Quaternary ammonium compounds, bis(hydrogenated tallow alkyl)dimethyl, chlorides, reaction products with polyethylenepolyamines and tall-oil fatty acids, humates hydrochlorides

Endpoint summary

Description of key information

Organolignite is a UVCB substance with no available analytical method to detect it in biological fluids or tissues. Despite this limitation, sufficient physicochemical data, acute hazard data, and repeat-dose inhalation toxicity data have been developed that can be used to assess organolignite's absorption, distribution, metabolism, and elimination. Physiochemical properties indicate that organolignite would not be absorbed from biological membranes, including the gastrointestinal tract. A repeated dose inhalation toxicity study indicates that organolignite is not distributed beyond the lung.

Additional information

Organolignite is a UVCB substance with no available analytical method to detect it in biological fluids or tissues. Despite this limitation, sufficient physicochemical data, acute hazard data, and repeat-dose inhalation toxicity data have been developed that can be used to assess organolignite's absorption, distribution, metabolism, and elimination. We refer to this process as the substance's toxicokinetic (TK) profile or TK. There is no human data regarding organolignite's TK. 

 

Physicochemical Properties

Inhalation is the primary human exposure route, however, the physical size of the particles that comprise bulk organolignite suggest little of it is respirable in the human lung. For example, particle size distribution data shows that less than 3% of organolignite is at or below 10 microns in diameter. On the molecular level, organolignite has a molecular weight > 20000 Da, which suggests that the substance will not readily cross biological membranes, including the gastrointestinal tract. This observation is strongly supported by organolignite's chemical properties (i.e., water solubility of 0.054 mg/L; log K_owof 3.6). The results of several acute toxicity studies, discussed below, further support this conclusion.

 

Acute Toxicity Studies

Acute dermal study data in laboratory animals demonstrates that organolignite is not an irritant/corrosive, it does not elicit an allergic response, and it does not cause any local or systemic toxicity when applied to the skin. It is generally recognized that exposure via the inhalation route leads to greater absorption of a substance when compared with exposure via the dermal route. An acute inhalation toxicity study in rats revealed no apparent toxicity by this route of exposure at a concentration of approximately 2000 mg/m³ (2.0 mg/L).

 

Repeat-Dose Toxicity Studies

A combined repeated dose toxicity study with a reproduction/developmental toxicity screening test showed no adverse effects, including no reproductive or developmental effects, even at the high dose exposure level of 300 mg/m³ (0.3 mg/L). Male rats in this study were exposed to organolignite for approximately 4 weeks and female rats were exposed for approximately 6 weeks. At necropsy, dark discoloration of the lungs was noted in males and females treated at the mid (50 mg/m³) and high dose. Other necropsy findings at the high dose included pale foci on the lungs, dark discoloration of the bronchial lymph nodes and dark discoloration of the mediastinal lymph nodes; both sets of lymph nodes are associated with the lung. Lung and lymph node discoloration is consistent with clearance because organolignite is dark in color. Based on histopathological examinations of key organs (e.g., liver, brain, heart, kidney, mammary gland, ovary, pancreas, skeletal muscle, spleen, and GI tract associated lymphoid tissue), there is no evidence that organolignite is distributed beyond the lung when exposure occurs via inhalation.