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Toxicological information

Acute Toxicity: dermal

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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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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:
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.
Body weight:
not specified
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.