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Carlson LM, Dean J, Stanek J, et al. Provisional Peer-Reviewed Toxicity Values for 3,5-Dinitroaniline (CASRN 618-87-1). Cincinnati (OH): U.S. Environmental Protection Agency; 2021 Aug.
As shown in Tables 3A and 3B, there are no potentially relevant short-term, subchronic, chronic, developmental, or reproductive toxicity studies of 3,5-dinitroaniline in humans or animals exposed by oral or inhalation routes. The phrase “statistical significance” and the term “significant,” used throughout the document, indicate a p-value of < 0.05 unless otherwise specified.
2.1. HUMAN STUDIES
2.1.1. Oral Exposures
No studies have been identified.
2.1.2. Inhalation Exposures
No studies have been identified.
2.2. ANIMAL STUDIES
2.2.1. Oral Exposures
No studies have been identified.
2.2.2. Inhalation Exposures
No studies have been identified.
2.3. OTHER DATA (SHORT-TERM TESTS, OTHER EXAMINATIONS)
Data pertaining to the toxicity of 3,5-dinitroaniline are limited to in vitro genotoxicity studies, as described below.
2.3.1. Genotoxicity
Genotoxicity studies of 3,5-dinitroaniline are summarized in Table 4. 3,5-Dinitroaniline was mutagenic when tested in Salmonella typhimurium strains TA98 and TA100 with or without metabolic activation (Assmann et al., 1997). Positive findings for 3,5-dinitroaniline were reported in S. typhimurium strains TA98, TA100, TA1537, and TA1538 without metabolic activation, and in TA1535 with or without metabolic activation, when tested at concentrations between 0.5 and 40 μg/plate (Spanggord et al., 1982). In the same study, 3,5-dinitroaniline was not mutagenic in strain TA100NR3 (mutant lacking nitroreductase activity) with or without activation.
Tables
Table 3ASummary of Potentially Relevant Noncancer Data for 3,5-Dinitroaniline (CASRN 618-87-1)
| Category | Number of Male/Female, Strain, Species, Study Type, Reported Doses, Study Duration | Dosimetry | Critical Effects | Reference (comments) | Notes |
|---|---|---|---|---|---|
| Human | |||||
| 1. Oral (mg/kg-d) | |||||
| ND | |||||
| 2. Inhalation (mg/m3) | |||||
| ND | |||||
| Animal | |||||
| 1. Oral (mg/kg-d) | |||||
| ND | |||||
| 2. Inhalation (mg/m3) | |||||
| ND | |||||
ND = no data.
Table 3BSummary of Potentially Relevant Cancer Data for 3,5-Dinitroaniline (CASRN 618-87-1)
| Category | Number of Male/Female, Strain, Species, Study Type, Reported Doses, Study Duration | Dosimetry | Critical Effects | Reference (comments) | Notes |
|---|---|---|---|---|---|
| Human | |||||
| 1. Oral (mg/kg-d) | |||||
| ND | |||||
| 2. Inhalation (mg/m3) | |||||
| ND | |||||
| Animal | |||||
| 1. Oral (mg/kg-d) | |||||
| ND | |||||
| 2. Inhalation (mg/m3) | |||||
| ND | |||||
ND = no data.
Table 4Summary of 3,5-Dinitroaniline (CASRN 618-87-1) Genotoxicity
| Endpoint | Test System | Doses/Concentrations Tested (μg/plate) | Results without Activation | Results with Activation | Comments | References |
|---|---|---|---|---|---|---|
| Genotoxicity studies in prokaryotic organisms | ||||||
| Mutation | Salmonella typhimurium strains TA98, TA100 | 0, 17, 34, 68, 135, 270 | + | + | Plate incorporation assay. 3,5-Dinitroaniline induced a doubling of the spontaneous mutation rate at ≥34 μg/plate in TA98 and ≥17 μg/plate in TA100. | Assmann et al. (1997) |
| Mutation | S. typhimurium strains TA98, TA100, TA1535, TA1537, TA1538, TA100NR3 (nitroreductase-deficient strain) | 0, 0.5–40 |
+ TA98, TA100, TA1535, TA1537, TA1538 − TA100NR3 |
+ TA1535 − TA98, TA100, TA1537, TA1538, TA100NR3 | Plate incorporation assay. Effective dose(s) were not reported. | Spanggord et al. (1982) |