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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation, other
Remarks:
Human volunteer study
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
05 June 1974
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
abstract

Data source

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

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
- Principle of test: Maximization test in human volunteers
- Short description of test conditions: Twenty five subjects were exposed to the test item for 24 hours.
- Parameters analysed / observed: No details reported.
GLP compliance:
no
Type of study:
patch test
Justification for non-LLNA method:
No details reported.

Test material

Constituent 1
Chemical structure
Reference substance name:
p-propylanisole
EC Number:
203-203-4
EC Name:
p-propylanisole
Cas Number:
104-45-0
Molecular formula:
C10H14O
IUPAC Name:
1-methoxy-4-propylbenzene
Specific details on test material used for the study:
No details reported.

In vivo test system

Test animals

Species:
other: Twenty five healthy adult human volunteers
Strain:
other: Not applicable
Sex:
male/female
Details on test animals and environmental conditions:
No details reported.

Results and discussion

Positive control results:
No details reported.

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
2nd reading
Hours after challenge:
24
Group:
test chemical
Dose level:
Not reported
No. with + reactions:
1
Total no. in group:
25
Clinical observations:
One case of sensitization was observed out of the 25 subjects. No further details reported.
Remarks on result:
other: Questionable sensitizer
Key result
Reading:
1st reading
Hours after challenge:
0
Group:
test chemical
Dose level:
Not reported
No. with + reactions:
1
Total no. in group:
25
Clinical observations:
One case of sensitization was observed out of the 25 subjects. No further details reported.
Remarks on result:
other: Questionable sensitizer

Any other information on results incl. tables

The test item produced 1 case of sensitization to a degree of 1 + (no details on the scoring system were reported). The remaining 24 volunteers did not produce a response to the test item. The author reports that the test item should be considered as a 'questionable sensitiser'.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item produced 1 case of sensitization to a degree of 1 + (no details on the scoring system were reported). The remaining 24 volunteers did not produce a response to the test item. The author reports that the test item should be considered as a 'questionable sensitiser'.
Executive summary:

The test item produced 1 case of sensitization to a degree of 1 + (no details on the scoring system were reported). The remaining 24 volunteers did not produce a response to the test item. The author reports that the test item should be considered as a 'questionable sensitiser'.