Fatty acids, C16-C18 (even numbered) and C18 (unsaturated) and Fatty acids, C16-C18 (even numbered) and C18 (unsaturated) methyl esters

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-study according to OECD test guideline 423

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Materials and methods

Test guideline

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:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

85049-31-6

Cas Number:

85049-31-6

IUPAC Name:

85049-31-6

Details on test material:

- Name of test material (as cited in study report): FAME, according SDA group C10-C18 and C12-C22 (Biodiesel, broad band)
- Physical state: yellowish viscous liquid
- Lot/batch No.: ASO 161418
- Expiration date of the lot/batch: 30 November 2010
- Storage condition of test material: +6°C +/- 3°C, darkness, under nitrogen

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

Six female Sprague Dawley rats (SPF Caw) originated from Elevage JANVIER (53940 Le Genest St
Isle – France), were used after an acclimatization period of at least five days. At the beginning of the
study, the animals of the treated group weighed between 191 g and 211 g and were 8 weeks old.

Housing
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 to 25°C and 30 to 70%, respectively.
The rate of air exchange was approximately fifteen 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.

Food and drink
Drinking water (tap-water from public distribution system) and foodstuff (M20-SDS) were supplied
freely. 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
IPL, Santé, Environnement Durables - Atlantique.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

The test item was administered by gavage under a volume of 2.29 mL/kg body weight (corresponding to 2g/kg body weight, according to the calculated density) using a suitable syringe graduated fitted with an oesophageal metal canula.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6

Control animals:

no

Results and discussion

Effect levels

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.

Gross pathology:

The macroscopical examination of the animals at the end of the study did not reveal treatment related
change.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In a GLP-Study according to OECD test guideline 423, the test substance did not induce any toxicity at a limit does of 2000 mg/kg bw. Consequently, it is considered to be practically non toxic.

Executive summary:

The test item was administered to a group of 6 female Sprague Dawley rats at the single dose of 2000 mg/kg bodyweight. The experimental protocol was established on the basis of the official method as defined in the OECD guideline No 423 dated December 17th, 2001 and the test method B.1tris of the Council regulation No 440/2008.

No mortality occurred during the study. No clinical signs related to the administration of the test item were observed. The body weight evolution of the animals remained normal throughout the study. The macroscopical examination of the animals at the end of the study did not reveal treatment related change.

In conclusion, the LD50 of the test item is higher than 2000 mg/kg body weight by oral route in the rat.

In accordance with the Regulation EC No 1272/2008 the test item does not have to be classified.