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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: inhalation

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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:
1994
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

Constituent 1
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.

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).