Registration Dossier

Administrative data

Description of key information

The test material Genamin 18R 100D (octadecylamines) 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 in a limit test at 2000 mg/kg body weight in sesame oil as vehicle. Clinical signs following treatment included irregular breathing and reduced spontaneous activity. An impairement of body weight development was not observed. Macroscopic findings of toxicological significance were not observed at gross pathology. The LD50 was greater 2000 mg/kg body weight. 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:
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 octadecylamines 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 octadecylamines as well as for all other category members of primary alkylamines. For octadecylamines a LD50 of greater 2000 mg/kg body weight was established. Comparable LD50 values indicating moderate acute oral toxicity were revealed also for tallow alkylamines and octodecenylamines. This view of only moderate toxicity 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

Octadecylamines do not fulfill the requirements for classification. Hence, no classification with regard to acute oral, acute dermal and/or acute inhalation toxicity is warranted.