Fatty acids, vegetable-oil, Me esters, sulfurized

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

17 JAN 2018 - 05 FEB 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, vegetable-oil, Me esters, sulfurized

EC Number:

276-337-4

EC Name:

Fatty acids, vegetable-oil, Me esters, sulfurized

Cas Number:

72102-30-8

IUPAC Name:

Fatty Acids, vegetable-oil, Me-Esters, sulfurized

Test material form:

liquid

Details on test material:

- Density: 0.95 g/mL
- Batch no.: 71012767

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dobrá Voda, Slovak Republic
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 9-12 weeks
- Weight at study initiation: 200 - 210
- Housing: The animals were housed in plastic cages suspended on stainless steel racks, 1-3 animals per cage, in a room equipped with central airconditioning. The sanitation was performed according to the standard operation procedures.
- Diet: A laboratory food ssniff (ssniff Spezialdiäten GmbH) was offered in recommended doses each day approximately at the same time.
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.75 ± 0.43 °C
- Humidity (%): 53.89 ± 1.98 %
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: the dorsal area of the trunk
- % coverage: approximately 10 % of the total body surface area
- Type of wrap if used: semi-occlusive dressing with non-irritating tape

REMOVAL OF TEST SUBSTANCE
- Washing: lukewarm water without altering the existing response or integrity of the epidermis
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount: 2000 mg/kg body weight
- Constant volume or concentration used: no

Duration of exposure:

24 hours

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed individually immediately after the application of the test item and then 0.5, 1, 2, 4 and 6 hours later. Each animal was inspected daily for the next 14 days. Individual weights of animals were determined shortly before the test item was applied and weekly thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: Observations included changes in skin and fur, eyes and mucous membranes, and also respiratory, circulatory, autonomic and central nervous systems, and somatomotor activity and behaviour pattern.
Attention was directed to observations of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma. In addition, the treatment site was observed at 24, 48 and 72 hours after removal of test chemical using the Draize criteria. Full, detailed gross necropsy included careful examination of external surface of the body, all orifices, and cranial, thoracic and abdominal cavities and their contents. All gross pathological changes were recorded for each animal.

Statistics:

All 3/3 females at the limit dose of 2000 mg/kg body weight survived. Animals lived through observation period without signs of intoxication. Neither change of health nor negative skin reactions were registered.

Results and discussion

Preliminary study:

A limit dose of 2000 mg/kg body weight was used as a starting dose. One female was dosed. Test item-related mortality was not observed during 48-hours exposure period.

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

>= 2 000

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

No mortality was observed during the study.

Clinical signs:

other: No signs of intoxication, neither a change of health nor negative skin reactions were registered.

Gross pathology:

During necropsy, no macroscopic changes were noticed.

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

Based on OECD Guideline 402 it can be concluded, that for the test item Fatty Acids, vegetable-oil, Me-Esters, sulfurized according to the Globally Harmonised System and Category Labelling of Chemicals can be classified in Category 5/Unclassified after single dermal application to Wistar rats.