Anhydro-D-glucitol trioleate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1967

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1967

Report date:

1967

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

dose volume exceeding the limit of 10 mL/kg bw

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Anhydro-D-glucitol trioleate

EC Number:

247-569-3

EC Name:

Anhydro-D-glucitol trioleate

Cas Number:

26266-58-0

Molecular formula:

C60H108O8

IUPAC Name:

1,4-anhydro-2,3,6-tri-O-oleoyl-L-iditol

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Manor Farms Research, Inc. (strain internally continued)
- Weight at study initiation: 134-164 g (average 150 g)
- Fasting period before study: 16 h

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 90% (w/v) suspension
- Amount of vehicle (if gavage): 5.0 mL/100 g bw

MAXIMUM DOSE VOLUME APPLIED: 5.0 mL/100 g bw

DOSAGE PREPARATION (if unusual): 90% (w/v) suspension in corn oil

Doses:

39,800 mg/kg bw

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations for signs of intoxication were made at intervals during the first six hours and daily thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Statistics:

LD50 values were calculated following the methods of Weil and Litchfield & Wilcoxon.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 39 800 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occured during the study period

Clinical signs:

other: Diarrhea was noted for some of the rats given the test material (details see table 1).

Gross pathology:

The following tissues were examined in all animals that were sacrificed at the end of fourteen days: adrenals, bladder, liver, spleen, stomach, kidneys, lungs, thymus, heart, small and large intestines (details see table 2).

Any other information on results incl. tables

Table 1: Clinical signs of intoxication in male and female rats treated with the test substance.

Dose [mg/kg bw]	Sign	No. of affected animals /         No. of total animals	Time point of observation
39,800	Depression	4/20	within 3 h
		6/20	24 h
		6/20 (slight)	48 h
	Diarrhea	2/20	within 3 h
		7/20 (slight)	48 h
	Mucoid diarrhea	1/20	3 h
		3/20	21 h
		1/20 (slight)	24 h
	Wet stained perineal nose	6/20	21 h
		20/20	24 h
		16/20	48 h
	Pallor	4/20	3 h
		6/20	24 h

All rats were apparently normal within four days after dosing.

Table 2: Gross pathological findings in male and female rats that were sacrificed fourteen days after treatment with the test substance.

Dose [mg/kg bw]	Organ	No. of affected animals / No. of total animals	Finding
39,800	heart	3/20	soft
	kidneys	4/20	hydronephrosis
	lungs	4/20	focal hemorrhage
		3/20 (2/3 slight)	congested

 

 

 

 

 

 

 

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified