Tar acids, brown-coal gasification

Skin sensitisation

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

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

Test material information

Constituent 1

Reference substance name:

Phenol

EC Number:

203-632-7

EC Name:

Phenol

Cas Number:

108-95-2

Molecular formula:

C6H6O

IUPAC Name:

phenol

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)

Induction

Induction 1

Route:

epicutaneous, semiocclusive

Vehicle:

petrolatum

Induction 2

Concentration / amount:

10% phenol in petrolatum for induction
1 and 0.1% phenol in petrolatum for challenge

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

petrolatum

Challenge 2

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 chemical

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.