Registration Dossier

Administrative data

Description of key information

Skin irritation / corrosion
0.5 mL of a 80% phosphoric acid solution was observed to be corrosive to rabbit skin after 24 hours of exposure.
Eye irritation:
No reliable data are available for the eye irritation endpoint. Nevertheless as the substance is skin corrosive and classified accordingly, the substance is as well considered as eye corrosive. This is as well in accordance with the results of the unreliable studies.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Skin irritation / corrosion:

BASF (1980) studied the skin irritant/corrosive properties of phosphoric acid on Vienna White rabbit skin (6 male rabbits tested according to guideline 1500.41 in the Federal Register Vol. 38, No. 187, S. 26019 from 1973 -09 -27). 0.5 mL of an 80% solution was applied to the shaved test sites (half of the test sites were abraded). After 24 hours of exposure, observations were done at 24 and 72 hours and at 8 days post dosing. The substance was observed to be corrosive to rabbit skin. These data were considered as key information for the skin irritation/corrosion endpoint. BASF (1980) studied as well the skin irritation properties of 0.5 mL 19% solution of phosphoric acid in 2 female Vienna White rabbit (4 hours of exposure). The test substance was considered as a non skin irritant substance.

Eye irritation:

Phosphoric acid is classified as a skin corrosive substance category 1B (concentration > or = 25%) and an eye irritant (10% < or = concentration < 25%) according to the CLP Regulation Annex VI, table 3.1 (EC Regulation 1272/2008 on classification, labelling and packaging of substances and mixtures). Therefore, according to the REACH Regulation, in vitro testing for eye irritation with this substance does not need to be conducted (column 2 adaptation, Annex VII, section 8.2). In vivo testing can be waived according to the REACH Regulation as phosphoric acid is classified as corrosive to the skin and as an eye irritant (column 2 adaptation, Annex VIII, section 8.2.1).

Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Justification for classification or non-classification

According to the available data, the substance is considered as a skin corrosive substance (80% solution tested). This is in the line with the Harmonized CLP classification where phosphoric acid is classified as a Skin Corrosive substance category 1B.

In addition, the harmonized classification (Table 3.1 of the CLP Regulation (EC) No 1272/2008 reports that phosphoric acid is a skin irrtant substance category 2 at following concentration limits: 10% < or = C <25% although the available data didn't show an irritant effect at a concentration of 19% phosphoric acid. The classification of the CLP Regulation will nevertheless be followed in this substance dossier.

According to the CLP Regulation (EC) 1272/2008, phosphoric acid is considered as an eye irritant substance category 2 with a concentration limit of 10% < or = C < 25% (Annex VI harmonized classification (Tabel 3.1)).