4-ethylphenol

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Deviations:

yes

Remarks:

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

Test material

Test material information

Constituent 1

Reference substance name:

p-cresol

EC Number:

203-398-6

EC Name:

p-cresol

Cas Number:

106-44-5

Molecular formula:

C7H8O

IUPAC Name:

p-cresol

Details on test material:

p-Tolyl alcohol, no further details stated in the publication

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.

In vivo test system

Test animals

Species:

guinea pig

Strain:

Hartley

Sex:

male/female

Details on test animals and environmental conditions:

ANIMALS

- Weight at study initiation: about 350 g
- Housing: 2/per cage, same sex
- Diet: pelleted guinea pig diet, cabbage, hay
- Water: ad libitum

Study design: in vivo (non-LLNA)

Induction

Route:

intradermal

Vehicle:

not specified

Concentration / amount:

0.1 mL; 2.5 x ICC

Day(s)/duration:

4 injections at one occasion

Challenge

Challenge 1

No.:

#1

Route:

intradermal and epicutaneous

Vehicle:

not specified

Concentration / amount:

0.1 mL; ICC / ACC

Day(s)/duration:

14 d after induction

Challenge 2

No.:

#2

Route:

intradermal and epicutaneous

Vehicle:

not specified

Concentration / amount:

0.1 mL; ICC / ACC

Day(s)/duration:

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

Results and discussion

Positive control results:

no data

In vivo (non-LLNA)

Results

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Total no. in group:

10

Clinical observations:

No data; only classification as sensitizer / non-sensitizer stated in the current publication.

Remarks on result:

no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The tested material was not sensitizing in a modified Draize test with guinea pigs.