Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

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'.