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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study is comparable to the Buehler test described in OECD Guideline 406 (adopted 1992) with acceptable restrictions (low number of animals, no negative control, low concentration of the test substance at challenge; partly limited documentation)

Data source

Reference
Reference Type:
publication
Title:
Sensitization potency of some phenolic compounds
Author:
Itoh M
Year:
1982
Bibliographic source:
J Dermatol 9: 223-233

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
(no control group)
GLP compliance:
not specified
Type of study:
other: modified Buehler test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
commerciaJ phenol was used; purification by fractional distillation (b.p. 8O.4°C/15 mmHg); source: Shiono Koryo Kaisha, Ltd.; purity 99.9%.
No further data available

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
female
Details on test animals and environmental conditions:
Albino, 350 to 400 g body weight at initiation. No further details given.

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, semiocclusive
Vehicle:
petrolatum
Concentration / amount:
10% phenol in petrolatum for induction
1 and 0.1% phenol in petrolatum for challenge
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
10% phenol in petrolatum for induction
1 and 0.1% phenol in petrolatum for challenge
No. of animals per dose:
10
Details on study design:
Pilot study for determination of irritant concentration
10 females per concentration used. Hair on the flank was shaved and about 20 mg of 10, 5, 2, 1, 0.5 and 0.2% of phenol in white petrolatum applied in Finn chambers on Scanpor tape (Epitest Co., Ltd.); Finn chambers applied to the shaved flanks and cloth tape (Dermicel) wrapped around the bodies of animals; foam pads applied over the cloth tape and secured to the animals' flanks with additional cloth tape; Forty-eight hours after application, the test materials removed; readings 1, 24 and 48 hours after the removal of test materials.

Sensitization Tests
10 females were used.
Induction: nape hair shaved and about 50 mg of 10% phenol in white petrolatum applied to round cloth (1.5 cm in diameter) of Torii's patch plaster [adhesive plaster] and applied to the napes; Dermicel cloth tape, Reston foam pads, and then Dermicel cloth tape placed over the patch plaster; test materials removed 48 hours after application (in OECD guideline 406 an exposure duration of 6 hours is recommended).
This procedure was repeated three times a week for two weeks (in OECD guideline 406 totally 3 applications in 2 weeks are recommended).
Challenge: 2 weeks after the end of the induction procedure, the flanks of the guinea pigs were shaved; 1% and 0.1% phenol (presumably both concentrations tested in the same group) in white petrolatum (presumably 50 mg) occluded with Finn chambers on Scanpor on the shaved flank areas (no further data). Further dressing in the same manner as for induction; test material removed 48 hours after application; degree of reaction determined 1, 24, 48 hours and one week after removal of the test material.
Challenge controls:
no negative control
Positive control substance(s):
yes
Remarks:
(in parallel trials with other phenolic substances clearly positive results were obtained)

Study design: in vivo (LLNA)

Positive control substance(s):
other: e.g. isoeugenol
Statistics:
No data

Results and discussion

Positive control results:
isoeugenol: positive results in 16 out of 20 animals in parallel experiments

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
1 or 0.1%
No. with + reactions:
0
Total no. in group:
9
Clinical observations:
no data
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1 or 0.1%. No with. + reactions: 0.0. Total no. in groups: 9.0. Clinical observations: no data.

Any other information on results incl. tables

Pilot test

Only 10% phenol in petrolatum (highest concentration tested) resulted in irritant effects in 9 out of 10 animals. No further details were given.

Sensitization test

Only data 24 h after removal were presented in a table. Results 1, 48 hours and one week after application were not documented but negative results are presumed.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Phenol has no sensitizing properties in the modified Buehler test.
Executive summary:

The study is comparable to the Buehler test described in OECD Guideline 406 (adopted 1992) with acceptable restrictions (low number of animals, no negative control, low concentration of the test substance at challenge; partly limited documentation).

The author used a modified Buehler test. Ten female guinea pigs received for induction semiocclusive patches with 50 mg of 10% phenol in white petrolatum (irritant concentration in a pilot study). This procedure was repeated three times a week for two weeks. Two weeks after the end of the induction procedure guinea pigs received for challenge occlusive patches with 1% and 0.1% phenol and test material was removed 48 hours after application; degree of reaction was evaluated 1, 24, 48 hours and one week after removal of the test material. No positive reaction was detected in 9 animals but in a parallel positive control group (isoeugenol: 16/20 animals positive).

Conclusion: Phenol has no sensitizing properties in the modified Buehler test.