Registration Dossier

Administrative data

Description of key information

7.3.1 Skin corrosion/irritation:

For acute skin irritation assessment, the data base compiles 38 studies performed between 1970 and 2015 with synthetic amorphous silica forms with the specific surface area (BET) ranging from 45-700 m2/g produced by different processes including both untreated and surface-treated test materials. The criteria of Klimisch score 1 is met by 19 and Klimisch score 2 by 16 of these studies performed according to OECD TG 404 or similar in vivo methods. Non-irritating to slightly irritating (with 0.5 g) properties were observed. There was no indication of a systemic effect of treatment. Body weight changes were not remarkable. Signs of significant skin damage or irritation that was not fully reversible were absent in all studies. The slight irritation observed in some studies is caused by hygroscopic properties of the test substance.

7.3.2 Eye irritation:

For acute eye irritation assessment, the data base compiles 45 studies performed between 1958 and 2015. Different forms of synthetic amorphous silica with the specific surface area (BET) ranging from 70-700 m2/g produced by different processes were tested including untreated and surface-treated test materials. 17 of these studies meet the criteria of Klimisch score 1 and 21 studies meet the criteria of Klimisch score 2. They were performed in vivo according or similar to OECD TG 405. The results vary from no irritation up to a conjunctivitis that completely recovered within 48 hours. Signs of significant eye damage or incompletely reversible irritation were absent in all studies. The slight irritation observed in some studies is caused by hygroscopic properties of the test substance.

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

Justification for classification or non-classification

Acute skin irritation:

According to Annex I of the Regulation (EC) 1272/2008 and GHS (Globally Harmonized Classification System), the test substance requires no classification and has no mandatory label requirement.

Acute eye damage/ irritation:

According to Annex I of the Regulation (EC) 1272/2008 and GHS (Globally Harmonized Classification System), the test substance requires no classification and has no mandatory label requirement.