Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
no data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generally accepted scientific principles, acceptable for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report date:
1974

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Maximization Test: The material was applied under occlusion for five alternate-day 48 hour periods.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Heptanal
EC Number:
203-898-4
EC Name:
Heptanal
Cas Number:
111-71-7
Molecular formula:
C7H14O
IUPAC Name:
heptanal
Details on test material:
- Name of test material (as cited in study report): RIFM 74-4-12
- Substance type: aldehyde C 7
- Physical state: no data
- Analytical purity: no data
- Purity test date: no data
- Lot/batch No.: no data
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: no data

Method

Type of population:
not specified
Controls:
no data
Route of administration:
dermal

Results and discussion

Results of examinations:
The test material produced no intances of contact-sensitization.

Applicant's summary and conclusion

Conclusions:
Under the conditions of this test, heptanal induced no instances of contact-sensitization.
Executive summary:

To determine the contact-sensitizing potential of heptanal, 25 healthy adult volunteers were exposed to the material under occlusion for five alternate-day 48 hour periods. The patch sites were pre-treated for 24 hours with 5 % aqueous sodium lauryl sulfate under occlusion. The challenge sites were read on removal of the patch and 24 hours thereafter. Under the conditions of this test, heptanal induced no instances of contact-sensitization.

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