Dioleamide

Skin irritation / corrosion

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Administrative data

Endpoint:

skin irritation: in vivo

Remarks:

In vivo study existed before In-vitro acceptance

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Test material form:

other: solid, not further specified

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: The Broekman Institute, Someren, The Netherlands
- Age at study initiation: 13-15 weeks
- Weight at study initiation: 2.42-2.85 kg
- Housing: Individually in plastic cages with perforated floors.
- Diet (e.g. ad libitum): Standard laboratory animal diet (LK-01, pellet diameter 4 mm; 100 g per day), obtained from Hope Farms, Woerden.
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5-22.0
- Humidity (%): 60-80
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

other: untreated contralateral flank served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

Test substance preparation: Approximately 5 g of test substance were scraped from the surface of the solid and transferred into a glass vial; before dose administration the test substance was heated to 60-70 °C, and 3 portions of 0.5 mL were transferred into aluminium vials using a plastic syringe. The portions of test substance were allowed to solidify in the vials. Each portion of test substance was spread on a 6 cm² patch of Metalline and applied to the animals as described below.

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL for moistening

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48, 72 hours

Number of animals:

3 females

Details on study design:

TEST SITE
- Area of exposure: 6 cm² of clipped area of 10 cm x 10 cm on the central back (right flank).
- Type of wrap if used: Test substance was spread on a 6 cm² patch of Metalline (Lohmann, FRG), mounted on permeable tape (Micropore, 3M, St. Paul, USA). Each portion of test substance was moistened with 0.5 mL of Milli-RO water (Millipore Corp., Bedford, Mass. USA). The patch containing the test substance was applied to the right flank of each animal, the left flank being covered with the same dressing without test substance. Finally, the animals were wrapped in flexible bandage (Coban, 3M, St. Paul, USA).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, remaining test substance was removed, using a tissue moistened with tap-water
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Reversibility:

other: no effects

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Reversibility:

other: no effects

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Reversibility:

other: no effects

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Reversibility:

other: no effects

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Reversibility:

other: no effects

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Reversibility:

other: no effects

Irritant / corrosive response data:

One hour after dosing the skin of 2 animals showed slight erythema which disappeared within the next 24 hours. Other dermal effects were not observed in any of the animals.

Other effects:

There were no signs of systemic intoxication observed.

Any other information on results incl. tables

Conclusion:

According to the criteria of EU Directive 67/845/EEC and Regulation (EC) No 1272/2008 the test substance does not have to be classified as irritating to the skin.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information

Conclusions:

Conclusion:
According to the criteria of EU Directive 67/845/EEC and Regulation (EC) No 1272/2008 the test substance does not have to be classified as irritating to the skin.

Executive summary:

Conclusion:

According to the criteria of EU Directive 67/845/EEC and Regulation (EC) No 1272/2008 the test substance does not have to be classified as irritating to the skin.