NOAEL Studies Cosmetic Ingredient

Tetraaminopyrimidine Sulfate NOAEL Studies

INCI: TETRAAMINOPYRIMIDINE SULFATE

CAS: 5392-28-9

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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NTP_ICE_eye_irritation 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP_ICE_eye_irritation EPA Classification 3 unitless Rabbit Ocular - In Vivo; Draize Eye Irritation/Corrosion Test sheet=Data; excel_row=388; Record_ID=eye_irritation_96; Data_Type=In Vivo; Concentration=100.0; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID0037023; Assay=Draize Eye Irritation/Corrosion Test; Endpoint=EPA Classification; Response=3; Response_Unit=Unitless; Species=Rabbit; Reference=ICCVAM 2006; URL=https://ntp.niehs.nih.gov/sites/default/files/iccvam/docs/ocutox_docs/oteval/otevalrpt.pdf; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID0037023
SCCS_vision_codex 24 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS_vision_codex NOAEL =600 mg/kg bw human oral sub-chronic repeated dose toxicity {"dose":"TAP showed in different studies alone or in formulations a low median lethal dose (LD50) of > 5.000 mg/kg.","effect":", final: “Most of the investigations/experiments which are reported in Submission I (Aug. 1997) have been carried out in the early eighties (1978-1983). For an appropriate evaluation a number of details are missing. The identification of the test substance is ambiguous. The respective test substance is not specified as to its chemical form in several experiments. TAP showed in different studies alone or in formulations a low median lethal dose (LD50) of > 5.000 mg/kg. The sub-chronic oral toxicity study lead to a NOAEL of 600 mg/kg bw. There were no signs of teratogenicity and embryo-toxicity; maternal toxicity between 500 to 1000 mg/kg bw. The NOAEL for foetal development has been determined at 500 mg/kg bw. TAP was “not irritating” when applied in different species and in appropriate doses on the skin. It was also “not irritating” on mucous membranes. No incompatibilities were observed in human tests. TAP was classified as “not-sensitizing”. A number of toxicokinetic studies have been carried out, using radio labelled TAP but","page":5,"pdf":"sccp_o_152.pdf","row_type":"noael_study","study_id":"sccp_o_152_noael_001"}
SCCS_vision_codex NOAEL =500 mg/kg bw human oral sub-chronic repeated dose toxicity {"dose":"TAP showed in different studies alone or in formulations a low median lethal dose (LD50) of > 5.000 mg/kg.","effect":"ghties (1978-1983). For an appropriate evaluation a number of details are missing. The identification of the test substance is ambiguous. The respective test substance is not specified as to its chemical form in several experiments. TAP showed in different studies alone or in formulations a low median lethal dose (LD50) of > 5.000 mg/kg. The sub-chronic oral toxicity study lead to a NOAEL of 600 mg/kg bw. There were no signs of teratogenicity and embryo-toxicity; maternal toxicity between 500 to 1000 mg/kg bw. The NOAEL for foetal development has been determined at 500 mg/kg bw. TAP was “not irritating” when applied in different species and in appropriate doses on the skin. It was also “not irritating” on mucous membranes. No incompatibilities were observed in human tests. TAP was classified as “not-sensitizing”. A number of toxicokinetic studies have been carried out, using radio labelled TAP but in concentrations mostly far below the applied in use concentration of 5 %. TAP has been tested in prokaryotic cells for gene mutation","page":5,"pdf":"sccp_o_152.pdf","row_type":"noael_study","study_id":"sccp_o_152_noael_002"}
SCCS_vision_codex NOAEL =28 - - - 28 days NOAEL study {"dose":"After 28 days of recovery period the treatment related lesions persisted in kidneys of high dose recovery group animals: the incidences were 10/12 in males and 03/12 in females.","effect":"group were observed, compared to one male of the control group (Table). After 28 days of recovery period the treatment related lesions persisted in kidneys of high dose recovery group animals: the incidences were 10/12 in males and 03/12 in females. Dose-dependent histopathological changes were observed in thymus, spleen, adrenals and lymph nodes; this might be suggestive of stress. The changes in thymus (starry sky appearance) were also found in lowest dose groups (5/10 in males and 6/10 females: Table). A clear NOAEL was also absent for the effects in spleens (males) and in adrenals (females). After the recovery period these treatment related changes were only partly reversed. The histopathological changes were substantiated by increases in spleen and adrenal weights and a slight decrease in thymus weights. Histopathological examination of other organs did not reveal treatment related adverse effects.","page":14,"pdf":"sccp_o_152.pdf","row_type":"noael_study","study_id":"sccp_o_152_noael_003"}
SCCS_vision_codex NOAEL =150 mg/kg bw/d rat oral 90-day repeated dose toxicity {"citation":"Ref.: 11 Comment Based on dose-dependently increased incidences of histopathological effects in thymus, spleen and adrenals observed in all treatment groups, the SCCP considers the Lowes","dose":"Sinusoidal congestion 1 (m) 1 (f) 0 (m) 3 (f) 2 (m) 4 (f) 4 (m) 8 (f) Conclusion The 90-day repeated dose oral exposure of rats to the test item affected haematological parameters at the highest dose level (1000 mg/kg bw/day).","effect":"1 (m) 1 (f) 5 (m) 6 (f) 6 (m) 7 (f) 7 (m) 7 (f) Spleen: Decrease cellularity in white pulp / decreased cellularity and size of white pulp 2 (m) 3 (f) 4 (m) 3 (f) 6 (m) 5 (f) 9 (m) 8 (f) Adrenals: Sinusoidal congestion 1 (m) 1 (f) 0 (m) 3 (f) 2 (m) 4 (f) 4 (m) 8 (f) Conclusion The 90-day repeated dose oral exposure of rats to the test item affected haematological parameters at the highest dose level (1000 mg/kg bw/day). Signs of nephrotoxicity were observed at 300 and 1000 mg/kg bw/day. The study authors derived a NOAEL of 150 mg/kg bw/d. Ref.: 11 Comment Based on dose-dependently increased incidences of histopathological effects in thymus, spleen and adrenals observed in all treatment groups, the SCCP considers the Lowest Observed Adverse Effect Level (LOAEL) of TAP in rats to be 150 mg/kg bw/day. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 (1997) Species/strain: Salmonella typhim","page":15,"pdf":"sccp_o_152.pdf","row_type":"noael_study","study_id":"sccp_o_152_noael_004"}
SCCS_vision_codex NOAEL =375 mg/kg/d rat dermal - developmental toxicity {"citation":"Ref.: 12 3","dose":"SCCP/1118/07 Opinion on tetra-Aminopyrimidine sulfate 20 Conclusion With respect to the mentioned slight maternal effects noticed in the mid and high dose group (salivation), the maternal No-Observed-Effect-Level (NOEL) was considered to be 375 mg/kg/d.","effect":"SCCP/1118/07 Opinion on tetra-Aminopyrimidine sulfate 20 Conclusion With respect to the mentioned slight maternal effects noticed in the mid and high dose group (salivation), the maternal No-Observed-Effect-Level (NOEL) was considered to be 375 mg/kg/d. The test chemical was neither embryo-lethal, embryotoxic nor teratogenic up to the highest dose tested (1500 mg/kg bw/day). Ref.: 12 3.3.9. Toxicokinetics Taken from SCCNFP/0695/03 Percutaneous penetration / dermal absorption of a hair dye formulation in vivo Guideline: / Species/strain: Wistar rats (SPFCpb) Test substance: radioactive labelled TAP (0.226%) + non labelled TAP; total 0.451% in a cream preparation (without developer) Radioactive purity: > 91% Batch: no data Dos","page":20,"pdf":"sccp_o_152.pdf","row_type":"noael_study","study_id":"sccp_o_152_noael_005"}
SCCS_vision_codex NOAEL =375 mg/kg bw/day rat oral subchronic repeated dose toxicity {"dose":"In a subchronic oral (gavage, 90 days) toxicity study in rats some histopathological effects in kidney, thymus, spleen and adrenals were observed at all dose levels (150, 300 and 1000 mg/kg bw).","effect":"value of Log Pow, without any reference to the respective pH, cannot be correlated to physiological conditions and to the pH conditions of the percutaneous absorption studies. General toxicity TAP has a low acute oral toxicity. In a subchronic oral (gavage, 90 days) toxicity study in rats some histopathological effects in kidney, thymus, spleen and adrenals were observed at all dose levels (150, 300 and 1000 mg/kg bw). Therefore, a LOAEL of 150 mg/kg bw/day was established. In a teratogenicity study, the maternal NOAEL was considered to be 375 mg/kg bw/day. The test substance was neither embryotoxic nor teratogenic up to 1500 mg/kg bw/day. Irritation, sensitisation The substance was not irritant when applied to skin but irritant to the eye. In the LLNA test, the highest concentration of the test substance (10%) tested is considered too low; other vehicles should have been used to obtain possible higher test concentrations. A possible sensitising potential cannot be excluded. Dermal absorption In an absorption study with pig sk","page":24,"pdf":"sccp_o_152.pdf","row_type":"noael_study","study_id":"sccp_o_152_noael_006"}
SCCS_vision_codex NOAEL =600 mg/kg bw human oral sub-chronic repeated dose toxicity {"dose":"TAP showed in different studies alone or in formulations a low median lethal dose (LD50) of > 5.000 mg/kg.","effect":", final: “Most of the investigations/experiments which are reported in Submission I (Aug. 1997) have been carried out in the early eighties (1978-1983). For an appropriate evaluation a number of details are missing. The identification of the test substance is ambiguous. The respective test substance is not specified as to its chemical form in several experiments. TAP showed in different studies alone or in formulations a low median lethal dose (LD50) of > 5.000 mg/kg. The sub-chronic oral toxicity study lead to a NOAEL of 600 mg/kg bw. There were no signs of teratogenicity and embryo-toxicity; maternal toxicity between 500 to 1000 mg/kg bw. The NOAEL for foetal development has been determined at 500 mg/kg bw. TAP was “not irritating” when applied in different species and in appropriate doses on the skin. It was also “not irritating” on mucous membranes. No incompatibilities were observed in human tests. TAP was classified as “not-sensitizing”. A number of toxicokinetic studies have been carried out, using radio labelled TAP but","page":5,"pdf":"sccp_o_152.pdf","row_type":"noael_study","study_id":"sccp_o_152_noael_001"}
SCCS_vision_codex NOAEL =500 mg/kg bw human oral sub-chronic repeated dose toxicity {"dose":"TAP showed in different studies alone or in formulations a low median lethal dose (LD50) of > 5.000 mg/kg.","effect":"ghties (1978-1983). For an appropriate evaluation a number of details are missing. The identification of the test substance is ambiguous. The respective test substance is not specified as to its chemical form in several experiments. TAP showed in different studies alone or in formulations a low median lethal dose (LD50) of > 5.000 mg/kg. The sub-chronic oral toxicity study lead to a NOAEL of 600 mg/kg bw. There were no signs of teratogenicity and embryo-toxicity; maternal toxicity between 500 to 1000 mg/kg bw. The NOAEL for foetal development has been determined at 500 mg/kg bw. TAP was “not irritating” when applied in different species and in appropriate doses on the skin. It was also “not irritating” on mucous membranes. No incompatibilities were observed in human tests. TAP was classified as “not-sensitizing”. A number of toxicokinetic studies have been carried out, using radio labelled TAP but in concentrations mostly far below the applied in use concentration of 5 %. TAP has been tested in prokaryotic cells for gene mutation","page":5,"pdf":"sccp_o_152.pdf","row_type":"noael_study","study_id":"sccp_o_152_noael_002"}
SCCS_vision_codex NOAEL =28 - - - 28 days NOAEL study {"dose":"After 28 days of recovery period the treatment related lesions persisted in kidneys of high dose recovery group animals: the incidences were 10/12 in males and 03/12 in females.","effect":"group were observed, compared to one male of the control group (Table). After 28 days of recovery period the treatment related lesions persisted in kidneys of high dose recovery group animals: the incidences were 10/12 in males and 03/12 in females. Dose-dependent histopathological changes were observed in thymus, spleen, adrenals and lymph nodes; this might be suggestive of stress. The changes in thymus (starry sky appearance) were also found in lowest dose groups (5/10 in males and 6/10 females: Table). A clear NOAEL was also absent for the effects in spleens (males) and in adrenals (females). After the recovery period these treatment related changes were only partly reversed. The histopathological changes were substantiated by increases in spleen and adrenal weights and a slight decrease in thymus weights. Histopathological examination of other organs did not reveal treatment related adverse effects.","page":14,"pdf":"sccp_o_152.pdf","row_type":"noael_study","study_id":"sccp_o_152_noael_003"}
SCCS_vision_codex NOAEL =150 mg/kg bw/d rat oral 90-day repeated dose toxicity {"citation":"Ref.: 11 Comment Based on dose-dependently increased incidences of histopathological effects in thymus, spleen and adrenals observed in all treatment groups, the SCCP considers the Lowes","dose":"Sinusoidal congestion 1 (m) 1 (f) 0 (m) 3 (f) 2 (m) 4 (f) 4 (m) 8 (f) Conclusion The 90-day repeated dose oral exposure of rats to the test item affected haematological parameters at the highest dose level (1000 mg/kg bw/day).","effect":"1 (m) 1 (f) 5 (m) 6 (f) 6 (m) 7 (f) 7 (m) 7 (f) Spleen: Decrease cellularity in white pulp / decreased cellularity and size of white pulp 2 (m) 3 (f) 4 (m) 3 (f) 6 (m) 5 (f) 9 (m) 8 (f) Adrenals: Sinusoidal congestion 1 (m) 1 (f) 0 (m) 3 (f) 2 (m) 4 (f) 4 (m) 8 (f) Conclusion The 90-day repeated dose oral exposure of rats to the test item affected haematological parameters at the highest dose level (1000 mg/kg bw/day). Signs of nephrotoxicity were observed at 300 and 1000 mg/kg bw/day. The study authors derived a NOAEL of 150 mg/kg bw/d. Ref.: 11 Comment Based on dose-dependently increased incidences of histopathological effects in thymus, spleen and adrenals observed in all treatment groups, the SCCP considers the Lowest Observed Adverse Effect Level (LOAEL) of TAP in rats to be 150 mg/kg bw/day. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 (1997) Species/strain: Salmonella typhim","page":15,"pdf":"sccp_o_152.pdf","row_type":"noael_study","study_id":"sccp_o_152_noael_004"}
SCCS_vision_codex NOAEL =375 mg/kg/d rat dermal - developmental toxicity {"citation":"Ref.: 12 3","dose":"SCCP/1118/07 Opinion on tetra-Aminopyrimidine sulfate 20 Conclusion With respect to the mentioned slight maternal effects noticed in the mid and high dose group (salivation), the maternal No-Observed-Effect-Level (NOEL) was considered to be 375 mg/kg/d.","effect":"SCCP/1118/07 Opinion on tetra-Aminopyrimidine sulfate 20 Conclusion With respect to the mentioned slight maternal effects noticed in the mid and high dose group (salivation), the maternal No-Observed-Effect-Level (NOEL) was considered to be 375 mg/kg/d. The test chemical was neither embryo-lethal, embryotoxic nor teratogenic up to the highest dose tested (1500 mg/kg bw/day). Ref.: 12 3.3.9. Toxicokinetics Taken from SCCNFP/0695/03 Percutaneous penetration / dermal absorption of a hair dye formulation in vivo Guideline: / Species/strain: Wistar rats (SPFCpb) Test substance: radioactive labelled TAP (0.226%) + non labelled TAP; total 0.451% in a cream preparation (without developer) Radioactive purity: > 91% Batch: no data Dos","page":20,"pdf":"sccp_o_152.pdf","row_type":"noael_study","study_id":"sccp_o_152_noael_005"}
SCCS_vision_codex NOAEL =375 mg/kg bw/day rat oral subchronic repeated dose toxicity {"dose":"In a subchronic oral (gavage, 90 days) toxicity study in rats some histopathological effects in kidney, thymus, spleen and adrenals were observed at all dose levels (150, 300 and 1000 mg/kg bw).","effect":"value of Log Pow, without any reference to the respective pH, cannot be correlated to physiological conditions and to the pH conditions of the percutaneous absorption studies. General toxicity TAP has a low acute oral toxicity. In a subchronic oral (gavage, 90 days) toxicity study in rats some histopathological effects in kidney, thymus, spleen and adrenals were observed at all dose levels (150, 300 and 1000 mg/kg bw). Therefore, a LOAEL of 150 mg/kg bw/day was established. In a teratogenicity study, the maternal NOAEL was considered to be 375 mg/kg bw/day. The test substance was neither embryotoxic nor teratogenic up to 1500 mg/kg bw/day. Irritation, sensitisation The substance was not irritant when applied to skin but irritant to the eye. In the LLNA test, the highest concentration of the test substance (10%) tested is considered too low; other vehicles should have been used to obtain possible higher test concentrations. A possible sensitising potential cannot be excluded. Dermal absorption In an absorption study with pig sk","page":24,"pdf":"sccp_o_152.pdf","row_type":"noael_study","study_id":"sccp_o_152_noael_006"}
SCCS_vision_codex NOAEL =600 mg/kg bw human oral sub-chronic repeated dose toxicity {"dose":"TAP showed in different studies alone or in formulations a low median lethal dose (LD50) of > 5.000 mg/kg.","effect":", final: “Most of the investigations/experiments which are reported in Submission I (Aug. 1997) have been carried out in the early eighties (1978-1983). For an appropriate evaluation a number of details are missing. The identification of the test substance is ambiguous. The respective test substance is not specified as to its chemical form in several experiments. TAP showed in different studies alone or in formulations a low median lethal dose (LD50) of > 5.000 mg/kg. The sub-chronic oral toxicity study lead to a NOAEL of 600 mg/kg bw. There were no signs of teratogenicity and embryo-toxicity; maternal toxicity between 500 to 1000 mg/kg bw. The NOAEL for foetal development has been determined at 500 mg/kg bw. TAP was “not irritating” when applied in different species and in appropriate doses on the skin. It was also “not irritating” on mucous membranes. No incompatibilities were observed in human tests. TAP was classified as “not-sensitizing”. A number of toxicokinetic studies have been carried out, using radio labelled TAP but","page":5,"pdf":"sccp_o_152.pdf","row_type":"noael_study","study_id":"sccp_o_152_noael_001"}
SCCS_vision_codex NOAEL =500 mg/kg bw human oral sub-chronic repeated dose toxicity {"dose":"TAP showed in different studies alone or in formulations a low median lethal dose (LD50) of > 5.000 mg/kg.","effect":"ghties (1978-1983). For an appropriate evaluation a number of details are missing. The identification of the test substance is ambiguous. The respective test substance is not specified as to its chemical form in several experiments. TAP showed in different studies alone or in formulations a low median lethal dose (LD50) of > 5.000 mg/kg. The sub-chronic oral toxicity study lead to a NOAEL of 600 mg/kg bw. There were no signs of teratogenicity and embryo-toxicity; maternal toxicity between 500 to 1000 mg/kg bw. The NOAEL for foetal development has been determined at 500 mg/kg bw. TAP was “not irritating” when applied in different species and in appropriate doses on the skin. It was also “not irritating” on mucous membranes. No incompatibilities were observed in human tests. TAP was classified as “not-sensitizing”. A number of toxicokinetic studies have been carried out, using radio labelled TAP but in concentrations mostly far below the applied in use concentration of 5 %. TAP has been tested in prokaryotic cells for gene mutation","page":5,"pdf":"sccp_o_152.pdf","row_type":"noael_study","study_id":"sccp_o_152_noael_002"}
SCCS_vision_codex NOAEL =28 - - - 28 days NOAEL study {"dose":"After 28 days of recovery period the treatment related lesions persisted in kidneys of high dose recovery group animals: the incidences were 10/12 in males and 03/12 in females.","effect":"group were observed, compared to one male of the control group (Table). After 28 days of recovery period the treatment related lesions persisted in kidneys of high dose recovery group animals: the incidences were 10/12 in males and 03/12 in females. Dose-dependent histopathological changes were observed in thymus, spleen, adrenals and lymph nodes; this might be suggestive of stress. The changes in thymus (starry sky appearance) were also found in lowest dose groups (5/10 in males and 6/10 females: Table). A clear NOAEL was also absent for the effects in spleens (males) and in adrenals (females). After the recovery period these treatment related changes were only partly reversed. The histopathological changes were substantiated by increases in spleen and adrenal weights and a slight decrease in thymus weights. Histopathological examination of other organs did not reveal treatment related adverse effects.","page":14,"pdf":"sccp_o_152.pdf","row_type":"noael_study","study_id":"sccp_o_152_noael_003"}
SCCS_vision_codex NOAEL =150 mg/kg bw/d rat oral 90-day repeated dose toxicity {"citation":"Ref.: 11 Comment Based on dose-dependently increased incidences of histopathological effects in thymus, spleen and adrenals observed in all treatment groups, the SCCP considers the Lowes","dose":"Sinusoidal congestion 1 (m) 1 (f) 0 (m) 3 (f) 2 (m) 4 (f) 4 (m) 8 (f) Conclusion The 90-day repeated dose oral exposure of rats to the test item affected haematological parameters at the highest dose level (1000 mg/kg bw/day).","effect":"1 (m) 1 (f) 5 (m) 6 (f) 6 (m) 7 (f) 7 (m) 7 (f) Spleen: Decrease cellularity in white pulp / decreased cellularity and size of white pulp 2 (m) 3 (f) 4 (m) 3 (f) 6 (m) 5 (f) 9 (m) 8 (f) Adrenals: Sinusoidal congestion 1 (m) 1 (f) 0 (m) 3 (f) 2 (m) 4 (f) 4 (m) 8 (f) Conclusion The 90-day repeated dose oral exposure of rats to the test item affected haematological parameters at the highest dose level (1000 mg/kg bw/day). Signs of nephrotoxicity were observed at 300 and 1000 mg/kg bw/day. The study authors derived a NOAEL of 150 mg/kg bw/d. Ref.: 11 Comment Based on dose-dependently increased incidences of histopathological effects in thymus, spleen and adrenals observed in all treatment groups, the SCCP considers the Lowest Observed Adverse Effect Level (LOAEL) of TAP in rats to be 150 mg/kg bw/day. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 (1997) Species/strain: Salmonella typhim","page":15,"pdf":"sccp_o_152.pdf","row_type":"noael_study","study_id":"sccp_o_152_noael_004"}
SCCS_vision_codex NOAEL =375 mg/kg/d rat dermal - developmental toxicity {"citation":"Ref.: 12 3","dose":"SCCP/1118/07 Opinion on tetra-Aminopyrimidine sulfate 20 Conclusion With respect to the mentioned slight maternal effects noticed in the mid and high dose group (salivation), the maternal No-Observed-Effect-Level (NOEL) was considered to be 375 mg/kg/d.","effect":"SCCP/1118/07 Opinion on tetra-Aminopyrimidine sulfate 20 Conclusion With respect to the mentioned slight maternal effects noticed in the mid and high dose group (salivation), the maternal No-Observed-Effect-Level (NOEL) was considered to be 375 mg/kg/d. The test chemical was neither embryo-lethal, embryotoxic nor teratogenic up to the highest dose tested (1500 mg/kg bw/day). Ref.: 12 3.3.9. Toxicokinetics Taken from SCCNFP/0695/03 Percutaneous penetration / dermal absorption of a hair dye formulation in vivo Guideline: / Species/strain: Wistar rats (SPFCpb) Test substance: radioactive labelled TAP (0.226%) + non labelled TAP; total 0.451% in a cream preparation (without developer) Radioactive purity: > 91% Batch: no data Dos","page":20,"pdf":"sccp_o_152.pdf","row_type":"noael_study","study_id":"sccp_o_152_noael_005"}
SCCS_vision_codex NOAEL =375 mg/kg bw/day rat oral subchronic repeated dose toxicity {"dose":"In a subchronic oral (gavage, 90 days) toxicity study in rats some histopathological effects in kidney, thymus, spleen and adrenals were observed at all dose levels (150, 300 and 1000 mg/kg bw).","effect":"value of Log Pow, without any reference to the respective pH, cannot be correlated to physiological conditions and to the pH conditions of the percutaneous absorption studies. General toxicity TAP has a low acute oral toxicity. In a subchronic oral (gavage, 90 days) toxicity study in rats some histopathological effects in kidney, thymus, spleen and adrenals were observed at all dose levels (150, 300 and 1000 mg/kg bw). Therefore, a LOAEL of 150 mg/kg bw/day was established. In a teratogenicity study, the maternal NOAEL was considered to be 375 mg/kg bw/day. The test substance was neither embryotoxic nor teratogenic up to 1500 mg/kg bw/day. Irritation, sensitisation The substance was not irritant when applied to skin but irritant to the eye. In the LLNA test, the highest concentration of the test substance (10%) tested is considered too low; other vehicles should have been used to obtain possible higher test concentrations. A possible sensitising potential cannot be excluded. Dermal absorption In an absorption study with pig sk","page":24,"pdf":"sccp_o_152.pdf","row_type":"noael_study","study_id":"sccp_o_152_noael_006"}
SCCS_vision_codex NOAEL =600 mg/kg bw human oral sub-chronic repeated dose toxicity {"dose":"TAP showed in different studies alone or in formulations a low median lethal dose (LD50) of > 5.000 mg/kg.","effect":", final: “Most of the investigations/experiments which are reported in Submission I (Aug. 1997) have been carried out in the early eighties (1978-1983). For an appropriate evaluation a number of details are missing. The identification of the test substance is ambiguous. The respective test substance is not specified as to its chemical form in several experiments. TAP showed in different studies alone or in formulations a low median lethal dose (LD50) of > 5.000 mg/kg. The sub-chronic oral toxicity study lead to a NOAEL of 600 mg/kg bw. There were no signs of teratogenicity and embryo-toxicity; maternal toxicity between 500 to 1000 mg/kg bw. The NOAEL for foetal development has been determined at 500 mg/kg bw. TAP was “not irritating” when applied in different species and in appropriate doses on the skin. It was also “not irritating” on mucous membranes. No incompatibilities were observed in human tests. TAP was classified as “not-sensitizing”. A number of toxicokinetic studies have been carried out, using radio labelled TAP but","page":5,"pdf":"sccp_o_152.pdf","row_type":"noael_study","study_id":"sccp_o_152_noael_001"}
SCCS_vision_codex NOAEL =500 mg/kg bw human oral sub-chronic repeated dose toxicity {"dose":"TAP showed in different studies alone or in formulations a low median lethal dose (LD50) of > 5.000 mg/kg.","effect":"ghties (1978-1983). For an appropriate evaluation a number of details are missing. The identification of the test substance is ambiguous. The respective test substance is not specified as to its chemical form in several experiments. TAP showed in different studies alone or in formulations a low median lethal dose (LD50) of > 5.000 mg/kg. The sub-chronic oral toxicity study lead to a NOAEL of 600 mg/kg bw. There were no signs of teratogenicity and embryo-toxicity; maternal toxicity between 500 to 1000 mg/kg bw. The NOAEL for foetal development has been determined at 500 mg/kg bw. TAP was “not irritating” when applied in different species and in appropriate doses on the skin. It was also “not irritating” on mucous membranes. No incompatibilities were observed in human tests. TAP was classified as “not-sensitizing”. A number of toxicokinetic studies have been carried out, using radio labelled TAP but in concentrations mostly far below the applied in use concentration of 5 %. TAP has been tested in prokaryotic cells for gene mutation","page":5,"pdf":"sccp_o_152.pdf","row_type":"noael_study","study_id":"sccp_o_152_noael_002"}
SCCS_vision_codex NOAEL =28 - - - 28 days NOAEL study {"dose":"After 28 days of recovery period the treatment related lesions persisted in kidneys of high dose recovery group animals: the incidences were 10/12 in males and 03/12 in females.","effect":"group were observed, compared to one male of the control group (Table). After 28 days of recovery period the treatment related lesions persisted in kidneys of high dose recovery group animals: the incidences were 10/12 in males and 03/12 in females. Dose-dependent histopathological changes were observed in thymus, spleen, adrenals and lymph nodes; this might be suggestive of stress. The changes in thymus (starry sky appearance) were also found in lowest dose groups (5/10 in males and 6/10 females: Table). A clear NOAEL was also absent for the effects in spleens (males) and in adrenals (females). After the recovery period these treatment related changes were only partly reversed. The histopathological changes were substantiated by increases in spleen and adrenal weights and a slight decrease in thymus weights. Histopathological examination of other organs did not reveal treatment related adverse effects.","page":14,"pdf":"sccp_o_152.pdf","row_type":"noael_study","study_id":"sccp_o_152_noael_003"}
SCCS_vision_codex NOAEL =150 mg/kg bw/d rat oral 90-day repeated dose toxicity {"citation":"Ref.: 11 Comment Based on dose-dependently increased incidences of histopathological effects in thymus, spleen and adrenals observed in all treatment groups, the SCCP considers the Lowes","dose":"Sinusoidal congestion 1 (m) 1 (f) 0 (m) 3 (f) 2 (m) 4 (f) 4 (m) 8 (f) Conclusion The 90-day repeated dose oral exposure of rats to the test item affected haematological parameters at the highest dose level (1000 mg/kg bw/day).","effect":"1 (m) 1 (f) 5 (m) 6 (f) 6 (m) 7 (f) 7 (m) 7 (f) Spleen: Decrease cellularity in white pulp / decreased cellularity and size of white pulp 2 (m) 3 (f) 4 (m) 3 (f) 6 (m) 5 (f) 9 (m) 8 (f) Adrenals: Sinusoidal congestion 1 (m) 1 (f) 0 (m) 3 (f) 2 (m) 4 (f) 4 (m) 8 (f) Conclusion The 90-day repeated dose oral exposure of rats to the test item affected haematological parameters at the highest dose level (1000 mg/kg bw/day). Signs of nephrotoxicity were observed at 300 and 1000 mg/kg bw/day. The study authors derived a NOAEL of 150 mg/kg bw/d. Ref.: 11 Comment Based on dose-dependently increased incidences of histopathological effects in thymus, spleen and adrenals observed in all treatment groups, the SCCP considers the Lowest Observed Adverse Effect Level (LOAEL) of TAP in rats to be 150 mg/kg bw/day. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 (1997) Species/strain: Salmonella typhim","page":15,"pdf":"sccp_o_152.pdf","row_type":"noael_study","study_id":"sccp_o_152_noael_004"}
SCCS_vision_codex NOAEL =375 mg/kg/d rat dermal - developmental toxicity {"citation":"Ref.: 12 3","dose":"SCCP/1118/07 Opinion on tetra-Aminopyrimidine sulfate 20 Conclusion With respect to the mentioned slight maternal effects noticed in the mid and high dose group (salivation), the maternal No-Observed-Effect-Level (NOEL) was considered to be 375 mg/kg/d.","effect":"SCCP/1118/07 Opinion on tetra-Aminopyrimidine sulfate 20 Conclusion With respect to the mentioned slight maternal effects noticed in the mid and high dose group (salivation), the maternal No-Observed-Effect-Level (NOEL) was considered to be 375 mg/kg/d. The test chemical was neither embryo-lethal, embryotoxic nor teratogenic up to the highest dose tested (1500 mg/kg bw/day). Ref.: 12 3.3.9. Toxicokinetics Taken from SCCNFP/0695/03 Percutaneous penetration / dermal absorption of a hair dye formulation in vivo Guideline: / Species/strain: Wistar rats (SPFCpb) Test substance: radioactive labelled TAP (0.226%) + non labelled TAP; total 0.451% in a cream preparation (without developer) Radioactive purity: > 91% Batch: no data Dos","page":20,"pdf":"sccp_o_152.pdf","row_type":"noael_study","study_id":"sccp_o_152_noael_005"}
SCCS_vision_codex NOAEL =375 mg/kg bw/day rat oral subchronic repeated dose toxicity {"dose":"In a subchronic oral (gavage, 90 days) toxicity study in rats some histopathological effects in kidney, thymus, spleen and adrenals were observed at all dose levels (150, 300 and 1000 mg/kg bw).","effect":"value of Log Pow, without any reference to the respective pH, cannot be correlated to physiological conditions and to the pH conditions of the percutaneous absorption studies. General toxicity TAP has a low acute oral toxicity. In a subchronic oral (gavage, 90 days) toxicity study in rats some histopathological effects in kidney, thymus, spleen and adrenals were observed at all dose levels (150, 300 and 1000 mg/kg bw). Therefore, a LOAEL of 150 mg/kg bw/day was established. In a teratogenicity study, the maternal NOAEL was considered to be 375 mg/kg bw/day. The test substance was neither embryotoxic nor teratogenic up to 1500 mg/kg bw/day. Irritation, sensitisation The substance was not irritant when applied to skin but irritant to the eye. In the LLNA test, the highest concentration of the test substance (10%) tested is considered too low; other vehicles should have been used to obtain possible higher test concentrations. A possible sensitising potential cannot be excluded. Dermal absorption In an absorption study with pig sk","page":24,"pdf":"sccp_o_152.pdf","row_type":"noael_study","study_id":"sccp_o_152_noael_006"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 6 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 28 - - - 28 days - SOURCE_SUBDIR=sccp_o_152; REPORT_TITLE=OPINION ON tetra-Aminopyrimidine sulfate COLIPA n° A53; OPINION_NUMBER=SCCP/1118/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=16 December 2008; VALUE_TEXT=unclear:group were observed, compared to one male of the control group (Table). After 28 days of recovery period the treatment related lesions persisted in kidneys of high dose recovery group animals: the incidences were 10/12 in males and 03/12 in females. Dose-dependent histopathological changes were observed in thymus, spleen, adrenals and lymph nodes; this might be suggestive of stress. The changes in thymus (starry sky appearance) were also found in lowest dose groups (5/10 in males and 6/10 females: Table). A clear NOAEL was also absent for the effects in spleens (males) and in adrenals (females). After the recovery period these treatment related changes were only partly reversed. The histopathological changes were substantiated by increases in spleen and adrenal weights and a slight decrease in thymus weights. Histopathological examination of other organs did not reveal treatment related adverse effects.; DOSE=After 28 days of recovery period the treatment related lesions persisted in kidneys of high dose recovery group animals: the incidences were 10/12 in males and 03/12 in females.; EFFECT=group were observed, compared to one male of the control group (Table). After 28 days of recovery period the treatment related lesions persisted in kidneys of high dose recovery group animals: the incidences were 10/12 in males and 03/12 in females. Dose-dependent histopathological changes were observed in thymus, spleen, adrenals and lymph nodes; this might be suggestive of stress. The changes in thymus (starry sky appearance) were also found in lowest dose groups (5/10 in males and 6/10 females: Table). A clear NOAEL was also absent for the effects in spleens (males) and in adrenals (females). After the recovery period these treatment related changes were only partly reversed. The histopathological changes were substantiated by increases in spleen and adrenal weights and a slight decrease in thymus weights. Histopathological examination of other organs did not reveal treatment related adverse effects.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"5392-28-9","citation":"","dose":"After 28 days of recovery period the treatment related lesions persisted in kidneys of high dose recovery group animals: the incidences were 10/12 in males and 03/12 in females.","duration":"28 days","effect":"group were observed, compared to one male of the control group (Table). After 28 days of recovery period the treatment related lesions persisted in kidneys of high dose recovery group animals: the incidences were 10/12 in males and 03/12 in females. Dose-dependent histopathological changes were observed in thymus, spleen, adrenals and lymph nodes; this might be suggestive of stress. The changes in thymus (starry sky appearance) were also found in lowest dose groups (5/10 in males and 6/10 females: Table). A clear NOAEL was also absent for the effects in spleens (males) and in adrenals (females). After the recovery period these treatment related changes were only partly reversed. The histopathological changes were substantiated by increases in spleen and adrenal weights and a slight decrease in thymus weights. Histopathological examination of other organs did not reveal treatment related adverse effects.","endpoint":"","ingredient":"Tetraaminopyrimidine sulfate","loael_value":"","noael_unit":"","noael_value":"unclear:group were observed, compared to one male of the control group (Table). After 28 days of recovery period the treatment related lesions persisted in kidneys of high dose recovery group animals: the incidences were 10/12 in males and 03/12 in females. Dose-dependent histopathological changes were observed in thymus, spleen, adrenals and lymph nodes; this might be suggestive of stress. The changes in thymus (starry sky appearance) were also found in lowest dose groups (5/10 in males and 6/10 females: Table). A clear NOAEL was also absent for the effects in spleens (males) and in adrenals (females). After the recovery period these treatment related changes were only partly reversed. The histopathological changes were substantiated by increases in spleen and adrenal weights and a slight decrease in thymus weights. Histopathological examination of other organs did not reveal treatment related adverse effects.","page":14,"route":"","species":"","study_id":"sccp_o_152_noael_003"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 375 mg/kg/d rat dermal - developmental toxicity SOURCE_SUBDIR=sccp_o_152; REPORT_TITLE=OPINION ON tetra-Aminopyrimidine sulfate COLIPA n° A53; OPINION_NUMBER=SCCP/1118/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=16 December 2008; VALUE_TEXT=375; DOSE=SCCP/1118/07 Opinion on tetra-Aminopyrimidine sulfate 20 Conclusion With respect to the mentioned slight maternal effects noticed in the mid and high dose group (salivation), the maternal No-Observed-Effect-Level (NOEL) was considered to be 375 mg/kg/d.; EFFECT=SCCP/1118/07 Opinion on tetra-Aminopyrimidine sulfate 20 Conclusion With respect to the mentioned slight maternal effects noticed in the mid and high dose group (salivation), the maternal No-Observed-Effect-Level (NOEL) was considered to be 375 mg/kg/d. The test chemical was neither embryo-lethal, embryotoxic nor teratogenic up to the highest dose tested (1500 mg/kg bw/day). Ref.: 12 3.3.9. Toxicokinetics Taken from SCCNFP/0695/03 Percutaneous penetration / dermal absorption of a hair dye formulation in vivo Guideline: / Species/strain: Wistar rats (SPFCpb) Test substance: radioactive labelled TAP (0.226%) + non labelled TAP; total 0.451% in a cream preparation (without developer) Radioactive purity: > 91% Batch: no data Dos; CITATION=Ref.: 12 3; CITATION_NUMBERS=[12,3]; REFERENCE=Ref.: 12 3; DETAILS_JSON={"cas_number":"5392-28-9","citation":"Ref.: 12 3","dose":"SCCP/1118/07 Opinion on tetra-Aminopyrimidine sulfate 20 Conclusion With respect to the mentioned slight maternal effects noticed in the mid and high dose group (salivation), the maternal No-Observed-Effect-Level (NOEL) was considered to be 375 mg/kg/d.","duration":"","effect":"SCCP/1118/07 Opinion on tetra-Aminopyrimidine sulfate 20 Conclusion With respect to the mentioned slight maternal effects noticed in the mid and high dose group (salivation), the maternal No-Observed-Effect-Level (NOEL) was considered to be 375 mg/kg/d. The test chemical was neither embryo-lethal, embryotoxic nor teratogenic up to the highest dose tested (1500 mg/kg bw/day). Ref.: 12 3.3.9. Toxicokinetics Taken from SCCNFP/0695/03 Percutaneous penetration / dermal absorption of a hair dye formulation in vivo Guideline: / Species/strain: Wistar rats (SPFCpb) Test substance: radioactive labelled TAP (0.226%) + non labelled TAP; total 0.451% in a cream preparation (without developer) Radioactive purity: > 91% Batch: no data Dos","endpoint":"developmental toxicity","ingredient":"Tetraaminopyrimidine sulfate","loael_value":"","noael_unit":"mg/kg/d","noael_value":"375","page":20,"route":"dermal","species":"rat","study_id":"sccp_o_152_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 600 mg/kg bw human oral sub-chronic repeated dose toxicity SOURCE_SUBDIR=sccp_o_152; REPORT_TITLE=OPINION ON tetra-Aminopyrimidine sulfate COLIPA n° A53; OPINION_NUMBER=SCCP/1118/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=16 December 2008; VALUE_TEXT=600; DOSE=TAP showed in different studies alone or in formulations a low median lethal dose (LD50) of > 5.000 mg/kg.; EFFECT=, final: “Most of the investigations/experiments which are reported in Submission I (Aug. 1997) have been carried out in the early eighties (1978-1983). For an appropriate evaluation a number of details are missing. The identification of the test substance is ambiguous. The respective test substance is not specified as to its chemical form in several experiments. TAP showed in different studies alone or in formulations a low median lethal dose (LD50) of > 5.000 mg/kg. The sub-chronic oral toxicity study lead to a NOAEL of 600 mg/kg bw. There were no signs of teratogenicity and embryo-toxicity; maternal toxicity between 500 to 1000 mg/kg bw. The NOAEL for foetal development has been determined at 500 mg/kg bw. TAP was “not irritating” when applied in different species and in appropriate doses on the skin. It was also “not irritating” on mucous membranes. No incompatibilities were observed in human tests. TAP was classified as “not-sensitizing”. A number of toxicokinetic studies have been carried out, using radio labelled TAP but; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"5392-28-9","citation":"","dose":"TAP showed in different studies alone or in formulations a low median lethal dose (LD50) of > 5.000 mg/kg.","duration":"sub-chronic","effect":", final: “Most of the investigations/experiments which are reported in Submission I (Aug. 1997) have been carried out in the early eighties (1978-1983). For an appropriate evaluation a number of details are missing. The identification of the test substance is ambiguous. The respective test substance is not specified as to its chemical form in several experiments. TAP showed in different studies alone or in formulations a low median lethal dose (LD50) of > 5.000 mg/kg. The sub-chronic oral toxicity study lead to a NOAEL of 600 mg/kg bw. There were no signs of teratogenicity and embryo-toxicity; maternal toxicity between 500 to 1000 mg/kg bw. The NOAEL for foetal development has been determined at 500 mg/kg bw. TAP was “not irritating” when applied in different species and in appropriate doses on the skin. It was also “not irritating” on mucous membranes. No incompatibilities were observed in human tests. TAP was classified as “not-sensitizing”. A number of toxicokinetic studies have been carried out, using radio labelled TAP but","endpoint":"repeated dose toxicity","ingredient":"Tetraaminopyrimidine sulfate","loael_value":"","noael_unit":"mg/kg bw","noael_value":"600","page":5,"route":"oral","species":"human","study_id":"sccp_o_152_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 500 mg/kg bw human oral sub-chronic repeated dose toxicity SOURCE_SUBDIR=sccp_o_152; REPORT_TITLE=OPINION ON tetra-Aminopyrimidine sulfate COLIPA n° A53; OPINION_NUMBER=SCCP/1118/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=16 December 2008; VALUE_TEXT=500 to 1000; DOSE=TAP showed in different studies alone or in formulations a low median lethal dose (LD50) of > 5.000 mg/kg.; EFFECT=ghties (1978-1983). For an appropriate evaluation a number of details are missing. The identification of the test substance is ambiguous. The respective test substance is not specified as to its chemical form in several experiments. TAP showed in different studies alone or in formulations a low median lethal dose (LD50) of > 5.000 mg/kg. The sub-chronic oral toxicity study lead to a NOAEL of 600 mg/kg bw. There were no signs of teratogenicity and embryo-toxicity; maternal toxicity between 500 to 1000 mg/kg bw. The NOAEL for foetal development has been determined at 500 mg/kg bw. TAP was “not irritating” when applied in different species and in appropriate doses on the skin. It was also “not irritating” on mucous membranes. No incompatibilities were observed in human tests. TAP was classified as “not-sensitizing”. A number of toxicokinetic studies have been carried out, using radio labelled TAP but in concentrations mostly far below the applied in use concentration of 5 %. TAP has been tested in prokaryotic cells for gene mutation; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"5392-28-9","citation":"","dose":"TAP showed in different studies alone or in formulations a low median lethal dose (LD50) of > 5.000 mg/kg.","duration":"sub-chronic","effect":"ghties (1978-1983). For an appropriate evaluation a number of details are missing. The identification of the test substance is ambiguous. The respective test substance is not specified as to its chemical form in several experiments. TAP showed in different studies alone or in formulations a low median lethal dose (LD50) of > 5.000 mg/kg. The sub-chronic oral toxicity study lead to a NOAEL of 600 mg/kg bw. There were no signs of teratogenicity and embryo-toxicity; maternal toxicity between 500 to 1000 mg/kg bw. The NOAEL for foetal development has been determined at 500 mg/kg bw. TAP was “not irritating” when applied in different species and in appropriate doses on the skin. It was also “not irritating” on mucous membranes. No incompatibilities were observed in human tests. TAP was classified as “not-sensitizing”. A number of toxicokinetic studies have been carried out, using radio labelled TAP but in concentrations mostly far below the applied in use concentration of 5 %. TAP has been tested in prokaryotic cells for gene mutation","endpoint":"repeated dose toxicity","ingredient":"Tetraaminopyrimidine sulfate","loael_value":"","noael_unit":"mg/kg bw","noael_value":"500 to 1000","page":5,"route":"oral","species":"human","study_id":"sccp_o_152_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 150 mg/kg bw/d rat oral 90-day repeated dose toxicity SOURCE_SUBDIR=sccp_o_152; REPORT_TITLE=OPINION ON tetra-Aminopyrimidine sulfate COLIPA n° A53; OPINION_NUMBER=SCCP/1118/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=16 December 2008; VALUE_TEXT=150; DOSE=Sinusoidal congestion 1 (m) 1 (f) 0 (m) 3 (f) 2 (m) 4 (f) 4 (m) 8 (f) Conclusion The 90-day repeated dose oral exposure of rats to the test item affected haematological parameters at the highest dose level (1000 mg/kg bw/day).; LOAEL_VALUE=150 mg/kg bw/day; EFFECT=1 (m) 1 (f) 5 (m) 6 (f) 6 (m) 7 (f) 7 (m) 7 (f) Spleen: Decrease cellularity in white pulp / decreased cellularity and size of white pulp 2 (m) 3 (f) 4 (m) 3 (f) 6 (m) 5 (f) 9 (m) 8 (f) Adrenals: Sinusoidal congestion 1 (m) 1 (f) 0 (m) 3 (f) 2 (m) 4 (f) 4 (m) 8 (f) Conclusion The 90-day repeated dose oral exposure of rats to the test item affected haematological parameters at the highest dose level (1000 mg/kg bw/day). Signs of nephrotoxicity were observed at 300 and 1000 mg/kg bw/day. The study authors derived a NOAEL of 150 mg/kg bw/d. Ref.: 11 Comment Based on dose-dependently increased incidences of histopathological effects in thymus, spleen and adrenals observed in all treatment groups, the SCCP considers the Lowest Observed Adverse Effect Level (LOAEL) of TAP in rats to be 150 mg/kg bw/day. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 (1997) Species/strain: Salmonella typhim; CITATION=Ref.: 11 Comment Based on dose-dependently increased incidences of histopathological effects in thymus, spleen and adrenals observed in all treatment groups, the SCCP considers the Lowes; CITATION_NUMBERS=[11]; REFERENCE=Ref.: 11 Comment Based on dose-dependently increased incidences of histopathological effects in thymus, spleen and adrenals observed in all treatment groups, the SCCP considers the Lowes; DETAILS_JSON={"cas_number":"5392-28-9","citation":"Ref.: 11 Comment Based on dose-dependently increased incidences of histopathological effects in thymus, spleen and adrenals observed in all treatment groups, the SCCP considers the Lowes","dose":"Sinusoidal congestion 1 (m) 1 (f) 0 (m) 3 (f) 2 (m) 4 (f) 4 (m) 8 (f) Conclusion The 90-day repeated dose oral exposure of rats to the test item affected haematological parameters at the highest dose level (1000 mg/kg bw/day).","duration":"90-day","effect":"1 (m) 1 (f) 5 (m) 6 (f) 6 (m) 7 (f) 7 (m) 7 (f) Spleen: Decrease cellularity in white pulp / decreased cellularity and size of white pulp 2 (m) 3 (f) 4 (m) 3 (f) 6 (m) 5 (f) 9 (m) 8 (f) Adrenals: Sinusoidal congestion 1 (m) 1 (f) 0 (m) 3 (f) 2 (m) 4 (f) 4 (m) 8 (f) Conclusion The 90-day repeated dose oral exposure of rats to the test item affected haematological parameters at the highest dose level (1000 mg/kg bw/day). Signs of nephrotoxicity were observed at 300 and 1000 mg/kg bw/day. The study authors derived a NOAEL of 150 mg/kg bw/d. Ref.: 11 Comment Based on dose-dependently increased incidences of histopathological effects in thymus, spleen and adrenals observed in all treatment groups, the SCCP considers the Lowest Observed Adverse Effect Level (LOAEL) of TAP in rats to be 150 mg/kg bw/day. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 (1997) Species/strain: Salmonella typhim","endpoint":"repeated dose toxicity","ingredient":"Tetraaminopyrimidine sulfate","loael_value":"150 mg/kg bw/day","noael_unit":"mg/kg bw/d","noael_value":"150","page":15,"route":"oral","species":"rat","study_id":"sccp_o_152_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 375 mg/kg bw/day rat oral subchronic repeated dose toxicity SOURCE_SUBDIR=sccp_o_152; REPORT_TITLE=OPINION ON tetra-Aminopyrimidine sulfate COLIPA n° A53; OPINION_NUMBER=SCCP/1118/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=16 December 2008; VALUE_TEXT=375; DOSE=In a subchronic oral (gavage, 90 days) toxicity study in rats some histopathological effects in kidney, thymus, spleen and adrenals were observed at all dose levels (150, 300 and 1000 mg/kg bw).; LOAEL_VALUE=150 mg/kg bw/day; EFFECT=value of Log Pow, without any reference to the respective pH, cannot be correlated to physiological conditions and to the pH conditions of the percutaneous absorption studies. General toxicity TAP has a low acute oral toxicity. In a subchronic oral (gavage, 90 days) toxicity study in rats some histopathological effects in kidney, thymus, spleen and adrenals were observed at all dose levels (150, 300 and 1000 mg/kg bw). Therefore, a LOAEL of 150 mg/kg bw/day was established. In a teratogenicity study, the maternal NOAEL was considered to be 375 mg/kg bw/day. The test substance was neither embryotoxic nor teratogenic up to 1500 mg/kg bw/day. Irritation, sensitisation The substance was not irritant when applied to skin but irritant to the eye. In the LLNA test, the highest concentration of the test substance (10%) tested is considered too low; other vehicles should have been used to obtain possible higher test concentrations. A possible sensitising potential cannot be excluded. Dermal absorption In an absorption study with pig sk; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"5392-28-9","citation":"","dose":"In a subchronic oral (gavage, 90 days) toxicity study in rats some histopathological effects in kidney, thymus, spleen and adrenals were observed at all dose levels (150, 300 and 1000 mg/kg bw).","duration":"subchronic","effect":"value of Log Pow, without any reference to the respective pH, cannot be correlated to physiological conditions and to the pH conditions of the percutaneous absorption studies. General toxicity TAP has a low acute oral toxicity. In a subchronic oral (gavage, 90 days) toxicity study in rats some histopathological effects in kidney, thymus, spleen and adrenals were observed at all dose levels (150, 300 and 1000 mg/kg bw). Therefore, a LOAEL of 150 mg/kg bw/day was established. In a teratogenicity study, the maternal NOAEL was considered to be 375 mg/kg bw/day. The test substance was neither embryotoxic nor teratogenic up to 1500 mg/kg bw/day. Irritation, sensitisation The substance was not irritant when applied to skin but irritant to the eye. In the LLNA test, the highest concentration of the test substance (10%) tested is considered too low; other vehicles should have been used to obtain possible higher test concentrations. A possible sensitising potential cannot be excluded. Dermal absorption In an absorption study with pig sk","endpoint":"repeated dose toxicity","ingredient":"Tetraaminopyrimidine sulfate","loael_value":"150 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"375","page":24,"route":"oral","species":"rat","study_id":"sccp_o_152_noael_006"}
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier 53QQY0I99M UNII - - - chemical {"approval_status":null,"molecular_formula":"C4H8N6.H2O4S","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"53QQY0I99M"}
openFDA substances FDA UNII substance identifier 53QQY0I99M UNII - - - chemical {"approval_status":null,"molecular_formula":"C4H8N6.H2O4S","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"53QQY0I99M"}
openFDA substances FDA UNII substance identifier 53QQY0I99M UNII - - - chemical {"approval_status":null,"molecular_formula":"C4H8N6.H2O4S","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"53QQY0I99M"}
openFDA substances FDA UNII substance identifier 53QQY0I99M UNII - - - chemical {"approval_status":null,"molecular_formula":"C4H8N6.H2O4S","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"53QQY0I99M"}