Sorbitan, isooctadecanoate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Jun 1977

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

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

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sorbitan, isooctadecanoate

EC Number:

276-171-2

EC Name:

Sorbitan, isooctadecanoate

Cas Number:

71902-01-7

Molecular formula:

C23H48O8

IUPAC Name:

2-(3,4-dihydroxyoxolan-2-yl)-2-hydroxyethyl 3-methylheptadecanoate

Details on test material:

- Name of test material (as cited in study report): only trade name given
- Analytical purity: no data

Test animals

Species:

rat

Strain:

other: CFY

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 94 to 106 g
- Fasting period before study: overnight

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 16 mL/kg bw

Doses:

16480 mg/kg bw (based on a density of 1.03 g/cm³)

No. of animals per sex per dose:

5

Control animals:

yes

Details on study design:

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

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 16 mL/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 16 480 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Based on a density of 1.03 g/cm³. No mortality occured.

Mortality:

No mortality occured during the test period.

Clinical signs:

other: Signs of reaction to treatment, observed shortly after dosing, consisted of abnormal body carriage (hunched posture) and piloerection. Recovery of all animals as judged by external appearance and behaviour was apparently complete within seven days of trea

Gross pathology:

Terminal autopsy findings were within normal limits.

Any other information on results incl. tables

Table 1: Mortality ratio and group mean bodyweight (g) of rats dosed orally with the test substance.

Sex	Dosage (ml/kg)	Bodyweight (g) at			Mortality ratio(No. of deaths)                        (No. dosed)
		Dosing	1 week	2 weeks
♂	0	107	183	249	0/5
	16	102	179	245	0/5
♀	0	103	159	186	0/5
	16	103	166	198	0/5

 

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