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Description of key information

The test material was determined to be non-irritating in a dermal irritation study on rabbits (Madetoja 2002a).
The test material was determined to be non-irritating in a eye irritation study on rabbits (Madetoja 2002b).

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

Skin

In order to evaluate the skin irritation potential of the test material registered, three studies according to OECD 404 were assessed, i.e. one key study with the test substance (Madetoja 2002a) and two studies (read across) with the analogue substance. For the key study the rabbits were each exposed to a dose of 0.5 ml test material for 4 hours and observed for the following 3 days for any sign of skin irritation. A single rabbit was dosed in the same way to a 0.5 ml dose of 1% SDS which acted as a positive control for the test. As expected, there was a positive skin reaction for the reference item. In animals dosed with the test material only one animal showed very slight erythema 60 minutes after patch removal. The positive skin reaction was reversible within one day. There were no other signs of skin irritation. During the study period of the two studies performed with the surrogate substance signs of irritation were observed in one study but these were not sufficient to warrant classification as a skin irritant. No irritant effects were observed in the third study. All three studies presented to assess the irritation and corrosion potential of the test material, were performed in line with GLP and to standardized guidelines with a high standard of reporting.

Eye

In order to evaluate the eye irritation potential of the test material registered, three studies according to OECD405 were assessed, i.e. one key study with the test substance (Madetoja 2002b) and two studies (read across) with the analogue substance. For the key study 0.1 ml of the test material was applied into one of each eye of three rabbits. The rabbits were observed for up to 5 days to determine the grade of ocular re1action to the test material. All tested animals had a mild positive reaction to the test material which were fully reversible within 5 days. During the study period of the two studies performed with the surrogate substance signs of irritation were observed but these were not sufficient to warrant classification as an eye irritant. All three studies presented to assess the irritation and corrosion potential of the test material, were performed in line with GLP and to standardized guidelines with a high standard of reporting.


Justification for selection of skin irritation / corrosion endpoint:
The key study (Madetoja, 2002a) was performed using a solution of potassium zirconium carbonate, rather than the pure solid, the results of the study are considered to be the worst case scenario since the solution has a higher pH (ca. 11 vs. 9.2). The study was performed according to GLP and the standardised guideline OECD 404. The study was therefore assigned a reliability score of 1 according to the principles for assessing data quality according to Klimisch (1997).

The two supporting studies (Karhi, 2001 and Mallet, 1986) were performed on a similar substance and have been provided on the basis of read-across given the substances common ionic components, ZrO2. Both studies were performed using ammonium zirconium carbonate in GLP compliant studies conducted according to OECD guideline 404. Both studies have been assigned a reliability score of 2 according to the principles for assessing data quality set out by Klimisch (1997).

Justification for selection of eye irritation endpoint:
The key study (Madetoja, 2002b) was performed using a solution of potassium zirconium carbonate, rather than the pure solid, the results of the study are considered to be the worst case scenario since the solution has a higher pH (ca. 11 vs. 9.2). The study was performed according to GLP and the standardised guideline OECD 405. The study was therefore assigned a reliability score of 1 according to the principles for assessing data quality according to Klimisch (1997).

The two supporting studies (Karhi 2000 and Cuthbert 1992b) were performed on a similar substance and have been provided on the basis of read-across given the substances common ionic components ZrO2. Both studies were performed using ammonium zirconium carbonate in GLP compliant studies conducted according to standardised guidelines. Both studies were performed in accordance with OECD 405, Cuthbert, 1992b followed an additional EU guideline B.5. Minor deviations from the standardised guidelines were noted, however these are not considered to have affected the reliability of the results. Both studies have been assigned a reliability score of 2 according to the principles for assessing data quality set out by Klimisch (1997).

Justification for classification or non-classification

Skin

In accordance with the criteria for classification as defined in Annex I, Regulation 1272/2008, the test material does not require classification for skin irritation.

 

Eye

In accordance with the criteria for classification as defined in Annex I, Regulation 1272/2008, the test material does not require classification for eye irritation.