Registration Dossier

Diss Factsheets

Administrative data

Description of key information

read accross with analogue source substance:

Non-sensitising; OECD 406 ; Drs. A.H.B.M. van Huygevoort., 2001c

Key value for chemical safety assessment

Skin sensitisation

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

A preliminary irritation study was conducted using 3 individuals in order to select the test substance concentrations to be used in the main study. The results concluded that intradermal injections at a concentration of 1 % test item and epidermal application at a concentration of 50 % test item were the highest concentrations that produced moderate irritation. These concentrations were therefore assigned in the induction phase of the main test. The highest epidermal concetration applied that did not cause irritation was 5 % test item. This concetration was therefore assigned in the challenge phase of the main test.

The main test was conducted using 15 individuals, 5 controls and 10 treated. On Day 1, each individual was subjected to three pairs of intradermal injection around the scapular region (0.1 mL/ site); 2 x 1:1 FCA:water, 2 x 1 % test item in corn oil (or corn oil only for controls), 2 x 1 % test item in FCA (1:1 mix) (corn oil: FCA mix for controls). The dermal reactions cused by the injections were assessed on Day 3 for irritation. On Day 8, the scapular region was clipped and a dermal application (0.5 mL) of the test item (50 % concentration) was applied (2 x 3 cm patch) between the injection sites. The patch was held in place for 48 using micropore tape and an elastic bandage. The patches were removed and the applications sites cleaned prior to assessment. On Day 21 each individual recieved a challenge dermal application, that was applied as previously described, at a concetration of 5 %. The patch was removed after 24 h contact time, the skin cleaned and assessment for irritation made at 24 and 48 h (after challenge application).

The results of the main studies showed moderate erythema (grade 3) at the injection and dermal patch sites after the induction of the test item at a concentration of 1 % and 50 %, respectively. It should be noted that signs of necrosis was observed in 2 treated individuals after the dermal induction phase. No skin reactions were observed following the challenge phase in any of the individuals. No mortality or systemic toxicity were observed during the main test and body weight increases in the treated individuals was in the same range as the controls.

In this study, Bisphenol AF is not a dermal sensitiser.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The substance does not meet the classification criteria for skin sensitisation in accordance with Regulation (EC) No 1272/2008 (CLP).