NOAEL Studies
Cosmetic Ingredient
Formic Acid NOAEL Studies
INCI: FORMIC ACID
CAS: 64-18-6
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
CIR Safety Assessment 8 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| CIR Safety Assessment | NOAEL | =945 | mg/kg body weight | rabbit | oral | 21 weeks | developmental toxicity | {"citation":"945; 22; (13","dose":"Two soft tissue variations (uni- or bilateral dilata- tion of the renal pelvis with or without dilated ureter) were detected in each group, including the controls, without any dose-dependent relationship.","effect":"l range. There were no external variations in any of the groups. Two soft tissue variations (uni- or bilateral dilata- tion of the renal pelvis with or without dilated ureter) were detected in each group, including the controls, without any dose-dependent relationship. No skeletal variations were seen in treated animals. The observed pattern of skeletal variations was not different from that seen in the historical controls, and the incidence was not dose related and did not suggest a treatment- related effect. The No-observed-adverse-effect-level (NOAEL) was 945 mg/kg body weight per day, the highest dose tested, for maternal toxicity, embryotoxicity, and teratogenicity.22 The developmental toxicity of sodium formate was evalu- ated in Himalayan rabbits (13-21 weeks old; groups of 25) in accordance with the OECD TG 414 protocol.22 The test sub- stance was administered as an aqueous solution (by gavage; dose volume ¼ 10 mL/kg) at doses of 100, 300, and 1,000 mg/kg body weight on gestation days 6 to 28. A third group served as the untreated control. Neither mortalities nor clinical...","page":9,"pdf":"PRS626.pdf","row_type":"noael_study","study_id":"PRS626_noael_001"} |
| CIR Safety Assessment | NOAEL | =945 | mg/kg body weight | rabbit | oral | 21 weeks | developmental toxicity | {"citation":"945; 22; (13","dose":"Two soft tissue variations (uni- or bilateral dilata- tion of the renal pelvis with or without dilated ureter) were detected in each group, including the controls, without any dose-dependent relationship.","effect":"l range. There were no external variations in any of the groups. Two soft tissue variations (uni- or bilateral dilata- tion of the renal pelvis with or without dilated ureter) were detected in each group, including the controls, without any dose-dependent relationship. No skeletal variations were seen in treated animals. The observed pattern of skeletal variations was not different from that seen in the historical controls, and the incidence was not dose related and did not suggest a treatment- related effect. The No-observed-adverse-effect-level (NOAEL) was 945 mg/kg body weight per day, the highest dose tested, for maternal toxicity, embryotoxicity, and teratogenicity.22 The developmental toxicity of sodium formate was evalu- ated in Himalayan rabbits (13-21 weeks old; groups of 25) in accordance with the OECD TG 414 protocol.22 The test sub- stance was administered as an aqueous solution (by gavage; dose volume ¼ 10 mL/kg) at doses of 100, 300, and 1,000 mg/kg body weight on gestation days 6 to 28. A third group served as the untreated control. Neither mortalities nor clinical...","page":9,"pdf":"PRS626.pdf","row_type":"noael_study","study_id":"PRS626_noael_001"} |
| CIR Safety Assessment | NOAEL | =945 | mg/kg body weight | rabbit | oral | 21 weeks | developmental toxicity | {"citation":"945; 22; (13","dose":"Two soft tissue variations (uni- or bilateral dilata- tion of the renal pelvis with or without dilated ureter) were detected in each group, including the controls, without any dose-dependent relationship.","effect":"l range. There were no external variations in any of the groups. Two soft tissue variations (uni- or bilateral dilata- tion of the renal pelvis with or without dilated ureter) were detected in each group, including the controls, without any dose-dependent relationship. No skeletal variations were seen in treated animals. The observed pattern of skeletal variations was not different from that seen in the historical controls, and the incidence was not dose related and did not suggest a treatment- related effect. The No-observed-adverse-effect-level (NOAEL) was 945 mg/kg body weight per day, the highest dose tested, for maternal toxicity, embryotoxicity, and teratogenicity.22 The developmental toxicity of sodium formate was evalu- ated in Himalayan rabbits (13-21 weeks old; groups of 25) in accordance with the OECD TG 414 protocol.22 The test sub- stance was administered as an aqueous solution (by gavage; dose volume ¼ 10 mL/kg) at doses of 100, 300, and 1,000 mg/kg body weight on gestation days 6 to 28. A third group served as the untreated control. Neither mortalities nor clinical...","page":9,"pdf":"PRS626.pdf","row_type":"noael_study","study_id":"PRS626_noael_001"} |
| CIR Safety Assessment | NOAEL | =945 | mg/kg body weight | rabbit | oral | 21 weeks | developmental toxicity | {"citation":"945; 22; (13","dose":"Two soft tissue variations (uni- or bilateral dilata- tion of the renal pelvis with or without dilated ureter) were detected in each group, including the controls, without any dose-dependent relationship.","effect":"l range. There were no external variations in any of the groups. Two soft tissue variations (uni- or bilateral dilata- tion of the renal pelvis with or without dilated ureter) were detected in each group, including the controls, without any dose-dependent relationship. No skeletal variations were seen in treated animals. The observed pattern of skeletal variations was not different from that seen in the historical controls, and the incidence was not dose related and did not suggest a treatment- related effect. The No-observed-adverse-effect-level (NOAEL) was 945 mg/kg body weight per day, the highest dose tested, for maternal toxicity, embryotoxicity, and teratogenicity.22 The developmental toxicity of sodium formate was evalu- ated in Himalayan rabbits (13-21 weeks old; groups of 25) in accordance with the OECD TG 414 protocol.22 The test sub- stance was administered as an aqueous solution (by gavage; dose volume ¼ 10 mL/kg) at doses of 100, 300, and 1,000 mg/kg body weight on gestation days 6 to 28. A third group served as the untreated control. Neither mortalities nor clinical...","page":9,"pdf":"PRS626.pdf","row_type":"noael_study","study_id":"PRS626_noael_001"} |
| CIR Safety Assessment | NOAEL | =1000 | mg/kg body weight/day | rat | - | - | reproductive toxicity | {"citation":"13; 0; 9","dose":"es (all within the historical con- trol range) in the following parameters were reported: postimplantation losses of 13.0% and 13.9% at doses of 300 and 1,000 mg/kg body weight, respectively, compared to 7.3% in controls, and the total incidence of external, skeletal, and soft tissue malformations was 6.7% at 1,000 mg/kg body weight/ day compared to 3.8%...","effect":"es (all within the historical con- trol range) in the following parameters were reported: postimplantation losses of 13.0% and 13.9% at doses of 300 and 1,000 mg/kg body weight, respectively, compared to 7.3% in controls, and the total incidence of external, skeletal, and soft tissue malformations was 6.7% at 1,000 mg/kg body weight/ day compared to 3.8% in controls. The incidence of total var- iations (external, skeletal, and soft tissue) was 66.1% to 67.2% in the treated groups compared to 58.0% in controls. The NOAEL for maternal toxicity and reproductive effects was 1,000 mg/kg body weight/day. In Vitro Formic acid. The effect of formic acid on embryonic develop- ment in vitro was evaluated using embryos from pregnant Spra- gue Dawley rats.38 Rat embryos (approximately 10 somites) were explanted during the afternoon of day 10 of pregnancy and cultured in rat serum. Formic acid (in water) was added to the cultured embryos at concentrations ranging from 0.141 to 1.055 mL formic acid per mL of serum (3.74-27.96 mmol formic acid per mL of serum). The no-effect concentration for fo...","page":9,"pdf":"PRS626.pdf","row_type":"noael_study","study_id":"PRS626_noael_002"} |
| CIR Safety Assessment | NOAEL | =1000 | mg/kg body weight/day | rat | - | - | reproductive toxicity | {"citation":"13; 0; 9","dose":"es (all within the historical con- trol range) in the following parameters were reported: postimplantation losses of 13.0% and 13.9% at doses of 300 and 1,000 mg/kg body weight, respectively, compared to 7.3% in controls, and the total incidence of external, skeletal, and soft tissue malformations was 6.7% at 1,000 mg/kg body weight/ day compared to 3.8%...","effect":"es (all within the historical con- trol range) in the following parameters were reported: postimplantation losses of 13.0% and 13.9% at doses of 300 and 1,000 mg/kg body weight, respectively, compared to 7.3% in controls, and the total incidence of external, skeletal, and soft tissue malformations was 6.7% at 1,000 mg/kg body weight/ day compared to 3.8% in controls. The incidence of total var- iations (external, skeletal, and soft tissue) was 66.1% to 67.2% in the treated groups compared to 58.0% in controls. The NOAEL for maternal toxicity and reproductive effects was 1,000 mg/kg body weight/day. In Vitro Formic acid. The effect of formic acid on embryonic develop- ment in vitro was evaluated using embryos from pregnant Spra- gue Dawley rats.38 Rat embryos (approximately 10 somites) were explanted during the afternoon of day 10 of pregnancy and cultured in rat serum. Formic acid (in water) was added to the cultured embryos at concentrations ranging from 0.141 to 1.055 mL formic acid per mL of serum (3.74-27.96 mmol formic acid per mL of serum). The no-effect concentration for fo...","page":9,"pdf":"PRS626.pdf","row_type":"noael_study","study_id":"PRS626_noael_002"} |
| CIR Safety Assessment | NOAEL | =1000 | mg/kg body weight/day | rat | - | - | reproductive toxicity | {"citation":"13; 0; 9","dose":"es (all within the historical con- trol range) in the following parameters were reported: postimplantation losses of 13.0% and 13.9% at doses of 300 and 1,000 mg/kg body weight, respectively, compared to 7.3% in controls, and the total incidence of external, skeletal, and soft tissue malformations was 6.7% at 1,000 mg/kg body weight/ day compared to 3.8%...","effect":"es (all within the historical con- trol range) in the following parameters were reported: postimplantation losses of 13.0% and 13.9% at doses of 300 and 1,000 mg/kg body weight, respectively, compared to 7.3% in controls, and the total incidence of external, skeletal, and soft tissue malformations was 6.7% at 1,000 mg/kg body weight/ day compared to 3.8% in controls. The incidence of total var- iations (external, skeletal, and soft tissue) was 66.1% to 67.2% in the treated groups compared to 58.0% in controls. The NOAEL for maternal toxicity and reproductive effects was 1,000 mg/kg body weight/day. In Vitro Formic acid. The effect of formic acid on embryonic develop- ment in vitro was evaluated using embryos from pregnant Spra- gue Dawley rats.38 Rat embryos (approximately 10 somites) were explanted during the afternoon of day 10 of pregnancy and cultured in rat serum. Formic acid (in water) was added to the cultured embryos at concentrations ranging from 0.141 to 1.055 mL formic acid per mL of serum (3.74-27.96 mmol formic acid per mL of serum). The no-effect concentration for fo...","page":9,"pdf":"PRS626.pdf","row_type":"noael_study","study_id":"PRS626_noael_002"} |
| CIR Safety Assessment | NOAEL | =1000 | mg/kg body weight/day | rat | - | - | reproductive toxicity | {"citation":"13; 0; 9","dose":"es (all within the historical con- trol range) in the following parameters were reported: postimplantation losses of 13.0% and 13.9% at doses of 300 and 1,000 mg/kg body weight, respectively, compared to 7.3% in controls, and the total incidence of external, skeletal, and soft tissue malformations was 6.7% at 1,000 mg/kg body weight/ day compared to 3.8%...","effect":"es (all within the historical con- trol range) in the following parameters were reported: postimplantation losses of 13.0% and 13.9% at doses of 300 and 1,000 mg/kg body weight, respectively, compared to 7.3% in controls, and the total incidence of external, skeletal, and soft tissue malformations was 6.7% at 1,000 mg/kg body weight/ day compared to 3.8% in controls. The incidence of total var- iations (external, skeletal, and soft tissue) was 66.1% to 67.2% in the treated groups compared to 58.0% in controls. The NOAEL for maternal toxicity and reproductive effects was 1,000 mg/kg body weight/day. In Vitro Formic acid. The effect of formic acid on embryonic develop- ment in vitro was evaluated using embryos from pregnant Spra- gue Dawley rats.38 Rat embryos (approximately 10 somites) were explanted during the afternoon of day 10 of pregnancy and cultured in rat serum. Formic acid (in water) was added to the cultured embryos at concentrations ranging from 0.141 to 1.055 mL formic acid per mL of serum (3.74-27.96 mmol formic acid per mL of serum). The no-effect concentration for fo...","page":9,"pdf":"PRS626.pdf","row_type":"noael_study","study_id":"PRS626_noael_002"} |
COSMOS DB 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| COSMOS DB | NOAEL | 1000 | mg/kg bw/day | rat | oral | 42 day | Short Term Toxicity | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
EFSA 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| EFSA | ADI (group) | =0.3 | mg/kg bw | Consumers | - | - | ADI (group) | EFSA CONTAM - 2012 - OutputID 602 - Consumers - Scientific Opinion on the evaluation of the substances currently on the list in the annex to Commission Directive 96/3/EC as acceptable previous cargoes for edible fats and oils - Part II of III - doi:10.2903/j.efsa.2012.2703 |
| EFSA | ADI (group) | =0.3 | mg/kg bw | Consumers | - | - | ADI (group) | EFSA CONTAM - 2012 - OutputID 602 - Consumers - Scientific Opinion on the evaluation of the substances currently on the list in the annex to Commission Directive 96/3/EC as acceptable previous cargoes for edible fats and oils - Part II of III - doi:10.2903/j.efsa.2012.2703 |
WHO/JECFA 17 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| WHO/JECFA | ADI | range:0-0.10.1 | mg/kg bw/day | - | - | - | Health guidance value | document_id=jecfa_jecmono_v040je10; title=906. Saturated aliphatic acyclic linear primary alcohols, aldehydes and acids (WHO Food Additives Series 40); path=mirror/documents/jecfa/jecmono/v040je10.htm; row_hash=5d4387b65b9adceb; raw_unit=mg/kg bw; context=A group ADI of 0-0.1 mg/kg bw was established for ocatanal and nonanal, singly or in combination, at the twenty-eighth meeting (Annex 1, reference 66). |
| WHO/JECFA | ADI | range:0-0.10.1 | mg/kg bw/day | - | - | - | Health guidance value | document_id=jecfa_jecmono_v040je10; title=906. Saturated aliphatic acyclic linear primary alcohols, aldehydes and acids (WHO Food Additives Series 40); path=mirror/documents/jecfa/jecmono/v040je10.htm; row_hash=5d4387b65b9adceb; raw_unit=mg/kg bw; context=A group ADI of 0-0.1 mg/kg bw was established for ocatanal and nonanal, singly or in combination, at the twenty-eighth meeting (Annex 1, reference 66). |
| WHO/JECFA | ADI | range:0-33 | mg/kg bw/day | - | - | - | Health guidance value | document_id=jecfa_jecmono_v040je10; title=906. Saturated aliphatic acyclic linear primary alcohols, aldehydes and acids (WHO Food Additives Series 40); path=mirror/documents/jecfa/jecmono/v040je10.htm; row_hash=8d756f164b09ae0e; raw_unit=mg/kg bw; context=he seventeenth meeting a group ADI "not limited" was allocated to acetic acid and its potassium and sodium salts, an ADI "not limited" was allocated to propionic acid, and a group ADI of 0-3 mg/kg bw was allocated to formic acid and ethyl formate (Annex 1, reference 32). |
| WHO/JECFA | ADI | range:0-33 | mg/kg bw/day | - | - | - | Health guidance value | document_id=jecfa_jecmono_v040je10; title=906. Saturated aliphatic acyclic linear primary alcohols, aldehydes and acids (WHO Food Additives Series 40); path=mirror/documents/jecfa/jecmono/v040je10.htm; row_hash=8d756f164b09ae0e; raw_unit=mg/kg bw; context=he seventeenth meeting a group ADI "not limited" was allocated to acetic acid and its potassium and sodium salts, an ADI "not limited" was allocated to propionic acid, and a group ADI of 0-3 mg/kg bw was allocated to formic acid and ethyl formate (Annex 1, reference 32). |
| WHO/JECFA | NOAEL | =577 | mg/kg bw/day | - | - | - | Toxicology study | document_id=jecfa_jecmono_v040je10; title=906. Saturated aliphatic acyclic linear primary alcohols, aldehydes and acids (WHO Food Additives Series 40); path=mirror/documents/jecfa/jecmono/v040je10.htm; row_hash=f3120ff6c5fbba73; raw_unit=mg/kg bw per day; context=A NOAEL of 1% (equal to 577 mg/kg bw per day) was determined from this study (Eibert, 1992). |
| WHO/JECFA | NOAEL | =577 | mg/kg bw/day | - | - | - | Toxicology study | document_id=jecfa_jecmono_v040je10; title=906. Saturated aliphatic acyclic linear primary alcohols, aldehydes and acids (WHO Food Additives Series 40); path=mirror/documents/jecfa/jecmono/v040je10.htm; row_hash=f3120ff6c5fbba73; raw_unit=mg/kg bw per day; context=A NOAEL of 1% (equal to 577 mg/kg bw per day) was determined from this study (Eibert, 1992). |
| WHO/JECFA | NOAEL | range:230-695695 | mg/kg bw/day | - | - | - | Toxicology study | document_id=jecfa_jecmono_v040je10; title=906. Saturated aliphatic acyclic linear primary alcohols, aldehydes and acids (WHO Food Additives Series 40); path=mirror/documents/jecfa/jecmono/v040je10.htm; row_hash=0aa653addd8a623a; raw_unit=mg/kg bw; context=A NOAEL of 1%, which corresponds to a daily intake of 230-695 mg/kg bw, was determined from this study (Eibert, 1992). |
| WHO/JECFA | NOAEL | range:230-695695 | mg/kg bw/day | - | - | - | Toxicology study | document_id=jecfa_jecmono_v040je10; title=906. Saturated aliphatic acyclic linear primary alcohols, aldehydes and acids (WHO Food Additives Series 40); path=mirror/documents/jecfa/jecmono/v040je10.htm; row_hash=0aa653addd8a623a; raw_unit=mg/kg bw; context=A NOAEL of 1%, which corresponds to a daily intake of 230-695 mg/kg bw, was determined from this study (Eibert, 1992). |
| WHO/JECFA | NOAEL | =807 | mg/kg bw/day | - | - | - | Toxicology study | document_id=jecfa_jecmono_v040je10; title=906. Saturated aliphatic acyclic linear primary alcohols, aldehydes and acids (WHO Food Additives Series 40); path=mirror/documents/jecfa/jecmono/v040je10.htm; row_hash=8329dbb2e5f588ef; raw_unit=mg/kg bw per day; context=A NOAEL of 3% (equal to 807 mg/kg bw per day) was determined from this study (Eibert, 1992). |
| WHO/JECFA | NOAEL | =807 | mg/kg bw/day | - | - | - | Toxicology study | document_id=jecfa_jecmono_v040je10; title=906. Saturated aliphatic acyclic linear primary alcohols, aldehydes and acids (WHO Food Additives Series 40); path=mirror/documents/jecfa/jecmono/v040je10.htm; row_hash=8329dbb2e5f588ef; raw_unit=mg/kg bw per day; context=A NOAEL of 3% (equal to 807 mg/kg bw per day) was determined from this study (Eibert, 1992). |
| WHO/JECFA | NOEL | =50 | mg/kg bw/day | Rabbit | oral | 6 months | Toxicology study | document_id=jecfa_jecmono_v040je10; title=906. Saturated aliphatic acyclic linear primary alcohols, aldehydes and acids (WHO Food Additives Series 40); path=mirror/documents/jecfa/jecmono/v040je10.htm; row_hash=aeb903e99331b8fb; raw_unit=mg/kg bw per day; context=The NOEL in rabbits given 0, 1.4, 14 or 50 mg/kg bw per day heptyl alcohol by gavage in sunflower oil for 6 months was 50 mg/kg bw per day (Voskoboinikova, 1966). |
| WHO/JECFA | NOEL | =50 | mg/kg bw/day | Rabbit | oral | 6 months | Toxicology study | document_id=jecfa_jecmono_v040je10; title=906. Saturated aliphatic acyclic linear primary alcohols, aldehydes and acids (WHO Food Additives Series 40); path=mirror/documents/jecfa/jecmono/v040je10.htm; row_hash=aeb903e99331b8fb; raw_unit=mg/kg bw per day; context=The NOEL in rabbits given 0, 1.4, 14 or 50 mg/kg bw per day heptyl alcohol by gavage in sunflower oil for 6 months was 50 mg/kg bw per day (Voskoboinikova, 1966). |
| WHO/JECFA | NOEL | =60 | mg/kg bw/day | - | - | - | Toxicology study | document_id=jecfa_jecmono_v040je10; title=906. Saturated aliphatic acyclic linear primary alcohols, aldehydes and acids (WHO Food Additives Series 40); path=mirror/documents/jecfa/jecmono/v040je10.htm; row_hash=6ec17c3894598585; raw_unit=mg/kg bw per day; context=A NOEL of 60 mg/kg bw per day was determined in this study (Hillbom et al ., 1974b). |
| WHO/JECFA | NOEL | =60 | mg/kg bw/day | - | - | - | Toxicology study | document_id=jecfa_jecmono_v040je10; title=906. Saturated aliphatic acyclic linear primary alcohols, aldehydes and acids (WHO Food Additives Series 40); path=mirror/documents/jecfa/jecmono/v040je10.htm; row_hash=6ec17c3894598585; raw_unit=mg/kg bw per day; context=A NOEL of 60 mg/kg bw per day was determined in this study (Hillbom et al ., 1974b). |
| WHO/JECFA | NOEL | =125 | mg/kg bw/day | Rat | oral | 4 weeks | Toxicology study | document_id=jecfa_jecmono_v040je10; title=906. Saturated aliphatic acyclic linear primary alcohols, aldehydes and acids (WHO Food Additives Series 40); path=mirror/documents/jecfa/jecmono/v040je10.htm; row_hash=3e2951d2e8de3604; raw_unit=mg/kg bw per day; context=2.2.2.1 Acetaldehyde A NOEL of 125 mg/kg bw per day was reported for acetaldehyde added to the drinking-water of male and female rats for 4 weeks at level of 0, 25, 125 or 625 mg/kg bw per day (Til et al., 1988); the only treatment-related effect was hyperkeratosis of the forestomach at 625 mg/kg bw per day. |
| WHO/JECFA | NOEL | =125 | mg/kg bw/day | Rat | oral | 4 weeks | Toxicology study | document_id=jecfa_jecmono_v040je10; title=906. Saturated aliphatic acyclic linear primary alcohols, aldehydes and acids (WHO Food Additives Series 40); path=mirror/documents/jecfa/jecmono/v040je10.htm; row_hash=3e2951d2e8de3604; raw_unit=mg/kg bw per day; context=2.2.2.1 Acetaldehyde A NOEL of 125 mg/kg bw per day was reported for acetaldehyde added to the drinking-water of male and female rats for 4 weeks at level of 0, 25, 125 or 625 mg/kg bw per day (Til et al., 1988); the only treatment-related effect was hyperkeratosis of the forestomach at 625 mg/kg bw per day. |
| WHO/JECFA | ADI | <=3 | mg/kg | Human | oral | - | Toxicity Value | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/650afe27e4b0d99f5a87f9c9; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://apps.who.int/food-additives-contaminants-jecfa-database/; SUBSOURCE_URL=https://apps.who.int/food-additives-contaminants-jecfa-database/Home/Chemical/1561; YEAR=1997; ORIGINAL_YEAR=1997; STUDY_GROUP=WHO JECFA ADI:15715522:-:--; 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_fa81f81ce94f45e674bf26fe14718c32 |
NTP ICE acute inhalation 3 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP ICE acute inhalation | LC50 | 7.4 | mg/L | - | Inhalation | Duration=4 hr | In Vivo; AcuteInhalNICEATM; Rat Acute Inhalation Toxicity | sheet=Data; excel_row=1445; Record_ID=acute_inhalation_1693; Data_Type=In Vivo; Internal_Data_Source=AcuteInhalNICEATM; Mixture=Chemical; DTXSID=DTXSID2024115; Assay=Rat Acute Inhalation Toxicity; Endpoint=LC50; Response=7.4; Response_Unit=mg/L; Reference=NIOSH; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2024115; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2024115 |
| NTP ICE acute inhalation | LC50 | 7.85 | mg/L | - | Inhalation | Duration=4 hr | In Vivo; AcuteInhalNICEATM; Rat Acute Inhalation Toxicity | sheet=Data; excel_row=1446; Record_ID=acute_inhalation_766; Data_Type=In Vivo; Internal_Data_Source=AcuteInhalNICEATM; Mixture=Chemical; DTXSID=DTXSID2024115; Assay=Rat Acute Inhalation Toxicity; Endpoint=LC50; Response=7.85; Response_Unit=mg/L; Reference=REACH; URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15127/7/3/3/?documentUUID=38cca90d-e2ec-4d48-b7b4-f7ca82e30097; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2024115; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2024115 |
| NTP ICE acute inhalation | LC50 | 15 | mg/L | - | Inhalation | Duration=0.25 hr | In Vivo; AcuteInhalNICEATM; Rat Acute Inhalation Toxicity | sheet=Data; excel_row=1444; Record_ID=acute_inhalation_2764; Data_Type=In Vivo; Internal_Data_Source=AcuteInhalNICEATM; Mixture=Chemical; DTXSID=DTXSID2024115; Assay=Rat Acute Inhalation Toxicity; Endpoint=LC50; Response=15; Response_Unit=mg/L; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2024115; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2024115 |
NTP ICE acute oral 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP ICE acute oral | LD50 | =1100 | mg/kg bw | Rat | oral | acute | Rat Acute Oral Toxicity | NLM Hazardous Substances Data Bank (undated); record_id=acute_oral_8831; row=4113; data_type=In Vivo; mixture=Chemical; chemical_name=Formic acid; preferred_name=Formic acid; dtxsid=DTXSID2024115; url=https://pubchem.ncbi.nlm.nih.gov/; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2024115; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID2024115; source_file=acute_oral.xlsx |
NTP ICE skin irritation 14 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP ICE skin irritation | Breakthrough Time | 6.5 | min | - | Dermal | - | In Vitro; Corrositex | sheet=Data_invitro; excel_row=1797; Record_ID=skin_irritation_invitro_96; Data_Type=In Vitro; Concentration=96; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID2024115; Assay=Corrositex; Endpoint=Breakthrough Time; Response=6.5; Response_Unit=min; Reference=Gordon et al. 1994; Not available; Not available; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2024115; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2024115 |
| NTP ICE skin irritation | Breakthrough Time | 15.7 | min | - | Dermal | - | In Vitro; Corrositex | sheet=Data_invitro; excel_row=1789; Record_ID=skin_irritation_invitro_97; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID2024115; Assay=Corrositex; Endpoint=Breakthrough Time; Response=15.7; Response_Unit=min; Reference=Botham et al. 1995; Not available; 10.1177/026119299502300207; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2024115; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2024115 |
| NTP ICE skin irritation | Breakthrough Time | 18.5 | min | - | Dermal | - | In Vitro; Corrositex | sheet=Data_invitro; excel_row=1794; Record_ID=skin_irritation_invitro_98; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID2024115; Assay=Corrositex; Endpoint=Breakthrough Time; Response=18.5; Response_Unit=min; Reference=Botham et al. 1995; Not available; 10.1177/026119299502300207; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2024115; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2024115 |
| NTP ICE skin irritation | TER | 1.8 | kiloohms | - | Dermal | - | In Vitro; TER Corrosion | sheet=Data_invitro; excel_row=1784; Record_ID=skin_irritation_invitro_2555; Data_Type=In Vitro; Concentration=33.9; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID2024115; Assay=TER Corrosion; Endpoint=TER; Response=1.8; Response_Unit=kiloohms; Reference=Botham et al. 1995; Not available; 10.1177/026119299502300207; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2024115; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2024115 |
| NTP ICE skin irritation | TER | 2.7 | kiloohms | - | Dermal | - | In Vitro; TER Corrosion | sheet=Data_invitro; excel_row=1785; Record_ID=skin_irritation_invitro_2556; Data_Type=In Vitro; Concentration=33.9; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID2024115; Assay=TER Corrosion; Endpoint=TER; Response=2.7; Response_Unit=kiloohms; Reference=Botham et al. 1995; Not available; 10.1177/026119299502300207; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2024115; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2024115 |
| NTP ICE skin irritation | Viability (240 minutes) | 5.8 | % | - | Dermal | - | In Vitro; EpiSkin Corrosion | sheet=Data_invitro; excel_row=1780; Record_ID=skin_irritation_invitro_2027; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID2024115; Assay=EpiSkin Corrosion; Endpoint=Viability (240 minutes); Response=5.8; Response_Unit=%; Reference=Alepee et al. 2014; 24211528; 10.1016/j.tiv.2013.10.016; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2024115; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2024115 |
| NTP ICE skin irritation | Viability (240 minutes) | 9.6 | % | - | Dermal | - | In Vitro; EpiSkin Corrosion | sheet=Data_invitro; excel_row=1777; Record_ID=skin_irritation_invitro_2025; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID2024115; Assay=EpiSkin Corrosion; Endpoint=Viability (240 minutes); Response=9.6; Response_Unit=%; Reference=Alepee et al. 2014; 24211528; 10.1016/j.tiv.2013.10.016; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2024115; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2024115 |
| NTP ICE skin irritation | Viability (240 minutes) | 9.9 | % | - | Dermal | - | In Vitro; EpiSkin Corrosion | sheet=Data_invitro; excel_row=1783; Record_ID=skin_irritation_invitro_2029; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID2024115; Assay=EpiSkin Corrosion; Endpoint=Viability (240 minutes); Response=9.9; Response_Unit=%; Reference=Alepee et al. 2014; 24211528; 10.1016/j.tiv.2013.10.016; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2024115; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2024115 |
| NTP ICE skin irritation | Viability (3 minutes) | 4.3 | % | - | Dermal | - | In Vitro; EpiSkin Corrosion | sheet=Data_invitro; excel_row=1782; Record_ID=skin_irritation_invitro_2025; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID2024115; Assay=EpiSkin Corrosion; Endpoint=Viability (3 minutes); Response=4.3; Response_Unit=%; Reference=Alepee et al. 2014; 24211528; 10.1016/j.tiv.2013.10.016; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2024115; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2024115 |
| NTP ICE skin irritation | Viability (3 minutes) | 5.7 | % | - | Dermal | - | In Vitro; EpiSkin Corrosion | sheet=Data_invitro; excel_row=1781; Record_ID=skin_irritation_invitro_2027; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID2024115; Assay=EpiSkin Corrosion; Endpoint=Viability (3 minutes); Response=5.7; Response_Unit=%; Reference=Alepee et al. 2014; 24211528; 10.1016/j.tiv.2013.10.016; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2024115; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2024115 |
| NTP ICE skin irritation | Viability (3 minutes) | 7.8 | % | - | Dermal | - | In Vitro; EpiSkin Corrosion | sheet=Data_invitro; excel_row=1776; Record_ID=skin_irritation_invitro_2029; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID2024115; Assay=EpiSkin Corrosion; Endpoint=Viability (3 minutes); Response=7.8; Response_Unit=%; Reference=Alepee et al. 2014; 24211528; 10.1016/j.tiv.2013.10.016; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2024115; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2024115 |
| NTP ICE skin irritation | Viability (60 minutes) | 4.4 | % | - | Dermal | - | In Vitro; EpiSkin Corrosion | sheet=Data_invitro; excel_row=1778; Record_ID=skin_irritation_invitro_2027; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID2024115; Assay=EpiSkin Corrosion; Endpoint=Viability (60 minutes); Response=4.40; Response_Unit=%; Reference=Alepee et al. 2014; 24211528; 10.1016/j.tiv.2013.10.016; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2024115; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2024115 |
| NTP ICE skin irritation | Viability (60 minutes) | 4.8 | % | - | Dermal | - | In Vitro; EpiSkin Corrosion | sheet=Data_invitro; excel_row=1779; Record_ID=skin_irritation_invitro_2029; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID2024115; Assay=EpiSkin Corrosion; Endpoint=Viability (60 minutes); Response=4.8; Response_Unit=%; Reference=Alepee et al. 2014; 24211528; 10.1016/j.tiv.2013.10.016; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2024115; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2024115 |
| NTP ICE skin irritation | Viability (60 minutes) | 5.6 | % | - | Dermal | - | In Vitro; EpiSkin Corrosion | sheet=Data_invitro; excel_row=1788; Record_ID=skin_irritation_invitro_2025; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID2024115; Assay=EpiSkin Corrosion; Endpoint=Viability (60 minutes); Response=5.6; Response_Unit=%; Reference=Alepee et al. 2014; 24211528; 10.1016/j.tiv.2013.10.016; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2024115; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2024115 |
ToxValDB DOE Protective Action Criteria 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB DOE Protective Action Criteria | LEL | =338836 | mg/m3 | Human | inhalation | - | acute | LONG_REF=U.S. Department of Energy (DOE) Protective Action Criteria (PAC). 2023. PAC Chemical Database. Updated 11 October 2023. Available: https://edms3.energy.gov/pac/ (Accessed November 16, 2023); TITLE=U.S. Department of Energy (DOE) Protective Action Criteria (PAC) Chemical Database; AUTHOR=U.S. Department of Energy; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/65428efee4b045b9ff7cc432; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://edms3.energy.gov/pac/TeelDocs; YEAR=2010; ORIGINAL_YEAR=2010; STUDY_GROUP=DOE Protective Action Criteria:15515694:-:--; 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_f9eb3484c605d0e0431dad6de8d3eac8 |
ToxValDB GESTIS DNEL 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB GESTIS DNEL | DNEL local | =9.5 | mg/m3 | Human | inhalation | - | Toxicity Value | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6543dd69e4b045b9ff7cd87e; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.dguv.de/ifa/gestis/gestis-dnel-liste/index-2.jsp; STUDY_GROUP=GESTIS DNEL:15632333:-:--; 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_7bcaa6992505e20e99e42f703be5fdba |
ToxValDB HPVIS 3 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB HPVIS | LOAEL | =0.12 | mg/L | Mouse | inhalation | subchronic; 13 weeks | subchronic | LONG_REF=Leach, C.L. et al.: The Toxicologist 9 (No.1), 144 (1989), abstract no. 575NTP Technical Report No. 19, Formic Acid, NIH-Publication 92-3342 (July 1992) More Details published in Zeiger et al. Environ Molec Mutagen. Vol 19 Supplement 21 2-141 (1992); EXTERNAL_SOURCE_ID=61300; EXTERNAL_SOURCE_ID_DESC=HPVIS ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/63861d6de4b04f6bb1480596; RECORD_SOURCE_LEVEL=Extraction document; STUDY_GROUP=HPVIS_dup_HPVIS Mammalian Repeat Dose_15639166_15639265:-:--; 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_093b91a18717d9a17bf0a46de80692cd |
| ToxValDB HPVIS | NOAEL | =0.06 | mg/L | Rat | inhalation | subchronic; 13 weeks | subchronic | LONG_REF=Leach, C.L. et al.: The Toxicologist 9 (No.1), 144 (1989), abstract no. 575NTP Technical Report No. 19, Formic Acid, NIH-Publication 92-3342 (July 1992) More Details published in Zeiger et al. Environ Molec Mutagen. Vol 19 Supplement 21 2-141 (1992); EXTERNAL_SOURCE_ID=60772; EXTERNAL_SOURCE_ID_DESC=HPVIS ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/63861d6de4b04f6bb1480596; RECORD_SOURCE_LEVEL=Extraction document; STUDY_GROUP=HPVIS_dup_HPVIS Mammalian Repeat Dose_15639101_15639231:-:--; 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_817fde6df9c55e1d3aa6de351827369e |
| ToxValDB HPVIS | NOAEL | =120.475 | mg/m3 | Rat | inhalation | subchronic; 13 weeks | subchronic | LONG_REF=Leach, C.L. et al.: The Toxicologist 9 (No.1), 144 (1989), abstract no. 575NTP Technical Report No. 19, Formic Acid, NIH-Publication 92-3342 (July 1992) More Details published in Zeiger et al. Environ Molec Mutagen. Vol 19 Supplement 21 2-141 (1992); EXTERNAL_SOURCE_ID=61826; EXTERNAL_SOURCE_ID_DESC=HPVIS ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/63861d6de4b04f6bb1480596; RECORD_SOURCE_LEVEL=Extraction document; STUDY_GROUP=HPVIS:15639230:-:--; 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_5a0f681c24423784d08c8c0bf33ffef9 |
ToxValDB PPRTV (CPHEA) 3 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB PPRTV (CPHEA) | LOAEL (HEC) | =2.7 | mg/m3 | Rat | inhalation | subchronic; 13 weeks | subchronic | LONG_REF=NTP 1992; AUTHOR=NTP; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/640754d6e4b08a6b3934b7cf; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.epa.gov/pprtv/basic-information-about-provisional-peer-reviewed-toxicity-values-pprtvs; SUBSOURCE_URL=https://cfpub.epa.gov/ncea/pprtv/chemicalLanding.cfm?pprtv_sub_id=1754; TOXICOLOGICAL_EFFECT=neutropenia and increased serum alkaline phosphatase; STUDY_GROUP=PPRTV (CPHEA):15653626:M/F:--; QC_CATEGORY=Manually extracted from unstructured data source; Source overall passed QC, and this record was manually checked; QC_STATUS=pass; SOURCE_HASH=ToxValhc_04d52fb4973279f9ed4e0295e8f0286b |
| ToxValDB PPRTV (CPHEA) | NOAEL | =277 | mg/kg bw/day | Rat | oral | chronic; 2 years | reproduction developmental | LONG_REF=Malorny 1969; AUTHOR=Malorny; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/640754d6e4b08a6b3934b7cf; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.epa.gov/pprtv/basic-information-about-provisional-peer-reviewed-toxicity-values-pprtvs; SUBSOURCE_URL=https://cfpub.epa.gov/ncea/pprtv/chemicalLanding.cfm?pprtv_sub_id=1754; TOXICOLOGICAL_EFFECT=no effects; STUDY_GROUP=PPRTV (CPHEA):15654079:M/F:--; QC_CATEGORY=Manually extracted from unstructured data source; Source overall passed QC, and this record was manually checked; QC_STATUS=pass; SOURCE_HASH=ToxValhc_d403e0654685233f75311c571d311699 |
| ToxValDB PPRTV (CPHEA) | RfC (provisional) | =0.0009 | mg/m3 | Human | inhalation | - | Toxicity Value | LONG_REF=NTP 1992; AUTHOR=NTP; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/640754d6e4b08a6b3934b7cf; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.epa.gov/pprtv/basic-information-about-provisional-peer-reviewed-toxicity-values-pprtvs; SUBSOURCE_URL=https://cfpub.epa.gov/ncea/pprtv/chemicalLanding.cfm?pprtv_sub_id=1754; TOXICOLOGICAL_EFFECT=Neutropenia and increased serum alkaline phosphatase in male/female rats; STUDY_GROUP=PPRTV (CPHEA):15653625:-:--; QC_CATEGORY=Manually extracted from unstructured data source; Source overall passed QC, and this record was manually checked; QC_STATUS=pass; SOURCE_HASH=ToxValhc_2262e0e9aed7ea49035a672707f652cb |
ToxValDB Pennsylvania DEP ToxValues 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB Pennsylvania DEP ToxValues | RfC | =0.0003 | mg/m3 | Human | inhalation | - | Toxicity Value | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/67599fbae4b0a7c65d37b2e3; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://files.dep.state.pa.us/EnvironmentalCleanupBrownfields/LandRecyclingProgram/LandRecyclingProgramPortalFiles/GuidanceTechTools/VaporIntrusion/November_2021/Table%205a.pdf; STUDY_GROUP=Pennsylvania DEP ToxValues:15650135:-:--; 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_e53ca58d9d572a808bba3afe463460d7 |
| ToxValDB Pennsylvania DEP ToxValues | RfD | =0.9 | mg/kg bw/day | Human | oral | - | Toxicity Value | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/67599fbae4b0a7c65d37b2e3; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://files.dep.state.pa.us/EnvironmentalCleanupBrownfields/LandRecyclingProgram/LandRecyclingProgramPortalFiles/GuidanceTechTools/VaporIntrusion/November_2021/Table%205a.pdf; STUDY_GROUP=Pennsylvania DEP ToxValues:15650134:-:--; 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_043790a628a033f37b160adfc390db5b |
Regulatory source 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| Regulatory source | developmental toxicity | 945 | mg/kg body weight | rabbit | oral | 21 weeks | developmental toxicity | SOURCE_SUBDIR=PRS626; REPORT_TITLE=Safety Assessment of Formic Acid and Sodium Formate as Used in Cosmetics Wilbur Johnson Jr1, Bart Heldreth2, Wilma F. Bergfeld3, Donald V. Belsito3, Ronald A. Hill3, Curtis D. Klaassen3, Daniel C. Liebler3, James G. Marks Jr3, Ronald C. Sha; OPINION_NUMBER=PRS626; COMMITTEE=Cosmetic Ingredient Review Expert Panel; REPORT_DATE=In 1997; VALUE_TEXT=945; DOSE=Two soft tissue variations (uni- or bilateral dilata- tion of the renal pelvis with or without dilated ureter) were detected in each group, including the controls, without any dose-dependent relationship.; EFFECT=l range. There were no external variations in any of the groups. Two soft tissue variations (uni- or bilateral dilata- tion of the renal pelvis with or without dilated ureter) were detected in each group, including the controls, without any dose-dependent relationship. No skeletal variations were seen in treated animals. The observed pattern of skeletal variations was not different from that seen in the historical controls, and the incidence was not dose related and did not suggest a treatment- related effect. The No-observed-adverse-effect-level (NOAEL) was 945 mg/kg body weight per day, the highest dose tested, for maternal toxicity, embryotoxicity, and teratogenicity.22 The developmental toxicity of sodium formate was evalu- ated in Himalayan rabbits (13-21 weeks old; groups of 25) in accordance with the OECD TG 414 protocol.22 The test sub- stance was administered as an aqueous solution (by gavage; dose volume ¼ 10 mL/kg) at doses of 100, 300, and 1,000 mg/kg body weight on gestation days 6 to 28. A third group served as the untreated control. Neither mortalities nor clinical...; CITATION=945; 22; (13; CITATION_NUMBERS=[945,22,13]; REFERENCE=945; 22; (13; DETAILS_JSON={"cas_number":"64-18-6","citation":"945; 22; (13","dose":"Two soft tissue variations (uni- or bilateral dilata- tion of the renal pelvis with or without dilated ureter) were detected in each group, including the controls, without any dose-dependent relationship.","duration":"21 weeks","effect":"l range. There were no external variations in any of the groups. Two soft tissue variations (uni- or bilateral dilata- tion of the renal pelvis with or without dilated ureter) were detected in each group, including the controls, without any dose-dependent relationship. No skeletal variations were seen in treated animals. The observed pattern of skeletal variations was not different from that seen in the historical controls, and the incidence was not dose related and did not suggest a treatment- related effect. The No-observed-adverse-effect-level (NOAEL) was 945 mg/kg body weight per day, the highest dose tested, for maternal toxicity, embryotoxicity, and teratogenicity.22 The developmental toxicity of sodium formate was evalu- ated in Himalayan rabbits (13-21 weeks old; groups of 25) in accordance with the OECD TG 414 protocol.22 The test sub- stance was administered as an aqueous solution (by gavage; dose volume ¼ 10 mL/kg) at doses of 100, 300, and 1,000 mg/kg body weight on gestation days 6 to 28. A third group served as the untreated control. Neither mortalities nor clinical...","endpoint":"developmental toxicity","ingredient":"Formic Acid and Sodium Formate","loael_value":"","noael_unit":"mg/kg body weight","noael_value":"945","page":9,"route":"oral","species":"rabbit","study_id":"PRS626_noael_001"} |
| Regulatory source | reproductive toxicity | 1000 | mg/kg body weight/day | rat | - | - | reproductive toxicity | SOURCE_SUBDIR=PRS626; REPORT_TITLE=Safety Assessment of Formic Acid and Sodium Formate as Used in Cosmetics Wilbur Johnson Jr1, Bart Heldreth2, Wilma F. Bergfeld3, Donald V. Belsito3, Ronald A. Hill3, Curtis D. Klaassen3, Daniel C. Liebler3, James G. Marks Jr3, Ronald C. Sha; OPINION_NUMBER=PRS626; COMMITTEE=Cosmetic Ingredient Review Expert Panel; REPORT_DATE=In 1997; VALUE_TEXT=1,000; DOSE=es (all within the historical con- trol range) in the following parameters were reported: postimplantation losses of 13.0% and 13.9% at doses of 300 and 1,000 mg/kg body weight, respectively, compared to 7.3% in controls, and the total incidence of external, skeletal, and soft tissue malformations was 6.7% at 1,000 mg/kg body weight/ day compared to 3.8%...; EFFECT=es (all within the historical con- trol range) in the following parameters were reported: postimplantation losses of 13.0% and 13.9% at doses of 300 and 1,000 mg/kg body weight, respectively, compared to 7.3% in controls, and the total incidence of external, skeletal, and soft tissue malformations was 6.7% at 1,000 mg/kg body weight/ day compared to 3.8% in controls. The incidence of total var- iations (external, skeletal, and soft tissue) was 66.1% to 67.2% in the treated groups compared to 58.0% in controls. The NOAEL for maternal toxicity and reproductive effects was 1,000 mg/kg body weight/day. In Vitro Formic acid. The effect of formic acid on embryonic develop- ment in vitro was evaluated using embryos from pregnant Spra- gue Dawley rats.38 Rat embryos (approximately 10 somites) were explanted during the afternoon of day 10 of pregnancy and cultured in rat serum. Formic acid (in water) was added to the cultured embryos at concentrations ranging from 0.141 to 1.055 mL formic acid per mL of serum (3.74-27.96 mmol formic acid per mL of serum). The no-effect concentration for fo...; CITATION=13; 0; 9; CITATION_NUMBERS=[13,9]; REFERENCE=13; 0; 9; DETAILS_JSON={"cas_number":"64-18-6","citation":"13; 0; 9","dose":"es (all within the historical con- trol range) in the following parameters were reported: postimplantation losses of 13.0% and 13.9% at doses of 300 and 1,000 mg/kg body weight, respectively, compared to 7.3% in controls, and the total incidence of external, skeletal, and soft tissue malformations was 6.7% at 1,000 mg/kg body weight/ day compared to 3.8%...","duration":"","effect":"es (all within the historical con- trol range) in the following parameters were reported: postimplantation losses of 13.0% and 13.9% at doses of 300 and 1,000 mg/kg body weight, respectively, compared to 7.3% in controls, and the total incidence of external, skeletal, and soft tissue malformations was 6.7% at 1,000 mg/kg body weight/ day compared to 3.8% in controls. The incidence of total var- iations (external, skeletal, and soft tissue) was 66.1% to 67.2% in the treated groups compared to 58.0% in controls. The NOAEL for maternal toxicity and reproductive effects was 1,000 mg/kg body weight/day. In Vitro Formic acid. The effect of formic acid on embryonic develop- ment in vitro was evaluated using embryos from pregnant Spra- gue Dawley rats.38 Rat embryos (approximately 10 somites) were explanted during the afternoon of day 10 of pregnancy and cultured in rat serum. Formic acid (in water) was added to the cultured embryos at concentrations ranging from 0.141 to 1.055 mL formic acid per mL of serum (3.74-27.96 mmol formic acid per mL of serum). The no-effect concentration for fo...","endpoint":"reproductive toxicity","ingredient":"Formic Acid and Sodium Formate","loael_value":"","noael_unit":"mg/kg body weight/day","noael_value":"1,000","page":9,"route":"","species":"rat","study_id":"PRS626_noael_002"} |
openFDA substances 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | 0YIW783RG1 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"CH2O2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"0YIW783RG1"} |
| openFDA substances | FDA UNII substance identifier | 0YIW783RG1 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"CH2O2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"0YIW783RG1"} |
| openFDA substances | FDA UNII substance identifier | 0YIW783RG1 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"CH2O2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"0YIW783RG1"} |
| openFDA substances | FDA UNII substance identifier | 0YIW783RG1 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"CH2O2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"0YIW783RG1"} |