Sorbitan palmitate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given (no data on test substance purity, dose volume exceeding the limit of 20 mL/kg bw).

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:

(no data on test substance purity, dose volume exceeding the limit of 20 mL/kg bw)

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sorbitan palmitate

EC Number:

247-568-8

EC Name:

Sorbitan palmitate

Cas Number:

26266-57-9

Molecular formula:

C22H42O6

IUPAC Name:

(2R)-2-[(2R,3R,4S)-3,4-dihydroxyoxolan-2-yl]-2-hydroxyethyl hexadecanoate

Details on test material:

- Name of test material (as cited in study report): sorbitan monopalmitate
- Substance type: organic
- Physical state: solid (cream colour)
- Analytical purity: no data
- Lot/batch No.: 5006C

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
- Diet: ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

0.5% aqueous suspension

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 30% (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): 30% (w/v) suspension in 0.5% aqueous CMC

Doses:

15,900 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 using the methods of Weil and Litchfield & Wilcoxon.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 15 900 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occured during the study period.

Clinical signs:

other: There were no signs of intoxication observed.

Gross pathology:

details see table 1

Any other information on results incl. tables

Table 1: Gross pathological findings in male and female rats that were sacrificed fourteen days after treatment.

Dose [mg/kg bw]	Organ	No. of affected animals / No. of total animals	Finding
15,900	heart	3/20	soft
	lungs	3/20 (2/3 slight)	congested
	kidneys	1/20	congested medulla
		5/20 (1/5 unilateral)	hydronephrosis

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