Registration Dossier

Administrative data

Description of key information

Oral acute toxicity
One key study and three supporting studies were found to determine the acute oral toxicity of diethylene triamine in the rat.
Acute inhalation toxicity
Two acute inhalations: one using Fischer 344 rats exposed to aerolosize diethylene triamine the other exposing rats to substantially saturated vapors of diethylene triamine at 23 degrees C for 8 hours.
Acute dermal toxicity
Two studies, one key and the other supporting were conducted to determine the dermal LD50 in rabbits for diethylene triamine.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
1 553 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Value:
70 mg/m³

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
Value:
1 045 mg/kg bw

Additional information

The key study indicated that the oral acute LD50 in rats was 1.620 ml/kg (1553 mg/kg) (Dow, 1977). Additional supporting studies on the acute toxicity of DETA indicate that this compound is moderately toxic with LD50s ranging from 1.18 to 2.33 ml/kg (1080 mg/kg to 2330 mg/kg). No adjustment was made on the basis of specific gravity or purity of the compound to the LD50s. Therefore, each ml/mg is approximately equal to 1000 mg/kg for the purpose of evaluating the LD50.

A NOEC for acute toxicity to aerosolized DETA was obtained at an exposure concentration of 0.07 mg/L for 4 hours. No lethality was observed during the 14 day post-exposure observation period. At the next exposure level, 0.30 mg/L, all animals survived the 4 hr/exposure; however, in the 14 day post-exposure period, all male rats died by test day six and all female rats died by test day 11. This study was considered a over a previous study which showed lethality at the 0.07 mg/L dose level because of a better characterization of the test atmosphere according to NIOSH Method 2540. As such, the chamber analysis gave the amount of total DETA in the atmosphere.

Another study was conducted to determine whether a saturated atmosphere of DETA was lethal to rats. Rats were exposed to a saturated atmosphere for 8 hours. No lethality occured and nothing remarkable was noted on gross pathology.

The results of the key acute dermal study for diethylene triamine calculated the LD50 at 1.09 ml/kg (ca. 1.045 mg/kg adjusted for the density value of 958.6 mg/m3). Gross observations in the animals that died indicated that the lungs were often congested and hemorrhagic; the kidneys were considerably damaged (pitted surface appearance and subcapsular hemorrhage. In survivors, stools were watery and often blood tinged. Additional information from the supporting study (LD50 = 0.707 ml/kg

ca. 678 mg/kg adjusted for the density value of 958.6 mg/m3) indicated that the livers and spleens in the victims were also congested.

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Justification for classification or non-classification

Based on the acute oral LD50s in the range of 1180 mg/kg to 2330 mg/kg, DETA can be given a GHS classification of Catagory 4.

Based on the acute inhalation data indicating that the LD0 = 0.07 mg/L and the LD100 = 0.30 mg/L, DETA (as aerosol) can be given a GHS classification of Catagory 2.

No lethality occurred when rats were exposed to a saturated atmosphere for 8 hours at ambient temperatures. Therefore DETA as a vapor is not classifiable under GHS.

Based on the acute dermal LD50 of 1.09 ml/kg (range 0.95 to 1.24 ml/kg) or when adjusted on the basisi of specific gravity LD50 of 1045 mg/kg (range 910 mg/kg to 1.24 mg/kg) in rabbits, DETA can be given a GHS classification of Category 4.