Registration Dossier
Registration Dossier
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EC number: 404-290-3 | CAS number: 7216-95-7
Endpoint summary
Administrative data
Description of key information
Multiple skin and eye irritation studies using the DTPA acid and the pentasodium and pentapotassium salts.
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
Skin Irritation:
The various studies available for DTPA acid, pentapotassium salt and pentasodium salt indicate that DTPA is not irritating to the skin. Whilst DTPA acid, and the pentasodium and potassium salts would not be irritating to the skin, the residual sodium hydroxide or potassium hydroxide present in some formulations of pentapotassium DTPA can result in the solution being irritant or even corrosive, however this is due entirely to the presence of the residual hydroxide.
Eye Irritation:
DTPA acid appears to be irritating in a minimally reported study. There was no assessment of the irritancy according to the Draize criteria, and the assessment of irritancy was therefore entirely qualitative. Studies performed using the sodium salt generally indicate a lack of irritancy to eyes whereas a study using the potassium salt showed slight eye irritation while a 40% solution of the potassium salt did not. These salts are placed on the market as solutions of approximately 40% chelating agent in water. Some of these solutions contain residual hydroxide left over by the manufacturing process. As with the skin irritation, this residual hydroxide can significantly increase the irritation potential. However if one considers the DTPA salts on their own, then the data indicate that there is a lack of eye irritation potential according to current guidelines with regard to the sodium salt and only slight irritation in case of the potassium salt
Effects on eye irritation: irritating
Justification for classification or non-classification
Pentapotassium DTPA does not meet the requirements for classification for skin irritation, but should be classified for eye irritation GHS Cat. 2 as described in the Guidance on the Application of the CLP criteria, Version 4.0 (2013).
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