Insulin Aspart Ethyl Ester

Endpoint summary

Description of key information

Acute oral toxicity studies (OECD 423) on the structural analogues MI3 and X14DesB30 both resulted in LD50 valus above 2000 mg/kg bw, as no lethaliiy occured at the highest dose levels of 2000 mg/kg bw. Thus, due to close structural similarity to these substances  low acute oral toxicity (LD50 > 2000 mg/kg) can be concluded for  Insulin aspart ethylester as well. The  low potential for acute oral toxicity is further supported by the data indicating very low -if any- oral absorption of the substance see section 7.1.1.

Data obtained from an OECD 402 study on MI3 indicate very low acute dermal toxicity potential as LD50 > 2000 mg/kg bw. Thus, due to close structural similarity to MI3 an dermal LD50 > 2000 mg/kg bw can be concluded for Insulin aspart ethylester as well. The absence of dermal acute toxicity is further supported by the lack of dermal uptake of the subtance as indicated in 7.1.1.

For further read-across justification see document attached in section 13.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

mg/kg bw

Justification for classification or non-classification

Low acute toxic potential is concluded for Insulin aspart ethyl ester as oral and dermal LD50 values were concluded to be above 2000 mg/kg bw. Thus, Insulin aspart ethyl ester is not to be classified for acute oral - or dermal - toxicity according to the CLP-classification criteria.