C16-18 (even numbered) and C18 (unsaturated) triglycerides, hydroxylated, oxidatively cleaved, hydrolised (glycerol free).

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

other: Read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

2014

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Justification for type of information:

Justification for Read Across is given in Section 13 of IUCLID.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

SS06_PS/Ketoacids

IUPAC Name:

SS06_PS/Ketoacids

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Italy s.r.l.
- Age at study initiation: 7 weeks
- Weight at study initiation: 157-163 grams
- Housing: Polisulphone solid bottomed cages measuring 59.5x38x20 cm with nesting material provided into suitable bedding bags
- Diet: 4RF18 (Mucedola S.r.l.); diet supplied ad libitum throughout the study except for the dosing procedure
- Water: Drinking water supplied to each cage via a water bottle, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2°C
- Humidity (%): 55+/- 15%
- Air changes: Approximately 15 to 20 air changes per hour
- Photoperiod: Artificial (fluorescent tubes), daily light/dark cycle of 12/12 hours.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/mL
- Maximum dose volume applied: 10 mL/kg.

Doses:

2000 mg/kg

No. of animals per sex per dose:

6 (2 groups of 3 female animals exposed to the same dose)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: on dosing, 0.5h after dosing, 2h after dosing, 4h after dosing and, afterwards, twice/day
- Necropsy of survivors performed: yes.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occured.

Clinical signs:

other: No clinical signs were observed.

Gross pathology:

No observed gross pathology.

Applicant's summary and conclusion

Interpretation of results:

other: The substance shall not be classified for acute toxicity according to the CLP Regulation (EC) No. 1272/2008.

Conclusions:

The test substance did not induce toxic effects in the rat following oral administration of a single dose at a level of 2000 mg/kg bw.

Executive summary:

The acute toxicity of the test item was investigated following a single oral administration to Sprague Dawley rat followed by a 14-day observation period, performed in accordance to the OECD Guideline 423. 3 female animals were dosed at 2000 mg/kg (Step 1). No mortality occurred and no clinical signs were observed. A second group of 3 female animals was then dosed at the same dose level (Step 2). No mortality occurred and no clinical signs were noted. Body weight changes recorded during the study were within the expected range for this strain and age of animals. No abnormalities were observed at necropsy examination performed at the end of the observation period on animals of both groups. Based on these results, the test item shall not be classified for oral acute toxicity according to the CLP Regulation (EC) No. 1272/2008.