Zeolite, silica rich, crystalline, synthetic, non-fibrous

Specific investigations: other studies

Administrative data

Endpoint:

specific investigations: other studies

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

other information

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given, scientifically acceptable, special study design for evaluation of silicogeneous properties. No negative control.

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Reference 2

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Reference 3

Reference Type:

publication

Title:

Zeolite A - a phosphate substitute for detergents: toxicological investigation

Author:

Gloxhuber C, Potokar M, Pittermann W, Wallat S, Bartnik F, Reuter H and Braig S

Year:

1983

Bibliographic source:

Fd. Chem. Toxic. 21 (2), 209-220

Materials and methods

Principles of method if other than guideline:

special designed study

GLP compliance:

no

Type of method:

in vivo

Test material

Test material information

Constituent 1

Reference substance name:

Automatically generated during migration to IUCLID 6, no data available

IUPAC Name:

Automatically generated during migration to IUCLID 6, no data available

Details on test material:

- Zeolite A
- Batch F 197
- Molar ratio Na2O:Al2O:SiO2 = 1.02:1:1.93
- Mean diameter: 9.3 µm
- Water content: 22%
- Framework: cuboidal
- Related CAS number. 1318-02-1

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Administration / exposure

Route of administration:

intraperitoneal

Details on exposure:

A comparative study was performed to evaluate the dose-effect after single i.p. administration. Test substances: Quartz DQ 12 as positive control, Tower powder (incomplete detergent formulation containing 17.8% SASIL) and SASIL (pure), suspended in 0.5 ml Tyrode`s solution. Animals received restricted food amounts of 20 g/animal/day.

Frequency of treatment:

single administration

Post exposure period:

observation period: 3, 6 or 11 months

Doses / concentrations

Remarks:

Doses / Concentrations:
1, 2.5, 5, 10 or 50 mg SASIL/animal
Basis:

No. of animals per sex per dose:

20

Examinations

Examinations:

Animals were necropsied and macroscopical and histopathological examined after 3, 6 or 11 months. Animals were killed in batches of 5 (3 and 6 months) or 10 animals (11 months) from each group (20 male rats/group) and organs were examined microscopically.

Positive control:

Quartz DQ 12 as positive control

Results and discussion

Details on results:

negative
Mortality rate was low in the Sasil treated group in which 2 animals died after 11 months. Four rats died in the quartz treated group and 8 rats were dead in the tower powder treated group at study term. Sasil treatment revealed at all dose level an increase in absolute organ weight when compared to Quartz DQ 12. Sasil application led to an aseptic superficial inflammation of abdominal organs, to deposits of the administered material in the regional lymph nodes, the abdominal cavity and the mediastinum without fibrogeneous and/or silicogeneous tendencies. At study term deposition seemed in many rats to be reversible with exception of the highest dose level. Administration of Zeolite A as a tower powder induced fewer deposits on the capsule of the liver, spleen and kidney than did the pure form. At all doses the administration of quartz led to the formation of quartz typical areas within the abdomen.