Reaction mass of ethyl dodecanoate and ethyl hexadecanoate and ethyl tetradecanoate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

between 12-12-1994 and 15-12-1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

The information is used for read across to Oenanthic ether

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Scantox A/S, Hestehavevef 36A, Ejby, 4623 LI, Skensved, Danmark

Test material

Test material information

Constituent 1

Reference substance name:

Musk T: 105-95-3

IUPAC Name:

Musk T: 105-95-3

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): Ethylenbrassylat/tibetogen
- Physical state: Viscous clear liquid
- Storage condition of test material: Kept at room temp in the dark

Test animals

Species:

rabbit

Strain:

other: SPF albino rabbits

Details on test animals or test system and environmental conditions:

Four female SPF albino rabbits weighing 2.0 - 2.1 kg of the stock Mol:Russian from Møllegaard Breeding and Research Centre AJS, Ejby, DK-4623 Lille Skensved were used.
The animals were earmarked on arrival with National Wing Bands. The study took place in animal room No. 1 provided with filtered air with a temperature of 21°C ± 3°C, relative humidity of 55% ± 15% and air changes 10 times/hour. The room was illuminated to give a 24 hour cycle of 12 hours light and 12 hours darkness. Light was on from 6 a.m. to 6 p.m.
During a pre-period of at least 1 week and throughout the experiment the rabbits were caged in single 62 x 52 cm PPO cages with perforated floor.
Diet: A pelleted complete rabbit diet “Altromin 2123” from Chr. Petersen, DK-4100 Ringsted, was available ad libitum. Analyses for major nutritive components and significant contaminants are performed regularly on the diet. Certificates of analysis are retained.
Drinking water: The animals had free access to bottles with domestic quality drinking water acidified with hydrochloric acid to pH 2.5 in order to prevent microbial growth.
Analyses for possible contaminants are performed regularly. Certificates of analysis are retained.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

other: Ethanol 96% and diethyl phthalate (DEP)

Controls:

no

Amount / concentration applied:

100%, 20% (w/w), 10% (w/w), 5% (w/w), 1% (w/w).
Ethanol 96% and diethyl phthalate (DEP) in a ratio 1 : 1 (w/w).

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 28, 72 hours after termination of exposure

Number of animals:

4 female SPF albino rabbits

Details on study design:

The day before the experiment was started the rabbits were weighed and an area of 10 x 10 cm on the back was clipped as closely as possible with an electric clipper.
On the experimental day the rabbits were physically restrained on a test table, and the clipped area was divided into 6 test sites: 2 anterior located test sites, 2 centrally located test sites and 2 posterior located test sites. To each of 6 gauze patches (2.5 x 2.5 cm) 0.5 ml of 1 of the test concentrations or the vehicle was applied and the patches were placed on the appropriate test site at the back of each rabbit. The gauze patches were secured with a semi-occlusive dressing by means of a 1 cm wide adhesive tape and fixed with Scanpor tape, 4.5 cm width, loosely wound round the trunk. The application schedule was made by a computerized randomization programme and the 5 different test concentrations and the vehicle were applied as follows:
Rabbit No. 7499 7500 7501 7502
A.L A.R. 100% 20% V 5% V 10% 100% 5%
M.L M.R 10% 5% 20% 1% 100% 20% 1% 20%
P.L P.R. 1% V 10% 100% 5% 1% 10% V

A.L: Anterior left treatment site P.L.: Posterior left treatment site
A.R.: Anterior right treatment site P.R.: Posterior right treatment site
M.L.: Mid-left treatment site V: Vehicle
M.R.: Mid-right treatment site

After an exposure time of 4 hours the tape and patches were removed and the treated skin was cleaned with soap and lukewarm water. The skin reactions were read 1 hour later according to the following scale:
Erythema and Eschar Formation: No erythema: 0; Very slight erythema (barely perceptible): 1; Well-defined erythema: 2; Moderate to severe erythema: 3; Severe erythema (beet redness) to slight eschar formation (injuries in depth): 4.
Oedema Formation: No oedema: 0; Very slight oedema (barely perceptible): 1; Slight oedema (edges of area well-defined by definite raising): 2; Moderate oedema (raised approximately 1 mm): 3; Severe oedema (raised more than 1 mm, extending beyond area of exposure): 4.

Reading was also made 24, 48 and 72 hours after termination of exposure. The scores for erythema and oedema formation for the 3 readings 24, 48 and 72 hours of each rabbit for each test concentration were obtained separately and divided by 3. The results are the mean scores for erythema and oedema formation of the individual rabbit for each test concentration.
The mean scores for erythema and oedema formation in the 4 rabbits used for each concentration tested were subsequently calculated.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects were seen at all

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects were seen at all

Irritant / corrosive response data:

Slight dose related (100%, 20% and 10% test concentrations) skin erythema was observed 1 hour after termination of exposure. Thereafter no abnormalities were observed.
The mean scores were as follows:
Erythema: 0.0 (100%), 0.0 (20%), 0.0 (10%), 0.0 (5%), 0.0 (1%), 0.0 (Vehicle)
Oedema: 0.0 (100%), 0.0 (20%), 0.0 (10%), 0.0 (5%), 0.0 (1%), 0.0 (Vehicle)

Other effects:

no

Applicant's summary and conclusion

Interpretation of results:

other: Not a skin irritant

Remarks:

according to EU CLP (EC No. 1272/2008 and its amendments).

Conclusions:

Based on the results of an OECD guideline 404 study conducted in compliance with GLP, the test substance is considered to be not irritating to the skin.

Executive summary:

In a skin irritation study performed in accordance with GLP and OECD guideline 404 (Scantox A/S, 1994), four albino rabbits were exposed semi-oclusive to 5 different concentrations (100, 20, 10, 5, and 1% w/w) of the test substance at 6 skin sites on the back. After 4 hours of exposure the test article was removed and the skin was examined 1, 24, 48 and 72 hours after termination of exposure. Slight dose related (100%, 20% and 10% test concentrations) skin erythema was observed 1 hour after termination of exposure. Thereafter, no abnormalities were observed. The test substance was found not to be skin irritant when applied topically to the rabbit.