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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

additional toxicological information
Type of information:
other: commissions report on workplace and workers safety
Adequacy of study:
other information

Data source

Reference Type:
review article or handbook
Zeolithe, synthetisch, nicht faserförmig
MAK commission
Bibliographic source:
MAK, 56. Lieferung, 2014

Materials and methods

Test material

Constituent 1
Chemical structure
Reference substance name:
Zeolite, cuboidal, crystalline, synthetic, non-fibrous
EC Number:
Cas Number:
Molecular formula:
M2/nO • Al2O3 • ySiO2 • wH2O (n is the valency of the cation M, predominantly Na, y can range from 0.64 to 8.8, and w is the number of water molecules (general formula) Na: 1.34 - 24.02%, Al: 2.20 - 39.51%, Si: 15.52 - 68.64% (general composition); additionally, depending on the water quality: Ca, Mg and K might be present below 6%
Zeolite, cuboidal, crystalline, synthetic, non-fibrous
Test material form:
solid: particulate/powder
no surface treatment

Results and discussion

Any other information on results incl. tables

Zeolites are sparingly soluble dusts, which accordingly have general particle effects of granular bio-persistent dusts. They differ in the additional ability to take up and release ions (ion exchange ability) and the adsorption capacity. The natural zeolites contain quartz and heavy metals, which makes an evaluation of these zeolites very difficult.

MAK Value
There is no experience in humans. Two inadequately documented inhalation studies on rats with exposure for 11 weeks and 22 months respectively cannot be used to derive the MAK value because only one concentration was tested, the scope of the investigation was too small and information on the number of animals with effects is missing. No NOAEC can be derived from the 55-week inhalation study in monkeys, since alveolar macrophage accumulation and areas with non-purulent bronchiolitis and alveolitis in the lungs were observed at the lowest concentration of 1 mg Zeolite A / m3.

Carcinogenic Effect
The findings from the various long-term studies do not give any indications of a carcinogenic potential, but are not suitable for a final assessment due to study deficiencies or insufficient documentation. Zeolites are not genotoxic, so they have not been classified in any of the carcinogenicity categories.

Germ Cell Mutagenic Effect
In the available genotoxicity studies, neither gene mutations nor chromosomal aberrations or dominant lethal mutations were induced. The structure also does not give rise to a corresponding suspicion, so there has been no classification in a category for germ cell mutagens.

Developmental Toxicity
There is only one inadequately described study on developmental toxicity, in which no developmental or maternally toxic effects occurred in rats and rabbits up to the highest dose of 1600 mg / kg body weight and day. Since no MAK value could be derived, it has not been assigned to a pregnancy group. 

Sensitizing effect
There are no clinical findings on dermal sensitisation and only one negative result from a very incompletely documented experimental study in guinea pigs. There are also no data on the effects of respiratory sensitisation. Therefore, Zeolites have not been marked with either “Sh” or “Sa”.

Skin absorption
A dermal absorption of the synthetic zeolites is not known. Because of their poor solubility in water and their ionic character, it can be assumed that zeolites cannot penetrate the intact skin (Fruijtier-Pölloth 2009; Gloxhuber et al. 1983). The dermal LD50 in rabbits for zeolite A, 4A and Y is higher than 2000 mg / kg body weight. Synthetic zeolites have therefore not been marked with an “H”.


Applicant's summary and conclusion