Oils, fish, oxidized

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

end on 22nd April 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Oils, fish, oxidized

EC Number:

269-122-1

EC Name:

Oils, fish, oxidized

Cas Number:

68187-75-7

Molecular formula:

Not necessary

IUPAC Name:

Triglycerides C12-24, even, saturated and unsaturated, oxidized

Details on test material:

- Name of test material (as cited in study report): Triglycerides, C12-24, saturated and unsaturated, oxidized- Substance type: UVCB- Physical state: liquid- Stability under test conditions: data not available- Storage condition of test material: room temperature

Test animals

Species:

rabbit

Strain:

other: SPF albino rabbit

Details on test animals or test system and environmental conditions:

TEST ANIMALS- Source: Charles River Deutschlan GmbH, D-88353, Kisslegg- Age at study initiation: 13 to 15 months- Weight at study initiation: 2.8 - 2.9 kg- Housing: individually in PPO cages (floor area: 2576 cm2) with perforated floor- Diet: a pelleted complete rabbit diet "Altromin 2123", ad libitum- Water (e.g. ad libitum): free access to bottles with domestic quality drinking water, which was acidified with hydrochloric acid to pH 2.5 in order to prevent microbial growth.- Acclimation period: at least one weekENVIRONMENTAL CONDITIONS- Temperature: 20 +/- 3°C- Humidity: 30 - 70%- Air changes: 10 times/hour- Photoperiod: 12 hrs dark / 12 hrs lightIN-LIFE DATES: From 27 October 2009 to 06 November 2009

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

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

Duration of treatment / exposure:

1st rabbit: 3 minutes, 1 hour and 4 hours2nd and 3rd rabbits: 4 hours

Observation period:

72 hours

Number of animals:

3

Details on study design:

TEST SITE- Area of exposure: 2.5cm x 2.5 cm- % coverage: data not available - Type of wrap if used: gauze patch secured with semi-occlusive adhesive Gotaplast tapeREMOVAL OF TEST SUBSTANCE- Washing (if done): with mild soap and lukewarm water- Time after start of exposure: 3 minutes, 1 hour or 4 hoursSCORING SYSTEM: according to OECD 404 guideline

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 1h, 24h, 48h and 72h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 1h, 24h, 48h and 72h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritant / corrosive response data:

Any skin reaction were not observed 1h, 24h, 48h and 72h after the termination of the application.

Other effects:

The animal used in the initial test showed a slight yellow coloration on the posterior right test field only, which was probably caused by the test item.

Any other information on results incl. tables

Table 1 : Results

Animal No.	Exposure time	Test field	erythema						edema
			0h	1h	24h	48h	72h	mean		0h	1h	24h	48h	72h	Mean
4347	3min	Anterior right	0	0	0	0	0			0	0	0	0	0
	1h	Middle right	0	0	0	0	0			0	0	0	0	0
	4h	Posterior right	0	0	0	0	0	0.00		0	0	0	0	0	0.00
4346	4h	Anterior right		0	0	0	0	0.00			0	0	0	0	0.00
4348	4h	Anterior right		0	0	0	0	0.00			0	0	0	0	0.00

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated informationCriteria used for interpretation of results: EU

Conclusions:

Triglycerides, C12-24, saturated and unsaturated, oxidized is not irritating to the skin in rabbit

Executive summary:

In a primary dermal irritation study according to OECD 404 and GLP, 3 female albino rabbits were dermally exposed to 0.5 mL of undiluted triglycerides, C12-24, even, saturated and unsaturated, oxidized for 4 hours to 2.5cmx2.5cm of the right back area. Animals then were observed for 3 days. Irritation was scored according to OECD method.

Under the experimental conditions, the mean scores for erythema and edema were 0.00.

In this study, triglycerides, C12-24, even, saturated and unsaturated, oxidized is not a dermal irritant. The substance is not classified according to Directive 67/548/EEC or CLP criteria.