Corn oil (Zea mays, Gramineae), peroxidised

Endpoint summary

Description of key information

LD50 oral, rat > 2000 mg/kg bw (OECD 423, GLP)
LD50 dermal, rat > 2000 mg/kg bw (OECD 402, GLP)

Additional information

Acute toxicity : oral

In an acute oral toxicity study according to OECD TG 423 and GLP (Vaeth A., 2011), scored as validity 1 according to Klimisch criteria, groups of fasted Wistarrats (6 females/dose level) were given a single oral dose of « Corn oil, peroxidised » in olive oil at the doses of 300 and 2000 mg/kg bw and observed for 14 days. Clinical signs and mortality were checked frequently during the hours following administration of the test substance, and at least once a day thereafter. Body weight was measured just before administration of the test substance on day 0 and then on days 7 and 17.

Under the experimental conditions, the oral LD50 of the test substance « Corn oil, peroxidised » is higher than 2000 mg/kg in rats.

No mortality was observed during the observation period. On the day of application after 30 minutes to 6 hrs, a hunched posture and/or piloerection were observed in animals receiving the doses of 300 and 2000 mg/kg bw. After 4 hrs or 6 hrs the rats showed normal behaviour. From day 1 to the end of the observation period on day 14 all animals were free of any abnormalities.

The development of the body weight was normal in all animals.

There were no pathological signs detected in the necropsy.

 

No classification for acute oral toxicity is warranted based on the absence of mortality up to a limit dose level, according to the criteria of EU GHS.

This study is classified as acceptable, as it is performed according to OECD guideline and GLP.

Acute toxicity: dermal

In an acute dermal toxicity study according to OECD TG 402 and GLP (Vaeth A., 2011), groups of Wistar rats (5/sex) were dermally exposed to undiluted peroxidised corn oil for 24 hours to 6x8cm at the dose of 2000 mg/kg bw (limit test).  Animals then were observed for 14 days. During the study clinical signs of reaction to the treatment were recorded daily. Body weight was recorded once a week. After the 2-week observation period, the animals were killed and subjected to gross necropsy examination.

 

Male/female LD50 > 2000 mg/kg bw

 

Neither male nor female rats died on account of the treatment or showed severe signs of toxicity.

The animals showed lower activity (apathy) probably caused by limited mobility resulting from the tape fixation of the patch on day 0 after 1 hr, 3 hrs and 6 hrs. From day 1 to the end of the observation period on day 14 no abnormalities were revealed.

The rats had a normal body weight gain during the study period.

The post mortem inspection revealed no pathological abnormalities.

No classification for acute dermal toxicity is warranted based on the absence of mortality up to a limit dose level, according to the criteria of EU GHS.

This study is classified as acceptable, as it is performed according to OECD guideline and GLP.

Acute toxicity: inhalation

No acute inhalation toxicity study is available. However this study can be waived based on column 2 adaptation (Reach regulation, Annex VIII, section 8.5), and because exposure of humans via inhalation is unlikely; handling of the registered substance does not produce vapour, aerosols or droplets. Furthermore, the most probable route of exposure is the dermal route since the substance is produced and commercialized as a liquid.

Justification for classification or non-classification

« Corn oil, peroxidised » induces no mortality in the rat following a single exposure by oral and dermal route up to a limit dose/concentration and thus should not to be classified for acute toxicity via the oral and dermal route as defined by the criteria of Annex VI Directive 67/548/EEC or UN/EU GHS classification criteria.