Registration Dossier
Registration Dossier
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EC number: 266-946-3 | CAS number: 67701-28-4 This substance is identified by SDA Substance Name: C8-C18 and C18 unsaturated trialkyl glyceride and SDA Reporting Number: 01-001-00.
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Study period:
- Not available
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Secondary literature source (documentation insufficient for assessment)
- Justification for data waiving:
- other:
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 2 001
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- other: Repeated-insult patch test
- 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
- IUPAC Name:
- Glycerides, C16-18
- Details on test material:
- - Name of test material (as cited in study report): Formulation containing 14.5% 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.
Test substance concentration: 14.5%
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, a formulation containing 14.5% fully hydrogenated cottonseed oil was found to be non-sensitizing in humans.
- Executive summary:
In a human repeated-insult patch test, a formulation containing 14.5% fully hydrogenated cottonseed oil was tested on 103 subjects. A total of nine 24 h induction patches were applied to the back within a 3 week period. Subjects were challenged, followed by a 2 week non-treatment period.
12 subjects had a single instance of a “barely perceptible” reaction during induction. No reactions were observed at challenge.
Under test conditions, 14.5% fully hydrogenated cottonseed oil was found to be non-sensitizing in humans.
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