Registration Dossier

Administrative data

Description of key information

Testing for skin irritation has proven negative, due to the nature of the substance it is scientifically unjustifiable to perform an eye irritation study 

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 study available

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Although negative results have only been obtained for skin, inhalation exposures using the nose only route produce simultaneous heavy exposures to the eyes, no reports of excess irritation exist. Animals exposed by inhalation similarly show no evidence of respiratory tract irritation, although the normal physiological response (macrophage accumulation) occurs. This is regarded as a physiological rather than a pathological response.

Human data has confirmed that only mechanical irritation occurs in humans and results in itching. Screening at manufacturers’ plants in the UK has failed to show any human cases of skin conditions related to fibre exposure, the study report is detailed in section 7.10.1. Magnesium Aluminium Silicate and Sodium Magnesium Silicate caused minimal eye irritation in a Draize eye irritation test (Elmore et al. 2003 - Elmore AR; Cosmetic Ingredient Review Expert Panel. Int J Toxicol. 2003;22 Suppl 1:37-102.). While most silicates used in cosmetics have not (for ethical reasons) been tested for eye irritation they are approved for use in cosmetics.

Justification for classification or non-classification

negative results in skin irritation studies in animals and no positive reports in humans result in non-classification for irritancy and corrosion