Registration Dossier

Administrative data

Description of key information

Acute toxicity: Oral LD50 > 2000 mg/kg for rat.

Key value for chemical safety assessment

Acute toxicity: via oral route

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

Additional information

Various studies have been performed to evaluate the acute oral toxicity of AAI substances. All studies with AAI substances show 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, but if so, this is very minimal. All substances within the AAI group show the same reactive groups, show similar composition of amide, imidazoline, and some dimer structures of both, with the length of original EA amines used for production as biggest difference. Inherent reactivity and toxicity is not expected to differ much between these substances. Consequently, the available information indicates that also Tall oil fatty acids, reaction products with polyethylenepolyamines is expected to have an LD50 > 2000 mg/kg.

 

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 + 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 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.