Registration Dossier

Administrative data

Description of key information

4B acid is neither a skin nor eye irritant. 

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

4B-acid is not irritating to the skin as determined in studies with direct exposure of humans orIn VitroSkin Irritation. The study performed in 2010 by C.A.F. Buskens was chosen as key study for skin irritation because it was performed with a commercial sample according to EU method B.46 and GLP and contains detailed sample information such as composition, origin and storage conditions in the study report. The overall study result is “non irritating”. None of the available studies gave an indication that 4B-acid has irritating properties on skin.

The key study for eye irritation (C.M Verspeek-Rip, 2010) was performed with a commercial product following OECD testing guideline 437 on Bovine corneal opacity and permeability test (BCOP test) and GLP. The meanin vitroirritancy score was 24 after 240 minutes of treatment with 4B-acid. Since the meanin vitroscore was below 55.1 4B-acid is considered to be non-irritant. Another study in rabbits (J. Marhold, 1986) showed moderately irritation at the dose of 500mg apparently 5 times more than allowed in OECD 405. However no information at all could be found about test substance, method, vehicle, number of animals, reversibility etc. and therefore the study has been disregarded.    

Experimental data on respiratory irritation is not available.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for skin or eye irritation under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC.

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified as a skin or eye irritant under Regulation (EC) No. 1272/2008.