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Description of key information

The test material Genamin TA 100 D (tallow alkylamines) 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 2000 and 2500  mg/kg body weight in sesam oil as vehicle. One out of 5 female animals died at each dose level tested. The rats that were killed at the end of the observation period were free of macroscopic findings. Based on the results of the study 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 tallow alkylamines 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 taking read-across principles into account. 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 tallow alkylamines as well as for all other category members of primary alkylamines. For tallow alkylamines a LD50 of greater 2000 mg/kg body weight was established. Comparable LD50 values indicating moderate acute oral toxicity were revealed also for the other primary alkylamines, which may be explained mainly on the basis of the corrosive properties of the tested substances.

Considering the apparently low systemic toxicity of the primary alkylamines, no need for further inhalative or dermal testing is seen. This view is in line with the existing EU risk assessment on primary alkylamines.

Justification for classification or non-classification

Tallow alkylamines do not fulfill the requirements for classification as Harmful with the designation R22 - harmful if swallowed with regard to acute oral toxicity. Likewise, no classification with regard to acute dermal toxicity and/or acute inhalation toxicity is deducible.

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