Registration Dossier
Registration Dossier
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EC number: 202-951-9 | CAS number: 101-54-2
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Non-human information
The skin sensitizing potential of 4-ADPA was evaluated in a guinea pig maximization test (Yamano 2009). The induction exposure was done intradermal and topical with a test substance concentration of 500 ppm (0.05%). Two weeks after induction exposure the animals were topical challenged with 50 ppm (0.005%) and 5000 ppm (0.5%) test substance. All treated animals showed positive skin reactions at 50 ppm and 5000 ppm (4/4).
This positive finding was confirmed by a local lymph node assay (Yamano 2009). Female BALB/c mice (four per group) treated with 4-ADPA showed a significant increase in the Stimulation Index (SI: 1.68, 1.82, 2.25, at 0.03%, 0.1 % and 0.3 %, respectively) at a non-irritant dose-range and thus was considered to be a positive skin sensitizer in the local lymph node assay.
Earlier skin sensitizing tests also indicated a skin sensitizing potential of 4-ADPA.
In a maximization test 19 out of 20 guinea pigs showed a positive reaction (Wahlberg 1985). The findings from another guinea pig test revealed a dose-dependent positive response. Using a 1% test substance concentration during induction and a 0.1% or 1% concentration for the challenge revealed a positive response (4/10 positive at 0.1% and 10/10 positive with 1% 4-ADPA) in this epicutaneous test (Ishihara 1985). The positive findings were confirmed by an open epicutaneous test with guinea pigs. 50% of the treated animals had a positive test result (Schäfer 1978).
Human information
A number of human patch test testing studies have been conducted using the test substance 4-ADPA on a wide range of dermatology patients including generally sensitized individuals, hairdressers and clients of hairdressers (summarised in SIDS 2004)
Migrated from Short description of key information:
The findings from several tests with guinea pigs and mice revealed that 4-ADPA is a skin sensitizer in animals. In addition, the test substance has repeatedly been demonstrated to be an allergen for humans.
Justification for classification or non-classification
Based on the findings of the above mentioned in vivo studies (see above) the test substance 4-ADPA is classified as skin sensitizer in animals according to the classification criteria 67/548/EWG and regulation no. 1272/2008 (GHS).
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