NOAEL Studies
Preservative
Polyaminopropyl Biguanide NOAEL Studies
INCI: POLYAMINOPROPYL BIGUANIDE
CAS: 32289-58-0
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
NTP ICE dart 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP ICE dart | LOEL | 40 | mg/kg bw/day | Rabbit | Oral | - | In Vivo; DART, Developmental malformation | sheet=Data; excel_row=44907; Record_ID=dart_38160; Data_Type=In Vivo; DTXSID=DTXSID2035726; Assay=DART, Developmental malformation; Endpoint=LOEL; Response=40; Response_Unit=mg/kg/day; Species=Rabbit; Strain=New Zealand White; Sex=Male/Female; Life_Stage=Fetal; Route=Oral; Critical_Effect=Yes; Unified_Medical_Language_System=UMLS;C0000768;CUI;Congenital Abnormality|UMLS;C0265509;CUI;Congenital anomaly of skeletal bone|UMLS;C0699952;CUI;Fused; Reference=ToxRefDB v2 , ID = 6106; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2035726 |
| NTP ICE dart | LOEL | 40 | mg/kg bw/day | Rabbit | Oral | - | In Vivo; DART, In life observation | sheet=Data; excel_row=45013; Record_ID=dart_38147; Data_Type=In Vivo; DTXSID=DTXSID2035726; Assay=DART, In life observation; Endpoint=LOEL; Response=40; Response_Unit=mg/kg/day; Species=Rabbit; Strain=New Zealand White; Sex=Female; Life_Stage=Adult; Route=Oral; Critical_Effect=Yes; Unified_Medical_Language_System=UMLS;C3540840;CUI;Sign or Symptom|UMLS;C0009264;CUI;Cold Temperature; Reference=ToxRefDB v2 , ID = 6106; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2035726 |
SCCS Opinion 28 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCS Opinion | NOAEL | =0.257 | - | - | - | - | irritation | p.45 |
| SCCS Opinion | NOAEL | =1 | - | - | oral | 2-year | NOAEL study | p.42 |
| SCCS Opinion | NOAEL | =3.1 | mg/kg bw/d | rat | oral | 104 week | NOAEL study | p.61 |
| SCCS Opinion | NOAEL | =8.5 | % | rat | oral | 104 week | NOAEL study | p.61 |
| SCCS Opinion | NOAEL | =10 | mg/kg/d | rabbit | oral | developmental | developmental toxicity | p.51 |
| SCCS Opinion | NOAEL | =15 | mg/kg bw/d | rat | oral | chronic | carcinogenicity | p.48 |
| SCCS Opinion | NOAEL | =20 | mg/kg bw/d | rat | dermal | 30 d | carcinogenicity | p.17 |
| SCCS Opinion | NOAEL | =20 | % | mouse | oral | 2-year | NOAEL study | p.32 |
| SCCS Opinion | NOAEL | =20 | mg/kg bw/day | rabbit | oral | - | irritation | p.33 |
| SCCS Opinion | NOAEL | =20.2 | % | rat | oral | 2-year | NOAEL study | p.33 |
| SCCS Opinion | NOAEL | =26 | - | rat | - | - | irritation | p.35 |
| SCCS Opinion | NOAEL | =36 | mg/kg bw/d | rat | oral | 2-year | genotoxicity | p.39 |
| SCCS Opinion | NOAEL | =36 | mg/kg bw/d | rat | oral | 2-year | reproductive toxicity | p.51 |
| SCCS Opinion | NOAEL | =40 | mg/kg bw/d | rabbit | oral | developmental | developmental toxicity | p.51 |
| SCCS Opinion | NOAEL | =54 | mg/kg bw/d | rat | - | - | NOAEL study | p.38 |
| SCCS Opinion | NOAEL | =54 | mg/kg bw | rat | oral | subchronic | repeated dose toxicity | p.39 |
| SCCS Opinion | NOAEL | =79 | mg/kg bw/d | rat | oral | 9 week | reproductive toxicity | p.49 |
| SCCS Opinion | NOAEL | =92.3 | mg/kg bw/d | mouse | oral | - | NOAEL study | p.36 |
| SCCS Opinion | NOAEL | =92.3 | mg/kg bw/d | - | oral | - | NOAEL study | p.47 |
| SCCS Opinion | NOAEL | =130 | mg/kg bw/d | rat | oral | Developmental | reproductive toxicity | p.50 |
| SCCS Opinion | NOAEL | =200 | mg/kg bw/day | rabbit | dermal | - | irritation | p.33 |
| SCCS Opinion | NOAEL | =200 | ppm | mouse | - | developmental | developmental toxicity | p.50 |
| SCCS Opinion | NOAEL | =224 | mg/kg bw/d | - | - | - | NOAEL study | p.36 |
| SCCS Opinion | NOAEL | =224 | mg/kg bw/d | rat | oral | 90-day | NOAEL study | p.48 |
| SCCS Opinion | NOAEL | =600 | ppm | rat | oral | 9 week | reproductive toxicity | p.49 |
| SCCS Opinion | NOAEL | =1000 | ppm | mouse | - | developmental | developmental toxicity | p.50 |
| SCCS Opinion | NOAEL | =1581 | - | - | - | - | repeated dose toxicity | p.78 |
| SCCS Opinion | NOAEL | =2000 | ppm | rat | oral | 3 weeks | repeated dose toxicity | p.39 |
EPA ToxRefDB v3 23 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| EPA ToxRefDB v3 | LEL | =7.5 | mg/kg bw/day | dog (beagle; beagle) | oral | 0 week to 52 week | CHR | study_id=6107; toxval_study_source_id=studyid6107_Adult_F0_F_systemic; toxval_effect_list=in life observation-clinical signs-fur (altered appearance)|pathology gross-uterus-discolored|in life observation-clinical signs-tremors|in life observation-clinical signs-scabbing|pathology microscopic-liver-hypertrophy|in life observation-clinical signs-emaciation|pathology microscopic-liver-pigmentation|clinical chemistry-alanine aminotransferase (alt/sgpt)-alanine aminotransferase (alt/sgpt)|pathology microscopic-skin-inflammation|pathology gross-skin-mass|in life observation-mortality-mortality|pathology gross-oral mucosa-mass|in life observation-clinical signs-reduced activity|pathology microscopic-kidney-concretion|in life observation-clinical signs-skin ulceration|pathology microscopic-nerve-mineralization|in life observation-clinical signs-abnormal gait|pathology gross-skin-discolored|pathology gross-stomach-discolored|pathology microscopic-liver-inclusion body intracytoplasmic; dose_level=1; study_year=1995; study_citation=Horner, SA. (1995) Polyhexamethylene biguanide: 1 year dietary toxicity study in dogs. Zeneca Central Tox Lab, Cheshire, UK. Lab report no. CTL/P/4488; Study no. PD0947. MRID 43620501.; dsstox_substance_id=DTXSID2035726; admin_method=Feed; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| EPA ToxRefDB v3 | LEL | =40 | mg/kg bw/day | rabbit (new zealand white; New Zealand White) | oral | 8 GD to 20 GD | DEV | study_id=6106; toxval_study_source_id=studyid6106_Adult Pregnancy_F0_F_reproductive; toxval_effect_list=reproductive performance-implantations-implantations|reproductive performance-estrous cycle-corpora lutea|reproductive performance-aborted-aborted|offspring survival early-birth index-birth index|reproductive performance-preimplantation loss-preimplantation loss; dose_level=3; study_year=1993; study_citation=Brammer, A. 1993. Polyhexamethylene biguanide: Developmental toxicity study in the rabbit. Zeneca Central Tox Lab., Study no. RBO 614. MRID 42865901.; dsstox_substance_id=DTXSID2035726; admin_method=Gavage/Intubation; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| EPA ToxRefDB v3 | LEL | =45.3 | mg/kg bw/day | rat (sprague dawley; Alpk: APSD) | oral | 0 week to 105 week | CHR | study_id=6110; toxval_study_source_id=studyid6110_Adult_F0_F_systemic; toxval_effect_list=in life observation-mortality-mortality|in life observation-body weight-body weight|organ weight-liver-absolute|pathology microscopic-liver-hemangiosarcoma|in life observation-food consumption-food efficiency|clinical chemistry-alkaline phosphatase (alp/alk)-alkaline phosphatase (alp/alk); dose_level=2; study_year=1996; study_citation=Horner, SA. (1996) Polyhexamethylene biguanide: 2-year feeding study in rats. Zeneca Central Tox Lab, Alderley Park, Macclesfield, Cheshire, UK. Lab Project ID CTL/P/4663, Study no. PR0936, June 5, 1996. MRID 44059301.; dsstox_substance_id=DTXSID2035726; admin_method=Feed; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| EPA ToxRefDB v3 | LEL | =55 | mg/kg bw/day | mouse (cd1) | oral | 0 week to 104 week | CHR | study_id=6109; toxval_study_source_id=studyid6109_Adult_F0_M_systemic; toxval_effect_list=pathology microscopic-intestine large-inflammation|pathology gross-ear-lesion(s) (nos)|in life observation-body weight-body weight gain|organ weight-liver-absolute|pathology microscopic-intestine large-metaplasia|pathology gross-liver-mass|pathology microscopic-liver-hemosiderosis|in life observation-clinical signs-swelling|pathology microscopic-intestine large-hyperplasia|pathology microscopic-liver-hypertrophy|pathology microscopic-liver-lipofuscin deposits|pathology microscopic-liver-nuclear alteration|pathology microscopic-gallbladder-hyperplasia|pathology gross-gallbladder-distended|in life observation-mortality-mortality|pathology gross-skin-reduced size|organ weight-testes-absolute|hematology-erythrocyte (rbc) count differential-erythrocyte (rbc)|pathology microscopic-intestine large-squamous cell carcinoma|in life observation-food consumption-food efficiency|pathology gross-intestine large-[other]|pathology gross-intestine large-mass|pathology microscopic-gallbladder-papilloma|hematology-hematocrit (hct)-hematocrit (hct)|pathology microscopic-liver-inflammation|pathology microscopic-gallbladder-dilatation|pathology gross-intestine large-discolored|pathology microscopic-liver-hemangiosarcoma|in life observation-food consumption-food consumption|pathology microscopic-skin-depletion|organ weight-testes-relative to body weight|pathology gross-testes-reduced size|hematology-hemoglobin (hgb)-hemoglobin (hgb)|pathology gross-intestine large-distended|in life observation-body weight-body weight|pathology microscopic-spleen-hematopoietic cell proliferation|pathology gross-intestine large-enlarged|pathology gross-intestine large-prolapse; dose_level=1; study_year=1996; study_citation=Milburn G.M. (1996) Polyhexamethylene Biguanide: Two Year Oncogenicity Study in Mice. Central Toxicology Laboratory, Alderley Park, Macclesfield, Cheshire, UK SK10 4TJ. Laboratory Study No. PM0937. June 21, 1996. MRID 44074201. Unpublished; dsstox_substance_id=DTXSID2035726; admin_method=Feed; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| EPA ToxRefDB v3 | LEL | =60 | mg/kg bw/day | rat (sprague dawley; Alpk: APSD) | dermal | 0 day to 21 day | SAC | study_id=6103; toxval_study_source_id=studyid6103_Adult_F0_F_systemic; toxval_effect_list=in life observation-clinical signs-scabbing|in life observation-clinical signs-erythema|pathology microscopic-skin-edema|pathology microscopic-skin-infiltration cellular; dose_level=2; study_year=1993; study_citation=Lees, D and AM Leah. 1993. PHMB: 21-day dermal toxicity study in the rat. Zeneca Central Tox Lab, Study no. LR0559. MRID 43047701.; dsstox_substance_id=DTXSID2035726; admin_method=Topical; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| EPA ToxRefDB v3 | LEL | =69.6 | mg/kg bw/day | rat (sprague dawley; Alpk: APSD) | oral | 10 weeks (premating) to 2 generation | MGR | study_id=2360; toxval_study_source_id=studyid2360_Adult_F0_M_systemic; toxval_effect_list=organ weight-kidney-nos|organ weight-epididymis-nos|in life observation-body weight-body weight|in life observation-food consumption-food efficiency; dose_level=2; study_year=1995; study_citation=PMRA; Milburn, G.M. (1995)Polyhexamethylene Biguanide: Multigeneration Study in the Rat. Sudy performed by Zeneca Central Toxicology Laboratory Study Nos: RR0621/F0; RR0621/F1. Study Completed March 8, 1995. Unpublished. MRID # 43617401.; dsstox_substance_id=DTXSID2035726; admin_method=Feed; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| EPA ToxRefDB v3 | LEL | =217 | mg/kg bw/day | mouse (cd1) | oral | 0 week to 104 week | CHR | study_id=6109; toxval_study_source_id=studyid6109_Adult_F0_F_systemic; toxval_effect_list=pathology microscopic-liver-hypertrophy|organ weight-liver-absolute|pathology microscopic-liver-hemosiderosis|in life observation-body weight-body weight gain|pathology microscopic-liver-inflammation|hematology-hemoglobin (hgb)-hemoglobin (hgb)|pathology microscopic-liver-lipofuscin deposits|pathology microscopic-gallbladder-dilatation|pathology microscopic-intestine large-metaplasia|pathology gross-liver-mass|pathology microscopic-liver-nuclear alteration|pathology gross-ear-lesion(s) (nos)|hematology-erythrocyte (rbc) count differential-erythrocyte (rbc)|pathology microscopic-skin-depletion|hematology-hematocrit (hct)-hematocrit (hct)|pathology gross-skin-reduced size|pathology microscopic-intestine large-inflammation|pathology microscopic-intestine large-hyperplasia|organ weight-adrenal gland-absolute|in life observation-clinical signs-swelling|pathology gross-intestine large-enlarged|pathology microscopic-intestine large-squamous cell carcinoma|pathology microscopic-spleen-hemangiosarcoma|pathology microscopic-liver-hemangiosarcoma|in life observation-food consumption-food consumption|pathology microscopic-gallbladder-hyperplasia|pathology microscopic-spleen-hematopoietic cell proliferation|organ weight-adrenal gland-relative to body weight|in life observation-body weight-body weight|in life observation-food consumption-food efficiency|pathology gross-intestine large-distended|in life observation-mortality-mortality|pathology gross-gallbladder-distended|pathology gross-intestine large-[other]|pathology microscopic-ovary-hemangiosarcoma; dose_level=2; study_year=1996; study_citation=Milburn G.M. (1996) Polyhexamethylene Biguanide: Two Year Oncogenicity Study in Mice. Central Toxicology Laboratory, Alderley Park, Macclesfield, Cheshire, UK SK10 4TJ. Laboratory Study No. PM0937. June 21, 1996. MRID 44074201. Unpublished; dsstox_substance_id=DTXSID2035726; admin_method=Feed; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| EPA ToxRefDB v3 | LEL | =258.2 | mg/kg bw/day | rat (sprague dawley; Alpk: APSD) | oral | 10 weeks (premating) to 2 generation | MGR | study_id=2360; toxval_study_source_id=studyid2360_Adult_F0_F_systemic; toxval_effect_list=in life observation-food consumption-food efficiency|in life observation-body weight-body weight; dose_level=3; study_year=1995; study_citation=PMRA; Milburn, G.M. (1995)Polyhexamethylene Biguanide: Multigeneration Study in the Rat. Sudy performed by Zeneca Central Toxicology Laboratory Study Nos: RR0621/F0; RR0621/F1. Study Completed March 8, 1995. Unpublished. MRID # 43617401.; dsstox_substance_id=DTXSID2035726; admin_method=Feed; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| EPA ToxRefDB v3 | LEL | =270.5 | mg/kg bw/day | rat (sprague dawley; Alpk: APSD) | oral | 10 weeks (premating) to 2 generation | MGR | study_id=2360; toxval_study_source_id=studyid2360_Adult_F1_F_systemic; toxval_effect_list=pathology microscopic-kidney-foreign body|pathology microscopic-kidney-hydronephrosis|in life observation-food consumption-food efficiency; dose_level=3; study_year=1995; study_citation=PMRA; Milburn, G.M. (1995)Polyhexamethylene Biguanide: Multigeneration Study in the Rat. Sudy performed by Zeneca Central Toxicology Laboratory Study Nos: RR0621/F0; RR0621/F1. Study Completed March 8, 1995. Unpublished. MRID # 43617401.; dsstox_substance_id=DTXSID2035726; admin_method=Feed; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| EPA ToxRefDB v3 | LEL | =275 | mg/kg bw/day | dog (beagle) | oral | 0 day to 90 day | SUB | study_id=6126; toxval_study_source_id=studyid6126_Adult_F0_F_systemic; toxval_effect_list=in life observation-body weight-body weight gain; dose_level=2; study_year=1966; study_citation=Ninety-Day Oral Toxicity of Antibacterial 9073-Beagle Dogs (Imperial Chemical Industries Limited, Industrial Hygiene Research Laboratories Report No. IHR, September 1966.; dsstox_substance_id=DTXSID2035726; admin_method=Feed; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| EPA ToxRefDB v3 | LOAEL | =75 | mg/kg bw/day | dog (beagle; beagle) | oral | 0 week to 52 week | CHR | study_id=6107; toxval_study_source_id=studyid6107_Adult_F0_F_systemic; toxval_effect_list=in life observation-clinical signs-tremors|clinical chemistry-alanine aminotransferase (alt/sgpt)-alanine aminotransferase (alt/sgpt)|in life observation-clinical signs-reduced activity|in life observation-clinical signs-abnormal gait; dose_level=3; study_year=1995; study_citation=Horner, SA. (1995) Polyhexamethylene biguanide: 1 year dietary toxicity study in dogs. Zeneca Central Tox Lab, Cheshire, UK. Lab report no. CTL/P/4488; Study no. PD0947. MRID 43620501.; dsstox_substance_id=DTXSID2035726; admin_method=Feed; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| EPA ToxRefDB v3 | LOAEL | >126.1 | mg/kg bw/day | rat (sprague dawley; Alpk: APSD) | oral | 0 week to 105 week | CHR | study_id=6110; toxval_study_source_id=studyid6110_Adult_F0_F_NA; dose_level=3; study_year=1996; study_citation=Horner, SA. (1996) Polyhexamethylene biguanide: 2-year feeding study in rats. Zeneca Central Tox Lab, Alderley Park, Macclesfield, Cheshire, UK. Lab Project ID CTL/P/4663, Study no. PR0936, June 5, 1996. MRID 44059301.; dsstox_substance_id=DTXSID2035726; admin_method=Feed; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| EPA ToxRefDB v3 | LOAEL | =167 | mg/kg bw/day | mouse (cd1) | oral | 0 week to 104 week | CHR | study_id=6109; toxval_study_source_id=studyid6109_Adult_F0_M_systemic; toxval_effect_list=in life observation-body weight-body weight gain|pathology microscopic-liver-hemosiderosis|pathology microscopic-liver-hypertrophy|pathology microscopic-intestine large-inflammation|pathology microscopic-liver-lipofuscin deposits|pathology microscopic-liver-nuclear alteration; dose_level=2; study_year=1996; study_citation=Milburn G.M. (1996) Polyhexamethylene Biguanide: Two Year Oncogenicity Study in Mice. Central Toxicology Laboratory, Alderley Park, Macclesfield, Cheshire, UK SK10 4TJ. Laboratory Study No. PM0937. June 21, 1996. MRID 44074201. Unpublished; dsstox_substance_id=DTXSID2035726; admin_method=Feed; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| EPA ToxRefDB v3 | NEL | >0 | mg/kg bw/day | dog (beagle; beagle) | oral | 0 week to 52 week | CHR | study_id=6107; toxval_study_source_id=studyid6107_Adult_F0_F_systemic; toxval_effect_list=pathology gross-skin-mass|in life observation-mortality-mortality|in life observation-clinical signs-skin ulceration|pathology gross-oral mucosa-mass|in life observation-clinical signs-reduced activity|pathology microscopic-kidney-concretion|pathology microscopic-nerve-mineralization|in life observation-clinical signs-fur (altered appearance)|in life observation-clinical signs-abnormal gait|pathology microscopic-liver-inclusion body intracytoplasmic|pathology gross-stomach-discolored|pathology gross-skin-discolored|in life observation-clinical signs-tremors|pathology gross-uterus-discolored|in life observation-clinical signs-scabbing|pathology microscopic-liver-hypertrophy|pathology microscopic-liver-pigmentation|in life observation-clinical signs-emaciation|clinical chemistry-alanine aminotransferase (alt/sgpt)-alanine aminotransferase (alt/sgpt)|pathology microscopic-skin-inflammation; dose_level=0; study_year=1995; study_citation=Horner, SA. (1995) Polyhexamethylene biguanide: 1 year dietary toxicity study in dogs. Zeneca Central Tox Lab, Cheshire, UK. Lab report no. CTL/P/4488; Study no. PD0947. MRID 43620501.; dsstox_substance_id=DTXSID2035726; admin_method=Feed; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| EPA ToxRefDB v3 | NEL | =14.9 | mg/kg bw/day | rat (sprague dawley; Alpk: APSD) | oral | 0 week to 105 week | CHR | study_id=6110; toxval_study_source_id=studyid6110_Adult_F0_F_systemic; toxval_effect_list=organ weight-liver-absolute|pathology microscopic-liver-hemangiosarcoma|in life observation-food consumption-food efficiency|clinical chemistry-alkaline phosphatase (alp/alk)-alkaline phosphatase (alp/alk)|in life observation-mortality-mortality|in life observation-body weight-body weight|organ weight-liver-relative to body weight; dose_level=1; study_year=1996; study_citation=Horner, SA. (1996) Polyhexamethylene biguanide: 2-year feeding study in rats. Zeneca Central Tox Lab, Alderley Park, Macclesfield, Cheshire, UK. Lab Project ID CTL/P/4663, Study no. PR0936, June 5, 1996. MRID 44059301.; dsstox_substance_id=DTXSID2035726; admin_method=Feed; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| EPA ToxRefDB v3 | NEL | =20 | mg/kg bw/day | rat (sprague dawley; Alpk: APSD) | dermal | 0 day to 21 day | SAC | study_id=6103; toxval_study_source_id=studyid6103_Adult_F0_F_systemic; toxval_effect_list=in life observation-clinical signs-scabbing|in life observation-clinical signs-erythema|pathology microscopic-skin-infiltration cellular|pathology microscopic-skin-edema; dose_level=1; study_year=1993; study_citation=Lees, D and AM Leah. 1993. PHMB: 21-day dermal toxicity study in the rat. Zeneca Central Tox Lab, Study no. LR0559. MRID 43047701.; dsstox_substance_id=DTXSID2035726; admin_method=Topical; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| EPA ToxRefDB v3 | NEL | =23 | mg/kg bw/day | rat (sprague dawley; Alpk: APSD) | oral | 10 weeks (premating) to 2 generation | MGR | study_id=2360; toxval_study_source_id=studyid2360_Adult_F0_M_systemic; toxval_effect_list=organ weight-epididymis-nos|organ weight-kidney-nos|in life observation-food consumption-food efficiency|in life observation-body weight-body weight; dose_level=1; study_year=1995; study_citation=PMRA; Milburn, G.M. (1995)Polyhexamethylene Biguanide: Multigeneration Study in the Rat. Sudy performed by Zeneca Central Toxicology Laboratory Study Nos: RR0621/F0; RR0621/F1. Study Completed March 8, 1995. Unpublished. MRID # 43617401.; dsstox_substance_id=DTXSID2035726; admin_method=Feed; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| EPA ToxRefDB v3 | NEL | =36.3 | mg/kg bw/day | rat (sprague dawley; Alpk: APSD) | oral | 0 week to 105 week | CHR | study_id=6110; toxval_study_source_id=studyid6110_Adult_F0_M_systemic; toxval_effect_list=organ weight-liver-relative to body weight|pathology microscopic-liver-fatty change|clinical chemistry-alkaline phosphatase (alp/alk)-alkaline phosphatase (alp/alk)|pathology microscopic-liver-spongiosis hepatis|in life observation-body weight-body weight|in life observation-food consumption-food efficiency|organ weight-liver-absolute; dose_level=2; study_year=1996; study_citation=Horner, SA. (1996) Polyhexamethylene biguanide: 2-year feeding study in rats. Zeneca Central Tox Lab, Alderley Park, Macclesfield, Cheshire, UK. Lab Project ID CTL/P/4663, Study no. PR0936, June 5, 1996. MRID 44059301.; dsstox_substance_id=DTXSID2035726; admin_method=Feed; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| EPA ToxRefDB v3 | NEL | =69 | mg/kg bw/day | mouse (cd1) | oral | 0 week to 104 week | CHR | study_id=6109; toxval_study_source_id=studyid6109_Adult_F0_F_systemic; toxval_effect_list=pathology gross-skin-reduced size|in life observation-mortality-mortality|pathology microscopic-intestine large-inflammation|pathology microscopic-intestine large-hyperplasia|pathology gross-intestine large-distended|in life observation-food consumption-food efficiency|in life observation-body weight-body weight|hematology-hematocrit (hct)-hematocrit (hct)|pathology microscopic-skin-depletion|pathology microscopic-ovary-hemangiosarcoma|pathology gross-intestine large-[other]|pathology gross-ear-lesion(s) (nos)|pathology microscopic-intestine large-metaplasia|pathology microscopic-liver-nuclear alteration|pathology gross-liver-mass|hematology-erythrocyte (rbc) count differential-erythrocyte (rbc)|pathology gross-gallbladder-distended|pathology microscopic-spleen-hemangiosarcoma|pathology microscopic-intestine large-squamous cell carcinoma|pathology gross-intestine large-enlarged|pathology microscopic-gallbladder-dilatation|in life observation-clinical signs-swelling|pathology microscopic-liver-lipofuscin deposits|pathology microscopic-liver-inflammation|organ weight-adrenal gland-absolute|hematology-hemoglobin (hgb)-hemoglobin (hgb)|organ weight-adrenal gland-relative to body weight|pathology microscopic-spleen-hematopoietic cell proliferation|in life observation-body weight-body weight gain|pathology microscopic-liver-hemosiderosis|pathology microscopic-gallbladder-hyperplasia|pathology microscopic-liver-hypertrophy|in life observation-food consumption-food consumption|organ weight-liver-absolute|pathology microscopic-liver-hemangiosarcoma; dose_level=1; study_year=1996; study_citation=Milburn G.M. (1996) Polyhexamethylene Biguanide: Two Year Oncogenicity Study in Mice. Central Toxicology Laboratory, Alderley Park, Macclesfield, Cheshire, UK SK10 4TJ. Laboratory Study No. PM0937. June 21, 1996. MRID 44074201. Unpublished; dsstox_substance_id=DTXSID2035726; admin_method=Feed; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| EPA ToxRefDB v3 | NEL | =77 | mg/kg bw/day | rat (sprague dawley; Alpk: APSD) | oral | 10 weeks (premating) to 2 generation | MGR | study_id=2360; toxval_study_source_id=studyid2360_Adult_F0_F_systemic; toxval_effect_list=in life observation-body weight-body weight|in life observation-food consumption-food efficiency; dose_level=2; study_year=1995; study_citation=PMRA; Milburn, G.M. (1995)Polyhexamethylene Biguanide: Multigeneration Study in the Rat. Sudy performed by Zeneca Central Toxicology Laboratory Study Nos: RR0621/F0; RR0621/F1. Study Completed March 8, 1995. Unpublished. MRID # 43617401.; dsstox_substance_id=DTXSID2035726; admin_method=Feed; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| EPA ToxRefDB v3 | NEL | =79.2 | mg/kg bw/day | rat (sprague dawley; Alpk: APSD) | oral | 10 weeks (premating) to 2 generation | MGR | study_id=2360; toxval_study_source_id=studyid2360_Adult_F1_F_systemic; toxval_effect_list=pathology microscopic-kidney-hydronephrosis|pathology microscopic-kidney-foreign body|in life observation-food consumption-food efficiency; dose_level=2; study_year=1995; study_citation=PMRA; Milburn, G.M. (1995)Polyhexamethylene Biguanide: Multigeneration Study in the Rat. Sudy performed by Zeneca Central Toxicology Laboratory Study Nos: RR0621/F0; RR0621/F1. Study Completed March 8, 1995. Unpublished. MRID # 43617401.; dsstox_substance_id=DTXSID2035726; admin_method=Feed; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| EPA ToxRefDB v3 | NEL | =137.5 | mg/kg bw/day | dog (beagle) | oral | 0 day to 90 day | SUB | study_id=6126; toxval_study_source_id=studyid6126_Adult_F0_F_systemic; toxval_effect_list=in life observation-body weight-body weight gain; dose_level=1; study_year=1966; study_citation=Ninety-Day Oral Toxicity of Antibacterial 9073-Beagle Dogs (Imperial Chemical Industries Limited, Industrial Hygiene Research Laboratories Report No. IHR, September 1966.; dsstox_substance_id=DTXSID2035726; admin_method=Feed; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| EPA ToxRefDB v3 | NOAEL | =37.5 | mg/kg bw/day | dog (beagle; beagle) | oral | 0 week to 52 week | CHR | study_id=6107; toxval_study_source_id=studyid6107_Adult_F0_F_systemic; toxval_effect_list=in life observation-clinical signs-abnormal gait|pathology microscopic-liver-inclusion body intracytoplasmic|pathology gross-stomach-discolored|pathology gross-skin-discolored|pathology microscopic-nerve-mineralization|in life observation-clinical signs-fur (altered appearance)|in life observation-mortality-mortality|in life observation-clinical signs-skin ulceration|pathology microscopic-kidney-concretion|pathology gross-oral mucosa-mass|in life observation-clinical signs-reduced activity|pathology gross-skin-mass|pathology microscopic-skin-inflammation|pathology microscopic-liver-pigmentation|in life observation-clinical signs-emaciation|clinical chemistry-alanine aminotransferase (alt/sgpt)-alanine aminotransferase (alt/sgpt)|pathology microscopic-liver-hypertrophy|in life observation-clinical signs-tremors|pathology gross-uterus-discolored|in life observation-clinical signs-scabbing; dose_level=2; study_year=1995; study_citation=Horner, SA. (1995) Polyhexamethylene biguanide: 1 year dietary toxicity study in dogs. Zeneca Central Tox Lab, Cheshire, UK. Lab report no. CTL/P/4488; Study no. PD0947. MRID 43620501.; dsstox_substance_id=DTXSID2035726; admin_method=Feed; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
ToxValDB AU DWG 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB AU DWG | NOEL | =20 | mg/kg bw/day | Rabbit | oral | (developmental) | reproduction developmental | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/68c82db5e4b02565fc7d237c; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.nhmrc.gov.au; SUBSOURCE_URL=https://www.nhmrc.gov.au/sites/default/files/documents/attachments/publications/Australian_Drinking_Water_Guidelines_ADWG_V3-8_Sep2022.pdf; TOXICOLOGICAL_EFFECT=maternotoxicity in pregnant rabbits; STUDY_GROUP=AU DWG:15951727:-:--; QC_CATEGORY=Manually extracted from unstructured data source; Source overall passed QC, and this record was manually checked; QC_STATUS=pass; SOURCE_HASH=ToxValhc_c3a8397d05993e9f88f63709a33b13c9 |
ToxValDB EPA OPP 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB EPA OPP | PAD (RfD) | =0.2 | mg/kg bw/day | Human | oral | - | Toxicity Value | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/63d99625e4b02a0c3a37c5d8; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.epa.gov/sdwa/2021-human-health-benchmarks-pesticides; YEAR=2021; ORIGINAL_YEAR=2021; STUDY_GROUP=EPA OPP_dup_HHBP_15789894_15789896:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_2fa3c50dac7acf3bef7fd3608145064b |
ToxValDB ToxRefDB 22 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB ToxRefDB | LEL | =7.5 | mg/kg bw/day | Dog | oral | chronic; 52 weeks | chronic | LONG_REF=Horner, SA. (1995) Polyhexamethylene biguanide: 1 year dietary toxicity study in dogs. Zeneca Central Tox Lab, Cheshire, UK. Lab report no. CTL/P/4488; Study no. PD0947. MRID 43620501.; TITLE=Polyhexamethylene biguanide: 1 year dietary toxicity study in dogs; AUTHOR=Horner, SA; EXTERNAL_SOURCE_ID=6107; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=1995; ORIGINAL_YEAR=1995; TOXICOLOGICAL_EFFECT=systemic: in life observation-clinical signs-fur (altered appearance)|systemic: pathology gross-skin-mass|systemic: pathology gross-uterus-discolored|systemic: in life observation-clinical signs-emaciation|systemic: pathology microscopic-liver-pigmentation|systemic: in life observation-clinical signs-tremors|systemic: pathology microscopic-nerve-mineralization|systemic: in life observation-clinical signs-scabbing|systemic: clinical chemistry-alanine aminotransferase (alt/sgpt)-alanine aminotransferase (alt/sgpt)|systemic: in life observation-clinical signs-abnormal gait|systemic: in life observation-mortality-mortality|systemic: pathology microscopic-skin-inflammation|systemic: pathology gross-skin-discolored|systemic: pathology gross-oral mucosa-mass|systemic: in life observation-clinical signs-reduced activity|systemic: pathology microscopic-kidney-concretion|systemic: pathology gross-stomach-discolored|systemic: pathology microscopic-liver-inclusion body intracytoplasmic|systemic: pathology microscopic-liver-hypertrophy|systemic: in life observation-clinical signs-skin ulceration; TOXICOLOGICAL_EFFECT_CATEGORY=clinical chemistry|clinical signs|gross pathology|mortality/survival|nonneoplastic histopathology; STUDY_GROUP=ToxRefDB_dup_-_15710949_15710950_15710951:F:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_8e1e97b40678f7ed3ccf8f879ccb97b3 |
| ToxValDB ToxRefDB | LEL | =40 | mg/kg bw/day | Rabbit | oral | short-term (developmental); 13 days | reproduction developmental | LONG_REF=Brammer, A. 1993. Polyhexamethylene biguanide: Developmental toxicity study in the rabbit. Zeneca Central Tox Lab., Study no. RBO 614. MRID 42865901.; TITLE=Polyhexamethylene biguanide: Developmental toxicity study in the rabbit; AUTHOR=Brammer, A; EXTERNAL_SOURCE_ID=6106; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=1993; ORIGINAL_YEAR=1993; TOXICOLOGICAL_EFFECT=reproductive: offspring survival early-birth index-birth index|reproductive: reproductive performance-implantations-implantations|reproductive: reproductive performance-estrous cycle-corpora lutea|reproductive: reproductive performance-aborted-aborted|reproductive: reproductive performance-preimplantation loss-preimplantation loss; TOXICOLOGICAL_EFFECT_CATEGORY=reproduction; STUDY_GROUP=ToxRefDB_dup_-_15710937_15710938:F:F0adult-pregnancy; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_575ce294626617f276d389dcba38741c |
| ToxValDB ToxRefDB | LEL | =45.3 | mg/kg bw/day | Rat | oral | chronic; 105 weeks | chronic | LONG_REF=Horner, SA. (1996) Polyhexamethylene biguanide: 2-year feeding study in rats. Zeneca Central Tox Lab, Alderley Park, Macclesfield, Cheshire, UK. Lab Project ID CTL/P/4663, Study no. PR0936, June 5, 1996. MRID 44059301.; TITLE=Polyhexamethylene biguanide: 2-year feeding study in rats; AUTHOR=Horner, SA; EXTERNAL_SOURCE_ID=6110; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=1996; ORIGINAL_YEAR=1996; TOXICOLOGICAL_EFFECT=systemic: in life observation-mortality-mortality|systemic: in life observation-body weight-body weight|systemic: pathology microscopic-liver-hemangiosarcoma|systemic: clinical chemistry-alkaline phosphatase (alp/alk)-alkaline phosphatase (alp/alk)|systemic: in life observation-food consumption-food efficiency|systemic: organ weight-liver-absolute; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|cancer|clinical chemistry|food and/or water consumption|mortality/survival|organ weight; STUDY_GROUP=ToxRefDB_dup_-_15710963_15710964_15710965_15710966:F:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_0df19c733d350a9f1c3abe2877d106ef |
| ToxValDB ToxRefDB | LEL | =55 | mg/kg bw/day | Mouse | oral | chronic; 104 weeks | chronic | LONG_REF=Milburn G.M. (1996) Polyhexamethylene Biguanide: Two Year Oncogenicity Study in Mice. Central Toxicology Laboratory, Alderley Park, Macclesfield, Cheshire, UK SK10 4TJ. Laboratory Study No. PM0937. June 21, 1996. MRID 44074201. Unpublished; TITLE=Polyhexamethylene Biguanide: Two Year Oncogenicity Study in Mice; AUTHOR=Milburn G.M; EXTERNAL_SOURCE_ID=6109; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=1996; ORIGINAL_YEAR=1996; TOXICOLOGICAL_EFFECT=systemic: pathology microscopic-intestine large-inflammation|systemic: organ weight-liver-absolute|systemic: in life observation-clinical signs-swelling|systemic: pathology gross-ear-lesion(s) (nos)|systemic: in life observation-body weight-body weight gain|systemic: pathology microscopic-intestine large-hyperplasia|systemic: pathology microscopic-liver-hypertrophy|systemic: pathology microscopic-intestine large-metaplasia|systemic: pathology gross-liver-mass|systemic: pathology microscopic-liver-nuclear alteration|systemic: pathology microscopic-liver-hemosiderosis|systemic: pathology microscopic-liver-lipofuscin deposits|systemic: pathology microscopic-gallbladder-hyperplasia|systemic: pathology gross-intestine large-[other]|systemic: pathology gross-intestine large-mass|systemic: hematology-hematocrit (hct)-hematocrit (hct)|systemic: pathology microscopic-gallbladder-papilloma|systemic: pathology microscopic-liver-inflammation|systemic: pathology microscopic-gallbladder-dilatation|systemic: pathology gross-gallbladder-distended|systemic: pathology gross-intestine large-distended|systemic: in life observation-mortality-mortality|systemic: pathology gross-intestine large-discolored|systemic: pathology gross-skin-reduced size|systemic: organ weight-testes-absolute|systemic: pathology microscopic-liver-hemangiosarcoma|systemic: in life observation-body weight-body weight|systemic: hematology-erythrocyte (rbc) count differential-erythrocyte (rbc)|systemic: in life observation-food consumption-food consumption|systemic: pathology microscopic-spleen-hematopoietic cell proliferation|systemic: pathology microscopic-skin-depletion|systemic: organ weight-testes-relative to body weight|systemic: pathology microscopic-intestine large-squamous cell carcinoma|systemic: pathology gross-intestine large-enlarged|systemic: pathology gross-intestine large-prolapse|systemic: pathology gross-testes-reduced size|systemic: in life observation-food consumption-food efficiency|systemic: hematology-hemoglobin (hgb)-hemoglobin (hgb); TOXICOLOGICAL_EFFECT_CATEGORY=body weight|cancer|clinical signs|food and/or water consumption|gross pathology|hematology|mortality/survival|nonneoplastic histopathology|organ weight; STUDY_GROUP=ToxRefDB_dup_-_15710960_15710961_15710962:M:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_4befb5bb06554af366e4d741a13d0027 |
| ToxValDB ToxRefDB | LEL | =60 | mg/kg bw/day | Rat | dermal | short-term; 21 days | short-term | LONG_REF=Lees, D & AM Leah. 1993. PHMB: 21-day dermal toxicity study in the rat. Zeneca Central Tox Lab, Study no. LR0559. MRID 43047701.; TITLE=PHMB: 21-day dermal toxicity study in the rat; AUTHOR=Lees, D & AM Leah; EXTERNAL_SOURCE_ID=6103; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=1993; ORIGINAL_YEAR=1993; TOXICOLOGICAL_EFFECT=systemic: in life observation-clinical signs-scabbing|systemic: in life observation-clinical signs-erythema|systemic: pathology microscopic-skin-edema|systemic: pathology microscopic-skin-infiltration cellular; STUDY_GROUP=ToxRefDB_dup_-_15710929_15710930_15710931_15710932:F:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_bc8b49ef9f05a4a53068c8e838498796 |
| ToxValDB ToxRefDB | LEL | =69.6 | mg/kg bw/day | Rat | oral | chronic (developmental) | reproduction developmental | LONG_REF=PMRA; Milburn, G.M. (1995)Polyhexamethylene Biguanide: Multigeneration Study in the Rat. Sudy performed by Zeneca Central Toxicology Laboratory Study Nos: RR0621/F0; RR0621/F1. Study Completed March 8, 1995. Unpublished. MRID # 43617401.; TITLE=Polyhexamethylene Biguanide: Multigeneration Study in the Rat; AUTHOR=Milburn, G.M; EXTERNAL_SOURCE_ID=2360; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=1995; ORIGINAL_YEAR=1995; TOXICOLOGICAL_EFFECT=systemic: organ weight-epididymis-nos|systemic: organ weight-kidney-nos|systemic: in life observation-body weight-body weight|systemic: in life observation-food consumption-food efficiency; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|food and/or water consumption|organ weight; STUDY_GROUP=ToxRefDB_dup_-_15693922_15693923_15693924_15693925:M:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_0149a29c47036433bd27ae36ddf04eb9 |
| ToxValDB ToxRefDB | LEL | =217 | mg/kg bw/day | Mouse | oral | chronic; 104 weeks | chronic | LONG_REF=Milburn G.M. (1996) Polyhexamethylene Biguanide: Two Year Oncogenicity Study in Mice. Central Toxicology Laboratory, Alderley Park, Macclesfield, Cheshire, UK SK10 4TJ. Laboratory Study No. PM0937. June 21, 1996. MRID 44074201. Unpublished; TITLE=Polyhexamethylene Biguanide: Two Year Oncogenicity Study in Mice; AUTHOR=Milburn G.M; EXTERNAL_SOURCE_ID=6109; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=1996; ORIGINAL_YEAR=1996; TOXICOLOGICAL_EFFECT=systemic: pathology microscopic-intestine large-metaplasia|systemic: pathology gross-liver-mass|systemic: pathology microscopic-liver-hypertrophy|systemic: pathology microscopic-liver-nuclear alteration|systemic: pathology microscopic-liver-inflammation|systemic: pathology gross-ear-lesion(s) (nos)|systemic: hematology-erythrocyte (rbc) count differential-erythrocyte (rbc)|systemic: organ weight-liver-absolute|systemic: hematology-hemoglobin (hgb)-hemoglobin (hgb)|systemic: pathology microscopic-skin-depletion|systemic: hematology-hematocrit (hct)-hematocrit (hct)|systemic: pathology gross-skin-reduced size|systemic: pathology microscopic-liver-lipofuscin deposits|systemic: pathology microscopic-liver-hemosiderosis|systemic: in life observation-body weight-body weight gain|systemic: pathology microscopic-intestine large-inflammation|systemic: pathology microscopic-gallbladder-dilatation|systemic: pathology microscopic-intestine large-hyperplasia|systemic: in life observation-body weight-body weight|systemic: pathology gross-gallbladder-distended|systemic: pathology microscopic-liver-hemangiosarcoma|systemic: in life observation-food consumption-food consumption|systemic: organ weight-adrenal gland-absolute|systemic: pathology microscopic-gallbladder-hyperplasia|systemic: in life observation-food consumption-food efficiency|systemic: pathology gross-intestine large-[other]|systemic: pathology microscopic-ovary-hemangiosarcoma|systemic: pathology microscopic-spleen-hematopoietic cell proliferation|systemic: in life observation-clinical signs-swelling|systemic: pathology gross-intestine large-distended|systemic: pathology gross-intestine large-enlarged|systemic: pathology microscopic-intestine large-squamous cell carcinoma|systemic: pathology microscopic-spleen-hemangiosarcoma|systemic: in life observation-mortality-mortality|systemic: organ weight-adrenal gland-relative to body weight; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|cancer|clinical signs|food and/or water consumption|gross pathology|hematology|mortality/survival|nonneoplastic histopathology|organ weight; STUDY_GROUP=ToxRefDB_dup_-_15710956_15710957_15710958_15710959:F:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_3f89de2672bf99f0902ade6308e585f4 |
| ToxValDB ToxRefDB | LEL | =258.2 | mg/kg bw/day | Rat | oral | chronic (developmental) | reproduction developmental | LONG_REF=PMRA; Milburn, G.M. (1995)Polyhexamethylene Biguanide: Multigeneration Study in the Rat. Sudy performed by Zeneca Central Toxicology Laboratory Study Nos: RR0621/F0; RR0621/F1. Study Completed March 8, 1995. Unpublished. MRID # 43617401.; TITLE=Polyhexamethylene Biguanide: Multigeneration Study in the Rat; AUTHOR=Milburn, G.M; EXTERNAL_SOURCE_ID=2360; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=1995; ORIGINAL_YEAR=1995; TOXICOLOGICAL_EFFECT=systemic: in life observation-food consumption-food efficiency|systemic: in life observation-body weight-body weight; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|food and/or water consumption; STUDY_GROUP=ToxRefDB_dup_-_15693918_15693919_15693920_15693921:F:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_54b56001791f0da0eeee6fb37ffc1a34 |
| ToxValDB ToxRefDB | LEL | =270.5 | mg/kg bw/day | Rat | oral | chronic (developmental) | reproduction developmental | LONG_REF=PMRA; Milburn, G.M. (1995)Polyhexamethylene Biguanide: Multigeneration Study in the Rat. Sudy performed by Zeneca Central Toxicology Laboratory Study Nos: RR0621/F0; RR0621/F1. Study Completed March 8, 1995. Unpublished. MRID # 43617401.; TITLE=Polyhexamethylene Biguanide: Multigeneration Study in the Rat; AUTHOR=Milburn, G.M; EXTERNAL_SOURCE_ID=2360; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=1995; ORIGINAL_YEAR=1995; TOXICOLOGICAL_EFFECT=systemic: pathology microscopic-kidney-foreign body|systemic: pathology microscopic-kidney-hydronephrosis|systemic: in life observation-food consumption-food efficiency; TOXICOLOGICAL_EFFECT_CATEGORY=food and/or water consumption|nonneoplastic histopathology; STUDY_GROUP=ToxRefDB_dup_-_15693926_15693927_15693928_15693929:F:F1adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_d4fa2c6587721b00f05bebc306914f51 |
| ToxValDB ToxRefDB | LEL | =275 | mg/kg bw/day | Dog | oral | subchronic; 90 days | subchronic | LONG_REF=Ninety-Day Oral Toxicity of Antibacterial 9073-Beagle Dogs (Imperial Chemical Industries Limited, Industrial Hygiene Research Laboratories Report No. IHR, September 1966.; TITLE=Ninety-Day Oral Toxicity of Antibacterial 9073-Beagle Dogs; AUTHOR=Imperial Chemical Industries Limited; EXTERNAL_SOURCE_ID=6126; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=1966; ORIGINAL_YEAR=1966; TOXICOLOGICAL_EFFECT=systemic: in life observation-body weight-body weight gain; TOXICOLOGICAL_EFFECT_CATEGORY=body weight; STUDY_GROUP=ToxRefDB_dup_-_15710991_15710992_15710993_15710994:F:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_29cc5938aa713ae379f772410ec2b1d4 |
| ToxValDB ToxRefDB | LOAEL | =75 | mg/kg bw/day | Dog | oral | chronic; 52 weeks | chronic | LONG_REF=Horner, SA. (1995) Polyhexamethylene biguanide: 1 year dietary toxicity study in dogs. Zeneca Central Tox Lab, Cheshire, UK. Lab report no. CTL/P/4488; Study no. PD0947. MRID 43620501.; TITLE=Polyhexamethylene biguanide: 1 year dietary toxicity study in dogs; AUTHOR=Horner, SA; EXTERNAL_SOURCE_ID=6107; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=1995; ORIGINAL_YEAR=1995; TOXICOLOGICAL_EFFECT=systemic: in life observation-clinical signs-tremors|systemic: clinical chemistry-alanine aminotransferase (alt/sgpt)-alanine aminotransferase (alt/sgpt)|systemic: in life observation-clinical signs-abnormal gait|systemic: in life observation-clinical signs-reduced activity; TOXICOLOGICAL_EFFECT_CATEGORY=clinical chemistry|clinical signs; STUDY_GROUP=ToxRefDB_dup_-_15710949_15710950_15710951:F:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_03ce4592deca9e2a6915cb79c52f4576 |
| ToxValDB ToxRefDB | LOAEL | >126.1 | mg/kg bw/day | Rat | oral | chronic; 105 weeks | chronic | LONG_REF=Horner, SA. (1996) Polyhexamethylene biguanide: 2-year feeding study in rats. Zeneca Central Tox Lab, Alderley Park, Macclesfield, Cheshire, UK. Lab Project ID CTL/P/4663, Study no. PR0936, June 5, 1996. MRID 44059301.; TITLE=Polyhexamethylene biguanide: 2-year feeding study in rats; AUTHOR=Horner, SA; EXTERNAL_SOURCE_ID=6110; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=1996; ORIGINAL_YEAR=1996; STUDY_GROUP=ToxRefDB_dup_-_15710963_15710964_15710965_15710966:F:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_b9ff89ceb4a1a46c362d9308cb5415c1 |
| ToxValDB ToxRefDB | LOAEL | =167 | mg/kg bw/day | Mouse | oral | chronic; 104 weeks | chronic | LONG_REF=Milburn G.M. (1996) Polyhexamethylene Biguanide: Two Year Oncogenicity Study in Mice. Central Toxicology Laboratory, Alderley Park, Macclesfield, Cheshire, UK SK10 4TJ. Laboratory Study No. PM0937. June 21, 1996. MRID 44074201. Unpublished; TITLE=Polyhexamethylene Biguanide: Two Year Oncogenicity Study in Mice; AUTHOR=Milburn G.M; EXTERNAL_SOURCE_ID=6109; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=1996; ORIGINAL_YEAR=1996; TOXICOLOGICAL_EFFECT=systemic: in life observation-body weight-body weight gain|systemic: pathology microscopic-liver-hypertrophy|systemic: pathology microscopic-intestine large-inflammation|systemic: pathology microscopic-liver-nuclear alteration|systemic: pathology microscopic-liver-hemosiderosis|systemic: pathology microscopic-liver-lipofuscin deposits; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|nonneoplastic histopathology; STUDY_GROUP=ToxRefDB_dup_-_15710960_15710961_15710962:M:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_a9ecb385529e1ce77054d6011883a9ad |
| ToxValDB ToxRefDB | NEL | =14.9 | mg/kg bw/day | Rat | oral | chronic; 105 weeks | chronic | LONG_REF=Horner, SA. (1996) Polyhexamethylene biguanide: 2-year feeding study in rats. Zeneca Central Tox Lab, Alderley Park, Macclesfield, Cheshire, UK. Lab Project ID CTL/P/4663, Study no. PR0936, June 5, 1996. MRID 44059301.; TITLE=Polyhexamethylene biguanide: 2-year feeding study in rats; AUTHOR=Horner, SA; EXTERNAL_SOURCE_ID=6110; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=1996; ORIGINAL_YEAR=1996; TOXICOLOGICAL_EFFECT=systemic: pathology microscopic-liver-hemangiosarcoma|systemic: in life observation-body weight-body weight|systemic: in life observation-food consumption-food efficiency|systemic: in life observation-mortality-mortality|systemic: clinical chemistry-alkaline phosphatase (alp/alk)-alkaline phosphatase (alp/alk)|systemic: organ weight-liver-relative to body weight|systemic: organ weight-liver-absolute; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|cancer|clinical chemistry|food and/or water consumption|mortality/survival|organ weight; STUDY_GROUP=ToxRefDB_dup_-_15710963_15710964_15710965_15710966:F:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_a10affe3bd4890e7d8a59c1a17d4dfd9 |
| ToxValDB ToxRefDB | NEL | =20 | mg/kg bw/day | Rat | dermal | short-term; 21 days | short-term | LONG_REF=Lees, D & AM Leah. 1993. PHMB: 21-day dermal toxicity study in the rat. Zeneca Central Tox Lab, Study no. LR0559. MRID 43047701.; TITLE=PHMB: 21-day dermal toxicity study in the rat; AUTHOR=Lees, D & AM Leah; EXTERNAL_SOURCE_ID=6103; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=1993; ORIGINAL_YEAR=1993; TOXICOLOGICAL_EFFECT=systemic: in life observation-clinical signs-scabbing|systemic: in life observation-clinical signs-erythema|systemic: pathology microscopic-skin-infiltration cellular|systemic: pathology microscopic-skin-edema; STUDY_GROUP=ToxRefDB_dup_-_15710929_15710930_15710931_15710932:F:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_307605357839d4b0c72c88fbcf976652 |
| ToxValDB ToxRefDB | NEL | =23 | mg/kg bw/day | Rat | oral | chronic (developmental) | reproduction developmental | LONG_REF=PMRA; Milburn, G.M. (1995)Polyhexamethylene Biguanide: Multigeneration Study in the Rat. Sudy performed by Zeneca Central Toxicology Laboratory Study Nos: RR0621/F0; RR0621/F1. Study Completed March 8, 1995. Unpublished. MRID # 43617401.; TITLE=Polyhexamethylene Biguanide: Multigeneration Study in the Rat; AUTHOR=Milburn, G.M; EXTERNAL_SOURCE_ID=2360; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=1995; ORIGINAL_YEAR=1995; TOXICOLOGICAL_EFFECT=systemic: in life observation-body weight-body weight|systemic: organ weight-kidney-nos|systemic: in life observation-food consumption-food efficiency|systemic: organ weight-epididymis-nos; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|food and/or water consumption|organ weight; STUDY_GROUP=ToxRefDB_dup_-_15693922_15693923_15693924_15693925:M:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_ba77734bb65e333269e035d5b99c1fee |
| ToxValDB ToxRefDB | NEL | =36.3 | mg/kg bw/day | Rat | oral | chronic; 105 weeks | chronic | LONG_REF=Horner, SA. (1996) Polyhexamethylene biguanide: 2-year feeding study in rats. Zeneca Central Tox Lab, Alderley Park, Macclesfield, Cheshire, UK. Lab Project ID CTL/P/4663, Study no. PR0936, June 5, 1996. MRID 44059301.; TITLE=Polyhexamethylene biguanide: 2-year feeding study in rats; AUTHOR=Horner, SA; EXTERNAL_SOURCE_ID=6110; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=1996; ORIGINAL_YEAR=1996; TOXICOLOGICAL_EFFECT=systemic: in life observation-food consumption-food efficiency|systemic: in life observation-body weight-body weight|systemic: pathology microscopic-liver-fatty change|systemic: clinical chemistry-alkaline phosphatase (alp/alk)-alkaline phosphatase (alp/alk)|systemic: organ weight-liver-absolute|systemic: pathology microscopic-liver-spongiosis hepatis|systemic: organ weight-liver-relative to body weight; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|clinical chemistry|food and/or water consumption|nonneoplastic histopathology|organ weight; STUDY_GROUP=ToxRefDB_dup_-_15710967_15710968_15710969_15710970:M:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_1c9f02b17acf159a6903d3e72bed1e86 |
| ToxValDB ToxRefDB | NEL | =69 | mg/kg bw/day | Mouse | oral | chronic; 104 weeks | chronic | LONG_REF=Milburn G.M. (1996) Polyhexamethylene Biguanide: Two Year Oncogenicity Study in Mice. Central Toxicology Laboratory, Alderley Park, Macclesfield, Cheshire, UK SK10 4TJ. Laboratory Study No. PM0937. June 21, 1996. MRID 44074201. Unpublished; TITLE=Polyhexamethylene Biguanide: Two Year Oncogenicity Study in Mice; AUTHOR=Milburn G.M; EXTERNAL_SOURCE_ID=6109; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=1996; ORIGINAL_YEAR=1996; TOXICOLOGICAL_EFFECT=systemic: hematology-hematocrit (hct)-hematocrit (hct)|systemic: organ weight-adrenal gland-relative to body weight|systemic: pathology gross-skin-reduced size|systemic: in life observation-mortality-mortality|systemic: pathology microscopic-spleen-hemangiosarcoma|systemic: pathology microscopic-skin-depletion|systemic: pathology microscopic-intestine large-squamous cell carcinoma|systemic: pathology gross-intestine large-enlarged|systemic: pathology microscopic-gallbladder-dilatation|systemic: pathology microscopic-intestine large-inflammation|systemic: in life observation-clinical signs-swelling|systemic: pathology microscopic-intestine large-hyperplasia|systemic: pathology gross-intestine large-distended|systemic: pathology microscopic-spleen-hematopoietic cell proliferation|systemic: in life observation-body weight-body weight gain|systemic: pathology microscopic-liver-hemosiderosis|systemic: pathology microscopic-ovary-hemangiosarcoma|systemic: pathology microscopic-liver-lipofuscin deposits|systemic: pathology gross-intestine large-[other]|systemic: pathology gross-ear-lesion(s) (nos)|systemic: in life observation-food consumption-food efficiency|systemic: pathology microscopic-liver-inflammation|systemic: pathology microscopic-intestine large-metaplasia|systemic: pathology microscopic-gallbladder-hyperplasia|systemic: pathology microscopic-liver-hypertrophy|systemic: pathology microscopic-liver-nuclear alteration|systemic: pathology gross-liver-mass|systemic: organ weight-adrenal gland-absolute|systemic: hematology-hemoglobin (hgb)-hemoglobin (hgb)|systemic: in life observation-food consumption-food consumption|systemic: hematology-erythrocyte (rbc) count differential-erythrocyte (rbc)|systemic: organ weight-liver-absolute|systemic: pathology gross-gallbladder-distended|systemic: pathology microscopic-liver-hemangiosarcoma|systemic: in life observation-body weight-body weight; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|cancer|clinical signs|food and/or water consumption|gross pathology|hematology|mortality/survival|nonneoplastic histopathology|organ weight; STUDY_GROUP=ToxRefDB_dup_-_15710956_15710957_15710958_15710959:F:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_e37d370629439bf35e67f9bf97f4e83e |
| ToxValDB ToxRefDB | NEL | =77 | mg/kg bw/day | Rat | oral | chronic (developmental) | reproduction developmental | LONG_REF=PMRA; Milburn, G.M. (1995)Polyhexamethylene Biguanide: Multigeneration Study in the Rat. Sudy performed by Zeneca Central Toxicology Laboratory Study Nos: RR0621/F0; RR0621/F1. Study Completed March 8, 1995. Unpublished. MRID # 43617401.; TITLE=Polyhexamethylene Biguanide: Multigeneration Study in the Rat; AUTHOR=Milburn, G.M; EXTERNAL_SOURCE_ID=2360; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=1995; ORIGINAL_YEAR=1995; TOXICOLOGICAL_EFFECT=systemic: in life observation-body weight-body weight|systemic: in life observation-food consumption-food efficiency; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|food and/or water consumption; STUDY_GROUP=ToxRefDB_dup_-_15693918_15693919_15693920_15693921:F:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_3bc793f04b662abad4d12715b55addce |
| ToxValDB ToxRefDB | NEL | =79.2 | mg/kg bw/day | Rat | oral | chronic (developmental) | reproduction developmental | LONG_REF=PMRA; Milburn, G.M. (1995)Polyhexamethylene Biguanide: Multigeneration Study in the Rat. Sudy performed by Zeneca Central Toxicology Laboratory Study Nos: RR0621/F0; RR0621/F1. Study Completed March 8, 1995. Unpublished. MRID # 43617401.; TITLE=Polyhexamethylene Biguanide: Multigeneration Study in the Rat; AUTHOR=Milburn, G.M; EXTERNAL_SOURCE_ID=2360; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=1995; ORIGINAL_YEAR=1995; TOXICOLOGICAL_EFFECT=systemic: in life observation-food consumption-food efficiency|systemic: pathology microscopic-kidney-foreign body|systemic: pathology microscopic-kidney-hydronephrosis; TOXICOLOGICAL_EFFECT_CATEGORY=food and/or water consumption|nonneoplastic histopathology; STUDY_GROUP=ToxRefDB_dup_-_15693926_15693927_15693928_15693929:F:F1adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_0c8ca0f9fccc9fa8204e84d08b84e2df |
| ToxValDB ToxRefDB | NEL | =137.5 | mg/kg bw/day | Dog | oral | subchronic; 90 days | subchronic | LONG_REF=Ninety-Day Oral Toxicity of Antibacterial 9073-Beagle Dogs (Imperial Chemical Industries Limited, Industrial Hygiene Research Laboratories Report No. IHR, September 1966.; TITLE=Ninety-Day Oral Toxicity of Antibacterial 9073-Beagle Dogs; AUTHOR=Imperial Chemical Industries Limited; EXTERNAL_SOURCE_ID=6126; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=1966; ORIGINAL_YEAR=1966; TOXICOLOGICAL_EFFECT=systemic: in life observation-body weight-body weight gain; TOXICOLOGICAL_EFFECT_CATEGORY=body weight; STUDY_GROUP=ToxRefDB_dup_-_15710991_15710992_15710993_15710994:F:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_507ff09edf708a3d3a0567920bd4adfa |
| ToxValDB ToxRefDB | NOAEL | =37.5 | mg/kg bw/day | Dog | oral | chronic; 52 weeks | chronic | LONG_REF=Horner, SA. (1995) Polyhexamethylene biguanide: 1 year dietary toxicity study in dogs. Zeneca Central Tox Lab, Cheshire, UK. Lab report no. CTL/P/4488; Study no. PD0947. MRID 43620501.; TITLE=Polyhexamethylene biguanide: 1 year dietary toxicity study in dogs; AUTHOR=Horner, SA; EXTERNAL_SOURCE_ID=6107; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=1995; ORIGINAL_YEAR=1995; TOXICOLOGICAL_EFFECT=systemic: pathology microscopic-skin-inflammation|systemic: in life observation-mortality-mortality|systemic: in life observation-clinical signs-abnormal gait|systemic: pathology microscopic-liver-pigmentation|systemic: in life observation-clinical signs-skin ulceration|systemic: pathology microscopic-liver-hypertrophy|systemic: pathology microscopic-liver-inclusion body intracytoplasmic|systemic: pathology gross-stomach-discolored|systemic: pathology microscopic-kidney-concretion|systemic: pathology gross-oral mucosa-mass|systemic: in life observation-clinical signs-reduced activity|systemic: pathology gross-skin-discolored|systemic: pathology microscopic-nerve-mineralization|systemic: in life observation-clinical signs-tremors|systemic: in life observation-clinical signs-emaciation|systemic: pathology gross-uterus-discolored|systemic: pathology gross-skin-mass|systemic: clinical chemistry-alanine aminotransferase (alt/sgpt)-alanine aminotransferase (alt/sgpt)|systemic: in life observation-clinical signs-scabbing|systemic: in life observation-clinical signs-fur (altered appearance); TOXICOLOGICAL_EFFECT_CATEGORY=clinical chemistry|clinical signs|gross pathology|mortality/survival|nonneoplastic histopathology; STUDY_GROUP=ToxRefDB_dup_-_15710949_15710950_15710951:F:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_ab45e3197680f8a693b72cc2e0e5bfc0 |
Regulatory source 32 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| Regulatory source | - | 1 | - | - | oral | 2-year | - | p.42 |
| Regulatory source | - | =3.1 | mg/kg bw/d | rat | oral | 104 week | - | p.61 |
| Regulatory source | - | 8.5 | % | rat | oral | 104 week | - | p.61 |
| Regulatory source | - | 20 | % | mouse | oral | 2-year | - | p.32 |
| Regulatory source | - | 20.2 | % | rat | oral | 2-year | - | p.33 |
| Regulatory source | - | =36 | mg/kg bw/d | rat | oral | 104 week | - | p.61 |
| Regulatory source | - | 54 | mg/kg bw/d | rat | - | - | - | p.38 |
| Regulatory source | - | 54 | mg/kg bw/d | rat | oral | 104 weeks | - | p.38 |
| Regulatory source | - | 92.3 | mg/kg bw/d | mouse | oral | - | - | p.36 |
| Regulatory source | - | 92.3 | mg/kg bw/d | - | oral | - | - | p.47 |
| Regulatory source | - | 224 | mg/kg bw/d | - | - | - | - | p.36 |
| Regulatory source | - | 224 | mg/kg bw/d | rat | oral | 90-day | - | p.48 |
| Regulatory source | carcinogenicity | 15 | mg/kg bw/d | rat | oral | chronic | carcinogenicity | p.48 |
| Regulatory source | carcinogenicity | 20 | mg/kg bw/d | rat | dermal | 30 d | carcinogenicity | p.17 |
| Regulatory source | developmental toxicity | 10 | mg/kg/d | rabbit | oral | developmental | developmental toxicity | p.51 |
| Regulatory source | developmental toxicity | 20 | mg/kg bw/d | rabbit | oral | developmental | developmental toxicity | p.52 |
| Regulatory source | developmental toxicity | 40 | mg/kg bw/d | rabbit | oral | developmental | developmental toxicity | p.51 |
| Regulatory source | developmental toxicity | 200 | ppm | mouse | - | developmental | developmental toxicity | p.50 |
| Regulatory source | developmental toxicity | 1000 | ppm | mouse | - | developmental | developmental toxicity | p.50 |
| Regulatory source | genotoxicity | 36 | mg/kg bw/d | rat | oral | 2-year | genotoxicity | p.39 |
| Regulatory source | irritation | 0.257 | - | - | - | - | irritation | p.45 |
| Regulatory source | irritation | 20 | mg/kg bw/day | rabbit | oral | - | irritation | p.33 |
| Regulatory source | irritation | 20 | % | rat | inhalation | 5 days | irritation | p.35 |
| Regulatory source | irritation | 26 | - | rat | - | - | irritation | p.35 |
| Regulatory source | irritation | 200 | mg/kg bw/day | rabbit | dermal | - | irritation | p.33 |
| Regulatory source | repeated dose toxicity | 54 | mg/kg bw | rat | oral | subchronic | repeated dose toxicity | p.39 |
| Regulatory source | repeated dose toxicity | 1581 | - | - | - | - | repeated dose toxicity | p.78 |
| Regulatory source | repeated dose toxicity | 2000 | ppm | rat | oral | 3 weeks | repeated dose toxicity | p.39 |
| Regulatory source | reproductive toxicity | 36 | mg/kg bw/d | rat | oral | 2-year | reproductive toxicity | p.51 |
| Regulatory source | reproductive toxicity | 79 | mg/kg bw/d | rat | oral | 9 week | reproductive toxicity | p.49 |
| Regulatory source | reproductive toxicity | 130 | mg/kg bw/d | rat | oral | Developmental | reproductive toxicity | p.50 |
| Regulatory source | reproductive toxicity | 600 | ppm | rat | oral | 9 week | reproductive toxicity | p.49 |
openFDA substances 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | 4XI6112496 | UNII | - | - | - | polymer | - |