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Toxicological Profile for N-Nitrosodimethylamine (NDMA). Atlanta (GA): Agency for Toxic Substances and Disease Registry (US); 2023 Apr.
Toxicological Profile for N-Nitrosodimethylamine (NDMA).
Show detailsTable 7-1Regulations and Guidelines Applicable to N-Nitrosodimethylamine (NDMA)
| Agency | Description | Information | Reference |
|---|---|---|---|
| Air | |||
| EPA | RfC | Not evaluated | IRIS 1987 |
| WHO | Air quality guidelines | No data | WHO 2010 |
| Water & Food | |||
| EPA | Drinking water standards and health advisories | EPA 2018a | |
| 1-Day health advisory (10-kg child) | No data | ||
| 10-Day health advisory (10-kg child) | No data | ||
| DWEL | No data | ||
| Lifetime health advisory | No data | ||
| 10−4 Cancer risk | 0.00007 mg/L | ||
| National primary drinking water regulations | Not listed | EPA 2009 | |
| RfD | Not evaluated | IRIS 1987 | |
| Provisional peer-reviewed toxicity values | EPA 2007 | ||
| Provisional RfD, subchronic and chronic | 8×10−6 mg/kg/day | ||
| WHO | Drinking water quality guidelines | WHO 2022 | |
| Guideline value | 0.0001 mg/L | ||
| FDA | Substances Added to Fooda | Not listed | FDA 2020b |
| Action level for malt beverages | 5 ppb (0.005 mg/L) | FDA 2005a | |
| Action level for rubber baby bottle nipples | 10 ppb (μg/kg) | FDA 2005b | |
| Acceptable intake limit in drug products | 96 ng/dayb | FDA 2021 | |
| Cancer | |||
| HHS | Carcinogenicity classification | Reasonably anticipated to be a human carcinogen | NTP 2021 |
| EPA | Carcinogenicity classification | B2c | IRIS 1987 |
| Inhalation unit risk | 1.4×10−2 per μg/m3 | ||
| Cancer slope factor | 51 per mg/kg/day | ||
| Cancer slope factor | 21 per mg/kg/day | EPA 2016 | |
| IARC | Carcinogenicity classification | Group 2Ad | IARC 1987 |
| Occupational | |||
| OSHA | PEL (8-hour TWA) for general industry, shipyards and construction | No data | OSHA 2021a, 2021b, 2021c |
| Worker exposure to be controlled through the required use of engineering controls, work practices, and personal protective equipment, including respirators | OSHA 2021d | ||
| NIOSH | REL (up to 10-hour TWA) | No datae | NIOSH 2019 |
| Emergency Criteria | |||
| EPA | AEGLs-air | No data | EPA 2018b |
| DOE | PACs-air | DOE 2018a | |
| PAC-1f | 0.082 mg/m3 | ||
| PAC-2f | 0.9 mg/m3 | ||
| PAC-3f | 10 mg/m3 | ||
- a
The Substances Added to Food inventory replaces EAFUS and contains the following types of ingredients: food and color additives listed in FDA regulations, flavoring substances evaluated by FEMA or JECFA, GRAS substances listed in FDA regulations, substances approved for specific uses in food prior to September 6, 1958, substances that are listed in FDA regulations as prohibited in food, delisted color additives, and some substances “no longer FEMA GRAS.”
- b
Limit if NDMA is the only nitrosamine. If the total quantity of nitrosamine impurities exceeds 26.5 ng/day, the manufacturer should contact the FDA for evaluation.
- c
B2: probable human carcinogen.
- d
Group 2A: probably carcinogenic to humans.
- e
Potential occupational carcinogen.
- f
Definitions of PAC terminology are available from DOE (2018b).
AEGL = acute exposure guideline levels; DOE = Department of Energy; DWEL = drinking water equivalent level; EAFUS = Everything Added to Food in the United States; EPA = Environmental Protection Agency; FDA = Food and Drug Administration; FEMA = Flavor and Extract Manufacturers Association of the United States; GRAS = generally recognized as safe; HHS = Department of Health and Human Services; IARC = International Agency for Research on Cancer; IRIS = Integrated Risk Information System; JECFA = Joint FAO/WHO Expert Committee on Food Additives; NIOSH = National Institute for Occupational Safety and Health; NTP = National Toxicology Program; OSHA = Occupational Safety and Health Administration; PAC = protective action criteria; PEL = permissible exposure limit; REL = recommended exposure limit; RfC = inhalation reference concentration; RfD = oral reference dose; TWA = time-weighted average; WHO = World Health Organization
- Table 7-1, Regulations and Guidelines Applicable to N-Nitrosodimethylamine (NDMA...Table 7-1, Regulations and Guidelines Applicable to N-Nitrosodimethylamine (NDMA) - Toxicological Profile for N-Nitrosodimethylamine (NDMA)
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