or any other signs of neurotoxicity during the study. The NOAEL obtained in this study was 100 mg/kg bw/day. Finally, it can be concluded that in general, comparable effects are noted in the 28-day and 90-day studies. Especially no increase in severity of the organ damages at almost identical dose levels occurred with increased exposure time (28- versus 90-day). The most susceptible organs were the testes. A clear NOAEL was obtained for testicular atrophy in both studies. The NOAEL in the 28-day study was 50 mg/kg bw/day and the NOAEL in the 90-day study was 100 mg/kg bw/day. As the apparently lower NOAEL may be due to the respective dose selection and as there was no significant increase in severity of the observed effects over time, an overall NOAEL of 100 mg/kg bw/day for repeated dose oral toxicity will be used for the calculation of the Margin of Safety (MoS). Irritation / sensitisation TPO has irritant potential to rabbit; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"75980-60-8","citation":"","dose":"The NOAEL obtained in this study was 100 mg/kg bw/day.","duration":"28-day","effect":"wed testicular atrophy. The testing for neurotoxic effects revealed no functional defects of any kind or any other signs of neurotoxicity during the study. The NOAEL obtained in this study was 100 mg/kg bw/day. Finally, it can be concluded that in general, comparable effects are noted in the 28-day and 90-day studies. Especially no increase in severity of the organ damages at almost identical dose levels occurred with increased exposure time (28- versus 90-day). The most susceptible organs were the testes. A clear NOAEL was obtained for testicular atrophy in both studies. The NOAEL in the 28-day study was 50 mg/kg bw/day and the NOAEL in the 90-day study was 100 mg/kg bw/day. As the apparently lower NOAEL may be due to the respective dose selection and as there was no significant increase in severity of the observed effects over time, an overall NOAEL of 100 mg/kg bw/day for repeated dose oral toxicity will be used for the calculation of the Margin of Safety (MoS). Irritation / sensitisation TPO has irritant potential to rabbit","endpoint":"repeated dose toxicity","ingredient":"codes........................................7","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"50","page":27,"route":"oral","species":"rabbit","study_id":"sccs_o_149_noael_011"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	repeated dose toxicity	50	mg/kg bw/day	rabbit	oral	28-day	repeated dose toxicity	SOURCE_SUBDIR=sccs_o_149; REPORT_TITLE=OPINION ON Trimethylbenzoyl diphenylphosphine oxide (TPO); OPINION_NUMBER=SCCS/1528/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=27 March 2014; VALUE_TEXT=50; DOSE=The NOAEL obtained in this study was 100 mg/kg bw/day.; EFFECT=aled no functional defects of any kind or any other signs of neurotoxicity during the study. The NOAEL obtained in this study was 100 mg/kg bw/day. Finally, it can be concluded that in general, comparable effects are noted in the 28-day and 90-day studies. Especially no increase in severity of the organ damages at almost identical dose levels occurred with increased exposure time (28- versus 90-day). The most susceptible organs were the testes. A clear NOAEL was obtained for testicular atrophy in both studies. The NOAEL in the 28-day study was 50 mg/kg bw/day and the NOAEL in the 90-day study was 100 mg/kg bw/day. As the apparently lower NOAEL may be due to the respective dose selection and as there was no significant increase in severity of the observed effects over time, an overall NOAEL of 100 mg/kg bw/day for repeated dose oral toxicity will be used for the calculation of the Margin of Safety (MoS). Irritation / sensitisation TPO has irritant potential to rabbit skin and rabbit eyes. TPO has been positively tested in an LLNA; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"75980-60-8","citation":"","dose":"The NOAEL obtained in this study was 100 mg/kg bw/day.","duration":"28-day","effect":"aled no functional defects of any kind or any other signs of neurotoxicity during the study. The NOAEL obtained in this study was 100 mg/kg bw/day. Finally, it can be concluded that in general, comparable effects are noted in the 28-day and 90-day studies. Especially no increase in severity of the organ damages at almost identical dose levels occurred with increased exposure time (28- versus 90-day). The most susceptible organs were the testes. A clear NOAEL was obtained for testicular atrophy in both studies. The NOAEL in the 28-day study was 50 mg/kg bw/day and the NOAEL in the 90-day study was 100 mg/kg bw/day. As the apparently lower NOAEL may be due to the respective dose selection and as there was no significant increase in severity of the observed effects over time, an overall NOAEL of 100 mg/kg bw/day for repeated dose oral toxicity will be used for the calculation of the Margin of Safety (MoS). Irritation / sensitisation TPO has irritant potential to rabbit skin and rabbit eyes. TPO has been positively tested in an LLNA","endpoint":"repeated dose toxicity","ingredient":"codes........................................7","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"50","page":27,"route":"oral","species":"rabbit","study_id":"sccs_o_149_noael_012"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	repeated dose toxicity	50	mg/kg bw/day	mouse	oral	28-day	repeated dose toxicity	SOURCE_SUBDIR=sccs_o_149; REPORT_TITLE=OPINION ON Trimethylbenzoyl diphenylphosphine oxide (TPO); OPINION_NUMBER=SCCS/1528/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=27 March 2014; VALUE_TEXT=50; DOSE=The NOAEL obtained in this study was 100 mg/kg bw/day.; EFFECT=gns of neurotoxicity during the study. The NOAEL obtained in this study was 100 mg/kg bw/day. Finally, it can be concluded that in general, comparable effects are noted in the 28-day and 90-day studies. Especially no increase in severity of the organ damages at almost identical dose levels occurred with increased exposure time (28- versus 90-day). The most susceptible organs were the testes. A clear NOAEL was obtained for testicular atrophy in both studies. The NOAEL in the 28-day study was 50 mg/kg bw/day and the NOAEL in the 90-day study was 100 mg/kg bw/day. As the apparently lower NOAEL may be due to the respective dose selection and as there was no significant increase in severity of the observed effects over time, an overall NOAEL of 100 mg/kg bw/day for repeated dose oral toxicity will be used for the calculation of the Margin of Safety (MoS). Irritation / sensitisation TPO has irritant potential to rabbit skin and rabbit eyes. TPO has been positively tested in an LLNA test in mice. An EC3 of 27% was calculated indicating; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"75980-60-8","citation":"","dose":"The NOAEL obtained in this study was 100 mg/kg bw/day.","duration":"28-day","effect":"gns of neurotoxicity during the study. The NOAEL obtained in this study was 100 mg/kg bw/day. Finally, it can be concluded that in general, comparable effects are noted in the 28-day and 90-day studies. Especially no increase in severity of the organ damages at almost identical dose levels occurred with increased exposure time (28- versus 90-day). The most susceptible organs were the testes. A clear NOAEL was obtained for testicular atrophy in both studies. The NOAEL in the 28-day study was 50 mg/kg bw/day and the NOAEL in the 90-day study was 100 mg/kg bw/day. As the apparently lower NOAEL may be due to the respective dose selection and as there was no significant increase in severity of the observed effects over time, an overall NOAEL of 100 mg/kg bw/day for repeated dose oral toxicity will be used for the calculation of the Margin of Safety (MoS). Irritation / sensitisation TPO has irritant potential to rabbit skin and rabbit eyes. TPO has been positively tested in an LLNA test in mice. An EC3 of 27% was calculated indicating","endpoint":"repeated dose toxicity","ingredient":"codes........................................7","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"50","page":27,"route":"oral","species":"mouse","study_id":"sccs_o_149_noael_013"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	repeated dose toxicity	100	mg/kg bw/day	mouse	oral	28-day	repeated dose toxicity	SOURCE_SUBDIR=sccs_o_149; REPORT_TITLE=OPINION ON Trimethylbenzoyl diphenylphosphine oxide (TPO); OPINION_NUMBER=SCCS/1528/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=27 March 2014; VALUE_TEXT=100; DOSE=was 100 mg/kg bw/day.; EFFECT=was 100 mg/kg bw/day. Finally, it can be concluded that in general, comparable effects are noted in the 28-day and 90-day studies. Especially no increase in severity of the organ damages at almost identical dose levels occurred with increased exposure time (28- versus 90-day). The most susceptible organs were the testes. A clear NOAEL was obtained for testicular atrophy in both studies. The NOAEL in the 28-day study was 50 mg/kg bw/day and the NOAEL in the 90-day study was 100 mg/kg bw/day. As the apparently lower NOAEL may be due to the respective dose selection and as there was no significant increase in severity of the observed effects over time, an overall NOAEL of 100 mg/kg bw/day for repeated dose oral toxicity will be used for the calculation of the Margin of Safety (MoS). Irritation / sensitisation TPO has irritant potential to rabbit skin and rabbit eyes. TPO has been positively tested in an LLNA test in mice. An EC3 of 27% was calculated indicating a moderate sensitising potential. Dermal absorption via human nail pla; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"75980-60-8","citation":"","dose":"was 100 mg/kg bw/day.","duration":"28-day","effect":"was 100 mg/kg bw/day. Finally, it can be concluded that in general, comparable effects are noted in the 28-day and 90-day studies. Especially no increase in severity of the organ damages at almost identical dose levels occurred with increased exposure time (28- versus 90-day). The most susceptible organs were the testes. A clear NOAEL was obtained for testicular atrophy in both studies. The NOAEL in the 28-day study was 50 mg/kg bw/day and the NOAEL in the 90-day study was 100 mg/kg bw/day. As the apparently lower NOAEL may be due to the respective dose selection and as there was no significant increase in severity of the observed effects over time, an overall NOAEL of 100 mg/kg bw/day for repeated dose oral toxicity will be used for the calculation of the Margin of Safety (MoS). Irritation / sensitisation TPO has irritant potential to rabbit skin and rabbit eyes. TPO has been positively tested in an LLNA test in mice. An EC3 of 27% was calculated indicating a moderate sensitising potential. Dermal absorption via human nail pla","endpoint":"repeated dose toxicity","ingredient":"codes........................................7","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"100","page":27,"route":"oral","species":"mouse","study_id":"sccs_o_149_noael_014"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	repeated dose toxicity	100	mg/kg bw/day	mouse	oral	90-day	repeated dose toxicity	SOURCE_SUBDIR=sccs_o_149; REPORT_TITLE=OPINION ON Trimethylbenzoyl diphenylphosphine oxide (TPO); OPINION_NUMBER=SCCS/1528/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=27 March 2014; VALUE_TEXT=100; DOSE=ease in severity of the organ damages at almost identical dose levels occurred with increased exposure time (28- versus 90-day).; EFFECT=ease in severity of the organ damages at almost identical dose levels occurred with increased exposure time (28- versus 90-day). The most susceptible organs were the testes. A clear NOAEL was obtained for testicular atrophy in both studies. The NOAEL in the 28-day study was 50 mg/kg bw/day and the NOAEL in the 90-day study was 100 mg/kg bw/day. As the apparently lower NOAEL may be due to the respective dose selection and as there was no significant increase in severity of the observed effects over time, an overall NOAEL of 100 mg/kg bw/day for repeated dose oral toxicity will be used for the calculation of the Margin of Safety (MoS). Irritation / sensitisation TPO has irritant potential to rabbit skin and rabbit eyes. TPO has been positively tested in an LLNA test in mice. An EC3 of 27% was calculated indicating a moderate sensitising potential. Dermal absorption via human nail plate There is no dermal absorption study or penetration study through the nail plate available for TPO. Whereas dermal penetration through the skin can; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"75980-60-8","citation":"","dose":"ease in severity of the organ damages at almost identical dose levels occurred with increased exposure time (28- versus 90-day).","duration":"90-day","effect":"ease in severity of the organ damages at almost identical dose levels occurred with increased exposure time (28- versus 90-day). The most susceptible organs were the testes. A clear NOAEL was obtained for testicular atrophy in both studies. The NOAEL in the 28-day study was 50 mg/kg bw/day and the NOAEL in the 90-day study was 100 mg/kg bw/day. As the apparently lower NOAEL may be due to the respective dose selection and as there was no significant increase in severity of the observed effects over time, an overall NOAEL of 100 mg/kg bw/day for repeated dose oral toxicity will be used for the calculation of the Margin of Safety (MoS). Irritation / sensitisation TPO has irritant potential to rabbit skin and rabbit eyes. TPO has been positively tested in an LLNA test in mice. An EC3 of 27% was calculated indicating a moderate sensitising potential. Dermal absorption via human nail plate There is no dermal absorption study or penetration study through the nail plate available for TPO. Whereas dermal penetration through the skin can","endpoint":"repeated dose toxicity","ingredient":"codes........................................7","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"100","page":27,"route":"oral","species":"mouse","study_id":"sccs_o_149_noael_015"}

openFDA substances 4 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
openFDA substances	FDA UNII substance identifier	B9EIM2D97X	UNII	-	-	-	chemical	{"approval_status":null,"molecular_formula":"C22H21O2P","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"B9EIM2D97X"}
openFDA substances	FDA UNII substance identifier	B9EIM2D97X	UNII	-	-	-	chemical	{"approval_status":null,"molecular_formula":"C22H21O2P","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"B9EIM2D97X"}
openFDA substances	FDA UNII substance identifier	B9EIM2D97X	UNII	-	-	-	chemical	{"approval_status":null,"molecular_formula":"C22H21O2P","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"B9EIM2D97X"}
openFDA substances	FDA UNII substance identifier	B9EIM2D97X	UNII	-	-	-	chemical	{"approval_status":null,"molecular_formula":"C22H21O2P","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"B9EIM2D97X"}