Fatty acids C8-18 (even numbered), mono- and diesters with sucrose

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

17 Apr - 10 Jun 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 in 1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

adopted in 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 C8-18 (even numbered), mono- and diesters with sucrose

EC Number:

947-862-2

Molecular formula:

not applicable, substance is UVCB

IUPAC Name:

Fatty acids C8-18 (even numbered), mono- and diesters with sucrose

Test animals

Species:

rat

Strain:

Wistar

Remarks:

Hoe: WISKf(SPF71)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst Aktiengesellschaft, Kastengrund, SPF breeding colony
- Age at study initiation: males ~7 weeks, females ~8 weeks
- Weight at study initiation: males: 170-179 g, females 163-170 g
- Fasting period before study: from about 16 hours before to 3 - 4 hours after treatment
- Housing: in fully air-conditioned rooms in macrolon cages (type 4) on soft wood granulate in groups of 5 animals
- Diet: commercial diet ( ssniff R/M-H (V 1534)), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least one day (breeding at identical conditions)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 50 ± 20
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 17 Apr 1996 - 01 May 1996

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE: The animals received the compound as a 20 % solution in deionized water.
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
DOSAGE PREPARATION: The test substance was dissolved in the stated concentration in deionized water and distributed homogeneously by means of a magnetic stirrer. The stability and the homogeneity of the test substance in the vehicle was determined by analytical methods.

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: Symptoms were recorded twice every day (in the morning and in the afternoon), on weekends and public holidays only once.
- Frequency of weighing: once a week
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Remarks:

rat

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No lethality occurred during the study.

Clinical signs:

other: All animals showed squatting posture and irregular respiration at 30 min up to 4 hours after administration. All animals showed swollen abdomen one and two days after administration. All clinical signs were resolved within day 4 (3rd day after administra

Gross pathology:

No macroscopically visible changes were seen during necropsy performed at the end of observation period.

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.