C16-18-(even numbered, saturated and unsaturated)-alkylamines

Endpoint summary

Description of key information

The test material Noram O ((Z)-octadec-9-enylamine) was tested for acute oral toxicity in a GLP compliant study according to OECD test guideline 401. The test item was applied via gavage to Wistar rats at doses of 200, 500, 1000 and 2000 mg/kg body weight in corn oil as vehicle. Clinical signs during the 14 day observation period included: hypokinesia and/or sedation, piloerection and dyspnea, abdominal swelling and decreases in body weight gain. An LD50 of 1200 mg/kg body weight for male rats and 1689 mg/kg body weight for female rats was calculated. With regard to acute dermal toxicity, a LD50 value of greater 2000 mg/kg body weight from a guideline conform study on C12-18-(even numbered)-alkylamines can be assumed based on read-across. Data from an inhalation study with C12-18-(even numbered)-alkylamines indicate a 1hour LC50 greater 0.099 mg/L and will be used as read-across.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Dose descriptor:

LD50

Value:

1 200 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Additional information

There are no human data on acute toxicity for (Z)-octadec-9 -enylamines nor for any of the other primary alkylamines considered a chemical category with respect to chemical safety assessment. In animals, data for all relevant exposure routes are available. For the inhalation route, there exists one rat screening study for C12 -18 -(even numbered)-alkylamines which did not indicate a strong toxic potential for this class of compounds when applied at a non-corrosive concentration. For the dermal route, one rat study performed also with C12 -18 -(even numbered)-alkylamines has likewise not revealed evident acute toxicity (LD50 > 2000 mg/kg body weight) indicating no significant toxicity with regard to this endpoint. Studies for the oral route are available for (Z)-octadec-9 -enylamines as well as for all other category members of primary alkylamines. For (Z)-octadec-9 -enylamines a LD50 of 1200 mg/kg body weight was established for the male rat. Comparable LD50 values indicating low to moderate acute oral toxicity were revealed also for the other primary alkylamines, which may be explained by the corrosive properties of the tested substances. This view was also taken in the existing EU risk assessment of primary alkylamines. Considering the apparently low systemic toxicity of the primary alkylamines, no need for further inhalative or dermal testing was seen.

Justification for classification or non-classification

(Z)-octadec-9 -enylamines fulfill the requirements for classification as Harmful with the designation R22 - harmful if swallowed. No classification with regard to acute dermal toxicity and/or acute inhalation toxicity is deducible.