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Toxicological information

Repeated dose toxicity: inhalation

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Administrative data

Endpoint:
short-term repeated dose toxicity: inhalation
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study meets generally accepted scientific principles

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Principles of method if other than guideline:
Repeated dose inhalation study with rats (no guideline mentioned)
GLP compliance:
no
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Sasil
- Chemical name: Zeolite, cuboidal, crystalline, synthetic, non-fibrous
- Framework: cuboidal
- Related CAS number: 1318-02-1
- Analytical purity: no data
- Lot/batch No.: F-325
- Molar ratio Na2O:Al2O:SiO2 = 1.02:1:1.95
- Mean diameter: 9.2 µm
- Water content: 20%

Test animals

Species:
rat
Strain:
Wistar
Sex:
male

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Analytical verification of doses or concentrations:
yes
Duration of treatment / exposure:
5 hours/day
Frequency of treatment:
3 times/week (Monday, Wednesday, Friday); 13 applications
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 20 mg SASIL/m³
Basis:

No. of animals per sex per dose:
25
Control animals:
yes
Details on study design:
25 male rats per control and treatment group each were assigned for determination of the silicon content of rat lungs exposed to the test substance (20 mg/m3) for 13 application days (Monday, Wednesdays, Friday; 5 h/days).

Results and discussion

Results of examinations

Body weight and weight changes:
no effects observed
Details on results:
Although a significant increase in silica content of the lungs occurred by the treatment (242 ppm vs. 142 ppm), no treatment-related toxic effects were noted. The weight gain of the animals was normal and no macroscopic changes were found on the inner organs.

Effect levels

Dose descriptor:
NOAEL
Effect level:
> 20 mg/m³ air
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: no treatment-related and adverse effects were noted

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion