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Toxicological information

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment

Data source

Reference
Reference Type:
review article or handbook
Title:
Final report on the safety assessment of hydrogenated cottonseed oil, cottonseed (gossypium) oil, cottonseed acid, cottonseed glyceride, and hydrogenated cottonseed glyceride
Author:
Cosmetic Ingredient Review (CIR) Panel
Year:
2001
Bibliographic source:
Int. J. Toxicol. 20(2):21–29

Materials and methods

Type of sensitisation studied:
skin
Study type:
other: Repeated-insult patch test
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
A repeated-insult patch test was carried out in humans to determine the sensitization potential of formulations containing fully hydrogenated cottonseed oil.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Glycerides, C16-18
EC Number:
268-084-3
EC Name:
Glycerides, C16-18
Cas Number:
68002-71-1
Molecular formula:
Not applicable
IUPAC Name:
Glycerides, C16-18
Details on test material:
- Name of test material (as cited in study report): Formulations containing 20.86 and 11.3% fully hydrogenated cottonseed oil (CAS N° 68334-00-9, EC N° 269-804-9); under the SDA nomenclature, the name of this substance is ‘Glycerides, C16-18 ’

Method

Type of population:
general
Controls:
None
Route of administration:
dermal
Details on study design:
Nine induction patches were applied, followed by a challenge.
Substance concentrations: 20.86 and 11.3%

Results and discussion

Results of examinations:
No sensitization observed during induction or challenge.

Any other information on results incl. tables

None

Applicant's summary and conclusion

Conclusions:
Under the test conditions, formulations containing 20.86 and 11.3% of the substance were found to be non-sensitizing in humans.
Executive summary:

In a human repeated-insult patch test, formulations containing 20.86 and 11.3% ‘glycerides, C16-18 (as fully hydrogenated cottonseed oil) were tested on 101 subjects. Nine induction patches were applied, followed by a challenge. Neither of the formulation produced reactions during induction or at challenge. Under the test conditions, formulations containing 20.86 and 11.3% test substance were found to be non-sensitizing in humans (CIR, 2001a)

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