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Toxicological information

Endpoint summary

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Administrative data

Description of key information

For the assessment of skin sensitization, the data base compiles 6 studies meeting the criteria for Klimisch score 1. From 1984 to 2015, different forms of synthetic amorphous silica with the specific surface area (BET) ranging from 125-290 m2/g were tested in 5 guinea pig maximisation tests according to OECD TG 406 or a local lymph node assay according to OECD guideline 429. None of these studies showed any sensitising potential.

Key value for chemical safety assessment

Skin sensitisation

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

Respiratory sensitisation

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

Justification for classification or non-classification

No skin sensitising potential was identified for different forms of the test material in valid tests using two different methods.

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