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Administrative data

Description of key information

The test material was determined to have a NOAEL of 1000 mg/kg/day in an OECD 422 reproduction screening study performed on the analogue substance, CAS # 61789-01-3 Fatty acids, tall-oil, epoxidized, 2-ethylhexyl esters.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
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.

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The following conclusions are from SIDS, 2006:

ETP was administered once daily orally (by gavage) to male rats for at least for 28 days and to female rats throughout the 14 day pre-pairing period, throughout pairing and gestation up to lactation day 4 according to OECD Guideline 422 (RCC, 2005b). The dose levels were 0 (vehicle control), 100, 300 and 1000 mg/kg bw/d. No test article-related mortalities or clinical signs were noted throughout the study. None of the parameters under investigation during the functional observational battery gave any indication of test item-related effects. Neither food consumption nor body weight development was affected by treatment with ETP at any dose level. The assessment of clinical chemistry and hematology parameters indicated no differences between animals treated with ETP and vehicle controls. During necropsy of parent animals no test article- related findings were noted. For males treated at 300 and 1000 mg/kg bw/d, mean absolute and relative liver weights were dose-dependently increased. For females treated at 1000 mg/kg bw/d, mean absolute and relative liver weights were increased. Histopathological findings included the following: Minimal hepatocellular hypertrophy in animals treated at 1000 mg/kg bw/d. This change was considered to represent an adaptive reaction most likely induced by an increased biotransformation of the test article. This was not considered an adverse effect. Increased incidence of minimal follicular cell hypertrophy in the thyroid of animals treated with 1000 mg/kg bw/d. The NOAEL for ETP in this repeat dose toxicity study was considered to be 1000 mg/kg bw/d.


Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
An OECD 422 is available for the analogous substance, CAS # 61789-01-3 Fatty acids, tall-oil, epoxidized, 2-ethylhexyl esters (ETP). No specific target organ 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 criteria for classification as defined in Annex I, Regulation 1272/2008, the test material does not require classification for specific organ toxicity, repeated dose. The effects observed in the available study are not considered to be toxicologically significant and do not indicate any signs of organ dysfunction.