Fatty acids, C16-18 and C18-unsatd., compds. with triethanolamine

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to internationally accepted test guidelines and is considered relevant, adequate and reliable.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

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)

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C16-18 and C18-unsatd., compds. with triethanolamine

EC Number:

270-279-3

EC Name:

Fatty acids, C16-18 and C18-unsatd., compds. with triethanolamine

Cas Number:

68424-19-1

Molecular formula:

Not applicable as the substance is a UVCB

IUPAC Name:

Fatty acids, C16-18 (even numbered) and C18-unsatd., compds. with triethanolamine.

Test material form:

semi-solid (amorphous): gel

Remarks:

paste

Details on test material:

- Name of test material (as cited in study report): Fatty Acids, C16-C18 and C18-unsatd., Compds. with Triethanolamine
- Physical state: Viscous, translucent yellowish waxy paste
- Analytical purity: >95%
- Impurities (identity and concentrations):See confidential details
- Composition of test material, percentage of components: See confidential details
- Purity test date: 01/2013
- Lot/batch No.: DDR02/91
- Expiration date of the lot/batch: October 2014
- Storage condition of test material: At +10° to +25°C
- Other: Manufacturer/Supplier: OLEON NV, Assenedestraat 2, 9940 Ertvelde, Belgium

Test animals

Species:

rabbit

Strain:

Himalayan

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: LPT Laboratory of Pharmacology and Toxicology GmbH & Co. KG, Branch Löhndorf, 24601 Löhndorf/Post Wankendorf, Germany
- Age at dosing: Approx. 12.5 – 17.5 months
- Weight at dosing:
Animal no. 1: 2.8 kg
Animal no. 2: 2.9 kg
Animal no. 3: 2.9 kg
- Housing: Before and after the 4-hour exposure period, the animals were kept singly in cages measuring 380 mm x 425 mm x 600 mm (manufacturer: Dipl. Ing. W. EHRET GmbH, 16352 Schön¬walde, Germany). During the exposure period, the animals were kept singly in restrainers which allowed free movement of the head but prevented a complete body turn. The cages excluded irritation of the skin by excrements and urine.
- Diet (e.g. ad libitum): ssniff® K-H V2333 (ssniff Spezialdiäten GmbH, 59494 Soest, Germany) served as food. The food was available ad libitum before and after the exposure period.
- Water (e.g. ad libitum): Drinking water was offered ad libitum before and after the exposure period.
- Acclimation period: At least 20 adaptation days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 3°C (maximum range)
- Humidity (%): 30% - 70% (maximum range)
- Air changes (per hr): Not provided
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: May 6, 2013 To: May 18, 2013

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: The surrounding untreated skin served as a control.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg test item

Duration of treatment / exposure:

Initial test (1 rabbit) : 4 hours
Confirmatory test (2 rabbits): 4 hours

Observation period:

72 hours

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: Approximately 24 hours before the test, the fur was removed by closely clipping the dorsal area of the trunk of the animals. Care was taken to avoid abrading the skin. Only animals with healthy intact skin were used.
- % coverage: area: approx. 6 cm2
- Type of wrap if used: The test item was applied to the test site and then covered with a gauze patch, which was held in place with non-irritating tape for the duration of the exposure period.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the exposure time no residual test item had to be removed.

SCORING SYSTEM:
Erythema and eschar formation
0 : no erythema
1 : very slight erythema (barely perceptible)
2 : well-defined erythema
3 : moderate to severe erythema
4 : severe erythema (beef redness) to eschar formation preventing grading of erythema
Oedema formation
0 : no oedema
1 : very slight oedema (barely perceptible)
2 : slight oedema (edges of area well defined by definite raising)
3 : moderate oedema (raised approx. 1 mm)
4 : severe oedema (raised more than 1 mm and extending beyond the area of exposure)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 h, 48 h, 72 h

Score:

0.33

Max. score:

4

Reversibility:

not fully reversible within: 48 h

Results 2

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 24 h, 48 h, 72 h)

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 24 h, 48 h, 72 h

Score:

0.33

Max. score:

4

Reversibility:

not fully reversible within: 48 h

Results 4

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 24 h, 48 h, 72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 5

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 h, 48 h, 72 h

Score:

0

Max. score:

4

Any other information on results incl. tables

Table 1. Acute dermal irritation/corrosion test (patch test) of Fatty acids, C16-18 and C18-unsatd., compds. with triethanolamine in rabbits

	Skin irritation scores
	Animal no.
	1 E/Oe	2 E/Oe	3 E/Oe
Time after removal of the patch (4-hour exposure)
60 minutes	0/0	1/0	1/0
24 hours	1/0	1/0	1/0
48 hours	0/0	0/0	0/0
72 hours	0/0	0/0	0/0

0 no pathological findings

E erythema and eschar formations

Oe oedeama

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

Fatty acids, C16-18 and C18-unsatd., compds. with triethanolamine is non-irritating to skin, hence, no labelling is required.

Executive summary:

Acute dermal irritation/corrosion test was tested by means of a semi-occlusive patch test in rabbits according to EC method B.4. (Regulation (EC) No. 440/2008) and OECD test guidance 404 (2002). 500 mg Fatty acids, C16-18 and C18-unsatd., compds. with triethanolamine were applied to the closely clipped dorsal area of the trunk of the animals. As it was expected that the test item would not produce any severe irritancy or corrosion, the test was started using at first only one animal, receiving a single patch for an exposure period of 4 hours.

As neither a corrosive effect nor a severe irritant effect was observed after a four-hour exposure, the test was completed using two additional animals, each with one patch only, for an exposure period of 4 hours. After the 4 hour exposure period the patch was removed and the skin sites were evaluated.Scores were taken 60 minutes, 24, 48 and 72 hours after patch removal.

Under the present test conditions, rabbits exposed for 4 hours to 500 mg Fatty acids, C16-18 and C18-unsatd., compds. with triethanolamine/animal showed slight skin reactions expressed as erythema at 60 minutes and/or 24 hours of observation. Mean 24-48h scores were 0.33 for erythema and 0.00 for oedema. The findings were reversible by 48 hours observation period and the scores were below the trigger value for classification.There were no systemic intolerance reactions.