Reaction product of the esterification of diglycerol with decanoic acid (Old name: 1,2,3-Propanetriol, homopolymer, decanoate)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2008.07.15. - 2008.07.30.

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

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:

1,2,3-Propanetriol, homoplymer, decanoate

EC Number:

616-105-5

Cas Number:

74504-65-7

Molecular formula:

Main component: C16H32O6

IUPAC Name:

1,2,3-Propanetriol, homoplymer, decanoate

Test material form:

liquid

Details on test material:

Reaction mass of 3-(2,3-dihydroxypropoxy)-2-hydroxypropyl decanoate and 1-(2,3-dihydroxypropoxy)-3-hydroxypropan-2-yl decanoate

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source: From sponsor; CIBA Inc.
- Batch No.of test material: 512051
- Expiration date of the lot/batch: December 2008
- Purity test date: certificate of analysis dated June 16, 2008
- pH: 7.15
- Colour: colourless
- Form: liquid

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature

The test item was considered as 100% for the study

Test animals

Species:

rabbit

Strain:

New Zealand White

Remarks:

Albinos

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage de Gérome (Quartier Labaste - F40260 Linxe)
- Age at study initiation: 12-13 weeks
- Weight at study initiation: 2.56-3.20 kg
- Housing: Each animal was kept in an individual box installed in conventional air conditioned animal husbanding
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22 °C
- Humidity (%): 43-63%
- Air changes (per hr): at least 10 per h; 22 volumes per hour measured
- Photoperiod (hrs dark / hrs light): 12 h/12 h

Test system

Type of coverage:

semiocclusive

Preparation of test site:

not specified

Controls:

not specified

Amount / concentration applied:

0,5 mg/L

Duration of treatment / exposure:

4 hours

Observation period:

4 hours; one animal was initially, after consideration of responses, two additional animals were treated

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: on one flanck of each animal
- Coverage area: 6 cm2
- Type of wrap if used: Patch secured in position with surgical tape

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
1, 24, 48 and 72 hours after removal of patch and on days until day 14

SCORING SYSTEM:
Grading scale: Erythema and Eschar/oedema formations
Scales 0-4
0: No erythema/oedema
1: Very slight erythema/oedema
2: Well defined erythema/ slight oedema
3: Moderate to severe erythema/ moderate oedema
4: Severe erythema/odema

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: All treated

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: day 5 - day 6

Remarks:

5 - 6 days

Remarks on result:

positive indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

animal: All treated

Time point:

24/48/72 h

Score:

>= 2 - <= 3

Max. score:

3

Reversibility:

fully reversible within: day 4 - day 7

Remarks on result:

positive indication of irritation

Other effects:

On the cutaneous structure, a dryness was noted on the treated area from day 3 in two animal and from day 4 in the last one. The skin recovered a normal aspect between day 7 and day 8 in two animals, but a slight dryness was still noted at the end of the observation time (day 14) in the last animal.

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

The results obtained under these experimental conditions (OECD 404) enable to conclude that the test item Dermosoft DGMC is irritant according to the scales of interpretation retained.
In accordance with the Globally Harmonized System (COM(2007)355 final), the test item must be classified in category 2 “irritant”. The signal word “Warning” and hazard statement H315 “Causes skin irritation” are required.

Executive summary:

The skin irritating properties of test item Dermosoft DGMC was tested in accordance with OECD guideline 404. The test item was applied at the dose og 0.5 ml. under semi-occlusive dressing during 4 hours on undamaged skin area of 3 rabbits.

No clinical signs related to the test item was observed. A well defined erythema associated with a moderate oedema was noted on the treated area of all treated animals 24 hours after the test item application. The oedematous reactions were totally reversible between day 4 and day 7 and the erythematous reactions were totally reversible between day 5 and day 6.

On the cutaneous structure, a dryness was noted on the treated area from day 3 in two animal and from day 4 in the last one. The skin recovered a normal aspect between day 7 and day 8 in two animals, but a slight dryness was still noted at the end of the observation time (day 14) in the last animal.

The mean scoring in relation to erythema for all three animals was 2 based on the 24; 48 and 72 h readings.

The mean scorings in relation to oedema were based on the 24;48 and 72 h readings 2.7; 2.3 and 2.7 for the indiviudal animals i.e. within the criteria range for classification as an irritant: at least two of three animals with a mean scoring >2.3 - <4.

The results obtained under these experimental conditions (OECD 404) enable to conlcude that the test item Dermosoft DGMC) is an irritant according to the scales of interpretattion retained. In accordance with the Globally Harmonized System (COM(2007)355 final) the test item must be classified in category 2 “irritant”. The signal word “Warning” and hazard statement H315 “Causes skin irritation” are required.