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Acute Toxicity: oral

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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

Referenceopen allclose all

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 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

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 levelsopen allclose all
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.

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.