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Diss Factsheets

Administrative data

Description of key information

Read-Across: p-Tolyl alcohol was tested in a skin sensitization study according to OECD Technical Guideline. This study was a modified Draize test conducted with guinea pigs. No indication of skin sensitization was observed with the tested material in this study. Since a read across from p-toloyl alcohol to 4-ethylphenol is appropriate due to expected comparable toxicological properties, the absence of skin sensitization potential can also be assumed for 4-ethylphenol.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Justification for type of information:
Justification for read-across: see attachment
Reason / purpose for cross-reference:
read-across source
equivalent or similar to guideline
OECD Guideline 406 (Skin Sensitisation)
The equivalent total dose was administered on one occasion as 4 intradermal injections, each 2.5 times the Injection Challenge Concentration (ICC)
Principles of method if other than guideline:
See "Any other information on materials and methods"
GLP compliance:
not specified
Type of study:
Draize test
Justification for non-LLNA method:
Historical data
Specific details on test material used for the study:
The perfume ingredients used in this study were random samples from commercial batches which had passed quality contral checks for odour and, in some cases, gas liquid chromatography to identify major components. These checks were carried out to ensure that the ingredients tested were representative of production batches.
guinea pig
Details on test animals and environmental conditions:

- Weight at study initiation: about 350 g
- Housing: 2/per cage, same sex
- Diet: pelleted guinea pig diet, cabbage, hay
- Water: ad libitum
not specified
Concentration / amount:
0.1 mL; 2.5 x ICC
4 injections at one occasion
intradermal and epicutaneous
not specified
Concentration / amount:
0.1 mL; ICC / ACC
14 d after induction
intradermal and epicutaneous
not specified
Concentration / amount:
0.1 mL; ICC / ACC
21 d after induction for positive reactions (controls included). In absence of sensitization reactions, the induction and challenge (controls included) procedures were repeated.
No. of animals per dose:
10 (4 males and 6 females or vice versa)
Details on study design:
For each test material preliminary irritation tests were done in guinea pigs to determine concentrations suitable for sensitization testing.
Guinea pigs were then treated by intradermal injection to induce sensitization and challenged 2 weeks later by both intradermal injection and topical application.
When there was no evidence of sensitization the induction and challenge procedures were repeated.
Challenge controls:
At each challenge with controls, 4 previously untreated animals of the same sex and similar weight to the test animals were treated intradermally and topically on opposite flanks with 0.1 mL aliquots of test substance at the ICC and ACC respectively.
Positive control substance(s):
not specified
Positive control results:
no data
Key result
1st reading
Hours after challenge:
test chemical
Total no. in group:
Clinical observations:
No data; only classification as sensitizer / non-sensitizer stated in the current publication.
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
GHS criteria not met
The tested material was not sensitizing in a modified Draize test with guinea pigs.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Justification for classification or non-classification

Based on information available for a read-across chemical, 4-ethylphenol is not to be classified according to Regulation (EC) No 1272/2008 in terms of skin sensitization.