Registration Dossier
Registration Dossier
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EC number: 270-700-0 | CAS number: 68476-80-2 Complex combination obtained by steam distillation of mixed vegetable oils followed by condensation of the steam. Contains fatty acids, sterols, aldehydes and ketones.
Sensitisation data (human)
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:
- 2 001
- 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
- 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 ’
Constituent 1
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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