Stearic acid, esters with methyl α-D-glucoside

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1990-10-01 to 1990-10-16

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: - Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

February 24, 1987

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Stearic acid, esters with methyl α-D-glucoside

Molecular formula:

Molecular formula cannot be given as substance is a mixture.

IUPAC Name:

Stearic acid, esters with methyl α-D-glucoside

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: 221 - 237 g, f: 180 - 204 g
- Fasting period before study: from 16 h before study until 3 - 4 h after administration of the test item
- Housing: collective housing up to a maximum of 5 animals per cage (Macrolon type III)
- Diet: ad libitum, Ssniff-R Alleindiäten (pellets 2.5 cm long, 1.0 vm diameter), Ssniff Spezialdiäten GmbH, Soest/Westfalen, Germany
- Water: ad libitum, drinking water as for human consumption
- Acclimation period: at least 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 2 °C
- Humidity (%): 50 - 85 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): artificial lighting (120 lux), 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

The test item was administered as a 20 % dispersion in aqua deionisata.
pH value: 7.62

Doses:

Range finding test: 2000 mg/kg bw
Main study: 2000 mg/kg bw

No. of animals per sex per dose:

Range finding test: 2 female animals
Main study: 10 (5 males, 5 females)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: 10 min, 2, 6, 24 h, and thereafter daily up to day 14
- Frequency of weighing: before treatment (day 0), and surviving animals were reweighed on days 7 and 14 (termination)
- Necropsy of survivors performed: yes (gross pathological examination)
- Other examinations performed: clinical signs, body weight

Statistics:

LD50 values were calculated according to Finney D.Y., Probit Analysis, 3rd. edition, Cambridge, 1997

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

act. ingr.

Remarks on result:

other: no mortality

Mortality:

Range finding test: no mortalities
Main study: no mortalities

Clinical signs:

other: - No clinical signs

Gross pathology:

Lung: lung of one male marbled
Kidney: kidneys of 2 males marbled, of one male deformed with red spot on the surface
Genital system: 2 females with hydrometra in the uterus
The macroscopic changes observed were attributable to the sacrificing procedure or to minor variations which often occur spontaneously in rats of this strain and age.

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)

Conclusions:

On the basis of the results obtained after a single oral administration, the oral LD50 of the test substance Stearic acid, esters with methyl α-D-glucoside (100 a.i.) was determined to be > 2000 mg/kg bw. The test substance was administered as a 20 % dispersion in water. No animal died. No clinical signs, effects on body weight were observed. The gross pathological findings were not test item dependent.

Executive summary:

In an acute oral toxicity study (limit test, according to OECD 401,1987), 5 male and 5 female Wistar rats were given a single oral dose of Stearic acid, esters with methyl α-D-glucoside (according to producer infromation 100 % a.i.) at a concentration of 2000 mg/kg bw and observed for 14 days. The test substance was administered as a 20 % dispersion in water.

Oral LD₅₀ Males and Females > 2000 mg/kg bw.

No animal died. No clinical signs or effects on body weight were observed. Gross pathological examinations at 14days p.a. (terminal necropsy) revealed a marbled lung of one male rat. The kidney of one male was deformed with a red spot on the surface, two males had a marbles kidney. A hydrometra was found in the uterus of two femals. The findings were considered to be spontaneous and not test item dependent.

Stearic acid, esters with methyl α-D-glucoside (100 % a.i.) is practically non toxic at an oral dose of 2000 mg/kg bw.