Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Skin sensitisation

Two key studies for skin sensitisation are available for the registered substance 2-phenylphenol (OPP).

The first key study (Gilbert, K. S., 1994b and Bomhard, E. M. et al., 2002) was conducted according to the OECD Guideline 406 (Buehler Test) but with few deviations. 10 male Hartley albino guinea pigs (357 – 411 g bw) received three dermal applications of 0.4 g of OPP moistened with 0.2 mL of distilled water during the three-week induction period. This concentration of OPP was shown in a preliminary skin irritation screen to cause slight irritation. Another ten guinea pigs received a 10% solution of DER 331 epoxy resin in dipropylene glycol monomethyl ether as a positive control. Guinea pigs were challenged with 0.4 mL of a 7.5% aqueous suspension of OPP (highest non-irritating dose) two weeks after the last induction application. Five naïve animals each also received an identical challenge application with 0.4 mL of a 7.5% aqueous suspension of OPP or 0.4 mL of a 10% solution of DER 331 epoxy resin. Each induction/challenge exposure was 6 h in duration. The challenge application sites did not show any evidence of erythema in the ten animals nor did any of the naïve animals have any signs of irritation. Challenge application with the positive control caused slight to moderate erythema, considered to reflect a hypersensitivity response, at the test site on 9 of 10 animals, with no effect noted in the corresponding naïve animals. Thus, OPP is not sensitising to guinea pigs under the conditions of this test.

The second key study (Andersen, K. E., 1986 and Bomhard, E. M. et al., 2002) was conducted similar to the OECD Guideline 406 (Guinea Pig Maximization Test). The sensitising potential of seven industrial antimicrobial agents (including OPP) was evaluated using out-bred female albino guinea pigs (350-450 g). Propylene glycol was used as a vehicle. 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. 20 guinea pigs were assigned to the test group and 20 animals were used as controls and treated with vehicle only. For challenge exposure, the control animals were challenged with the highest non-irritant challenge concentration. 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. 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. OPP did not induce skin reactions in any of the animals tested and was therefore considered to be not sensitising to guinea pigs under the conditions of this test.

Further skin sensitisation data are available for the registered substance. A Buehler Test resulted in non-sensitising properties for OPP (Berdasco, N. M., 1991 and Bomhard, E. M. et al., 2002) and a study with 200 human volunteers revealed that OPP was not sensitising in the human patch test (Hodge, H. C. et al., 1952 and Bomhard, E. M. et al., 2002).

In conclusion, 2-phenylphenol was not sensitising to the rabbits’ skin and to humans’ skin in several studies and therefore does not meet the criteria to be classified for skin sensitisation according to EU Directive 67/548/EEC and Regulation (EC) No 1272/2008.


Migrated from Short description of key information:
GPMT, similar to OECD 406: not sensitising
Buehler Test, OECD 406: not sensitising

Justification for selection of skin sensitisation endpoint:
Hazard assessment is based on information from two different studies; both were considered as key studies as both studies are reliable and of good quality, but represent different study types.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available data for the registered substance, 2-phenylphenol does not meet the criteria to be classified for skin sensitisation according to EU Directive 67/548/EEC and Regulation (EC) No 1272/2008.

 

No data are available for the assessment of respiratory sensitisation.