Registration Dossier
Registration Dossier
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EC number: 947-741-4 | CAS number: -
Repeated dose toxicity: inhalation
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:
- 1 977
- 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 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:
- - 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%
Constituent 1
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
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