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Description of key information

Repeat dose toxicity studies include a 90-day (subchronic) dietary toxicity study with the dichloride salt of diethylenetriamine (DETA) in Albino Rats and a 7 day oral gavage study in rats and 7 day dietary study.
One chronic dermal study in rats was evaluated where DETA was applied throughout the lifetime of the animal
One subacute inhalation toxicity study in rats.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
70 mg/kg bw/day

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEC
550 mg/m³

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
114 mg/kg bw/day

Additional information

DETA-HCL was administered for 90 days in the diet of rats at the follow concentrations: 0, 1000, 7500, or 15000 ppm which correspond to mean intake levels of 70, 530, and 1060 mg/kg/day for males; and 80, 620, and 1210 mg/kg/day for females. No treatment related effects related to clinical signs, gross necropsy, or histopathology were found with any treatment regardless of sex.

For males in the mid-dose group, treatment related changes were observed in the following endpoints: decreased body weight or body weight gain, and an increase in MCV and MCH. For males in the high dose group, treatment related changes were observed in the following endpoints: decreased food consumption, decreased body weight or body weight gain, and an increase in MCV and MCH. For females in the mid-dose, the following treatment related effects were observed: decreased body weight or body weight gain, decreased glucose, increased MCV, increased urine pH, and increased kidney and liver weights. For females in the high dose group, the follwing treatment related effects were observed, decreased food consumption, decreased body weight or body weight gain, decreased glucose, albumin and MCV, and increased liver, kidney and adrenal glands weights. Based on these findings the NOAEL is 1000 ppm (70 mg/kg/day for males, 80 mg/kd/day for females). The LOAEL is 7500 ppm (530 mg/kd/day for males and 620 mg/kg/day for females).

In a chronic dermal study, Wistar rats were administered 0.4 mls of a 100 mg/cc solution of DETA. Five animals/sex/dose were administered 0.4 mls once a day six times per week. The average number of survival days was 407 days. The body weights of both male and female groups treatment group were similar to controls. No average weight was given, instead body weights were represented by a graph with an estimated lifetime average of 350 gram for males and 250 grams for females upon inspection. Therefore, the average daily dose was estimated to be 114 mg/kg for males and 160 mg/kg for females. No treatment related effects were noted on the numbers of erythrocytes and leucocytes, body weight, numbers of litters, and histopathology. The NOAEL for chronic dermal application of DETA was 114 mg/kg.

In a subacute inhalation toxicity study using Alderley Park specific-pathogen-free rats, the animals were administered 0.55 mg/L of DETA for 6 hours per day 5 days a week for 3 weeks. No overt signs of toxicity were noted. Organs appeared normal upon gross pathology.

Justification for classification or non-classification

DETA is not classifiable under GHS. Target organ systemic effects upon repeat exposure were not observed at oral doses at or below 100 mg/kg/day which is the cut-off value for GHS classification catagory 2.