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Toxicological information

Specific investigations: other studies

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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

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980
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

Reference
Name:
Unnamed
Type:
Constituent
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%
- Chemical name: Zeolite, cuboidal, crystalline, synthetic, non-fibrous
- 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.

Applicant's summary and conclusion