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Administrative data

Description of key information

Acute toxicity: Oral LD50 > 2000 mg/kg for rat (LD50 cut-off: 2500 mg/kg bw)

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 500 mg/kg bw

Additional information

Fatty acid C18 unsaturated + TEPA was tested for acute oral toxicity according to acute toxic class method. The study showed one death out of 6 dosed at 2000 mg/kg, and no mortality at 300 mg/kg.

At 300 mg clinical signs included lethargy, hunched posture, uncoordinated movements and/or piloerection on Day 1.

 

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 oral toxicity amidoamines/imidazolines:

 

Fatty acid C18 unsat + DETA

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

Fatty acid C18 unsat + DETA

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

Fatty acid C18 unsat + 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

Fatty acid C18 unsat + Poly(Amide)

>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 Tall oil + TEPA show limited acute toxicity, with a LD50 above 2000 mg/kg bw. 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.