Sucrose and glycerol, reaction products with C12-18, C18unsatd. fatty acids

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

August 1989

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sucrose and glycerol, reaction products with C12-18, C18unsatd. fatty acids

Molecular formula:

Representative, generic structures are given in "structural formula" wherein R = H or fatty acid residue and R' = sucrose residue, glycerol residue, H or alkali. Additional citric acid resp. its salt is present.

IUPAC Name:

Sucrose and glycerol, reaction products with C12-18, C18unsatd. fatty acids

Test material form:

semi-solid (amorphous): gel

Remarks:

migrated information: paste

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: no data
- Weight at study initiation: m: 182 - 201g; f: 167 - 209g
- Fasting period before study: 16 hours
- Housing: collective caging, cage type: Macrolon type IlI./max. 5
- Diet: ad libitum; Ssniff Spezialdiäten GmbH, 4770 Soest/Westfalen
- Water: ad libitum; Macrolon dringking bottles, Becker & Co. 4620 Castrop-Rauxel
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 2
- Humidity (%): 50 - 80
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hours daily, fluorescent light, 120 lux

IN-LIFE DATES:
From: 09.08.1989 To: 24.08.1989

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

20% dispersion

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20% dispersion
- Amount of vehicle (if gavage): no data

The test substance wa heated up to about 37°C and diluted with Aqua deion. by using a magnetic stirrer in order to get a 20 % dispersion.
The pH-value was 7.9.

MAXIMUM DOSE VOLUME APPLIED: 2.1 mL

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

Range finding study:
Two female rats were employed in a preliminary range finding study. The dosage of the single oral administration was 2000 mg/kg bw. This preliminary study showed no mortalities.

Main study:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: the body weights were recorded at day 0 (beginning of the experiment), at day 7 and at day 14 (terminal necropsy) on the surviving animals.
- Necropsy of survivors performed: yes
- Clinical signs: the evaluation of the clinical-toxicological signs (a modified Irwin-Screening by Screening methods in pharmacology, R. A. Turner, 1965) was done individually and depends on the nature of the signs. If the symptoms persist to the same degree for a longer period of time, this was noted in the corresponding protocols. Records were made according to the following intervals: approx. 20', 1 h, 2 + 3 h, 6 h, 24 h, thereafter once daily up to day 14.

Observation:
Records were made according to the following intervals: approx. 20', 1 h, 2+3 h, 6 h, 24 h, thereafter once daily up to day 14.

Results and discussion

Preliminary study:

Two female rats were employed in a preliminary range finding study. The dosage of the single oral administration was 2000 mg/kg bw. This preliminary study showed no mortalities.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

no

Clinical signs:

other: The sampIe induced during the entire observation period of 14 days no clinical-/toxicological symptoms.

Gross pathology:

Necropsies performed on all animals at the end of the 14-day observation period showed no test compound-related macroscopic findings in the cranial-, thoracic- and abdominal cavity.

Any other information on results incl. tables

The LD50 deterrnination showed the following result: 24 h + 14 days, male + female > 2000 mg/kg bw

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008) and DSD (Directive 67/548/EEC)

Conclusions:

The toxicity after a single oral intake of the test sample is above the dose limit 2000 mg/kg bw. The substances does not need to be classified according to CLP, EU GHS (Regulation (EC) No 1272/2008) and according to DSD (Directive 67/548/EEC).

Executive summary:

In an acute oral toxicity study (limit test) performed according to the OECD Guideline 401 (Acute Oral Toxicity), groups of fasted Wistar rats (5/sex)

were given a single oral dose of Sucroglyceride C12-18, C18unsatd. in water at a dose of 2000 mg/kg bw and observed for 14 days.

Oral LD50:

Males > 2000 mg/kg bw

Females > 2000 mg/kg bw

Combined > 2000 mg/kg bw

There were no treatment related clinical signs, necropsy findings or changes in body weight.

Sucroglyceride C12-18, C18unsatd. is practically nontoxic based on the LD50 in males/females.