Diallylamine

Endpoint summary

Description of key information

Acute oral toxicity:

Key data:

Female Sprague-Dawley rats were administered, by gavage, a single dose of diallylamine at 215, 464, 1000 and 4640 mg/kg.

No observable effects occurred at the lowest tested dose, while mortality was induced at higher doses within 20 hours of dosing.

In the same study, male Sprague-Dawley rats administered diallylamine at 215, 464, 1000 and 2150 mg/kg exhibited a dose-dependent depression (lethargy) in all exposed groups. At lower doses, death sometimes occurred a week or later after dosing, while at 1000 mg/kg and higher, all male rats died within 2 hours.

Based on the results of the study the following LD50 values were reported: 316 mg/k for males and 501 mg/kg for females.

Weight of evidence data:

Male rats were administered, by gavage, a sinlge dose of diallylamine at dose levels 267 - 600 mg/kg. The acute oral LD50 was reported as 578 mg/kg.

Acute dermal toxicity:

Key data:

Diallylamine was applied for 24 hours to the intact skin of New Zealand white rabbits, at doses of 215, 464, 1000 and 2150 mg/kg. Necrosis, erythema and edema were observed. Mortality data are as follows: 215 mg/kg (0/4), 464 mg/kg (1/4), 1000 mg/kg (4/4) and 2150 mg/kg (4/4).

All deaths occured within 24 hours of dosing, most in less than 4 hours.

The LD50 was reported as 562 mg/kg.

Weight of evidence data:

Male rabbits (3 per group) were administered a single dose of diallylamine for several hours under a patch, at dose levels of 100 - 800 mg/kg. The acute dermal LD50 was reported as 356 mg/kg. Substantial local redness, swelling and scarring of skin was observed.

Acute inhalation toxicity:

Key data:

The actue inhalation toxicity of diallylamine was examined by exposure (vapour) to rats for 1, 4 and 8 hours.

Rats were exposed to diallylamine (vapour) for 1, 4 and 8 hours. The tested concentrations were:

1 hour exposure: 7000 ppm (27.8 mg/L)

4 hour exposure: 1500 - 5070 ppm (5.96 mg/L - 20.15 mg/L).

8 hour exposure: 450 - 1500 ppm (0.45 - 5.96 mg/L)

The following results are reported:

A 4-hour rat LC50 of 10.95 mg/L is reported.

No mortalities were observed after the 1 hour exposure and a 1 hour LC50 of 27.8 mg/L is reported. This converts to a 4 hour LC50 estimate of 13.9 mg/L.

A 8-hour LC50 of 3.16 mg/L is reported. This converts to a 4 hour LC50 estimate of 4.47 mg/L

Weight of evidence data:

10 Rats (5 male and 5 female) were exposed to diallylamine (vapour) for 1 hour at a test concentration of 6.3 mg/l and observed for 14 days.

No deaths occured. Moderate eye irritation and depression (lethargy) were observed during exposure and persisted after cessation of treatment, but rats appeared normal after 24 hours.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

316 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LC50

Value:

10 950 mg/m³

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

562 mg/kg bw

Justification for classification or non-classification

Acute oral toxicity:

All reported LD50 results from acute oral toxicity tests fall within the CLP Category 4 range (>300 to ≤2000 mg/kg bodywieght), including the worst case result of 316 mg/kg (in males).

The substance shall therefore be classified for acute toxicity (oral) Category 4; H302: Harmful if swallowed.

Acute dermal toxicity:

All reported LD50 results from acute dermal toxicity tests fall within the CLP Category 3 range (>200 to ≤1000 mg/kg bodywieght).

The substance shall therefore be classified for actue toxicity (dermal) Category 3; H311: Toxic in contact with skin.

Acute inhalation toxicity:

1 -hour exposure to the substance to rats did not result in mortalities in two tests. Classification based on these 1 -hour exposures would not be required.

A 4 -hour exposure to the substance to rats (as vapour) gave a 4-hour rat LC50 of 10.95 mg/L. This result warrants classification for acute toxicity (inhalation) Category 4.

A 8 -hour exposure to the substance to rats (as vapour gave a 8 -hour LC50 of 3.16 mg/L. This was converted into a 4 -hour LC50 estimaet of 4.47 mg/L. This result could warrant classification for acute toxicity (inhalation) Category 4.

However, it is considered that the 4 -hour exposure result is most reliable for classification as:

- 8 hour exposure time not a standard exposure time in acute inhalaiton studies

- CLP classification criteria based on 4 hour exposure

- CLP provides a standard approach for the conversion of 1 hour exposure data into 4 hour data, but does not provide a standard approach for converting >4 hour exposure data into 4 hour data.

- The lack of mortalities observed after 1 hour expousre in two studies suggests the substane is not highly toxic by the inhalaiton route.

The substane shall therefore be classified for acute toxicity (inhalation) Category 4; H332: Harmful if inhaled.