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Administrative data

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 (especially X14DesB30 which also as inuslin human methyl ester binds to the inuslin receptor) low acute oral toxicity (LD50 > 2000 mg/kg) can be concluded for Insulin Human Methyl Ester as well.

 

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 Human Methyl Ester as well based on low -if any- dermal absorption of the substance.

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

Additional information

Justification for classification or non-classification

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