Fatty acids, vegetable-oil, Me esters, sulfurized

Endpoint summary

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 17 JAN 2018 to 01 FEB 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

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: 9-11 weeks
- Weight at study initiation: 185 - 200
- Fasting period before study: prior to dosing food but not water was withheld over-night
- Housing: The animals were housed in plastic cages suspended on stainless steel racks, 3 animals per cage in a room equipped with central airconditioning.
- Diet (e.g. ad libitum): The laboratory food ssniff (Spezialdiäten GmbH, Germany) was offered at recommended doses each day approximately at the same time.
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.80 ± 0.44 °C
- Humidity (%): 53.83 ± 2.00 %
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12 / 12

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

VEHICLE
- Justification for choice of vehicle: Olive oil is a standard vehicle according to OECD TG 423
- Lot/batch no.: L63417

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6

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 administration of the test item and 0.5, 1, 2, and 4 hours later. Each animal was inspected daily for the next 14 days. Individual weights of animals were measured immediately prior to administration of the test item and weekly thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: Observations included: changes in skin, fur, eyes, mucous membranes, respiratory, circulatory, autonomic and central nervous systems, somatomotor activity, and behavioural pattern. Particular attention was given to potential neurologic endpoints such as tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.

Statistics:

Based on Annex 2d Test Procedure with a Starting Dose of 2000 mg/kg body weight of OECD Guideline 423 it can be concluded that the test item Fatty Acids, vegetable-oil, Me-Esters, sulfurized is according to UN Globally Harmonized System of Classification, Labelling and Packaging of Chemicals classified Category 5/Unclassified with a LD50 cut off value equal to or greater than 5000 mg/kg body weight according to Regulation (EU) Nr. 1272/2008 (CLP), after single oral administration to Wistar rats.

Preliminary study:

A limit dose of 2000 mg/kg body weight was used as a starting dose. One group of 3 females was dosed. Test item-related mortality was not observed during 24 hours.

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

>= 2 000 mg/kg bw

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 mortality was observed during the study. During the follow up period, no animals displayed signs of intoxication, change of health, nor any other adverse reaction.

Gross pathology:

All animals were necropsied. During necropsy, no macroscopic findings were observed.

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

Based on Annex 2d Test Procedure with a Starting Dose of 2000 mg/kg body weight of OECD Guideline 423 it can be concluded that the test item Fatty Acids, vegetable-oil, Me-Esters, sulfurized is according to UN Globally Harmonized System of Classification, Labelling and Packaging of Chemicals classified Category 5/Unclassified with a LD50 cut off value equal to or greater than 5000 mg/kg body weight according to Regulation (EU) Nr. 1272/2008 (CLP), after single oral administration to Wistar rats.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

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

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

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

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.

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.

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Justification for classification or non-classification

Not fulfilling the classification criteria