Fatty acids C16-18 (even numbered), mono, di and tri esters with sucrose

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

November 4 - December 2, 2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)

GLP compliance:

yes (incl. QA statement)

Test type:

up-and-down procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: SAGE Labs
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8-11 weeks
- Weight at study initiation: 166-212 g
- Fasting period before study: overnight
- Housing: Singly in suspended stainless steel cages.
- Diet: Envigo Teklad Global 16% Protein Rodent Diet #2016, ad libitum
- Water: ad libitum
- Acclimation period: 5-16 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 44-65
- Air changes (per hr): 12-13
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: November 4, 2015 To: December 2, 2015

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 30%
- Amount of vehicle (if gavage): 70%

MAXIMUM DOSE VOLUME APPLIED: 1.4 mL

DOSAGE PREPARATION: Test substance was ground and mixed with water to form a 30% (w/w) solution.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for the first 30 minutes post dosing, and for several hours thereafter. After the first day, animals were observed daily. Body weights were assessed prior to dosing and on Day 6 or 7, and Day 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology

Results and discussion

Preliminary study:

One animal was dosed initially. As the animal survived, another four were also dosed.

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

All animals survived the study.

Clinical signs:

No signs of adverse effects were noted at any observation.

Body weight:

All animals gained weight as expected during the study.

Gross pathology:

No signs of gross toxicity were noted.

Other findings:

- Histopathology: No gross abnormalities were noted.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008

Conclusions:

The acute oral LD50 is > 2000 mg/kg bw.

Executive summary:

The acute oral toxicity of the test substance Sucrose Palmitate Stearate MDT Grade was tested in rats. 5 female rats were exposed to a single dose of 2000 mg/kg bw of test substance by oral gavage.

All animals survived the exposure. There were no signs of adverse effects in the animals for 14 days after exposure. The acute oral LD50 is > 2000 mg/kg bw. The test substance is not toxic via the oral route.