Registration Dossier
Registration Dossier
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EC number: 700-155-0 | CAS number: -
Endpoint summary
Administrative data
Description of key information
- Skin irritation: not irritating
- Eye irritation: not irritating
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Skin irritation:
In a primary dermal irritation study according to ISO 10993 (Drai, 2009), New Zealand White rabbits (3 males between 2.7 and 3.5 kg) were dermally exposed to 0.5 mL of peroxidised corn oil (as Sanyrene/Corpitol) for 24 hours to two dorsal areas of 25mm x 25 mm. Animals then were observed for 72 hours.
The mean scores at 24, 48 and 72h for erythema and oedema were:
- Eryhtema: 0; 0.8, 0.7
- Oedema: 0; 0; 0
In this study, peroxidised corn oil (as Sanyrene/Corpitol) is not a dermal irritant according to EU criteria.
Eye irritation:
In a primary eye irritation study according to OECD TG 405 and GLP, scored as validity 1 according to Klimisch criteria, (
Vaeth, 2011), 0.1 mLof undiluted peroxidised corn oil was instilled into the conjunctival sac of one eye of three females Russian rabbits for 24 hours. Animals then were observed for 72 hours. Irritation was scored according to the guideline.The following mean values, based on the results from the 24-hour, 48-hour and 72-hours readings were calculated:
Animal No. |
Opacity of the cornea |
Iris lesion |
Redness of conjunctivae |
Oedema of conjunctivae |
1 |
0.00 |
0.00 |
0.33 |
0.33 |
2 |
0.00 |
0.00 |
0.33 |
0.00 |
3 |
0.00 |
0.00 |
0.33 |
0.00 |
Based on the results, peroxidised corn oil shall not be classified as irritating to the eyes according to categories 1 or 2 of the CLP regulation.
Justification for classification or non-classification
Based on the classification criteria of Annex VI Directive 67/548/EEC or UN/EU GHS, the low level of dermal irritation and of ocular irritation in rabbits resulted in no classification of peroxidised corn oil for skin and eye irritation.
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