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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Link to relevant study record(s)

Description of key information

Key value for chemical safety assessment

Additional information

 

General information

Name: peroxidised corn oil

Molecular weight: n.a. (UVCB)

Molecular formula: n.a. (UVCB)

Physical state: viscous liquid

Stability: stable in water

Water solubility: ≤ 25 mg/L

n-octanol/water partition coefficient Log Pow ≥ 7

Vapour pressure: < 1x10-5 hPa

Relative density: 0.92

Toxicological information

Acute toxicity rat, oral > 2000mg/kg (no mortality and no sign of toxicological relevance at this dose)

Acute toxicity rat, dermal > 2000mg/kg (no mortality and no sign of toxicological relevance at this dose)

Skin irritation : not irritant

Eye irritation : not irritant

Skin sensitisation: Not sensitising (LLNA test)

In-vitro mutagenicity: no evidence of mutagenicity (Ames test, mammalian chromosome aberration test, and gene mutation assay in mammalian cells)

NOAEL systemic (OECD 422, rat, oral gavage) = 1000 mg/kg bw/d (no effects observed at this dose)

NOAEL fertility (OECD 422, rat, oral gavage) = 300 mg/kg bw/d in females (mating index; fertility index; number of implantation sites; pregnancy index; litter size; litter weight) and 1000 mg/kg bw/d in males (no effect)

 

The following basic toxicokinetic information can be extrapolated from the experimental toxicology data available on peroxidised corn oil:

 

- Regarding its absorption:

Following a single administration either by oral route (at the limit dose of 2000 mg/kg) or dermal route (at the limit dose of 2000 mg/kg), no relevant systemic clinical sign or changes in body weight was observed.

No specific study on dermal absorption is available. However, as peroxidised corn oil is an oily substance with low water solubility and high LogKow (≥ 7), no significant dermal absorption is expected. As an illustration, following acute exposure of rats to a dermal dose of 2000 mg/kg and observation up to 14 days following application, no noteworthy systemic clinical sign.

Following repeated dose administration of the substance by the oral route at doses up to the limit dose of 1000 mg/kg bw/d in rats (OECD, guideline No. 422), there was no relevant sign of systemic toxicity in any of the parameters studied, including clinical signs, body weight, food consumption, hematology or blood biochemistry, and urine analysis. The absence of toxic effects in this study indicates that the test substance and/or its degradation products or metabolites are not absorbed or devoid of toxicity following oral dosing with peroxidised corn oil.

No toxicologically meaningful sign of toxicity was also observed in male rats (including sperm parameters) up to the highest dose of 1000 mg/kg bw/day in this reproduction/developmental toxicity study screening (OECD guideline No. 422). In female rats, some effects on mating index, fertility index, number of implantation sites, pregnancy index, litter size, litter weight were observed at 1000 mg/kg bw/d, giving a NOAEL fertility at 300 mg/kg bw/d. No effect in offsprings were observed in this screening study.

- Regarding its distribution:

Following repeated dose administration by the oral route at doses up to the limit dose of 1000 mg/kg bw/d in rats (OECD guidelines No. 422), the only effect observed was on the fertility parameters in female rats at the highest dose tested (1000 mg/kg bw/d), showing. No effect on organ weights or blood/urine parameters were observed, showing that the substance is of low toxicity following oral route or is poorly absorbed.

- Regarding its metabolism:

The presence or absence of exogenous metabolic activation system made no difference in the results of in vitro mutagenicity testing. No conclusion can therefore be made regarding the transformation of the test substance and/or its degradation products or metabolites by hepatic microsomal fractions.

No adverse microscopic finding in the major metabolizing tissues (liver, kidneys) illustrative of metabolic activity were seen following repeated dose administration by the oral route at doses up to the limit dose of 1000 mg/kg bw/d.

- Regarding its elimination:

No specific study on elimination is available.