Fatty acids lanolin, di-, tri- and tetraesters with pentaerythritol and rape fatty acid

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study with acceptable restrictions (lack of data on test substance)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

lack of data on test substance

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

189200-42-8

Cas Number:

189200-42-8

IUPAC Name:

189200-42-8

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: HRP Inc., Denver, PA, USA
- Age at study initiation: 15 weeks
- Weight at study initiation: 2.2 - 2.6 kg
- Housing: animals were housed separately in suspended stainless steel and wire mesh cages with absorbent paper below the cages.
- Diet: certified Rabbit Diet 5322 (PMI Feeds Inc., Richmond, IN, USA), the amount of feed was limited on a not further specified daily basis
- Water: tap water, ad libitum
- Acclimation period: 8 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 21
- Humidity (%): 40 - 60
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES:
From: 22 Aug 1995
To: 25 Aug 1995

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: not required, untreated sites of the same animal served as control

Amount / concentration applied:

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

Duration of treatment / exposure:

4 h

Observation period:

72 h
Reading time points: 1, 24, 48 and 72 h

Number of animals:

6 males

Details on study design:

TEST SITE
- Area of exposure: ca. 6.5 cm² on the dorsal area from the shoulder to the lumbar region
- Type of wrap if used: the treated skin was covered with a non-irritating tape, held in place with a semi-occlusive dressing.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the test site was wiped with paper towels and water.
- Time after start of exposure: 4h

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

out of all 6 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: Reversibility: not applicable

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

out of all 6 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: Reversibility: not applicable

Irritant / corrosive response data:

The dermal application of the test substance did not result in erythema or edema in any of the animals tested at any observation time point.

Other effects:

Clinical signs were not observed in any animal during the study period. At the 72 h reading, two animals were observed with desquamation.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.