Propanamide, 3-amino-2,2-dimethyl-

Endpoint summary

Description of key information

Oral: LD50 > 2000 mg/kg bw, (rat, according to EU Method B.1 tris)
Dermal: LD50 > 2000 mg/kg bw (rat, according to EU Method B.3 and OECD guideline 402)

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Additional information

Oral

In an acute oral toxicity study (Limit Test) conducted by RIOS (2003) according to EU Method B.1 tris, a dose of 2000 mg/kg bw was administered by gavage to 3 Wistar rats per sex. The animals were observed for 15 days for lethality and clinical signs of intoxication. No mortality and no clinical signs of intoxication were observed in males and females. Macroscopic changes were diagnosed during necropsy in all animals. In the lung, lung oedema and small haemorrhage were detected in both sexes.

The LD50 is higher than 2000 mg/kg bw for male and female rats.

 

Inhalation

There are no data available for acute inhalation toxicity.

 

Dermal

In an acute toxicity study (Limit Test) conducted by ARC (2005) according to EU Method B.3 and OECD 402 (1987), a single dermal administration of 3-amino-2,2-dimethyl-propionamide was performed by spreading a dose of 2000 mg/kg bw of the undiluted test substance on an area of at least 10% of the estimated body surface of 5 young Wistar rats per sex. The duration of the semi occlusive exposure was 24 hours. At the end of the exposure period the residual test substance was wiped off. The observation period following administration was 14 days. No mortality, no test substance related effects were observed from clinical observations or post-mortem examination. The mean body weight gain shown by the animals over the study period was considered to be similar to that expected of normal untreated animals of the same age and strain. Slight body weight loss was noted in 1/5 females in the first week after dosing. This was assumed to be due to the discomfort, caused by the dressing and was not considered to be toxicologically relevant. Therefore, the LD50 for dermal exposure of 3 -amino-2,2-dimethyl-propionamide is higher than 2000 mg/kg bw for male and female rats.

Justification for classification or non-classification

Based on the oral and dermal LD50 of >2000 mg/kg bw for rats the substance does not need to be classified according to Directive 67/548/EEC and according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.