Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
The quality of the database is not possible to assess as the conclusions are based on published robust study summaries for the Epoxidized Oils and Derivates Chemical Category rather than study reports (SIDS, 2006). The authors consider the data reliable without restriction.
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information
Justification for selection of Effect on fertility via oral route:
An OECD 422 is available for the analogous substance, CAS # 61789-01-3 Fatty acids, tall-oil, epoxidized, 2-ethylhexyl esters (ETP). No specific reproductive toxicity was identified that would lead to classification for this endpoint (NOAEL=1000 mg/kg bw/d).

Effects on developmental toxicity

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
The quality of the database is not possible to assess as the conclusions are based on published robust study summaries for the Epoxidized Oils and Derivates Chemical Category rather than study reports (SIDS, 2006). The authors consider the data reliable without restriction.
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information
Justification for selection of Effect on developmental toxicity: via oral route:
An OECD 422 is available for the analogous substance, CAS # 61789-01-3 Fatty acids, tall-oil, epoxidized, 2-ethylhexyl esters (ETP). No specific developmental toxicity was identified that would lead to classification for this endpoint (NOAEL=1000 mg/kg bw/d).

Justification for classification or non-classification

In accordance with with criteria for classification as defined in Regulation 1272/2008, the test material does not require classification for reproductive or developmental toxicity as no signs of toxicity were noted during the course of the study.