Propiophenone

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: study well documented, meets generally accepted scientific principles. However, there are no details about tested susbtance (i.e. purity, composition, etc).

Data source

Reference

Reference Type:

publication

Title:

The sensitization potential of some perfume ingredients tested using a modified Draize procedure.

Author:

Sharp D.W.

Year:

1978

Bibliographic source:

Toxicology 9: 261-271

Materials and methods

Principles of method if other than guideline:

Modified Draize test performed to assess the test item potential to induce allergic contact dermatitis in guinea pigs.

GLP compliance:

no

Remarks:

pre GLP

Type of study:

Draize test

Justification for non-LLNA method:

A LLNA study has not been conducted because a adequate data from a previously conducted experiment already exists.

Test material

Test material information

Constituent 1

Reference substance name:

1-phenylethanone

IUPAC Name:

1-phenylethanone

In vivo test system

Test animals

Species:

guinea pig

Strain:

Hartley

Sex:

male/female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: inbred albino guinea pigs bred in the testing laboratory colony.
- Weight at study initiation: about 350 g.
- Housing: animals were housed in wire mesh cages in pairs of the same sex.
- Diet: pelleted guinea pig diet, cabbage, ad libitum.
- Water: ad libitum.

Study design: in vivo (non-LLNA)

Induction

Route:

intradermal

Vehicle:

not specified

Concentration / amount:

Intradermal injection challenge concentration (ICC): 0.25 %

Challenge

Route:

epicutaneous, open

Vehicle:

not specified

Concentration / amount:

Topical application challenge concentration (ACC): 20 %

Day(s)/duration:

21

No. of animals per dose:

10

Details on study design:

SENSITIVITY
For demonstration of sensitivity by challenge with the test substance, the hair was shaved from both flanks with Oster animal clippers, size 40 blades, and the test substance injected intradermally into one flank and applied topically without occlusion to the other flank.

PRELIMINARY IRRITATION TEST
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.Intradermal injection. Four animals of the same sex and weighing about 450 g were each injected intradermally on the shaved flanks with 0.1 ml aliquots of a range of concentrations of tests material in a suitable solvent. The reactions were examined for size (two largest diameters), erythema and oedema 24 h later and the concentration giving slight but perceptible irritation with no oedema was selected as the injection challenge concentration (ICC).Topical application. Aliquots (0.1 ml) of a range of concentrations of test substance in a suitable solvent were applied in small circular areas to the shaved flanks of 4 guinea pigs of the same sex and weighing about 450 g. The reactions were examined for erythema 24 h later and the highest concentration which caused no irritation was selected as the application challenge concentration (ACC).

MAIN TEST
Induction treatmentFor each animal 0.1 ml aliquots of test substance at 2.5 times the ICC were injected intradermally at 4 sites which overlie the 2 auxillary and 2 inguinal lymph nodes.Challenge treatmentFourteen days after induction each animal was challenged intradermally in one flank and topically in the other with 0.1 ml aliquots of test substance at the respective ICC and ACC: the topical application was made by spreading 0.1 ml of the test substance onto the shaved flank in a small circular area which was not covered.Twenty-four hours later the reactions were scored.Apparent sensitization reactions would be confirmed 7 days later by a second challenge with controls included.In the absence of sensitization reactions at first challenge the induction and challenge procedures were repeated, but this time a comfirmatory challenge with controls was included irrespective of any apparent sensitization reactions at the previous challenge.SCORINGReactions were examined under a Philips colour-matching unit with 3 Philips 40 W Actinic Blue 05 fluorescent tubes and 3 Philips 40 W White 35 fluorescent tubes. Each injection reaction was given a total score based on size (2 largest diameters), erythema and oedema. Individual reactions were considered positive when their total score was significantly greater than the average total score for control reactions. Application reactions were scored on a 0 to +++ scale and individual reactions were considered positive if (a) they were + or greater and (b) there were no erythema reactions in controls.

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.

Results and discussion

In vivo (non-LLNA)

Results

Remarks on result:

no indication of skin sensitisation

Any other information on results incl. tables

non-sensitizer

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Conclusions:

The substance was evaluated to be non sensitising on guinea pigs.

Executive summary:

Modified Draize test was performed to assess the test item potential to induce allergic contact dermatitis in guinea pigs. 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. The Injection challenge concentration was 0.25 %, while the application challenge concentration (ACC) was 20 %. The test item does not shown signs of sensitisation potential.

Conclusion

non-sensitizer