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Administrative data

Description of key information

Acute toxicity: Oral LD50 > 2000 mg/kg for rat. (Cut-off value 5000 mg/kg)

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

Additional information

Tall oil fatty acids, reaction products with polyethylenepolyamines (Amidoamine) was tested for acute oral toxicity according to the Acute Toxic Class Method.

The substance was administered by oral gavage to two subsequent groups of three female Wistar rats at 2000 mg/kg body weight. No mortality occurred. Hunched posture and piloerection were observed among all animals on Days 1 and/or 2. The body weight gain was normal. No abnormalities were found at macroscopic post mortem examination of the animals. The study conclude that the oral LD50 > 2000 mg/kg bw, with a LD50 cut-off value of 5000 mg/kg bw.

 

All other studies with AAI substancesshow similar acute oral toxicity, all with a LD50 > 2000 mg/kg bw. There is possibly a small tendency of decreased toxicity with increasing size of the EA.

Acute toxicity amidazolines:

    TO + DETA                        >2000 mg/kg bw ,Cat.5; ATC cut off 2500mg/kg bw

    TO + DETA                        >2000 mg/kg bw, Cat.5; ATC cut off 2500mg/kg bw

    TO + TEPA                        >2000 mg/kg bw, Cat.5; ATC cut off 2500mg/kg bw

    C16-18,C18 unsat+TEPA  >2000 mg/kg bw, Cat.5; Limit test 20% mortality

    TO + PolyEA(Amidoamine)>2000 mg/kg bw ,Cat.5; ATC cut off 5000mg/kg bw

Acute dermal toxicity: AAI are corrosive to the skin. Testing for acute dermal toxicity is therefore not justified. Toxicity following dermal exposure is characterised by local tissue damage, rather than the result of percutaneously absorbed material.

 

Acute inhalation toxicity: Physical-chemical properties of AAI indicate a low likelihood for exposure via inhalation having a boiling point > 300 °C and a low vapour pressure (0.00017 mPa at 25°C for DETA based AAI).

Furthermore, the substance is classified as corrosive and no acute toxicity testing should normally be conducted.

Justification for classification or non-classification

Acute oral exposure of all AAI tested show limited acute toxicity, with a LD50 above 2000 mg/kg bw. Similar results are expected for Tall oil fatty acids, reaction products with polyethylenepolyamines, and hence no classification is required.

 

Acute dermal testing with corrosive materials is not justified. As a consequence no classification can be made for acute dermal toxicity. Effects will be characterised by local tissue damage. Systemic uptake via skin is likely to be very limited. The low acute oral toxicity indicate a low systemic toxicity.

No classification for acute dermal toxicity is therefore indicated.

 

Also for acute inhalation toxicity information for classification is lacking, and is testing not justified. Due to very low vapour pressure is the likelihood of exposure low.

 

AAI do not contain containing aliphatic, alicyclic and aromatic hydrocarbons and have a relatively high viscosity and so do not indicate an immediate concern for aspiration hazard.