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

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

08 May - 22 May 1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

adopted Feb 24, 1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Version / remarks:

Commission Directive No 92/69/EEC of July 31, 1992

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

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

EC Number:

947-854-9

Molecular formula:

not applicable, substance is UVCB

IUPAC Name:

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

Test animals

Species:

rat

Strain:

Wistar

Remarks:

Hoe: W1SKf(SPF71)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst Aktiengesellschaft, Kastengrund, Germany; SPF breeding colony
- Age at study initiation: 6 - 8 weeks (males) and 7 - 10 weeks (females)
- Weight at study initiation: 163 - 175 g (males) and 162 - 173 g (females)
- Fasting period before study: from 16 h before to 3 - 4 h after treatment
- Housing: in groups of 5 animals in macrolon cages (type 4) on soft wood granulate
- Diet: ssnitt® R/M-H (V 1534), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least one day

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 50 ± 20
- Air changes (per hr): fully air-conditioned
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: deionised water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 10%
- Amount of vehicle: 20 mL/kg bw

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw

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 clinical signs twice a day (in the morning and in the afternoon), on weekends and public holidays only once. Body weights were determined weekly.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study period.

Clinical signs:

other: No clinical signs of toxicity were observed up to the end of the 14-day observation period.

Gross pathology:

Gross pathology revealed no substance-related findings.

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:

In this acute oral toxicity study a LD50 value of > 2000 mg/kg bw was derived in male and female rats.