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:

In the EU-RAR (2006; Section 4.1.2.5, page 88) it was concluded that phenol did not cause any signs of skin sensitisation in the tests conducted.

 

Experimental studies

In a modified Buehler test in guinea pigs (Itoh, 1982) no skin sensitization was detected after repeated dermal exposure to phenol. In accord, the results in a mouse ear swelling test suggested no sensitizing properties of phenol (Descotes, 1988; see robust study summaries of both studies in IUCLID Section 7.4.1).

 

Human data

Wantke et al. (1996, cited in EU-RAR 2006) investigated the sensitizing potency by measuring the specific IgE against phenol in 45 students before and after a 4-week anatomy dissection course (no details given about exposure to phenol). There was no evidence of allergic contact dermatitis caused by phenol.

In the maximization test phenol did not act as a sensitizer in 24 volunteers after induction with 2% phenol in solution and challenge with 1% solution (Kligman, 1966; additional information in IUCLID Section 7.4.1).


Migrated from Short description of key information:
Phenol did not cause skin sensitisation in a modified Buehler test and in a mouse ear swelling test. Furthermore there is no evidence of allergic contact dermatitis in humans in a maximization study and a study measuring IgE-mediated sensitization. Although phenol is used since decades no relevant data on sensitization have been reported. Therefore, labelling with R 43 is not warranted.

Justification for classification or non-classification

The available data indicated that classification as skin sensitizer is not warranted