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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Administrative data

Endpoint:
sensitisation data (humans)
Remarks:
Human Repeat Insult Patch Test
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
18.01.-26.02.1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Type of sensitisation studied:
skin
Test guideline
Qualifier:
according to guideline
Guideline:
other: Shelanski/Shelanski method (Ref: Shelanski H A and Shelanski M V 1953. A New Technique of Human Patch Tests, Proc Sci Section Toil Group Assoc 19).
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
2,6-Octadienal, 3,7-dimethyl-, acid-isomerized
EC Number:
291-768-8
EC Name:
2,6-Octadienal, 3,7-dimethyl-, acid-isomerized
Cas Number:
90480-35-6
IUPAC Name:
1-methyl-4-(propan-2-yl)benzene; ethanol

Method

Type of population:
not specified
Ethical approval:
not specified
Subjects:
- Age: 21 - 65+
- Females: 72
- Males: 20
Remark: All subjects were required to complete a questionnaire before the start of the test, and to read and sign an informed consent form.
Clinical history:
not specified
Route of administration:
dermal
Details on study design:
A. INDUCTION EXPOSURE
- No. of exposures: 9
- Exposure period: 3 weeks
- Test groups: 92 volunteers
- Control group: no
- Site: 2 x 2 cm
- Frequency of applications: 3 x per week (Monday, Wednesday and Friday)
- Duration: 24h
- Concentrations: 0.3 ml of 10% in DEP/EtOH 1:1,


B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 14 days later
- Test groups: 92 volunteers
- Control group: no
- Site: 2 x 2 cm
- Concentrations: 10%
- Evaluation (hr after challenge): 48 and 96

Results and discussion

Results of examinations:
Ninety two volunteers started in the test. Nine volunteers dropped out during induction due to different reasons not related to adverse effects of the test item.
Very little irritation was recorded during induction.
At challenge, the test item did not produce reactions indicative of skin sensitisation.

Applicant's summary and conclusion

Conclusions:
The test item did not produce reactions indicative of skin sensitisation.
Executive summary:

In the current study the skin sensitising potential of the test item was assessed in a Human Repeat Insult

Patch Test was carried out with 92 volunteersover the age of 18 years. Important to mention is that 3

other fragrances were tested at the same time, but the results are reported seperately.

The test item was applied at a concentration of 10% in DEP/EtOH both during the induction and

challenge phase.

The volunteers received 9 topical inductions and after a rest period of 14 days, they were challenged.

Challenges were read 48 and 92 hours later.

During the induction phase 9 volunteers dropped out because of various reasons not related to adverse effects of the test item.

Therefore a total of 81 volunteers completed the test.

Low levels of irritation were recorded during induction and at challenge no reactions indicative of skin sensitisation were recorded.

It is concluded from the test results that test item did not elicit reactions indicative of skin sensitisation under the test conditions.