NOAEL Studies Cosmetic Ingredient

Laurtrimonium Bromide NOAEL Studies

INCI: LAURTRIMONIUM BROMIDE

CAS: 1119-94-4

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 16 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
CIR_vision_codex NOAEL =10 mg/kg/d mouse dermal 21-day NOAEL study {"citation":"6; 12; 4","dose":"The dermal no observed effects level (NOEL) was 10 mg/kg/d.","effect":"days 6 to 12 in 4 rabbits; it subsided by day 17. There was inter- mittent slight edema during week 4 in 2 rabbits and 1 rabbit developed edema on day 20. There was no desquamation or coriaceousness observed. Three rabbits had slight atonia up to week 4. Slight skin fissuring was observed in most of the treated rabbits that typically disappeared by the end of the study. The SCCP concluded that the skin changes were due to local irritation and not evidence of systemic toxicity. The dermal no observed effects level (NOEL) was 10 mg/kg/d. Polymeric trimonium ingredients. A 21-day dermal toxicity test of a conditioner containing polyquaternium-10 (1%) demon- strated no toxicity to rabbits (n ¼ 10).7 Short-Term Intraparenteneal Toxicity Alkanol trimonium ingredients. Choline (200 mg/kg) was administered ip to Balb/c mice of both sexes (n ¼ 10) every other day for 28 days.47 Saline served as the control. No effects on body weights, organ weights, hematological parameters, splenic cell counts, pathology of the organs, and clinical bio- chemistry, except for increased creatinine levels, w...","page":28,"pdf":"PRS572.pdf","row_type":"noael_study","study_id":"PRS572_noael_002"}
CIR_vision_codex NOAEL =10 mg/kg/d mouse dermal 21-day NOAEL study {"citation":"6; 12; 4","dose":"The dermal no observed effects level (NOEL) was 10 mg/kg/d.","effect":"days 6 to 12 in 4 rabbits; it subsided by day 17. There was inter- mittent slight edema during week 4 in 2 rabbits and 1 rabbit developed edema on day 20. There was no desquamation or coriaceousness observed. Three rabbits had slight atonia up to week 4. Slight skin fissuring was observed in most of the treated rabbits that typically disappeared by the end of the study. The SCCP concluded that the skin changes were due to local irritation and not evidence of systemic toxicity. The dermal no observed effects level (NOEL) was 10 mg/kg/d. Polymeric trimonium ingredients. A 21-day dermal toxicity test of a conditioner containing polyquaternium-10 (1%) demon- strated no toxicity to rabbits (n ¼ 10).7 Short-Term Intraparenteneal Toxicity Alkanol trimonium ingredients. Choline (200 mg/kg) was administered ip to Balb/c mice of both sexes (n ¼ 10) every other day for 28 days.47 Saline served as the control. No effects on body weights, organ weights, hematological parameters, splenic cell counts, pathology of the organs, and clinical bio- chemistry, except for increased creatinine levels, w...","page":28,"pdf":"PRS572.pdf","row_type":"noael_study","study_id":"PRS572_noael_002"}
CIR_vision_codex NOAEL =10 mg/kg/d mouse dermal 21-day NOAEL study {"citation":"6; 12; 4","dose":"The dermal no observed effects level (NOEL) was 10 mg/kg/d.","effect":"days 6 to 12 in 4 rabbits; it subsided by day 17. There was inter- mittent slight edema during week 4 in 2 rabbits and 1 rabbit developed edema on day 20. There was no desquamation or coriaceousness observed. Three rabbits had slight atonia up to week 4. Slight skin fissuring was observed in most of the treated rabbits that typically disappeared by the end of the study. The SCCP concluded that the skin changes were due to local irritation and not evidence of systemic toxicity. The dermal no observed effects level (NOEL) was 10 mg/kg/d. Polymeric trimonium ingredients. A 21-day dermal toxicity test of a conditioner containing polyquaternium-10 (1%) demon- strated no toxicity to rabbits (n ¼ 10).7 Short-Term Intraparenteneal Toxicity Alkanol trimonium ingredients. Choline (200 mg/kg) was administered ip to Balb/c mice of both sexes (n ¼ 10) every other day for 28 days.47 Saline served as the control. No effects on body weights, organ weights, hematological parameters, splenic cell counts, pathology of the organs, and clinical bio- chemistry, except for increased creatinine levels, w...","page":28,"pdf":"PRS572.pdf","row_type":"noael_study","study_id":"PRS572_noael_002"}
CIR_vision_codex NOAEL =10 mg/kg/d mouse dermal 21-day NOAEL study {"citation":"6; 12; 4","dose":"The dermal no observed effects level (NOEL) was 10 mg/kg/d.","effect":"days 6 to 12 in 4 rabbits; it subsided by day 17. There was inter- mittent slight edema during week 4 in 2 rabbits and 1 rabbit developed edema on day 20. There was no desquamation or coriaceousness observed. Three rabbits had slight atonia up to week 4. Slight skin fissuring was observed in most of the treated rabbits that typically disappeared by the end of the study. The SCCP concluded that the skin changes were due to local irritation and not evidence of systemic toxicity. The dermal no observed effects level (NOEL) was 10 mg/kg/d. Polymeric trimonium ingredients. A 21-day dermal toxicity test of a conditioner containing polyquaternium-10 (1%) demon- strated no toxicity to rabbits (n ¼ 10).7 Short-Term Intraparenteneal Toxicity Alkanol trimonium ingredients. Choline (200 mg/kg) was administered ip to Balb/c mice of both sexes (n ¼ 10) every other day for 28 days.47 Saline served as the control. No effects on body weights, organ weights, hematological parameters, splenic cell counts, pathology of the organs, and clinical bio- chemistry, except for increased creatinine levels, w...","page":28,"pdf":"PRS572.pdf","row_type":"noael_study","study_id":"PRS572_noael_002"}
CIR_vision_codex NOAEL =69 % mouse oral - developmental toxicity {"citation":"20,000; 1; 18","dose":"nistered choline chlor- ide (1250 to 20,000 mg/kg/d) in feed on gestations days 1 to 18.20 There were no untreated controls.","effect":"nistered choline chlor- ide (1250 to 20,000 mg/kg/d) in feed on gestations days 1 to 18.20 There were no untreated controls. All groups except the lowest dose group had reduced maternal body weight gain. All fetuses were resorbed in the highest dose group but no resorp- tions were observed in the lowest dose group. At 4160 and 10 800 mg/kg/d, there was 35% and 69% embryonic/fetal leth- ality. Developmental toxicity was observed in all but the lowest dose group. There were no increases in malformations observed. An NOAEL was not determined for teratogenicity due to the lack of pups. Genotoxicity Straight and Branched Chain Alkyl Trimonium Ingredients In a reverse mutation assay using S typhimurium, laurtrimo- nium chloride (0.004 to 0.4 ml/plate) was not cytotoxic or gen- otoxic, with or without metabolic activation.70 In a forward mutation assay using L5178Y/TKþ/\u0005 mouse lymphoma cells, laurtrimonium chloride (0.0038-0.050 ml/mL without meta- bolic activation and 0.012-0.16 ml/mL with metabolic activa- tion) was not mutagenic. The results were negative in an unscheduled DNA synthes...","page":35,"pdf":"PRS572.pdf","row_type":"noael_study","study_id":"PRS572_noael_004"}
CIR_vision_codex NOAEL =69 % mouse oral - developmental toxicity {"citation":"20,000; 1; 18","dose":"nistered choline chlor- ide (1250 to 20,000 mg/kg/d) in feed on gestations days 1 to 18.20 There were no untreated controls.","effect":"nistered choline chlor- ide (1250 to 20,000 mg/kg/d) in feed on gestations days 1 to 18.20 There were no untreated controls. All groups except the lowest dose group had reduced maternal body weight gain. All fetuses were resorbed in the highest dose group but no resorp- tions were observed in the lowest dose group. At 4160 and 10 800 mg/kg/d, there was 35% and 69% embryonic/fetal leth- ality. Developmental toxicity was observed in all but the lowest dose group. There were no increases in malformations observed. An NOAEL was not determined for teratogenicity due to the lack of pups. Genotoxicity Straight and Branched Chain Alkyl Trimonium Ingredients In a reverse mutation assay using S typhimurium, laurtrimo- nium chloride (0.004 to 0.4 ml/plate) was not cytotoxic or gen- otoxic, with or without metabolic activation.70 In a forward mutation assay using L5178Y/TKþ/\u0005 mouse lymphoma cells, laurtrimonium chloride (0.0038-0.050 ml/mL without meta- bolic activation and 0.012-0.16 ml/mL with metabolic activa- tion) was not mutagenic. The results were negative in an unscheduled DNA synthes...","page":35,"pdf":"PRS572.pdf","row_type":"noael_study","study_id":"PRS572_noael_004"}
CIR_vision_codex NOAEL =69 % mouse oral - developmental toxicity {"citation":"20,000; 1; 18","dose":"nistered choline chlor- ide (1250 to 20,000 mg/kg/d) in feed on gestations days 1 to 18.20 There were no untreated controls.","effect":"nistered choline chlor- ide (1250 to 20,000 mg/kg/d) in feed on gestations days 1 to 18.20 There were no untreated controls. All groups except the lowest dose group had reduced maternal body weight gain. All fetuses were resorbed in the highest dose group but no resorp- tions were observed in the lowest dose group. At 4160 and 10 800 mg/kg/d, there was 35% and 69% embryonic/fetal leth- ality. Developmental toxicity was observed in all but the lowest dose group. There were no increases in malformations observed. An NOAEL was not determined for teratogenicity due to the lack of pups. Genotoxicity Straight and Branched Chain Alkyl Trimonium Ingredients In a reverse mutation assay using S typhimurium, laurtrimo- nium chloride (0.004 to 0.4 ml/plate) was not cytotoxic or gen- otoxic, with or without metabolic activation.70 In a forward mutation assay using L5178Y/TKþ/\u0005 mouse lymphoma cells, laurtrimonium chloride (0.0038-0.050 ml/mL without meta- bolic activation and 0.012-0.16 ml/mL with metabolic activa- tion) was not mutagenic. The results were negative in an unscheduled DNA synthes...","page":35,"pdf":"PRS572.pdf","row_type":"noael_study","study_id":"PRS572_noael_004"}
CIR_vision_codex NOAEL =69 % mouse oral - developmental toxicity {"citation":"20,000; 1; 18","dose":"nistered choline chlor- ide (1250 to 20,000 mg/kg/d) in feed on gestations days 1 to 18.20 There were no untreated controls.","effect":"nistered choline chlor- ide (1250 to 20,000 mg/kg/d) in feed on gestations days 1 to 18.20 There were no untreated controls. All groups except the lowest dose group had reduced maternal body weight gain. All fetuses were resorbed in the highest dose group but no resorp- tions were observed in the lowest dose group. At 4160 and 10 800 mg/kg/d, there was 35% and 69% embryonic/fetal leth- ality. Developmental toxicity was observed in all but the lowest dose group. There were no increases in malformations observed. An NOAEL was not determined for teratogenicity due to the lack of pups. Genotoxicity Straight and Branched Chain Alkyl Trimonium Ingredients In a reverse mutation assay using S typhimurium, laurtrimo- nium chloride (0.004 to 0.4 ml/plate) was not cytotoxic or gen- otoxic, with or without metabolic activation.70 In a forward mutation assay using L5178Y/TKþ/\u0005 mouse lymphoma cells, laurtrimonium chloride (0.0038-0.050 ml/mL without meta- bolic activation and 0.012-0.16 ml/mL with metabolic activa- tion) was not mutagenic. The results were negative in an unscheduled DNA synthes...","page":35,"pdf":"PRS572.pdf","row_type":"noael_study","study_id":"PRS572_noael_004"}
CIR_vision_codex NOAEL =100 mg/kg rat oral 28 days oral toxicity {"citation":"100; (200; 10)","dose":"of the forestomach mucosa, associated with edema and sporadic ulceration in males and females in the high-dose group.","effect":"of the forestomach mucosa, associated with edema and sporadic ulceration in males and females in the high-dose group. Inflammatory edema in the forestomach mucosa, sporadic ulceration, and acanthosis up to papillomatous hyperplasia were observed in both sexes in the high-dose group at microscopic examination. No histopathological or microscopic alterations were observed in the mid- and low-dose groups. All treatment-related effects were reversed following the recovery period. The authors con- cluded that the oral no observed adverse effect level (NOAEL) was 100 mg/kg. Alkanol trimonium ingredients. Choline (200 mg/kg) was orally administered to Balb/c mice of both sexes (n ¼ 10) daily for 28 days.47 Saline served as the control. No effects to body weights, organ weights, hematological parameters, splenic cell counts, pathology of the organs, and clinical biochemistry were reported. Wistar rats were administered L-carnitine and DL-carnitine (1.2 mmol/kg/d) in drinking water for 7 days.80 Neither enan- tiomerically pure nor racemic carnitine had an effect on glyce- mia, food ingesti...","page":28,"pdf":"PRS572.pdf","row_type":"noael_study","study_id":"PRS572_noael_001"}
CIR_vision_codex NOAEL =100 mg/kg rat oral 28 days oral toxicity {"citation":"100; (200; 10)","dose":"of the forestomach mucosa, associated with edema and sporadic ulceration in males and females in the high-dose group.","effect":"of the forestomach mucosa, associated with edema and sporadic ulceration in males and females in the high-dose group. Inflammatory edema in the forestomach mucosa, sporadic ulceration, and acanthosis up to papillomatous hyperplasia were observed in both sexes in the high-dose group at microscopic examination. No histopathological or microscopic alterations were observed in the mid- and low-dose groups. All treatment-related effects were reversed following the recovery period. The authors con- cluded that the oral no observed adverse effect level (NOAEL) was 100 mg/kg. Alkanol trimonium ingredients. Choline (200 mg/kg) was orally administered to Balb/c mice of both sexes (n ¼ 10) daily for 28 days.47 Saline served as the control. No effects to body weights, organ weights, hematological parameters, splenic cell counts, pathology of the organs, and clinical biochemistry were reported. Wistar rats were administered L-carnitine and DL-carnitine (1.2 mmol/kg/d) in drinking water for 7 days.80 Neither enan- tiomerically pure nor racemic carnitine had an effect on glyce- mia, food ingesti...","page":28,"pdf":"PRS572.pdf","row_type":"noael_study","study_id":"PRS572_noael_001"}
CIR_vision_codex NOAEL =100 mg/kg rat oral 28 days oral toxicity {"citation":"100; (200; 10)","dose":"of the forestomach mucosa, associated with edema and sporadic ulceration in males and females in the high-dose group.","effect":"of the forestomach mucosa, associated with edema and sporadic ulceration in males and females in the high-dose group. Inflammatory edema in the forestomach mucosa, sporadic ulceration, and acanthosis up to papillomatous hyperplasia were observed in both sexes in the high-dose group at microscopic examination. No histopathological or microscopic alterations were observed in the mid- and low-dose groups. All treatment-related effects were reversed following the recovery period. The authors con- cluded that the oral no observed adverse effect level (NOAEL) was 100 mg/kg. Alkanol trimonium ingredients. Choline (200 mg/kg) was orally administered to Balb/c mice of both sexes (n ¼ 10) daily for 28 days.47 Saline served as the control. No effects to body weights, organ weights, hematological parameters, splenic cell counts, pathology of the organs, and clinical biochemistry were reported. Wistar rats were administered L-carnitine and DL-carnitine (1.2 mmol/kg/d) in drinking water for 7 days.80 Neither enan- tiomerically pure nor racemic carnitine had an effect on glyce- mia, food ingesti...","page":28,"pdf":"PRS572.pdf","row_type":"noael_study","study_id":"PRS572_noael_001"}
CIR_vision_codex NOAEL =100 mg/kg rat oral 28 days oral toxicity {"citation":"100; (200; 10)","dose":"of the forestomach mucosa, associated with edema and sporadic ulceration in males and females in the high-dose group.","effect":"of the forestomach mucosa, associated with edema and sporadic ulceration in males and females in the high-dose group. Inflammatory edema in the forestomach mucosa, sporadic ulceration, and acanthosis up to papillomatous hyperplasia were observed in both sexes in the high-dose group at microscopic examination. No histopathological or microscopic alterations were observed in the mid- and low-dose groups. All treatment-related effects were reversed following the recovery period. The authors con- cluded that the oral no observed adverse effect level (NOAEL) was 100 mg/kg. Alkanol trimonium ingredients. Choline (200 mg/kg) was orally administered to Balb/c mice of both sexes (n ¼ 10) daily for 28 days.47 Saline served as the control. No effects to body weights, organ weights, hematological parameters, splenic cell counts, pathology of the organs, and clinical biochemistry were reported. Wistar rats were administered L-carnitine and DL-carnitine (1.2 mmol/kg/d) in drinking water for 7 days.80 Neither enan- tiomerically pure nor racemic carnitine had an effect on glyce- mia, food ingesti...","page":28,"pdf":"PRS572.pdf","row_type":"noael_study","study_id":"PRS572_noael_001"}
CIR_vision_codex NOAEL =500 mg/kg/d rat oral 1 year oral toxicity {"citation":"10, 20; 45; 1","dose":"In the original safety assessment, rats administered cetrimonium bro- mide at 10, 20, and 45 mg/kg/d in their drinking water for 1 year exhibited decreased body weight gain in the high-dose group.1 Alkanol trimonium ingredients.","effect":"ingredients. In the original safety assessment, rats administered cetrimonium bro- mide at 10, 20, and 45 mg/kg/d in their drinking water for 1 year exhibited decreased body weight gain in the high-dose group.1 Alkanol trimonium ingredients. Fischer 344 rats (n not pro- vided) were administered choline chloride (500 mg/kg/d) in feed for 72 weeks followed by 30 weeks of observation.84 Necropsy was performed at 103 weeks. Survival rates, body weights, and relative liver weights were not affected by treat- ment. The NOAEL was \u0007500 mg/kg/d. Male CD1 mice were fed choline-rich (1.6%; n ¼ 6), choline-deficient (0%; n ¼ 7), or normal choline (0.36%; n ¼ 9) diets for 20 to 24 months.85 There were no differences in body weight throughout the experiment. There were no differ- ences in mortalities, and these were similar to historical survival for this strain of mice. There were no differences in dendritic spine densities. CD-1 mice were orally administered choline (0 [n ¼ 23] or 1.6% [n ¼ 17]) in feed for 20 to 24 months.86 The mice were killed and the brains examined. There were no differe...","page":29,"pdf":"PRS572.pdf","row_type":"noael_study","study_id":"PRS572_noael_003"}
CIR_vision_codex NOAEL =500 mg/kg/d rat oral 1 year oral toxicity {"citation":"10, 20; 45; 1","dose":"In the original safety assessment, rats administered cetrimonium bro- mide at 10, 20, and 45 mg/kg/d in their drinking water for 1 year exhibited decreased body weight gain in the high-dose group.1 Alkanol trimonium ingredients.","effect":"ingredients. In the original safety assessment, rats administered cetrimonium bro- mide at 10, 20, and 45 mg/kg/d in their drinking water for 1 year exhibited decreased body weight gain in the high-dose group.1 Alkanol trimonium ingredients. Fischer 344 rats (n not pro- vided) were administered choline chloride (500 mg/kg/d) in feed for 72 weeks followed by 30 weeks of observation.84 Necropsy was performed at 103 weeks. Survival rates, body weights, and relative liver weights were not affected by treat- ment. The NOAEL was \u0007500 mg/kg/d. Male CD1 mice were fed choline-rich (1.6%; n ¼ 6), choline-deficient (0%; n ¼ 7), or normal choline (0.36%; n ¼ 9) diets for 20 to 24 months.85 There were no differences in body weight throughout the experiment. There were no differ- ences in mortalities, and these were similar to historical survival for this strain of mice. There were no differences in dendritic spine densities. CD-1 mice were orally administered choline (0 [n ¼ 23] or 1.6% [n ¼ 17]) in feed for 20 to 24 months.86 The mice were killed and the brains examined. There were no differe...","page":29,"pdf":"PRS572.pdf","row_type":"noael_study","study_id":"PRS572_noael_003"}
CIR_vision_codex NOAEL =500 mg/kg/d rat oral 1 year oral toxicity {"citation":"10, 20; 45; 1","dose":"In the original safety assessment, rats administered cetrimonium bro- mide at 10, 20, and 45 mg/kg/d in their drinking water for 1 year exhibited decreased body weight gain in the high-dose group.1 Alkanol trimonium ingredients.","effect":"ingredients. In the original safety assessment, rats administered cetrimonium bro- mide at 10, 20, and 45 mg/kg/d in their drinking water for 1 year exhibited decreased body weight gain in the high-dose group.1 Alkanol trimonium ingredients. Fischer 344 rats (n not pro- vided) were administered choline chloride (500 mg/kg/d) in feed for 72 weeks followed by 30 weeks of observation.84 Necropsy was performed at 103 weeks. Survival rates, body weights, and relative liver weights were not affected by treat- ment. The NOAEL was \u0007500 mg/kg/d. Male CD1 mice were fed choline-rich (1.6%; n ¼ 6), choline-deficient (0%; n ¼ 7), or normal choline (0.36%; n ¼ 9) diets for 20 to 24 months.85 There were no differences in body weight throughout the experiment. There were no differ- ences in mortalities, and these were similar to historical survival for this strain of mice. There were no differences in dendritic spine densities. CD-1 mice were orally administered choline (0 [n ¼ 23] or 1.6% [n ¼ 17]) in feed for 20 to 24 months.86 The mice were killed and the brains examined. There were no differe...","page":29,"pdf":"PRS572.pdf","row_type":"noael_study","study_id":"PRS572_noael_003"}
CIR_vision_codex NOAEL =500 mg/kg/d rat oral 1 year oral toxicity {"citation":"10, 20; 45; 1","dose":"In the original safety assessment, rats administered cetrimonium bro- mide at 10, 20, and 45 mg/kg/d in their drinking water for 1 year exhibited decreased body weight gain in the high-dose group.1 Alkanol trimonium ingredients.","effect":"ingredients. In the original safety assessment, rats administered cetrimonium bro- mide at 10, 20, and 45 mg/kg/d in their drinking water for 1 year exhibited decreased body weight gain in the high-dose group.1 Alkanol trimonium ingredients. Fischer 344 rats (n not pro- vided) were administered choline chloride (500 mg/kg/d) in feed for 72 weeks followed by 30 weeks of observation.84 Necropsy was performed at 103 weeks. Survival rates, body weights, and relative liver weights were not affected by treat- ment. The NOAEL was \u0007500 mg/kg/d. Male CD1 mice were fed choline-rich (1.6%; n ¼ 6), choline-deficient (0%; n ¼ 7), or normal choline (0.36%; n ¼ 9) diets for 20 to 24 months.85 There were no differences in body weight throughout the experiment. There were no differ- ences in mortalities, and these were similar to historical survival for this strain of mice. There were no differences in dendritic spine densities. CD-1 mice were orally administered choline (0 [n ¼ 23] or 1.6% [n ¼ 17]) in feed for 20 to 24 months.86 The mice were killed and the brains examined. There were no differe...","page":29,"pdf":"PRS572.pdf","row_type":"noael_study","study_id":"PRS572_noael_003"}
UnifiedCodex:CIR:beta.noael_studies 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
UnifiedCodex:CIR:beta.noael_studies - 10 mg/kg/d mouse dermal 21-day - SOURCE_SUBDIR=PRS572; REPORT_TITLE=Safety Assessment of Trimoniums as Used in Cosmetics Lillian C. Becker1, Wilma F. Bergfeld2, Donald V. Belsito2, Ronald A. Hill2, Curtis D. Klaassen2, Daniel Liebler2, James G. Marks Jr2, Ronald C. Shank2, Thomas J. Slaga2,; OPINION_NUMBER=PRS572; COMMITTEE=Cosmetic Ingredient Review Expert Panel; REPORT_DATE=Empigen 5089; VALUE_TEXT=10; DOSE=The dermal no observed effects level (NOEL) was 10 mg/kg/d.; EFFECT=days 6 to 12 in 4 rabbits; it subsided by day 17. There was inter- mittent slight edema during week 4 in 2 rabbits and 1 rabbit developed edema on day 20. There was no desquamation or coriaceousness observed. Three rabbits had slight atonia up to week 4. Slight skin fissuring was observed in most of the treated rabbits that typically disappeared by the end of the study. The SCCP concluded that the skin changes were due to local irritation and not evidence of systemic toxicity. The dermal no observed effects level (NOEL) was 10 mg/kg/d. Polymeric trimonium ingredients. A 21-day dermal toxicity test of a conditioner containing polyquaternium-10 (1%) demon- strated no toxicity to rabbits (n ¼ 10).7 Short-Term Intraparenteneal Toxicity Alkanol trimonium ingredients. Choline (200 mg/kg) was administered ip to Balb/c mice of both sexes (n ¼ 10) every other day for 28 days.47 Saline served as the control. No effects on body weights, organ weights, hematological parameters, splenic cell counts, pathology of the organs, and clinical bio- chemistry, except for increased creatinine levels, w...; CITATION=6; 12; 4; CITATION_NUMBERS=[6,12,4]; REFERENCE=6; 12; 4; DETAILS_JSON={"cas_number":"1119-94-4","citation":"6; 12; 4","dose":"The dermal no observed effects level (NOEL) was 10 mg/kg/d.","duration":"21-day","effect":"days 6 to 12 in 4 rabbits; it subsided by day 17. There was inter- mittent slight edema during week 4 in 2 rabbits and 1 rabbit developed edema on day 20. There was no desquamation or coriaceousness observed. Three rabbits had slight atonia up to week 4. Slight skin fissuring was observed in most of the treated rabbits that typically disappeared by the end of the study. The SCCP concluded that the skin changes were due to local irritation and not evidence of systemic toxicity. The dermal no observed effects level (NOEL) was 10 mg/kg/d. Polymeric trimonium ingredients. A 21-day dermal toxicity test of a conditioner containing polyquaternium-10 (1%) demon- strated no toxicity to rabbits (n ¼ 10).7 Short-Term Intraparenteneal Toxicity Alkanol trimonium ingredients. Choline (200 mg/kg) was administered ip to Balb/c mice of both sexes (n ¼ 10) every other day for 28 days.47 Saline served as the control. No effects on body weights, organ weights, hematological parameters, splenic cell counts, pathology of the organs, and clinical bio- chemistry, except for increased creatinine levels, w...","endpoint":"","ingredient":"Trimoniums","loael_value":"","noael_unit":"mg/kg/d","noael_value":"10","page":28,"route":"dermal","species":"mouse","study_id":"PRS572_noael_002"}
UnifiedCodex:CIR:beta.noael_studies developmental toxicity 69 % mouse oral - developmental toxicity SOURCE_SUBDIR=PRS572; REPORT_TITLE=Safety Assessment of Trimoniums as Used in Cosmetics Lillian C. Becker1, Wilma F. Bergfeld2, Donald V. Belsito2, Ronald A. Hill2, Curtis D. Klaassen2, Daniel Liebler2, James G. Marks Jr2, Ronald C. Shank2, Thomas J. Slaga2,; OPINION_NUMBER=PRS572; COMMITTEE=Cosmetic Ingredient Review Expert Panel; REPORT_DATE=Empigen 5089; VALUE_TEXT=69; DOSE=nistered choline chlor- ide (1250 to 20,000 mg/kg/d) in feed on gestations days 1 to 18.20 There were no untreated controls.; EFFECT=nistered choline chlor- ide (1250 to 20,000 mg/kg/d) in feed on gestations days 1 to 18.20 There were no untreated controls. All groups except the lowest dose group had reduced maternal body weight gain. All fetuses were resorbed in the highest dose group but no resorp- tions were observed in the lowest dose group. At 4160 and 10 800 mg/kg/d, there was 35% and 69% embryonic/fetal leth- ality. Developmental toxicity was observed in all but the lowest dose group. There were no increases in malformations observed. An NOAEL was not determined for teratogenicity due to the lack of pups. Genotoxicity Straight and Branched Chain Alkyl Trimonium Ingredients In a reverse mutation assay using S typhimurium, laurtrimo- nium chloride (0.004 to 0.4 ml/plate) was not cytotoxic or gen- otoxic, with or without metabolic activation.70 In a forward mutation assay using L5178Y/TKþ/ mouse lymphoma cells, laurtrimonium chloride (0.0038-0.050 ml/mL without meta- bolic activation and 0.012-0.16 ml/mL with metabolic activa- tion) was not mutagenic. The results were negative in an unscheduled DNA synthes...; CITATION=20,000; 1; 18; CITATION_NUMBERS=[20,1,18]; REFERENCE=20,000; 1; 18; DETAILS_JSON={"cas_number":"1119-94-4","citation":"20,000; 1; 18","dose":"nistered choline chlor- ide (1250 to 20,000 mg/kg/d) in feed on gestations days 1 to 18.20 There were no untreated controls.","duration":"","effect":"nistered choline chlor- ide (1250 to 20,000 mg/kg/d) in feed on gestations days 1 to 18.20 There were no untreated controls. All groups except the lowest dose group had reduced maternal body weight gain. All fetuses were resorbed in the highest dose group but no resorp- tions were observed in the lowest dose group. At 4160 and 10 800 mg/kg/d, there was 35% and 69% embryonic/fetal leth- ality. Developmental toxicity was observed in all but the lowest dose group. There were no increases in malformations observed. An NOAEL was not determined for teratogenicity due to the lack of pups. Genotoxicity Straight and Branched Chain Alkyl Trimonium Ingredients In a reverse mutation assay using S typhimurium, laurtrimo- nium chloride (0.004 to 0.4 ml/plate) was not cytotoxic or gen- otoxic, with or without metabolic activation.70 In a forward mutation assay using L5178Y/TKþ/\u0005 mouse lymphoma cells, laurtrimonium chloride (0.0038-0.050 ml/mL without meta- bolic activation and 0.012-0.16 ml/mL with metabolic activa- tion) was not mutagenic. The results were negative in an unscheduled DNA synthes...","endpoint":"developmental toxicity","ingredient":"Trimoniums","loael_value":"","noael_unit":"%","noael_value":"69","page":35,"route":"oral","species":"mouse","study_id":"PRS572_noael_004"}
UnifiedCodex:CIR:beta.noael_studies oral toxicity 100 mg/kg rat oral 28 days oral toxicity SOURCE_SUBDIR=PRS572; REPORT_TITLE=Safety Assessment of Trimoniums as Used in Cosmetics Lillian C. Becker1, Wilma F. Bergfeld2, Donald V. Belsito2, Ronald A. Hill2, Curtis D. Klaassen2, Daniel Liebler2, James G. Marks Jr2, Ronald C. Shank2, Thomas J. Slaga2,; OPINION_NUMBER=PRS572; COMMITTEE=Cosmetic Ingredient Review Expert Panel; REPORT_DATE=Empigen 5089; VALUE_TEXT=100; DOSE=of the forestomach mucosa, associated with edema and sporadic ulceration in males and females in the high-dose group.; EFFECT=of the forestomach mucosa, associated with edema and sporadic ulceration in males and females in the high-dose group. Inflammatory edema in the forestomach mucosa, sporadic ulceration, and acanthosis up to papillomatous hyperplasia were observed in both sexes in the high-dose group at microscopic examination. No histopathological or microscopic alterations were observed in the mid- and low-dose groups. All treatment-related effects were reversed following the recovery period. The authors con- cluded that the oral no observed adverse effect level (NOAEL) was 100 mg/kg. Alkanol trimonium ingredients. Choline (200 mg/kg) was orally administered to Balb/c mice of both sexes (n ¼ 10) daily for 28 days.47 Saline served as the control. No effects to body weights, organ weights, hematological parameters, splenic cell counts, pathology of the organs, and clinical biochemistry were reported. Wistar rats were administered L-carnitine and DL-carnitine (1.2 mmol/kg/d) in drinking water for 7 days.80 Neither enan- tiomerically pure nor racemic carnitine had an effect on glyce- mia, food ingesti...; CITATION=100; (200; 10); CITATION_NUMBERS=[100,200,10]; REFERENCE=100; (200; 10); DETAILS_JSON={"cas_number":"1119-94-4","citation":"100; (200; 10)","dose":"of the forestomach mucosa, associated with edema and sporadic ulceration in males and females in the high-dose group.","duration":"28 days","effect":"of the forestomach mucosa, associated with edema and sporadic ulceration in males and females in the high-dose group. Inflammatory edema in the forestomach mucosa, sporadic ulceration, and acanthosis up to papillomatous hyperplasia were observed in both sexes in the high-dose group at microscopic examination. No histopathological or microscopic alterations were observed in the mid- and low-dose groups. All treatment-related effects were reversed following the recovery period. The authors con- cluded that the oral no observed adverse effect level (NOAEL) was 100 mg/kg. Alkanol trimonium ingredients. Choline (200 mg/kg) was orally administered to Balb/c mice of both sexes (n ¼ 10) daily for 28 days.47 Saline served as the control. No effects to body weights, organ weights, hematological parameters, splenic cell counts, pathology of the organs, and clinical biochemistry were reported. Wistar rats were administered L-carnitine and DL-carnitine (1.2 mmol/kg/d) in drinking water for 7 days.80 Neither enan- tiomerically pure nor racemic carnitine had an effect on glyce- mia, food ingesti...","endpoint":"oral toxicity","ingredient":"Trimoniums","loael_value":"","noael_unit":"mg/kg","noael_value":"100","page":28,"route":"oral","species":"rat","study_id":"PRS572_noael_001"}
UnifiedCodex:CIR:beta.noael_studies oral toxicity 500 mg/kg/d rat oral 1 year oral toxicity SOURCE_SUBDIR=PRS572; REPORT_TITLE=Safety Assessment of Trimoniums as Used in Cosmetics Lillian C. Becker1, Wilma F. Bergfeld2, Donald V. Belsito2, Ronald A. Hill2, Curtis D. Klaassen2, Daniel Liebler2, James G. Marks Jr2, Ronald C. Shank2, Thomas J. Slaga2,; OPINION_NUMBER=PRS572; COMMITTEE=Cosmetic Ingredient Review Expert Panel; REPORT_DATE=Empigen 5089; VALUE_TEXT=500; DOSE=In the original safety assessment, rats administered cetrimonium bro- mide at 10, 20, and 45 mg/kg/d in their drinking water for 1 year exhibited decreased body weight gain in the high-dose group.1 Alkanol trimonium ingredients.; EFFECT=ingredients. In the original safety assessment, rats administered cetrimonium bro- mide at 10, 20, and 45 mg/kg/d in their drinking water for 1 year exhibited decreased body weight gain in the high-dose group.1 Alkanol trimonium ingredients. Fischer 344 rats (n not pro- vided) were administered choline chloride (500 mg/kg/d) in feed for 72 weeks followed by 30 weeks of observation.84 Necropsy was performed at 103 weeks. Survival rates, body weights, and relative liver weights were not affected by treat- ment. The NOAEL was 500 mg/kg/d. Male CD1 mice were fed choline-rich (1.6%; n ¼ 6), choline-deficient (0%; n ¼ 7), or normal choline (0.36%; n ¼ 9) diets for 20 to 24 months.85 There were no differences in body weight throughout the experiment. There were no differ- ences in mortalities, and these were similar to historical survival for this strain of mice. There were no differences in dendritic spine densities. CD-1 mice were orally administered choline (0 [n ¼ 23] or 1.6% [n ¼ 17]) in feed for 20 to 24 months.86 The mice were killed and the brains examined. There were no differe...; CITATION=10, 20; 45; 1; CITATION_NUMBERS=[10,20,45,1]; REFERENCE=10, 20; 45; 1; DETAILS_JSON={"cas_number":"1119-94-4","citation":"10, 20; 45; 1","dose":"In the original safety assessment, rats administered cetrimonium bro- mide at 10, 20, and 45 mg/kg/d in their drinking water for 1 year exhibited decreased body weight gain in the high-dose group.1 Alkanol trimonium ingredients.","duration":"1 year","effect":"ingredients. In the original safety assessment, rats administered cetrimonium bro- mide at 10, 20, and 45 mg/kg/d in their drinking water for 1 year exhibited decreased body weight gain in the high-dose group.1 Alkanol trimonium ingredients. Fischer 344 rats (n not pro- vided) were administered choline chloride (500 mg/kg/d) in feed for 72 weeks followed by 30 weeks of observation.84 Necropsy was performed at 103 weeks. Survival rates, body weights, and relative liver weights were not affected by treat- ment. The NOAEL was \u0007500 mg/kg/d. Male CD1 mice were fed choline-rich (1.6%; n ¼ 6), choline-deficient (0%; n ¼ 7), or normal choline (0.36%; n ¼ 9) diets for 20 to 24 months.85 There were no differences in body weight throughout the experiment. There were no differ- ences in mortalities, and these were similar to historical survival for this strain of mice. There were no differences in dendritic spine densities. CD-1 mice were orally administered choline (0 [n ¼ 23] or 1.6% [n ¼ 17]) in feed for 20 to 24 months.86 The mice were killed and the brains examined. There were no differe...","endpoint":"oral toxicity","ingredient":"Trimoniums","loael_value":"","noael_unit":"mg/kg/d","noael_value":"500","page":29,"route":"oral","species":"rat","study_id":"PRS572_noael_003"}
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier 6IC8NZ97S2 UNII - - - chemical {"approval_status":null,"molecular_formula":"C15H34N.Br","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"6IC8NZ97S2"}
openFDA substances FDA UNII substance identifier 6IC8NZ97S2 UNII - - - chemical {"approval_status":null,"molecular_formula":"C15H34N.Br","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"6IC8NZ97S2"}
openFDA substances FDA UNII substance identifier 6IC8NZ97S2 UNII - - - chemical {"approval_status":null,"molecular_formula":"C15H34N.Br","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"6IC8NZ97S2"}
openFDA substances FDA UNII substance identifier 6IC8NZ97S2 UNII - - - chemical {"approval_status":null,"molecular_formula":"C15H34N.Br","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"6IC8NZ97S2"}