Reaction mass of m-terphenyl and o-terphenyl

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:

other: Non-GLP guideline study with some reporting deficits, no appropriate positive control

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Contact allergy to chlorocresol, formaldehyde and other biocides.

Author:

Andersen, K.E.

Year:

1986

Bibliographic source:

Acta Dermato-Verereologica, Supplementum 125, pp. 2-21.

Reference 2

Reference Type:

publication

Title:

The Sensitising Potential of Metalworking Fluid Biocides (Phenolic and Thiazole Compounds) in the Guinea-Pig Maximization Test in relation to Patch Test Reactivity in Eczema Patients.

Author:

Andersen, K.E. and Hamann, K.

Year:

1984

Bibliographic source:

Department of Dematology, Gentofte Hospital, Hellerup, Denmark. Fd. Chem. Toxic. 22(8), pp 655-660, 1984

Materials and methods

Principles of method if other than guideline:

No guideline; the method used essentially follows the procedure for the GPMT (Magnusson-Kligman, 1970) laid down in Directive 96/54/EC Method B.6.

GLP compliance:

no

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

Intracutaneous in-vivo test with Guinea pigs was performed before the LLNA was set as preferred test method.

Test material

Test material information

Constituent 1

Reference substance name:

Biphenyl-2-ol

EC Number:

201-993-5

EC Name:

Biphenyl-2-ol

Cas Number:

90-43-7

Molecular formula:

C12H10O

IUPAC Name:

biphenyl-2-ol

Details on test material:

o-phenylphenol

In vivo test system

Test animals

Species:

guinea pig

Study design: in vivo (non-LLNA)

Induction

Induction 1

Vehicle:

other: propylene glycol (PG) for the intradermal induction; for induction and challenge patch tests yellow petroleum was used

Induction 2

Route:

intradermal

Vehicle:

propylene glycol

Concentration / amount:

0.5 % intracutaneous

Induction 3

Route:

epicutaneous, occlusive

Vehicle:

other: yellow petroleum

Concentration / amount:

25 %

Challenge

Challenge 1

Vehicle:

other: propylene glycol (PG) for the intradermal induction; for induction and challenge patch tests yellow petroleum was used

Challenge 2

Route:

epicutaneous, occlusive

Vehicle:

other: yellow petroleum

Concentration / amount:

5 %

Details on study design:

1st application: Induction 0.5 % intracutaneous (on day 0)
2nd application: Induction 25 % occlusive epicutaneous (on day 7)
3rd application: Challenge 5 % occlusive epicutaneous (on day 21)

Results and discussion

In vivo (non-LLNA)

Results

Results 1

Key result

Reading:

1st reading

Hours after challenge:

48

Group:

test chemical

Dose level:

5 %

Total no. in group:

20

Remarks on result:

no indication of skin sensitisation

Results 2

Key result

Reading:

2nd reading

Hours after challenge:

72

Group:

test chemical

Dose level:

5 %

Total no. in group:

20

Remarks on result:

no indication of skin sensitisation

Results 3

Group:

negative control

Remarks on result:

other: no details specified

Remarks:

.

Results 4

Group:

positive control

Remarks on result:

other: no details specified

Remarks:

.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Conclusions:

OPP has been shown to be not skin sensitising according to the results of the present investigation.

Executive summary:

The sensitising potential of seven industrial antimicrobial agents (including biphenyl-2 -ol (OPP) and its sodium salt, SOPP) was evaluated using the guinea pig maximisation test. Out-bred female albino guinea pigs (350-450 g) were used for the test. Propylene glycol was used as a vehicle for OPP while SOPP was dissolved in water. Moderately irritant concentrations were assessed in an irritancy test on a maximum of 4 guinea pigs and used for the topical inductions. For the challenge a non-irritant concentration and dilutions thereof were used. The tests were done in series of up to five groups of 20 guinea pigs. Four compounds could be tested simultaneously, 20 animals were used as controls and treated with vehicle only. In the series where four biocides were tested simultaneously, the control animals were challenged with the four biocides in the highest non-irritant challenge concentration. OPP and SOPP were tested at two concentrations in a total of 80 animals. The concentrations in vehicle were 0.5% or 5% for the intradermal induction (day 0) and 25% for the topical induction (day 7), for both compounds. The challenge was done on day 21 with a 5% concentration. In one case, the challenge was repeated after 1-2 weeks. The right and left flanks were used alternately. Blind reading of challenge reactions was done at 48 and 72 h. The Magnusson-Kligman grading scale was used to evaluate the challenge reactions. A grade 1 reaction was not regarded as sensitisation. The overall classification is based on the day 21 reading. OPP has been shown to be not skin sensitising according to the results of the present investigation.