Castor oil, ester with sorbitol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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 dermal toxicity of test chemical in rabbit.

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:

rabbit

Strain:

other: Albino rabbits

Sex:

male/female

Details on test animals or test system and environmental conditions:

not specified

Administration / exposure

Type of coverage:

other: patch test

Vehicle:

other: cosmetic cleansing cream

Details on dermal exposure:

VEHICLE
- Concentration in vehicle: cosmetic cleansing cream containing 3% Sorbitan Sesquioleate.

Duration of exposure:

24 hour

Doses:

6800 mg/kg and 10200 mg/kg bw

No. of animals per sex per dose:

Total = 8 (2 groups of 2 male and 2 female albino rabbits)
Group 1 – 6800 mg/kg bw – 2M, 2F
Group 2 – 10200 mg/kg bw – 2M, 2F

Control animals:

not specified

Details on study design:

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

Statistics:

not specified

Results and discussion

Preliminary study:

not specified

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 10 200 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality was observed

Mortality:

No mortality was observed at 10200 mg/kg bw

Clinical signs:

other: Abnormal behavior, adverse body weight changes, or gross alterations were noted during the 14-day observation period. At the end of the 24-hour contact period, definite red, well-defined erythema was observed at the contact site on each animal. The erythe

Gross pathology:

not specified

Other findings:

not specified

Any other information on results incl. tables

Table: Acute Dermal Toxicity

lngredient	Vehicle	Species and No. of rats	Concentration (percent)	Ingredient Dose	Time		Comments
					Contact	Observation
S. Sesquioleate	Cream product	2M, 2Frabbits	3.0	0.2 g/kg	24 hours	14 days	No deaths or abnormalities; definite erythema. Nontoxic; irritant
S. Sesquioleate	Cream product	2M, 2Frabbits	3.0	0.3 g/kg	24 hours	14 days	No deaths or abnormalities; definite erythema. Nontoxic; irritant

 

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Conclusions:

Acute Dermal toxicity dose (LD50) was considered to be >10200 mg/kg bw, when 8 male and female albino rabbits were treated with test chemical by dermal application.

Executive summary:

Acute Dermal toxicity study was conducted by using test chemical in 8 male and female albino rabbits at dose of 6800 mg/kg and 10200 mg/kg bw. 2 groups of 2 male and 2 female albino rabbits received a 24-hour patch test of a cosmetic cleansing cream containing 3% test chemical. One group received the undiluted product in a dose of 6.8 g/kg; the other, 10.2 g/kg.Animals were observed for mortality and clinical signs for 14 days. No mortality was observed at 10200 mg/kg bw. Abnormal behavior, adverse body weight changes, or gross alterations were noted during the 14-day observation period. At the end of the 24-hour contact period, definite red, well-defined erythema was observed at the contact site on each animal. The erythema subsided by Day 7. Therefore, LD50 was considered to be >10200 mg/kg bw, when 8 male and female albino rabbits were treated with test chemical by dermal application.