Decanoic acid, monoester with glycerol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

20 - 23 Nov 2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Ministerium für Umwelt und Naturschutz, Landwirtschaft und Verbraucherschutz des Landes Nordrhein-Westfalen, Düsseldorf, Germany

Test material

Test material information

Constituent 1

Reference substance name:

97593-30-1 (C12)

IUPAC Name:

97593-30-1 (C12)

Details on test material:

- Name of test material (as cited in study report): only trade name given
- Chemical name: Acetylided glyceride-mixture
- Physical state: clear, slight yellowish fluid
- Analytical purity: 99.8%
- Lot/batch No.: CH70920C
- Expiration date of the lot/batch: 20 Sep 2008
- Storage condition of test material: at room temperature

Test animals

Species:

rabbit

Strain:

other: Crl:KBL(NZW)BR

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, Kißlegg, Germany
- Age at study initiation: young adults
- Weight at study initiation: 3.1-3.5 kg
- Housing: individually in cage units Metall/Noryl. Excrement trays below the cages contained low dust wood granulate bedding. The wood granulate was changed at least twice weekly. The animals were regularly transferred to clean cages. The animal room was provided with sound from a radio program.
- Diet: standard diet "Ssniff K-Z" 4mm (Ssniff Spezialdiäten GmbH, Soest, Germany), approx. 100 g per animal per day. To satisfy the needs of roughage, hay was offered additionally (hay, irradiated, delivered by Harlan Winkelmann, Borchen, Germany; respectively hay pellets delivered by Ssniff Spezialdiäten GmbH, Soest, Germany).
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 50 ± 25
- Photoperiod (hrs dark / hrs light): 12/12

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 applied: 0.5 mL

Duration of treatment / exposure:

Initial test: 3 min, 1 and 4 h
Confirmatory test: 4 h

Observation period:

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

Number of animals:

3 females

Details on study design:

TEST SITE
- Area of exposure: approx. 2.5 cm by 2.5 cm on the dorso-lateral areas of the trunk
- Type of wrap if used: the treated skin was covered with a gauze patch, held in place with non-irritating tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the exposed skin area was carefully washed with water without altering the existing response or the integrity of the epidermis.
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scoring system

TESTING PROCEDURE
- Initial test: due to a possible irritant potential of the test substance, in the first step only one animal was used and three patches were applied successively to this animal. The first patch was removed after 3 min. As no serious skin reactions were observed, the second patch was applied and removed after 1 h. At this stage, the observations indicated that with respect to animal welfare the exposure can be allowed to extend to 4 h. Therefore, the third patch was applied and removed after 4 h and the responses were graded 1 h later.
- Confirmatory test: the test was completed using two additional animals exposed for 4 h.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 4

Irritation parameter:

edema score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritant / corrosive response data:

Initial test:
In the first animal, no skin reactions were observed immediately after patch removal following 3 min and 1 h of exposure, respectively.

Confirmatory test:
1 h post-application: very slight erythema was observed in 2/3 animals, being fully reversible in one animal at the 24 h reading. No edema was noted in any animal.
24-48 h post-application: very slight erythema was observed in 1/3 animals at both reading time points, being fully reversible at the 72 h reading. No edema was noted in any animal.
72 h post-application: No skin reactions were observed in any animal.

Other effects:

No further local effects were reported. There were no systemic intolerance reactions.

Any other information on results incl. tables

Table 1. Results of skin irritation study.

Observation time	Rabbit no.
	1		2		3
	Erythema	Edema	Erythema	Edema	Erythema	Edema
1 h	1	0	0	0	1	0
24 h	1	0	0	0	0	0
48 h	1	0	0	0	0	0
72 h	0	0	0	0	0	0
Mean value 24 + 48 + 72 h	0.67	0.00	0.00	0.00	0.00	0.00

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.