Aluminium potassium bis(sulphate)

Acute Toxicity: oral

Administrative data

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)

Data source

Reference

Reference 1

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

Reference 2

Reference Type:

secondary source

Title:

TOXICOLOGICAL PROFILE FOR ALUMINUM

Author:

ATSDR

Year:

2008

Bibliographic source:

Agency for Toxic Substances and Disease Registry Division of Toxicology and Environmental Medicine/Applied Toxicology Branch 1600 Clifton Road NE Mailstop F-32 Atlanta, Georgia 30333, p. 51 - 61

Materials and methods

Test guideline

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

Test material

Test material information

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:

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

Results and discussion

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

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD0

Effect level:

2 other: %

Based on:

test mat.

Remarks:

Aluminium potassium bis(sulphate)*12H2O

Effect levels 2

Sex:

male/female

Dose descriptor:

LD0

Effect level:

3 000 mg/kg bw

Based on:

test mat.

Remarks:

AlK(SO4)2*12H2O

Effect levels 3

Sex:

male/female

Dose descriptor:

LD0

Effect level:

170 mg/kg bw

Based on:

dissolved

Remarks:

Aluminium from AlK(SO4)2*12H2O

Effect levels 4

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

Effect levels 5

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.

Applicant's summary and conclusion

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.