Registration Dossier

Administrative data

Description of key information

Regarding Skin irritation:
p-Hydroxybenzoic acid is considered as not skin corrosive and not as skin irritating. The substance does not have to be classified as skin irritant according to DSD/ CLP classification criteria as the limits for classification were not passed in an in-vivo test (see Colas 2009) according to OECD No. 404 with female New-Zealand White rabbits (exposure of 4 hours), in which however, a short term mild irritation in one animal was observed.
Regarding Eye Irritation:
According to the rules of the EC regulation No 1272/2008 (EU-GHS) 4-HBA has to be classified as: category 1 "irreversible effects on the eye" based on the in vivo study on Rabbits (Richeux, 2010, see section 5.4.1. below).
Regarding respiratory irritation:
Data from the inhalation study with repeated doses revealed respiratory irritation (NOEL = 60 mg/m³).

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:
adverse effect observed (irritating)

Additional information

Effects on eye irritation: corrosive

Effect level: empty Endpoint conclusion: Adverse effect observed

Justification for classification or non-classification

The classification of the eye irritating properties is based on the reaction of one albino rabbit in the study of Richeux (2010). According to the rules of the EC regulation No 1272/2008 (EU-GHS) 4-HBA has to be classified as: category 1 "irreversible effects on the eye". In literature (BUA Stoffbericht 164) there are 2 other studies mentioned in which 4-HBA proved to be only slightly to moderately irritating to the eyes. However, based on all available studies it was revealed that 4-HBA has to be classified only as corrosive to eyes, whereas a classification with hazard class Skin corrosion/Irritation is not warranted.