Sorbitan tristearate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

25 Jan - 09 Feb 1983

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

(dose volume exceeding limit of 10 mL/kg bw)

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sorbitan tristearate

EC Number:

247-891-4

EC Name:

Sorbitan tristearate

Cas Number:

26658-19-5

Molecular formula:

Molecular formula cannot be given as substance is a mixture.

IUPAC Name:

(2R)-2-[(2R,3R,4S)-3,4-bis(octadecanoyloxy)oxolan-2-yl]-2-hydroxyethyl octadecanoate; (2R)-2-[(2R,3R,4S)-3,4-dihydroxyoxolan-2-yl]-2-hydroxyethyl octadecanoate; (2R)-2-hydroxy-2-[(2R,3R,4S)-3-hydroxy-4-(octadecanoyloxy)oxolan-2-yl]ethyl (9Z)-octadec-9-enoate

Details on test material:

- Name of test material (as cited in study report): sorbitan tristearate
- Physical state: wax-like particles with a slightly rancid odour
- Analytical purity: no data

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 155 g (mean females), 174 g (mean males)

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 100 g/L
- Amount of vehicle (if gavage): 20 mL/kg bw

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw

DOSAGE PREPARATION (if unusual): The test substance was suspended in a 2% carboxymethyl cellulose solution; stirring and warming was necessary for dosage preparation.

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: body weights were recorded prior to application and 48 h, 1 week and 2 weeks after dosing
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

Statistical analysis was performed following the method of Litchfield and Wilcoxon.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occured during the test period

Clinical signs:

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

Gross pathology:

Necropsy and gross pathology revealed no substance-related findings.

Any other information on results incl. tables

Table 1: Group mean body weight development of rats dosed orally with [test compound].

Sex	Dose (mg/kg)	Bodyweight (g) at
		Dosing	48 h	1 week	2 weeks
♂	2000	174	191	210	236
♀	2000	155	163	166	177

 

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