Dodecylamine

Endpoint summary

Description of key information

The test material Genamin 12 R 100D (dodecylamines) 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 the limit dose of 2000 mg/kg body weight in sesam oil as vehicle. Clinical signs included squatting posture, stilted gait, irregular breathing, and reduced spontaneous activity. Symptoms started between 10-60 minutes after onset of treatment and were present until day 6 (female animals) or day 9 (male animals). Gross pathology revealed no findings except in one male animal. This animal showed partly connation of stomach epithelia with lobes of liver, spleen, pancreas and abdominal wall which was most probably caused by the corrosive properties of the test material. With regard to acute dermal toxicity, a LD50 value of greater 2000 mg/kg body weight from a guideline conform study on the analogous compound C12-18-(even numbered)-alkylamines can be assumed based on read-across. Data from an inhalation study also with C12-18-(even numbered)-alkylamines indicate a 1hour LC50 greater 0.099 mg/L.

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

There are no human data on acute toxicity for dodecylamines nor for any of the other primary alkylamines considered a chemical category with respect to chemical safety assessment. In animals, data for dodecylamines are available for the oral route of exposure indicating a LD50 value of greater 2000 mg/kg body weight. For the dermal route and to a limited extend also for the inhalation route of exposure data is available for analogous primary alkylamines. For the inhalation route, there exists one rat screening study for the analogous 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 also available for all other category members of primary alkylamines considered in the EU risk assessment. For C12 -18 -(even numbered)-alkylamines a LD50 of 1300 mg/kg body weight was established. However, in another GLP compliant acute oral toxicity study according to OECD TG 401 a LD50 of greater 2000 mg/kg body weight was revealed. Comparable LD50 values indicating moderate acute oral toxicity for primary alkylamines were revealed also for tallow alkylamines and octodecenylamines. This view of moderatly acute toxicity was also taken in the existing EU risk assessment of primary alkylamines. Considering the apparently low systemic acute toxicity of the primary alkylamines in general, no need for further inhalative or dermal testing of dodecylamines is seen.

Justification for classification or non-classification

Based on the LD50 value greater than 2000 mg/kg body weight, dodecylamines are not subject for labelling and classification requirements with regard to acute oral toxicty. No classification with regard to acute dermal toxicity and/or acute inhalation toxicity is deducible.