Fatty acids, rape-oil, mixed esters with 1,4:3,6-dianhydro-d-glucitol, sorbitan and sorbitol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Study period:

1966

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1966

Report date:

1966

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

limited reporting

GLP compliance:

no

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:

C126H228O21

IUPAC Name:

1,4-anhydro-5,6-di-O-oleoyl-D-glucitol

Details on test material:

- Name of test material (as cited in study report): Sorbitan sesquioleate
- Substance type: organic
- Analytical purity: no data
- Lot/batch No.: 5157C

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Manor Farms Inc., internally continued
- Weight at study initiation: 133-148 g (males, average 141.4 g), 145-162 g (females, average 152.3 g)
- Fasting period before study: 16 h
- Diet: ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 90% (w/v)

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

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: For details see tables 1 and 2.

Gross pathology:

The following tissues were examined in all animals that were killed at the end of 14 days: lungs, liver, thymus, spleen, adrenals, heart, kidneys, bladder, pancreas, stomach, small and large intestines (details see tables 3 and 4).

Any other information on results incl. tables

Table 1: Clinical signs of intoxication in male rats.

Dose [mg/kg bw]	Sign	No. of affected animals / No. of total animals	Time point of observation
39,800	Decreased respiration	10/10	30 min
		9/10	1 h
		9/10	2 h
		9/10	4 h
		10/10	7 h
		7/10	24 h
		0/10	48 h
	Depression	3/10	30 min
		7/10	1 h
		8/10	2 h
		9/10	4 h
		10/10	7 h
		4/10	24 h
		0/10	48 h
	Messy fur	3/10	24 h
		8/10	48 h
		2/10	72 h
		2/10	96 h
		0/10	120 h
	Diarrhea	9/10	24 h
		6/10	48 h
		0/10	72 h

 

  Table 2: Clinical signs of intoxication in female rats.

Dose [mg/kg bw]	Sign	No. of affected animals / No. of total animals	Time point of observation
39,800	Decreased respiration	7/10	30 min
		7/10	1 h
		6/10 (1/6 irregular)	2 h
		3/10 (1/3 irregular)	4 h
		3/10	7 h
		0/10	24 h
	Depression	4/10	30 min
		4/10	1 h
		4/10	2 h
		3/10	4 h
		1/10	7 h
		0/10	24 h
	Messy fur	1/10	7 h
		2/10	24 h
		4/10	48 h
		0/10	72 h
	Diarrhea	2/10	4 h
		3/10	7 h
		6/10	24 h
		4/10	48 h
		0/10	72 h

 

Table 3: Gross pathological findings in male rats.

Dose             [mg/kg bw]	Organ	No. of affected animals /         No. of total animals	Finding
39,800	Lungs	4/10	congested
		1/10	edema
	Adrenals	1/10	congested
	Kidneys	3/10	medullary congestion
		2/10	dilated pelvis
	Bladder	1/10	filled with fluid
	Stomach	1/10	mucosa slightly congested

Table 4: Gross pathological findings in female rats.

Dose [mg/kg bw]	Organ	No. of affected animals / No. of total animals	Finding
39,800	Lungs	8/10	congested
		1/10	consolidated
	Kidneys	3/10	medullary congestion

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