Reaction product of resin acid and rosin acid, 12-Hydroxyoctadecanoic and stearic acid with dipentaerythritol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

11. July - 19. July 2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Reaction product of resin acid and rosin acid, 12-Hydroxyoctadecanoic and stearic acid with dipentaerythritol

EC Number:

685-540-0

Cas Number:

208126-52-7

Molecular formula:

from C112-130 H190-232 O13-19

IUPAC Name:

Reaction product of resin acid and rosin acid, 12-Hydroxyoctadecanoic and stearic acid with dipentaerythritol

Test material form:

solid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 7-2-A
- Expiration date of the lot/batch: April 2010
- Purity test date: not stated

RADIOLABELLING INFORMATION (if applicable)
not applicable

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Stability under test conditions: stable under storage conditions
- Solubility and stability of the test substance in the solvent/vehicle: assumed stable
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not applicable

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
none

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Netherlands BV, Kreuzelweg 53, NL-5961 NM Horst/ The Netherlands
- Age at study initiation: 12 weeks
- Weight at study initiation: 2314 - 2530 g
- Housing: Individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23 °C
- Humidity (%): 30-70 %
- Air changes (per hr): 10 - 15 /h
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: 11. July 2007 To: 19. July 2007

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.5 g

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 10 cm x 10 cm test site, 2.5 cm x 2.5 cm
- % coverage: not stated
- Type of wrap if used: semi-occlusive

REMOVAL OF TEST SUBSTANCE
- Washing (if done): done with lukewarm tap water
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
(indicate if minutes, hours or days) 1, 24, 48, 72 hours

SCORING SYSTEM:
- Method of calculation: according to the numerical scoring system layed down i Commission Directive 2004/73/EC, April 29, 2004

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

8

Reversibility:

fully reversible

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 3

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritant / corrosive response data:

The test item did not elicit any skin rections at the application site of any animal at any of the bservation times.

Other effects:

no other effects observed

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of the reported study, Salacos 168 ARV is not irritating to the rabbit skin.

Executive summary:

The primary skin irritation potentail of Salacos 168 ARV was investiggated according to OECD test guideline no. 404. The test item was applied by topical semi-occlusive application of 0.5 g to the intact left flank of each of three young adult Nwe Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reaction s was performed 1, 24, 48 and 72 hours after removal of the dressing.

The test item didn ot elicit any skin reactions at the application site of any animal at any of the observation times (all scores 0). The individual mean score for erythema/eschar and oedema for each of the three animals was therefore 0.

The test item caused no staining of the treated skin. No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals and no clinical signs were observed.