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Toxicological information

Sensitisation data (human)

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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:
2001

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

Constituent 1
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 ’

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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