Reaction products of “Fatty Acids, C16-18 and C18-unsatd., Me esters; sulfuric acid and sodium hydroxide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

21/01/2020 to 05/02/2020

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2020

Report date:

2020

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction products of “Fatty Acids, C16-18 and C18-unsatd., Me esters; sulfuric acid and sodium hydroxide

EC Number:

951-929-1

Molecular formula:

Not available. UVCB

IUPAC Name:

Reaction products of “Fatty Acids, C16-18 and C18-unsatd., Me esters; sulfuric acid and sodium hydroxide

Test material form:

liquid

Specific details on test material used for the study:

Batch: 2018060002
pH: 7.60
moisture content: 30.29%

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

Six Sprague Dawley rats (SPF Caw), supplied by Elevage JANVIER LABS (53940 Le Genest St Isle – France), were used after an acclimatization period of at least five days. The animals were nulliparous and non-pregnant.
At the beginning of the study, the animals were 8 weeks old. They were identified prior to inclusion in the test by means of a numbered ring on the edge of one ear.

Healthy female rats were housed by group of three in solid-bottomed clear polycarbonate cages with a stainless-steel mesh lid. Each cage contains sawdust bedding which was changed at least 2 times a week. Each cage was installed in conventional air-conditioned animal husbandry.

The temperature and relative humidity of the main test were controlled to remain within target ranges of 19°C to 25°C and 30% to 70%, respectively.

The rate of air exchange was at least ten changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (07.00 to 19.00) and twelve hours darkness.

Drinking water (tap-water from public distribution system) and foodstuff (ENVIGO - 2016) were supplied ad libitum. Food was removed on D-1 and then redistributed 4 hours after the test item administration.

Microbiological and chemical analyses of the water were carried out once every six months by Bureau Veritas – Eurofins (FRANCE).

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

In the first and second steps of the study, the test item was administered by gavage under a volume of 2.00 mL/kg body weight (corresponding to 2 g/kg body weight, according to the calculated density) using a suitable graduated syringe fitted with an oesophageal metal canula.

Doses:

2 g/kg

No. of animals per sex per dose:

3

Control animals:

no

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study.

Clinical signs:

other: No clinical signs related to the administration of the test item were observed during the study.

Gross pathology:

The macroscopic examination of the animals at the end of the study revealed a white thickening of forestomach in one animal (1/6).

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 of the test item is higher than 2000 mg/kg body weight. In accordance with the O.E.C.D. Test Guideline No. 423, the LD50 cut-off of the test item may be considered as 5000 mg/kg body weight by oral route in the rat.

The test item does not have to be classified in accordance with the Regulation EC No. 1272/2008 on classification, labelling and packaging of substances and mixtures.
No signal word or hazard statement is required.

Executive summary:

The test item was administered to a group of 6 female Sprague Dawley rats at the dose of 2000 mg/kg body weight.

The experimental protocol was established according to the official method as defined in the O.E.C.D. Test Guideline No. 423 dated December 17th, 2001.

No mortality occurred during the study.

No clinical signs related to the administration of the test item were observed during the study.

The body weight evolution of the animals remained normal during the study.

The macroscopic examination of the animals at the end of the study revealed a white thickening of forestomach in one animal (1/6).

In conclusion, the LD50 of the test item is higher than 2000 mg/kg body weight. In accordance with the O.E.C.D. Test Guideline No. 423, the LD50 cut-off of the test item may be considered as 5000 mg/kg body weight by oral route in the rat.

The test item does not have to be classified in accordance with the Regulation EC No. 1272/2008 on classification, labelling and packaging of substances and mixtures.

No signal word or hazard statement is required.