Registration Dossier
Registration Dossier
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EC number: 205-391-3 | CAS number: 140-01-2
Endpoint summary
Administrative data
Description of key information
MUltiple skin and eye irritation studies using pentasodium or pentapotassium DTPA
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
Skin Irritation:
The various studies available for DTPA pentapotassium salt and pentasodium salt indicate that DTPA is not irritating to the skin.
Whilst the DTPA pentasodium and potassium salts would not be irritating to the skin, the residual sodium hydroxide or potassium hydroxide present in some formulations of these salts of 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:
Studies performed using the salts (sodium and potassium) generally indicate a lack of irritancy to eyes. 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 salts on their own, then the data indicate that there is a lack of eye irritation potential according to current guidelines.
Justification for classification or non-classification
The irritancy potential of the Sodium salt of DTPA is linked to the presence of residual hydroxide. The 'pure' Pentasodium DTPA, containing no residual hydroxide would not be irritating to the skin or eyes. Therefore the classification of this substance should be 'not irritating to the skin or eyes'. However when classifying the commercially available products, the amount of residual hydroxide should be taken into account, thus classification as irritating or corrosive of these commercial formulations may be ultimately necessary.
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