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Description of key information

Based on the long-term key study from Oneda et al. the calculated LD50-mouse oral should be >  2000 mg/kg bw.
This result was used for classification of  the substance. 
Based on the oral NOAEL value of the key study the inhalative NOAEL  of the substance was calculated.
NOAEL inhalative calculated from NOAEL oral:
NOAEL inhalative = 13.05 mg/m³. 
The calculated LC50-inhalative should be > 5 mg/L (Limit CLP).
Based on the key study ( ATSDR report and publication of Lansdown) the calculated LD50-dermal 
of aluminium potassium bis sulphate from read across substance aluminium sulfate resulted in a 
calculated LD50-dermal of 100000 mg/kg bw aluminium potassium bis sulphate.
Based on all acute toxicity results aluminium potassium bis sulphate is not classified as acute toxic oral, inhalative and dermal according 
EU regulation 1272/2008 and EU regulation 286/2011 (2. ATP).

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1994
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: well documented study from Oneda et al according to EU Method B.33 (Combined Chronic Toxicity / Carcinogenicity Test),peer-reviewed report from ATSDR (2008)
Qualifier:
equivalent or similar to guideline
Guideline:
other: EU Method B.33 (Combined Chronic Toxicity / Carcinogenicity Test)
Deviations:
not specified
Principles of method if other than guideline:
In a preliminary study with male and female mice B6C3F1 5 week-diet was given in concentration of 2, 1, 0.2 and 0% Aluminium potassium bis(sulphate) for testing maximal dose of the substance.
GLP compliance:
not specified
Test type:
other: combined repeated dose and carcinogenicity
Limit test:
no
Species:
mouse
Strain:
B6C3F1
Sex:
male/female
Route of administration:
oral: feed
Vehicle:
other: basal diet
Doses:
Preliminary study: 5 weeks, daily dietConcentration: 2, 1, 0.2 and 0% (w/w)No deaths, no abnormalities in clinical signs, food consumption, body weight or pathological evaluations at any dose.Main study: 20 months, daily dietConcentrations: 10, 5, 2.5, 1 and 0 % (w/w)
No. of animals per sex per dose:
300 male, 300 female
Control animals:
yes
Preliminary study:
2, 1, 0.2 and 0% (w/w) AlK(SO4)2*12H2O = 3000, 1500, 300 and 0 mg aluminium potassium bis(sulphate) or 170, 85, 17 and 0 mg Al/kg bw
Sex:
male/female
Dose descriptor:
LD0
Effect level:
2 other: %
Based on:
test mat.
Remarks:
Aluminium potassium bis(sulphate)*12H2O
Sex:
male/female
Dose descriptor:
LD0
Effect level:
3 000 mg/kg bw
Based on:
test mat.
Remarks:
AlK(SO4)2*12H2O
Sex:
male/female
Dose descriptor:
LD0
Effect level:
170 mg/kg bw
Based on:
dissolved
Remarks:
Aluminium from AlK(SO4)2*12H2O
Sex:
male/female
Dose descriptor:
other: NOAEL
Effect level:
8 160 other: mg/kg bw/day
Based on:
other: calculated from 10 % Aluminium potassium bis sulphate in diet
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
other: calculated from oral NOAEL: based on relation LD50/NOAEL ca. 2.3
Remarks on result:
other: Calculation LD50 from oral NOAEL= 8160 mg/kg bw/day: according to ATSDR 2008 p. 51-61 relation LD50 oral/NOAEL oral ca. 2.26. Therefore based on NOAEL oral from study of Oneda et al. the calculated LD50 oral is LD50 = 8160x2.26 = 18442 mg/kg bw
Mortality:
No death
Clinical signs:
other: No abnormalities in clinical signs, food consumption, body weight or pathological evaluations.
Interpretation of results:
not classified
Remarks:
Migrated informationCriteria used for interpretation of results: EU
Conclusions:
LD0-5 weeks male/female Mice B6C3F1 = 2 % (w/w) as Aluminium potassium bis sulphate dodecahydrate in diet.LD0-5 weeks male/female mouse B6C3F1 = 3000 mg/kg bw Aluminium potassium bis sulphate dodecahydrate = LD0-5 weeks male/female mouse B6C3F1 = 1634 mg/kg bw Aluminium potassium bis sulphateCalculation of LD50 from NOAEL oral :Relation LD50 oral/NOAEL oral according to ATSDR 2008 ca. 2.26NOAEL oral - 20 months mouse B6C3F1 = 8160 mg/kg bw/day (see Key study Repeated dose toxicity oral)Calculated LD50 oral from NOAEL oral = 8160 x 2.26 = 18144 mg/kg bw Aluminium potassium bis sulphate.The calculated LD50 value should be LD50 > 2000 mg/kg bw (Limit acute oral toxicity GHS).Therefore the substance Aluminium potassium bis sulphate is not classified as acute oral toxic according to EU regulation 1272/2008 and EU regulation 286/2011 (2. ATP) under the test conditions.
Executive summary:

LD0-5 weeks male/female Mice B6C3F1 = 2 % (w/w) as Aluminium potassium bis sulphate dodecahydrate.

LD0-5 weeks male/female mouse B6C3F1 = 3000 mg/kg bw Aluminium potassium bis sulphate dodecahydrate =

LD0-5 weeks male/female mouse B6C3F1 = 1634 mg/kg bw Aluminium potassium bis sulphate.

Calculation of LD50 from NOAEL oral :

Relation LD50 oral/NOAEL oral according to ATSDR 2008 ca. 2.26

NOAEL oral - 20 months mouse B6C3F1 = 8160 mg/kg bw/day (see Key study Repeated dose toxicity oral).

Calculated LD50 oral from NOAEL oral = 8160 x 2.26 = 18144 mg/kg bw Aluminium potassium bis sulphate.

The calculated LD50 value should be LD50 > 2000 mg/kg bw (Limit acute oral toxicity GHS).

Therefore the substance Aluminium potassium bis sulphate is not classified as acute oral toxic according to EU regulation 1272/2008 and EU regulation 286/2011 (2. ATP) under the test conditions.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
8 160 mg/kg bw
Quality of whole database:
Based on the long-term key study from Oneda et al. the calculated LD50 oral from NOAEL oral= 8160 mg/kg bw/day should be > 2000 mg/kg bw Aluminium potassium bis sulphate.

Acute toxicity: via inhalation route

Link to relevant study records
Reference
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.
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
Species:
mouse
Strain:
B6C3F1
Sex:
male/female
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
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
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).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LC50
Value:
13.05 mg/m³ air
Quality of whole database:
Calculated from oral NOAEL-20 month mouse = 8160 mg/kg bw*d the LC50 inhalative should be > 5 mg/m³ Aluminium potassium bis sulphate.

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
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: peer-reviewed report
Qualifier:
equivalent or similar to guideline
Guideline:
EPA OPP 81-2 (Acute Dermal Toxicity)
Deviations:
not specified
GLP compliance:
not specified
Test type:
standard acute method
Species:
mouse
Strain:
other: Carworth TF1
Sex:
female
Type of coverage:
not specified
Vehicle:
not specified
Duration of exposure:
5d/ 1x/d
Control animals:
not specified
Sex:
female
Dose descriptor:
LD0
Effect level:
10 other: % (w/v)
Based on:
dissolved
Remarks:
Aluminium as Aluminium sulfate
Remarks on result:
other: LD0 = 10% (w/v) Aluminium as Aluminium sulfate
Mortality:
no mortality
Clinical signs:
other: no skin damage
Interpretation of results:
not classified
Remarks:
Migrated informationCriteria used for interpretation of results: EU
Conclusions:
NOAEL-5d/1x/d mouse TFI: 10% (w/v) = 100 g/L as Aluminium sulfateCalculated for KAl(SO4)2: NOAEL: 13.25 % (w/v) = 132.5 g/L as KAl(SO4)2.The estimated LD50 should be > 2000 mg/kg bw for Aluminium potassium bis sulphate.Therefore aluminium potassium bis sulphate is not classified according to EU Regulation 1272/2008and 286/2011 (2. ATP).
Executive summary:

NOAEL-5d/1x/d mouse TFI: 10% (w/v) = 100 g/L as Aluminium sulfate

Calculated for KAl(SO4)2:

NOAEL: 13.25 % (w/v) = 132.5 g/L as KAl(SO4)2.

The estimated LD50 should be > 2000 mg/kg bw for Aluminium potassium bis sulphate.

Therefore aluminium potassium bis sulphate is not classified according to EU Regulation 1272/2008

and 286/2011 (2. ATP).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
100 000 mg/kg bw
Quality of whole database:
Based on the key study the LD50 dermal is > 2000 mg/kg bw (Limit value GHS).

Additional information

Based on the long-term key study from Oneda et al. the calculated LD50-mouse oral should be > 2000 mg/kg bw.

This result was used for classification of the substance.

Based on the oral NOAEL of the key study the inhalative NOAEL of the substance was calculated.

Calculated NOAEL-inhalative: 13.05 mg/m³.

The corresponding LC50 -inhalative should be LC50 inhalative > 5 mg/L air (Limit CLP).

Based on the key study ( ATSDR report and publication of Lansdown) the calculated LD50-dermal

of aluminium potassium bis sulphate from read across substance aluminium sulfate resulted in an

calculated LD50-dermal of 100000 mg/kg bw aluminium potassium bis sulphate.

Based on all acute toxicity results aluminium potassium bis sulphate is not classified as acute oral, inhalative and dermal toxic

according EU regulation 1272/2008 and EU regulation 286/2011 (2. ATP).


Justification for selection of acute toxicity – oral endpoint
Well documented repeated dose study of aluminium potassium bis sulphate and peer-reviewed ATSDR
report. Calculation of LD50 oral from NOAEL oral.

Justification for selection of acute toxicity – inhalation endpoint
In the main study with male and female mice B6C3F1 5 week-diet was given in concentrations of 10, 5, 2.5, 1 and 0 % (w/w) in diet.
Exposure duration: 20 months, daily.
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: 1/7x2.5
Intra-species factor: 1/5 for workers
Inhalative absorption rate: 50%
Worker body weight: 70 kg
Inhalation volumen/8h: 10 m³ air
Calculation NOAEL-inhalative mouse: 8160/100/7x2.5/5x2x70/10 = 13.05 mg Aluminium potassium bis sulphate/m³ air.

Justification for selection of acute toxicity – dermal endpoint
Based on Key study the LD50 dermal is > 13.25% (m/v).
Calculated LD50: 100000 mg/kg bw

Justification for classification or non-classification

Based on the results of acute oral values and calculated long-term inhalative and acute dermal values

the substance aluminium potassium bis(sulphate) is not classified as acute oral, inhalative and dermal toxic

according CLP regulation EU 1272/2008 and EU regulation 286/2011 (2. ATP).