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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
