Registration Dossier

Toxicological information

Endpoint summary

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Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information
Short description of key information:
All available studies on toxicity to reproduction of Glycerides resulted in NOAELs ≥ 1000 mg/kg bw/day:
Reproductive/developmental toxicity screening studies (OECD 422): NOAEL (male/female) ≥ 1000 mg/kg bw/day
Two-generation reproduction toxicity and developmental neurotoxicity study (OECD 416/426): NOAEL (P; male/female) ≥ 1159/2200 mg/kg bw/day NOAEL (F1; male/female) ≥ 1342/2262 mg/kg bw/day

Effects on developmental toxicity

Description of key information
All available studies on developmental toxicity and teratogenicity of Glycerides resulted in NOAELs ≥ 1000 mg/kg bw/day:
Rat: NOAEL (F1/F2 ≥ 1342/2262 mg/kg bw/day (OECD 416/426)
Rabbit: NOAEL = 1000 mg/kg bw/day (similar to OECD 414)
Mouse: NOAEL = 9540 mg/kg bw/day (teratogenicity study)
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available

Justification for classification or non-classification