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Description of key information

In vivo skin irritation study (OECD TG 404) and in vivo eye irritation study (OECD TG 405). Bentonite acid leached was not irritating to skin or eyes.  

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:

In the key skin irritation study (Sanders 2005) 0.5g of bentonite acid leached was applied to the intact skin of three rabbits under a semi-occlusive dressing for 4 hours. 3 minute and 1 hour semi-occluded applications were applied to the intact skin of one rabbit. Animals were observed at 24, 48 and 72 hours after removal of the patch and test sites were examined for evidence of irritation and scored according to the Draize classification scale. A single 4 hour, semi-occluded application of the test material to the intact skin of three rabbits produced no evidence of skin irritation. 3 minute and 1 hour semi-occluded applications of test material to the intact skin of one rabbit produced no evidence of skin irritation.

In a supporting study (Nitka 1985) 0.5 g of bentonite aicd leached was applied to the intact and abraded skin of six rabbits under an occlusive dressing for 24 hours. Each test site was examined 24 and 72 hours for erythema and edema using teh Draize scoring scale. The mean scores for the 24 and 72 hour gradings were averaged to determine the primary skin irritation index. A score of 5 was indicative of skin irritation. The primary irritation index was determined to be 0.05.

Eye irritation

In the key eye irritation study (Sanders 2005) 0.1 g of bentonite acid leached was instilled into the eyes of three rabbits. Eyes were scored for irritation responses at 1, 24, 48 and 72 hours after instillation. Minimal conjunctival irritation was noted in all treated eyes one hour after treatment and at the 24 and 48-hour observations. All treated eyes appeared normal at the 72-hour observation with no evidence of ocular irritation.

In a supporting study (Nitka 1985) 0.1 g of bentonite acid leached was instilled into the eyes of six rabbits. The contralteral eye reamined untreated and served as a control. The eyes of all animals remained unwashed for 24 hours. Observations of ocular irritation were recorded at 24, 48 and 72 hours. All treated eye appeared normal after 72 hours with no evidence of ocular irriation.

Justification for classification or non-classification

Bentonite acid leached was non-irritant in both the in vivo skin and eye irritation studies and therefore requires no classification according to CLP Regulation (EC) No 1272/2008

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