Castor oil, ester with sorbitol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Data is from publication.

Data source

Reference

Reference Type:

publication

Title:

3 Final Report on the Safety Assessment of test chemical.

Author:

Cosmetic Ingredient Review

Year:

1985

Bibliographic source:

International Journal of Toxicology

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: As mentioned below

Principles of method if other than guideline:

Acute oral toxicity of test chemical in rat.

GLP compliance:

not specified

Test type:

other: not specified

Limit test:

no

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:

Sorbitan sesquioleate

Details on test material:

- IUPAC Name: Sorbitan sesquioleate
- InChI: 1S/3C18H34O2.2C6H14O6/c3*1-2-3-4-5-6-7-8-9-10-11-12-13-14-15-16-17-18(19)20;2*7-1-3(9)5(11)6(12)4(10)2-8/h3*9-10H,2-8,11-17H2,1H3,(H,19,20);2*3-12H,
1-2H2/b3*10-9-;;/t;;;2*3-,4+,5-,6-/m...11/s1
- Smiles: CCCCCCCC/C=C\CCCCCCCC(=O)O.CCCCCCCC /C=C\ CCCCCCCC(=O)O.CCCCCCCC/C=C\ CCCCCCCC (=O)O.C(O)[C@@H](O)[C@@H] (O)[C@H](O) [C@@H](O)CO.C(O) [C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)CO
- Molecular formula :C126H228O21
- Molecular weight :1211.735 g/mole
- Substance type:Organic

Test animals

Species:

rat

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Fasting period before study: Fasting was done

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 90% w/v concentration in corn oil.

Doses:

39800 mg/kg bw

No. of animals per sex per dose:

20 rats (Sex/Dose)

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Other examinations performed: Animals were observed for mortality.

Statistics:

not specified

Results and discussion

Preliminary study:

not specified

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 39 800 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality was observed

Mortality:

No mortality was observed at 39800 mg/kg bw

Clinical signs:

other: not specified

Gross pathology:

not specified

Other findings:

not specified

Any other information on results incl. tables

 

Table: Acute Oral Toxicity

lngredient	Vehicle	Species and No. of rats	Concentration (percent)	Ingredient Dose	Observation period	Comments
S. Sesquioleate	Corn oil	10 M, 10 F	90	39.8 g/kg	14 days	No deaths

 

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Conclusions:

Acute Oral toxicity dose (LD50) was considered to be >39800 mg/kg bw, when 20 male and female rats were treated with test chemical via oral route.

Executive summary:

Acute Oral toxicity study was conducted by using test chemical in 20 fasted rats at oral dose 39.8 g/kg as a 90% w/v concentration in corn oil. Animals were observed for mortality for 14 days. No mortality was observed at 39800 mg/kg bw. Therefore, LD50 was considered to be >39800 mg/kg bw, when 20 male and female rats were treated with test chemical via oral route.