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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

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, C16-18 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:

rat

Strain:

other: CD/Crl:CD(SD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at dosing: Males: 7 weeks; Females: 9 weeks
- Weight at dosing: Males: 220 – 241 g; Females: 210 – 219 g
- Fasting period before study: Feeding was discontinued approx. 16 hours before administration; only tap water was then available ad libitum.
- Housing: During the 14-day observation period the animals were kept singly in MAKROLON cages (type III plus). Granulated textured wood (Granulat A2, J. Brandenburg, 49424 Goldenstedt, Germany) was used as bedding material for the cages. The cages were changed and cleaned twice a week.
- Diet (e.g. ad libitum): Commercial diet, ssniff® R/M-H V1534 (ssniff Spezialdiäten GmbH, 59494 Soest, Germany) served as food. This food was offered ad libitum.
- Water (e.g. ad libitum): Drinking water was offered in bottles ad libitum.
- Acclimation period: 5 adaptation days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.8°C -24.8°C
- Humidity (%): 58% -64%
- Air changes (per hr): Not provided
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: March 11, 2013 To: April 3, 2013

Administration / exposure

Type of coverage:

occlusive

Vehicle:

other: sesame oil

Details on dermal exposure:

TEST SITE
- Area of exposure: The site was situated on the animal's back between the fore and hind extremities.
- % coverage: An area of at least 5 cm x 6 cm = 10% of body surface
- Type of wrap if used: The test patch was occlusive. The test item was held in contact with the skin with 8 layers of gauze. The gauze was covered with a plastic sheet and secured with adhesive plaster strips on the application site.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not necessary (no residuals)
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 3000 mg/kg bw of the mixture, correlating with 2000 mg test item/ kg bw
- Concentration (if solution): 10000 mg Fatty acids, C16-18 and C18-unsatd., compds. with triethanolamine were moistened with 5000 mg sesame oil
- Constant volume or concentration used: yes, 3000 mg/kg bw

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw (limit test)

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were performed before and immediately, 5, 15, 30 and 60 min, as well as 3, 6 and 24 hours after administration. All surviving animals were observed for a period of 14 days.
During the follow-up period (at least 2 weeks) changes in skin and fur, eyes and mucous membranes, and the respiratory, circulatory, autonomic and central nervous system and somatomotor activity and behaviour pattern were observed at least once a day until all symptoms have subsided, thereafter each working day. Attention was also paid to possible tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma. Animals found in a moribund condition and animals showing severe pain or enduring signs of severe distress were humanely killed.
Observations on deaths were made at least once daily to minimize loss of animals during the study. Individual body weights were recorded before administration of the test item and thereafter in weekly intervals up to the end of the study. Changes in weight were calculated and recorded.
The skin was observed for the development of erythema and oedema and was rated.
- Necropsy of survivors performed: yes. At the end of the experiments, all animals were sacrificed, dissected and inspected macroscopically. All gross pathological changes were recorded. No histopathology was carried out as no macroscopical findings were noted at autopsy.

Statistics:

The LD50 could not be calculated as no animal died prematurely.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

A single dermal administration of 2000 mg test item/kg bw to rats revealed no deaths.

Clinical signs:

other: A single dermal administration of 2000 mg test item/kg bw to rats revealed no signs of toxicity. A very slight erythema was observed on test day 2 in all 5 of 5 male and 5 of 5 female animals.

Gross pathology:

No macroscopic findings were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

A very slight erythema was observed on test day 2 in all 5 of 5 male and 5 of 5 female animals.
LD50 > 2000 mg/kg bw.

Executive summary:

Acute dermal toxicity was tested in rats according to Council Regulation (EC) No. 440/2008 part B.3 and OECD guideline 402. The test item Fatty acids, C16-18 and C18-unsatd., compds. with triethanolamine was moistened with sesame oil and administered at 2000 mg/kg bw.

No-effect dose level by dermal administration was > 2000 mg/kg bw.  Dose level with first intolerance reactions by dermal administration was > 2000 mg/kg bw. Lowest lethal dose level by dermal administration was > 2000 mg/kg bw. There were no test item-related findings at necropsy.

Under the present test conditions, a single dermal administration of 2000 mg test item/kg bw to rats revealed no signs of toxicity and no deaths. All animals gained the expected body weight throughout the whole experimental period. A very slight erythema was observed on test day 2 in all 5 of 5 male and 5 of 5 female animals. No signs or abnormalities were noted at necropsy. LD₅₀ > 2000 mg/kg bw.