Corn oil (Zea mays, Gramineae), peroxidised

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from 20 February 2009 to 10 March 2009

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was performed in accordance with ISO 10993, well described, but not GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: ISO 10993

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

peroxidised corn oil

IUPAC Name:

peroxidised corn oil

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories France (BP 109, 69592 L'Arbresle)
- Age at study initiation: no data
- Weight at study initiation: 2.7 kg to 3.5 kg
- Housing: in accordance with EEC/86/609
- Diet: complete pelleted diet for rabbit, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature: 17-21°C
- Humidity: > 30%
- Air changes (per hr): no data
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: from 24 to 28 February 2009

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: 2 other dorsal sites on the same rabbits were exposed to sesame oil

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 mL
- Concentration (if solution): undiluted

Duration of treatment / exposure:

24 hours

Observation period:

72 hours

Number of animals:

3 males

Details on study design:

TEST SITE
- Area of exposure: 25mm x 25 mm (2 areas)
- % coverage: no data
- Type of wrap if used: compress + plastic film + elastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing: no

SCORING SYSTEM: edema and erythema were scored

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48, 72h

Score:

0.5

Remarks on result:

other: individual results: 0; 0.8, 0.7

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0

Remarks on result:

other: individual scores: 0; 0; 0

Other effects:

no data

Any other information on results incl. tables

Table 1 : results

Animal No.	Weight (kg)	Site	Observation	Readings
				1h		24h		48h		72h
				Site 1	Site 2	Site 1	Site 2	Site 1	Site 2	Site 1	Site 2
1	3.1	Treated	Erythema Oedema	1 0	1 0	0 0	0 0	0 0	0 0	0 0	0 0
		Control	Erythema Oedema	0 0	1 0	0 0	0 0	0 0	0 0	0 0	0 0
2	3.5	Treated	Erythema Oedema	1 1	1 0	1 0	1 0	1 0	1 0	1 0	0 0
		Control	Erythema Oedema	1 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0
3	3.7	Treated	Erythema Oedema	1 0	1 0	0 0	1 0	0 0	1 0	0 0	0 0
		Control	Erythema Oedema	1 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Peroxidised corn oil is not considered as a skin irritant.

Executive summary:

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.