Registration Dossier

Administrative data

Description of key information

Not irritating to the skin and 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 vitro

There is no data available for aluminatesilicate. Therefore a read-across was conducted from structurally related substances. The skin irritation potential of silicic acid, aluminium salt was determined by Paulus (2010, in vitro, RL2) according to OECD guideline (Draft proposal for a new guideline. In vitro skin irritation: human skin model test, Dezember, 2007). Approx. 25 mg of the test item were applied to EpiDermTM tissues. After 35 minutes incubation tissues were rinsed and incubated for further 42 hours. The cell viability was measured photometric by dehydrogenase conversion of MTT. No decrease of cell viability was detected compared to the negative control. Under these test conditions the substance has no skin irritation potential.

In vivo 

Five-tenths of a gram of kaolin clay polydimethylsiloxane as 50% (w/w) mixture in distilled water was applied to the skin of New Zealand rabbits (Engelhard Corp., 1997, RL2). The study was performed according to OECD guideline 404 under GLP-conditions. The observation period was 72 hours instead of 14 days, but no dermal irritation was noted. The primary dermal irritation index was 0.

No skin irritation potential of aluminatesilicate is expected.

 

Eye irritation

There is only an in vitro study available for the evaluation of aluminatesilicate. Available in vivo data for Surround WP Crop Protectant is considered to be data of structurally related substance with similar toxicological properties.

In vitro The eye irritancy potential of aluminatesilicate was screened by using the Hen's Egg Test - Chorioallantoic Membrane (HET-CAM) test following ICCVAM recommended test method protocol dated November 2006 (Paulus and Andres, 2010, RL1). 0,3 mL of the powdery test item were added pure to the membrane of 6 nine day incubated Lohmann Leghorn chicken eggs. The reactions on the CAM were observed over a period of 300 seconds.

Aluminatesilicate showed no effects on the blood vessels of the CAM. The calculated mean irritation score was 0.00. Under these experimental conditions aluminatesilicate possesses no irritation potential.

In vivo

Surround WP Crop Protectant was tested in a primary eye irritation study in rabbits (Engelhard Corp., 2000, RL2). The test substance was instilled into the conjunctival sac of the right eye of one male and two female rabbits without washing off. One hour following test substance instillation, all three treated eyes exhibited conjunctivitis. The overall incidence and severity of irritation decreased thereafter. All animals were free of ocular irritation by 48 hours.

Respiratory irritation

No data available.

Justification for classification or non-classification

Skin

Based on read-across data there is no need for classification.

Eye

There is conclusive data available which is not sufficient for classification.