Registration Dossier
Registration Dossier
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EC number: 233-141-3 | CAS number: 10043-67-1
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- calculation (if not (Q)SAR)
- Remarks:
- Migrated phrase: estimated by calculation
- Adequacy of study:
- key study
- Study period:
- 2012
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Calculated from long-term oral key study from Oneda et al.
Data source
Reference
- Reference Type:
- publication
- Title:
- Chronic toxicity and tumorigenicity study of aluminum potassium sulfate in B6C3F1 mice
- Author:
- Oneda S, Takasaki T, Kurowaki K, et al.
- Year:
- 1 994
- Bibliographic source:
- In Vivo 8(3):271-278
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other:
- Deviations:
- not specified
- Principles of method if other than guideline:
- In the main study with male and female mice B6C3F1 5 week-diet was given in concentration of 10, 5, 2.5, 1 and 0 % (w/w) in diet.Exposure duration: 20 months, daily diet.Effects: No deaths, no abnormalities in clinical signs, food consumption, body weight or pathological evaluations at any dose.Calculation from repeated dose oral NOAEL-20 months for mouse = 8160 mg Aluminium potassium bis sulphate/kg bw*d.Oral absorption rate: 1%Inter-species factor: 1/7x2.5Intra-species factor: 1/5 for workersInhalative absorption rate: 50%Worker body weight: 70 kgInhalation volumen/8h: 10 m³ airCalculation NOAEL-inhalative mouse: 8160/100/7x2.5/5x2x70/10 = 13.05 mg Aluminium potassium bis sulphate/m³ air.
- GLP compliance:
- not specified
- Test type:
- fixed concentration procedure
- Limit test:
- yes
Test material
- Reference substance name:
- AlK(SO4)2*12H2O
- IUPAC Name:
- AlK(SO4)2*12H2O
- Details on test material:
- Aluminium potassium bis(sulphate) as dodecahydrateLot No. M5P2968 from Nacalai Tesque Co. Ltd, Kyoto.
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- male/female
Administration / exposure
- Route of administration:
- other: calculation from oral NOAEL
- Type of inhalation exposure:
- other: calculation from oral NOAEL
- Vehicle:
- other: calculation from oral NOAEL
- Details on inhalation exposure:
- Calculation from oral NOAEL
- Analytical verification of test atmosphere concentrations:
- no
- Remarks:
- calculation from oral NOAEL
- Duration of exposure:
- 600 d
- Concentrations:
- Administration of aluminium potassium sulphate (APS) to B6C3F1 mice (60 males and 60 females per group) at levels of 0, 1,2.5, 5 or 10% in the diet for 20 months (equivalent to 1500, 3750, 7500 or 15000 mg/kgbw/day of aluminium potassium sulphate and 85, 213, 427 or 853 mg Al/kg bw/day).
- No. of animals per sex per dose:
- 300 male, 300 female
- Control animals:
- yes
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- other: NOAEL
- Effect level:
- 13.05 mg/m³ air
- Based on:
- other: test material: Calculation from oral NOAEL-mouse
- Exp. duration:
- 600 d
- Remarks on result:
- other: calculation from oral NOAEL-600d mouse
- Mortality:
- No death
- Clinical signs:
- other: No abnormalities in clinical signs, food consumption, body weight or pathological evaluations
- Body weight:
- no effects
- Gross pathology:
- no effects
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated informationCriteria used for interpretation of results: EU
- Conclusions:
- Calculation based on long-term oral key study of aluminium potassium bis sulphate from Oneda et al. resulted in an NOAEL inhalative -20 month mouse of NOAEL inhalative= 13.05 mg Aluminium potassium bis sulphate/m³ air.The resulting LC50 inhalative should be > 5 mg/L air (Limit GHS).Therefore the substance is not classified according to EU regulation 1272/2008 and EU regulation286/2011 (2. ATP).
- Executive summary:
Calculation based on long-term oral key study of aluminium potassium bis sulphate from Oneda et al.
resulted in an NOAEL inhalative -20 month mouse of NOAEL inhalative = 13.05 mg Aluminium potassium bis sulphate/m³ air.
The resulting LC50 inhalative should be > 5 mg/L air (Limit GHS).
Therefore the substance is not classified according to EU regulation 1272/2008 and EU regulation
286/2011 (2. ATP).
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