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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:
disregarded due to major methodological deficiencies
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Does not meet important criteria of todays stadard methods (analytical purity of test substance not provided, only 3% test substance evaluated, test substance part of a cosmetic cleansing cream, no information on doses).

Data source

Referenceopen allclose all

Reference Type:
secondary source
Title:
Final Report on the Safety Assessment of Sorbitan Stearate, Sorbitan Laurate, Sorbitan Sesquioleate, Sorbitan Oleate, Sorbitan Tristearate, Sorbitan Palmitate, and Sorbitan Triolate
Author:
Elder, R.L., ed.
Year:
1985
Bibliographic source:
Journal of the American College of Toxicology 4(3): 65-121
Reference Type:
study report
Title:
Unnamed
Year:
1968
Report Date:
1968

Materials and methods

Principles of method if other than guideline:
Cosmetic cleansing cream containing 3% of test substance was tested in a patch test after 24 hour exposure. 14 days observation time.
GLP compliance:
no
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): sorbitan sesquioleate
- Analytical purity: no data

Test animals

Species:
rabbit
Strain:
other: albino
Sex:
male/female

Administration / exposure

Type of coverage:
not specified
Vehicle:
not specified
Duration of exposure:
24 hours
Doses:
200 and 300 mg/kg bw (3% of 6800 and 10200 mg/kg bw applied cleansing cream)
No. of animals per sex per dose:
2
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Other examinations performed: clinical signs, dermal effects

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 300 mg/kg bw
Based on:
test mat.
Mortality:
No mortality observed.
Clinical signs:
Definite erythema at application site was observed.
Body weight:
No data
Gross pathology:
No data

Applicant's summary and conclusion

Interpretation of results:
other: inconclusive
Remarks:
Criteria used for interpretation of results: EU