regAssist Monitor — Parameters

Req ID	Category	Intent	Legal Status	Name	Subdomain(s)	Limit Type	Limit Value	Context	Conditions	Confidence
#P001	chemical	health	guideline	Health-based value (HBV) for antimony	drinking water	requirement	0.003 mg/L	Calculated by multiplying the antimony TDI of 0.0002 mg Sb/kg body weight per day by the average adult body weight of 74 kg by the allocation factor for drinking water of 0.3, divided by 1.53 L/day.	Applicable for adult exposure via drinking water	high
#P002	chemical	health	guideline	Tolerable daily intake (TDI) of antimony	drinking water	unknown	0.0002 mg Sb/kg bw per day	Calculated by dividing the NOAEL of 0.06 mg Sb/kg body weight per day by the uncertainty factor of 300.		high
#P003	chemical	health	recommended	Absorption factor for dietary intake of antimony	other	unknown	10 %	The International Commission on Radiological Protection recommends the use of a 10% absorption factor for the dietary intake of antimony.		high
#P004	chemical	health	recommended	Default absorption factor for antimony	other	unknown	5 %	An absorption of 5% is recommended for situations where specific information is not available.	Situations where specific information is not available	high
#P005	chemical	health	guideline	Point of Departure (NOAEL) for HBV derivation	drinking water	requirement	0.06 mg Sb/kg bw per day	Point of departure chosen for deriving the HBV based on liver histology and serum biochemistry changes in rats	Poon et al. (1998) 13-week drinking water study	high
#P006	chemical	health	guideline	Uncertainty factor for antimony HBV derivation	drinking water	requirement	300 unitless	Accounts for interspecies variation (10x), intraspecies variation (10x), and subchronic study duration (3x)		high
#P007	chemical	health	guideline	Average adult body weight	drinking water	requirement	74 kg	Used for HBV derivation for a Canadian adult		high
#P008	chemical	health	guideline	Drinking water intake rate for a Canadian adult	drinking water	requirement	1.53 L/day	Used for HBV derivation for a Canadian adult		high
#P009	chemical	health	guideline	Drinking water allocation factor for antimony	drinking water	requirement	0.3 unitless	Based on the upper bound of the estimated intake for drinking water		high
#P010	chemical	health	unknown	NOAEL for B6C3F1 mice (14 days)	drinking water	requirement	99 mg Sb/kg bw per day	Forestomach lesions and increased liver weight observed in NTP (1992) study	14 days exposure via drinking water	high
#P011	chemical	health	unknown	NOAEL for F344/N rats (14 days)	drinking water	requirement	61 mg Sb/kg bw per day	Increase in relative liver weight in NTP (1992) study	14 days exposure via drinking water	high
#P012	chemical	health	unknown	NOAEL for Wistar rats (90 days)	drinking water	requirement	1408 mg Sb/kg bw per day	Small increase in liver weight and plasma enzymes observed in Hext et al. (1999) study	90 days exposure via diet	high
#P013	chemical	health	unknown	LOEL for Wistar rats (24 weeks)	drinking water	requirement	418 mg Sb/kg bw per day	Liver histopathological changes and increased AST activity in Sunagawa (1981) study	24 weeks exposure via diet	high
#P014	chemical	health	unknown	NOAEL for SD rats (Gestational Day 6 to 19)	drinking water	requirement	49 mg Sb/kg bw per day	Delayed skeletal development in mid and high dose groups in ECHA (2014) study	Gestational Day 6 to 19 exposure via gavage	high
#P015	chemical	health	unknown	LOAEL for Long-Evans rats (Lifetime)	drinking water	requirement	0.43 mg Sb/kg bw per day	Reduced survival rate and reduced non-fasting serum glucose levels in Schroeder et al. (1970) study	Lifetime exposure via drinking water	high
#P016	physical	health	unknown	Antimony-induced emetic threshold (adults)	drinking water	unknown	0.4 to 0.9 mg Sb/kg bw	Exposure to levels between 0.4 and 0.9 mg Sb/kg bw has been reported to induce vomiting in adults.	Adult humans, oral ingestion	high
#P017	chemical	health	unknown	Oral median lethal dose (LD50) for APT in rabbits/rats	other	unknown	115 mg/kg bw	Indicates acute toxicity of antimony potassium tartrate in experimental animals.	Oral exposure	high
#P018	chemical	health	unknown	Oral median lethal dose (LD50) for APT in mice	other	unknown	600 mg/kg bw	Indicates acute toxicity of antimony potassium tartrate in mice.	Oral exposure	high
#P019	chemical	health	unknown	Oral median lethal dose (LD50) for sodium hexahydroxoantimonate	other	unknown	> 2000 mg/kg bw	Indicates lower acute toxicity for sodium hexahydroxoantimonate compared to APT.	Oral exposure	high
#P020	chemical	health	unknown	Oral median lethal dose (LD50) for ATO	other	unknown	> 20000 mg/kg bw	Indicates very low acute toxicity for antimony trioxide (ATO).	Oral exposure	high
#P021	chemical	health	guideline	Alternative point of departure (BMDL10) from OEHHA (2016)	drinking water	unknown	0.14 mg Sb/kg bw per day	Used by OEHHA to derive the public health goal for antimony, based on liver anisokaryosis in males.	Poon et al. (1998) rat study data	high
#P022	chemical	health	guidance	Alternative NOAEL proposed by Lynch et al. (1999)	drinking water	unknown	6 mg Sb/kg bw per day	Proposed alternative NOAEL suggesting histological effects were not necessarily indicative of overt toxicity.	Review of Poon et al. (1998) study	high
#P023	chemical	health	unknown	Rapid elimination phase half-life	other	unknown	24 to 72 hours	Reported in patients treated with meglumine antimoniate for 30 days.	Patients treated for leishmaniasis; 5 mg Sb/kg bw per day dose	high
#P024	chemical	health	unknown	Slow elimination phase half-life	other	unknown	> 50 days	Reported in patients treated with meglumine antimoniate for 30 days.	Patients treated for leishmaniasis; 5 mg Sb/kg bw per day dose	high
#P025	chemical	health	unknown	Antimony trichloride dose in mice study (Wan et al. 2021)	other	unknown	15 mg/kg	Dose used to investigate nephrotoxicity induced by antimony exposure via intragastric intubation.	60 days duration in mice	high
#P026	chemical	health	unknown	Antimony trichloride concentration in in vitro study (Wan et al. 2021)	other	unknown	25 µM	Concentration used to treat renal tubular epithelial (TCMK-1) cells.	24 hours duration	high
#P027	chemical	health	unknown	Gastrointestinal absorption of diantimony trioxide (ATO) in humans	other	unknown	1 %	Reported for the relatively insoluble ATO form in humans.		high
#P028	chemical	health	unknown	Dermal absorption of diantimony trioxide at 100 µg/cm2	other	unknown	0.26 %	Total estimated dermal absorption from in vitro exposure of human skin samples.	24-hour exposure period	high
#P029	chemical	health	unknown	Dermal absorption of diantimony trioxide at 300 µg/cm2	other	unknown	0.14 %	Total estimated dermal absorption from in vitro exposure of human skin samples.	24-hour exposure period	high
#P030	chemical	health	guideline	Health-based value (HBV) for antimony	drinking water	requirement	0.003 mg/L	Calculated based on TDI, adult body weight (74 kg), allocation factor (0.3), and intake rate (1.53 L/day).	Applicable for adult exposure via drinking water	high
#P031	chemical	health	guideline	Tolerable daily intake (TDI) of antimony	drinking water	unknown	0.0002 mg Sb/kg bw per day	Calculated by dividing the NOAEL of 0.06 mg Sb/kg body weight per day by the uncertainty factor of 300.		high
#P032	chemical	health	recommended	Absorption factor for dietary intake of antimony	other	unknown	10 %	The ICRP recommends use of a 10% factor for dietary intake.		high
#P033	chemical	health	recommended	Default absorption factor for antimony	other	unknown	5 %	Recommended for situations where specific information is not available due to variability.	Situations where specific information is not available	high
#P034	chemical	treatment	unknown	Therapeutic dose for visceral leishmaniasis treatment	other	requirement	20 mg/kg	Sodium stibogluconate administered i.m. once daily for 30 days in pregnant women; associated with spontaneous abortions.	Intramuscular injection	high
#P035	microbiological	health	unknown	Spontaneous abortion (SA) risk odds ratio for antimony	other	unknown	1.65 unitless	Noticeable positive relation with risk of SA in maternal blood models (95% CI: 1.08 to 2.52).	Early gestation mothers	high
#P036	chemical	health	unknown	Absorption of antimony potassium tartrate (APT) in humans	other	unknown	5 %	Reported from acute intoxication data for 4 individuals exposed to APT.	Acute intoxication (poisoning)	high
#P037	chemical	treatment	unknown	Meglumine antimoniate treatment dose	other	unknown	5 mg Sb/kg bw per day	Dose administered by intramuscular injection for 30 days in patients studied for elimination kinetics.	Intramuscular injection for 30 days	high

Req ID	Name	Context	Confidence
#D001	GI	Gastrointestinal	high
#D002	APT	antimony potassium tartrate	high
#D003	GSH	reduced glutathione	high
#D004	SA	spontaneous abortion	high
#D005	TEND	Tehran Environment and Neurodevelopmental Defects	high
#D006	LD50	median lethal dose	high
#D007	AST	aspartate transaminase	high
#D008	ROS	reactive oxygen species	high
#D009	SOD	superoxide dismutase	high
#D010	HBV	health-based value	high
#D011	POD	point of departure	high
#D012	TDI	tolerable daily intake	high
#D013	antimonials	antimony-based drugs	high
#D014	leishmaniasis	a parasitic disease	high
#D015	autophagy and pyroptosis	2 types of programmed cell death	high
#D016	TCMK-1	renal tubular epithelial cells	high
#D017	anisokaryosis	variation in size and shape	high
#D018	hyperchromicity	increased optical density	high
#D019	BMDL10	10% benchmark dose level	high

Parameter Viewer

Q Qualitative Requirements (0)

P Quantitative Requirements (37)

D Definitions (19)