Registration Dossier
Registration Dossier
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EC number: 203-185-8 | CAS number: 104-21-2
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1975
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- no guideline followed
- GLP compliance:
- no
Test material
- Reference substance name:
- p-methoxybenzyl acetate
- EC Number:
- 203-185-8
- EC Name:
- p-methoxybenzyl acetate
- Cas Number:
- 104-21-2
- Molecular formula:
- C10H12O3
- IUPAC Name:
- 4-methoxybenzyl acetate
Constituent 1
Method
- Type of population:
- general
- Subjects:
- - Number of subjects exposed: 50 (in two groups at 25)
- Sex: male/female
- Age: 18-58
- Race: B/W - Clinical history:
- healthy
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST USED: patch test (epicutaneous test)
ADMINISTRATION
- Type of application: occlusive
- Dose: 4 and 10 %
- Vehicle: Petrolatum
A pre-test with 5 subjects was performed to determine whether sodium lauryl sulfate pre-treatment was required.
The patch was applied to normal sites on the volar forearms for 48 hours under occlusion and for the main test in five alternate-day 48 h periods.
In the main test the patch site was 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.
Results and discussion
- Results of examinations:
- The pre-test showed no irritation due to the test substance.
In the main test there were no instances of contact-sensitization from the test substance on the Maximization Test.
Applicant's summary and conclusion
- Conclusions:
- The pre-test showed no irritation due to the test substance.
In the main test there were no instances of contact-sensitization from the test substance (4 and 10 %) on the Maximization Test. - Executive summary:
A test for the skin sensitization properties of the test substance (4 and 10 %) with 2 groups of 25 volunteers was conducted. The pre-test with 5 subjects showed no skin irritation due to the test substance. In the main test the application side was pretreated with 5 % aqueous sodium lauryl sulfate. There were no instances of contact-sensitization from the test substance on the Maximization Test. Therefore it was concluded that it is unlikely that the test substance would present a danger of contact-sensitization in normal, intended use.
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