Sorbitan, (Z)-9-octadecenoate (2:3)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12 Jun - 27 Sep 1984

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given (no data on test substance purity, only 2 animals per sex/dose).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

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, only 2 animals per sex/dose)

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sorbitan, (Z)-9-octadecenoate (2:3)

EC Number:

232-360-1

EC Name:

Sorbitan, (Z)-9-octadecenoate (2:3)

Cas Number:

8007-43-0

Molecular formula:

C42H76O7

IUPAC Name:

(1R)-1-[(2R,3R,4S)-4-hydroxy-3-[(9Z)-octadec-9-enoyloxy]oxolan-2-yl]-2-[(9Z)-octadec-9-enoyloxy]ethyl (9Z)-octadec-9-enoate; (2R)-2-[(2R,3R,4S)-3,4-dihydroxyoxolan-2-yl]-2-hydroxyethyl (9Z)-octadec-9-enoate; (2R)-2-hydroxy-2-[(2R,3R,4S)-3-hydroxy-4-[(9Z)-octadec-9-enoyloxy]oxolan-2-yl]ethyl (9Z)-octadec-9-enoate

Details on test material:

- Name of test material (as cited in study report): Only trade name given
- Substance type: organic
- Physical state: yellow clear liquid, water insoluble
- 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: 198 g (males), 163 g (females)
- Fasting period before study: 15 h

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

peanut oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: no data

Doses:

5,000 mg/kg bw

No. of animals per sex per dose:

2

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 24 h, 7 days and 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occured during the study period.

Clinical signs:

other: During the 14 day observation period, no symptoms of acute intoxication were observed at all.

Gross pathology:

14 days after the treatment, the inner organs of all the animals were without any pathological findings.

Any other information on results incl. tables

Table 1: Average body weights of the 2 male and the 2 female rats in g.

	sex	before application	24 h	7 days	14 days
			after treatment
	male	198	202	232	255
	female	163	164	176	181

 

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