Registration Dossier

Administrative data

Description of key information

Platinum dioxide was not irritant in a limited (pre-GLP) study, involving 24-hr occluded application to the intact and abraded skin of 6 male rabbits (Campbell et al., 1975).
In a guideline study, to GLP, instillation of platinum dioxide (0.1 g) produced moderate irritation in three rabbits after a 72-hr observation period (Allen, 1994).
No relevant respiratory tract irritation data were identified.

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)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

No relevant irritation/corrosion human data were identified.

 

In a pre-GLP study, the dermal irritancy of 14 materials, including platinum dioxide, was assessed in albino rabbits. Test materials, mixed with water, were applied to intact and abraded skin of 6 male albino rabbits as 24-hour occluded patches. Coverings were then removed and sites scored immediately and 48 hours later, using a scale from 0 (non-irritant) to 4 (corrosive). Platinum dioxide failed to give any indication of irritation (score 0) on both intact and abraded skin (mean of reactions at 24 and 72 hours) (Campbell et al., 1975).

 

In an OECD Test Guideline 405 study, conducted to GLP, the potential of platinum dioxide to cause eye irritation was assessed in rabbits. The test material (0.1 g) was instilled into the conjunctival sac of the right eye of each of three New Zealand White rabbits, without irrigation. Diffuse corneal opacity, iridial inflammation and moderate conjunctival irritation were observed during the 72-hr observation period; only conjunctival redness had not reversed during this period (though it had lessened in severity). The test material produced a maximum group mean score of 17.0 and was classified as a moderate irritant (Class 5 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system (Allen, 1994).

 

No respiratory tract irritation data were identified. A new study was not conducted as it is not a REACH Standard Information Requirement.


Justification for selection of skin irritation / corrosion endpoint:
US Guideline study, pre-GLP, and the only skin irritation study available.

Justification for selection of eye irritation endpoint:
OECD guideline study, and the only eye irritation study available.

Justification for classification or non-classification

Based on the results of the available skin and eye irritation studies in rabbits, platinum dioxide does not require classification for skin or eye irritation according to EU CLP criteria (EC 1272/2008).