Silicon dioxide

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

other: Opinion of the IVDK on skin sensitising effect of synthetic amorphous silica (CAS no. 7631-86-9), SiO2 or silica

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Data source

Reference

Reference Type:

review article or handbook

Title:

Unnamed

Year:

2020

Report date:

2020

Materials and methods

Test material

Test material information

Constituent 1

Reference substance name:

Silicon dioxide

EC Number:

231-545-4

EC Name:

Silicon dioxide

Cas Number:

7631-86-9

Molecular formula:

O2Si

IUPAC Name:

dioxosilane

Applicant's summary and conclusion

Conclusions:

In the dermatological-allergological literature there is no convincing evidence for a skin sensitising effect of synthetic amorphous silica (CAS no. 7631-86-9), SiO2 or silica in humans.

Executive summary:

The IVDK (Informationsverbund Dermatologischer Kliniken -Information Network of Departments of Dermatology) is a network of currently 58 dermatological departments in Germany, Switzerland and Austria dedicated to the clinical epidemiology of contact allergy. In the participating hospitals, anamnestic and clinical data of all patients tested epicutaneously are recorded electronically in standardized form together with the test results. Pseudonymised extracts from the databases of the clinics are regularly sent to the IVDK headquarters, where they are integrated into the central database of the IVDK after standardised quality control. The IVDK was founded in 1988 and maintains the largest database in the world in terms of clinical data on contact allergy. It currently comprises data sets of 286,680 patients (after quality control); every year the data of about 10,000 patients are added.

Synthetic amorphous silica (CAS No. 7631-86-9), SiO₂or silica have not been epicutaneously tested in the IVDK. Therefore, the IVDK does not have its own data in this regard.

An extensive literature research on 16^thApril 2020 on the question of a possible contact allergy against amorphous silica, SiO₂or silica listed only 2 case reports from the years 1987 and 2016.

In the dermatological-allergological literature there is no convincing evidence for a skin sensitising effect of synthetic amorphous silica (CAS no. 7631-86-9), SiO2 or silica in humans.