Linseed oil, epoxidized

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Description of key information

A screening study (OECD 422) and a one-generation reproductive toxicity study are available and show no advrese effects at the limit dose of 1000 mg/kg bw/d.

Effect on fertility: via oral route

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEL

Study duration:

subchronic

Species:

rat

Effect on fertility: via inhalation route

Endpoint conclusion:

no study available

Effect on fertility: via dermal route

Endpoint conclusion:

no study available

Additional information

Read across to a study result from an investigation using a similar material is justified for members of the Epoxidised Oils and Derivatives group. Four epoxidised oils and esters (linseed, soybean,9-octadecanoate propylene glycol ester and 2-ethylhexyl tallate ester ETP). The C14-C22, 2-ethylhexylesters are listed as similar products on the market to ETP based on fatty acids from other naturally occurring fatty acids This group of epoxies are identified as sharing common structural and functional similarities, recognised in an OECD SIDS review as a single category, and therefore justifying read-across between data for different members of the group. Consequently data sharing between ESBO epoxidised soybean oil, ELO epoxidised Linseed oil and ETP epoxidised 2ethylhexyl tallate and fatty acids, C14-C22, 2-ethylhexylesters, epoxidised and

fatty acids, C12 -C20 and C12 -20 unsaturated, 2-ethylhexylestershas been

utilised in the preparation of this dossier. A single generation reproductive toxicity study with ESBO inicates that

fatty acids, C12 -C20 and C12 -20 unsaturated, 2-ethylhexylesters is unlikely to induce any toxic effects in parental males and females, nor disturb their capacity for reproduction and does not impair the development of the F1 offspring. Under the test conditions, the highest tested dose of 1000 mg/kg bw/day was found to be the NOEL for fertility, reproduction and developmental toxicity.

In a screening test for reproductive toxicity, fatty acids, tall-oil, epoxidized, 2-ethylhexylesters (ETP) was administered once daily orally (by gavage) to males for at least 28 days and to female rats throughout the prepairing and pairing periods until day 3 of lactation. The dose levels were 100, 300 and 1000 mg/kg bw/day. In the absence of any adverse effects on reproductive parameters, the NOAEL and NOEL for reproduction/developmental toxicity were considered to be 1000 mg/kg bw/day.

The NOAEL derived from a 28 day oral toxicity investigation, used for dose-ranging in the reproductive toxicity investigation, was also 1000 mg/kg bw/day.

The developmental toxicity of 2 -ethylhexyl stearate was investigated in rats, given doses of 100, 300 or 1000 mg/kg bw/day in a 5 mL/kg volume of arachadis oil.

2-Ethylhexyl stearate did not affect maternal rats during the entire pregnancy. No mortalities occurred in the dams during the study, either in the vehicle control or in the groups exposed to 2-ethylhexyl stearate up to 1000 mg/kg body weight. The absolute and the corrected body weight and body weight gain was comparable between the groups. Gross macroscopic examination of the maternal organs including ovaries and uterus revealed no alterations. The no-adverse-effect dose of 1000 mg/kg bw /day corresponds to repeated dose toxicity data which also indicated the same dose to be compatible to rats. The number of corpora lutea, implantation sites, living foetuses, foetal sex ratio, resorptions and foetal deaths, and foetal and placenta weight in treated groups were not significantly different to those of the control group. No compound-related differences were noted between the mean reproduction data. There were no dose-related statistically significant differences in the conception rate, mean number of corpora lutea or pre-implantation loss. With the exception of one dead foetus in the 1000 mg/kg bw group all foetuses in treated and control groups were alive.

The weights of live foetuses exhibited no significant differences on a litter and individual basis. In comparison with the control group in the 100 and 1000 mg/kg bw group, the post-implantation loss and total embryonic deaths were significantly decreased. Non-dose-related findings were considered to be incidental, due to the high control values. Mean foetal placental and uterus weights were not affected by treatment. Foetal sex ratio was comparable in all groups. A hydrops was noted in one control group foetus. Findings both on the individual foetus and on the litter basis did not differ from the historical control. From the visceral examinations, one hydrocephalus internus was found which has to be considered as an individual non-dose-related finding which also occurs in the historical data at a comparable level (0.4%). All changes were slight and also occurred in the control population. Concerning the skeletal examination on the basis of the foetal incidence, there are differentiated results in some findings such as `non-ossification' of sternebrae (retardation). However, the total frequency of the findings `incomplete ossification' including `non-ossification' of all sternebrae show no substantial differences between the untreated and treated groups. The percentage of these findings varies from approximately 60% (dose group 0, 300 and 1000 mg/kg) up to 77% (dose group 100 mg/kg). There is also no difference to the historical control data showing a percentage of about 62%. The reason for the differentiated results may be the individual age-related development of the foetuses. Therefore, it can be concluded that there were no differences in the incidences of external, visceral or skeletal malformations or variations among all groups.

The developmental toxicity NOEL for maternal and embryo-foetal/ teratogenicity effects was in excess of the limit dose of 1000 mg/kg bw/day.

Effects on developmental toxicity

Description of key information

No effects of treatment were seen in a rat PNDT study at the limit dose of 1000 mg/kg bw/d.

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

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

There is no indication of reproductive or developmental toxicity at the limit dose of 1000 mg/kg bw/d in a number of studies. No classification is therefore proposed for reproductive toxicity according to the CLP Regulation.