Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Additional toxicological data

Currently viewing:

Administrative data

Endpoint:
additional toxicological information
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: well documented study, meeting basic scientific standards

Data source

Reference
Reference Type:
publication
Title:
Influence of particle dose on the cytotoxicity of hamster and rat pulmonary alveolar macrophage in vitro.
Author:
Warshawsky, D., R. Reilman, et al.
Year:
1994
Bibliographic source:
J Toxicol Environ Health.42(4): 407-21.

Materials and methods

Type of study / information:
in vitro study
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The cytotoxicity of the substances to hamster and rat alveolar macrophages (AM) in vitro was measured at 0.0-0.5 mg/10-6 cells at 24 and 48 h using dye exclusion procedures.
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
gelled silica
IUPAC Name:
gelled silica
Constituent 2
Reference substance name:
precipitated silica
EC Number:
927-048-3
IUPAC Name:
precipitated silica
Constituent 3
Reference substance name:
fumed silica
IUPAC Name:
fumed silica
Constituent 4
Reference substance name:
crystalline silica
IUPAC Name:
crystalline silica
Details on test material:
- crystalline silica: Min-U-Sil
- fumed silica: Cab-O-Sil® M-5
- The medium diameter for amorphous silica was <0.38 μm and for crystalline 0.83 μm. The surface areas for the amorphous silicas ranged from 235 to 125 m2/g (order: gelled > fumed > precipitated) and for crystalline silica 4.3 m2/g.

Results and discussion

Any other information on results incl. tables

With gelled silica the viability of the hamster alveolar macrophages decreased to 27% at 0.05 mg/ml and to zero at 0.1 mg/ml t 24 h. At doses of 0.05 and 0.1 mg/ml of crystalline, precipitated or fumed silica, the percent viability decreased significantly to 76-67% and 51-42%, respectively, and to zero at 0.5 mg/ml. The count of macrophages viable at 24 h decreased further at 48 h compared with the control value. The order of toxicities was: gelled > precipitated, fumed, and crystalline.

Applicant's summary and conclusion

Conclusions:
The order of cytotoxicity was: gelled silica> precipitated, fumed, and crystalline silica.
Executive summary:

Warshawsky et al. (1994) studied crystalline (Min-U-Sil), gelled, precipitated and fumed (pyrogenic, Cab-O-Sil® M-5) silicas with alveolar macrophages. The cytotoxicity of the silicas to hamster and rat alveolar macrophages (AM) in vitro was measured at 0.0-0.5 mg/10-6cells at 24 and 48 hours using dye exclusion procedures. The medium diameter for amorphous silica was <0.38 μm and for crystalline 0.83 μm. The surface areas for the amorphous silicas ranged from 235 to 125 m2/g (order: gelled > fumed > precipitated) and for crystalline silica 4.3 m2/g.

With gelled silica, the viability of the hamster alveolar macrophages decreased to 27% at 0.05 mg/ml and to zero at 0.1 mg/ml t 24 hours. At doses of 0.05 and 0.1 mg/ml of crystalline, precipitated or fumed silica, the percent viability decreased significantly to 76-67% and 51-42%, respectively, and to zero at 0.5 mg/ml. The count of macrophages viable at 24 hours decreased further at 48 hours compared with the control value. The order of toxicities was: gelled > precipitated, fumed, and crystalline.