Fatty acids, C16-18, 2-butyloctyl esters

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2005-02-15 - 2005-02-25

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study, GLP-study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C16-18, 2-butyloctyl esters

EC Number:

309-831-6

EC Name:

Fatty acids, C16-18, 2-butyloctyl esters

Cas Number:

101227-08-1

Molecular formula:

C28H56O2 - C30H60O2

IUPAC Name:

Fatty acids, C16-18, 2-butyloctyl esters

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): ISOFOL ESTER 1202
- Molecular formula (if other than submission substance): not mentioned
- Molecular weight (if other than submission substance): not mentioned
- Smiles notation (if other than submission substance): not mentioned
- InChl (if other than submission substance): not mentioned
- Substance type: Ester
- Physical state: liquid

Test animals

Species:

rabbit

Strain:

other: Little Russian

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source:Charles River GmbH, 97633 Sulzfeld
- Age at study initiation: approx. 13 to 17 months
- Weight at study initiation: 2.4 - 2.6 kg b.w.
- Housing: The study took place in animal room No. 6 and 8 provided with filtered air. During a pre-period of at least one week and throughout the experiment the rabbits were caged individually in PPO cages (floor area: 2576 sq. cm) with perforated floor.
- Diet (e.g. ad libitum): A pelleted complete rabbit diet "Altromin 2123" from Altromin, 0-32791 Lage, Lippe, was available ad libitum. Analyses for major nutritive components and relevant possible contaminants are performed regularly on the diet.
- Water (e.g. ad libitum): 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 relevant possible contaminants are performed regularly.
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23°C
- Humidity (%): 40 - 70%
- Air changes (per hr): 10 times/hour
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: To: not mentioned

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated area on the test animals

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL, test substance was applied to the 16-layer gauze patch (2.5 x 2.5 cm) and the test patch was secured to the animals skin with adhesive Gothaplast tape (2.5 cm) (semiocclusive)

Duration of treatment / exposure:

4 h

Observation period:

72 h

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: rabbit back (2.5 cm x 2.5 cm)
- % coverage: no data
- Type of wrap if used: test patch: Gothaplast tape (2.5 cm and 5 cm wide)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes; with mild soap and lukewarm water
- Time after start of exposure: 3 min, 1 h, 4 h (3 different exposure times)

SCORING SYSTEM: according to table in OECD TG 404 (Draize system)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 0, 1, 24, 48, and 72 h

Score:

0

Max. score:

4

Remarks on result:

other: no effects observed

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 0, 1, 24, 48, and 72 h

Score:

0

Max. score:

4

Remarks on result:

other: no effects observed

Irritant / corrosive response data:

no effects

Other effects:

no effects

Any other information on results incl. tables

Skin reactions following a single topical application of 0.5 mL of Isofol ester 1202 to rabbits (grading according to OECD TG 404)

 

None of the animals showed an edema reaction or erythema.

 

Animal	Skin reaction	1 h afterpatch removal	24 h  afterpatch removal	48 h  afterpatch removal	72 h  after patch removal	Mean (24 -72 h) after patch removal
1	Erythema	0	0	0	0	-
	Edema	0	0	0	0	-
2	Erythema	0	0	0	0	-
	Edema	0	0	0	0	-
3	Erythema	0	0	0	0	-
	Edema	0	0	0	0	-

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the results of the study described in this report and according to the directive of the EEC commission 2001/59/EC from August 6th, 2001 the test substance was not skin irritating and shall not be classified as skin irritating.

Executive summary:

During an initial test using one female albino rabbit a sequential application (exposure time 3 min., 1 h. and 4 h.) of the test substance was carried out on one site of the right back area each. The skin was examined for signs of irritation straight after as well as 1 h., 24 h., 48 h. and 72 h. after the termination of exposure. Since the animal did not show signs of skin irritation and no full thickness destruction of the skin within the observation period of 72 hours it was decided to carry out a confirmatory test with two additional animals in order to allow a categorization of the test item based on the classification criteria.Two female albino rabbits were exposed to the test item at one skin site on the back during the confirmatory test. After 4-hour exposure time the test item was removed and the skin was examined 1 h., 24 h., 48 h. and 72 h after the termination of exposure. No skin reactions were observed in these animals, too. Under the experimental conditions described in this final report, the mean score for erythema was 0.0 and for oedema 0.0. Based on the results of the study described in this report and according to the directive of the EEC commission 2001/59/EC from August 6th, 2001 the test substance was not skin irritating and shall not be classified as skin irritating.