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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1998-05-27 to 1998-06-19
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
adopted March 22, 1996
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Version / remarks:
dated September 30, 1996
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Aluminium trilactate
EC Number:
242-670-9
EC Name:
Aluminium trilactate
Cas Number:
18917-91-4
Molecular formula:
C9H15AlO9
IUPAC Name:
Aluminium trilactate
Test material form:
solid: crystalline
Details on test material:
- Name of test material (as cited in study report): Aluminium-L-lactate

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Wistar outbred rat; CrI:(WI) WU BR
- Age at study initiation: 6-7 weeks
- Weight at study initiation: 122 - 143 g (females), 161 - 193 g (males)
- Fasting period before study: overnight. Approximately four houes after dosing, they had access to food again.
- Housing: maximum 5 animals per cage, stainless steel cages, fitted with wire screen floor and front
- Diet (e.g. ad libitum): standard laboratory rodent diet ad libitum(SDS Special Diets services, Whitham, England)
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 6 - 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%):47.5-86% (upper limit higher than 70% due to wet cleaning, occurred for max. 1 hour)
- Air changes (per hr): ca. 10
- Photoperiod (hrs dark / hrs light): 12 hours dark/ 12 hours light

IN-LIFE DATES: From: 27 May 1998 To: 19 June 1998

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg body weight.
- Justification for choice of vehicle: no data

MAXIMUM DOSE VOLUME APPLIED: The exact amount of the test substance to be dosed was calculated for each animal individually.

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: not given
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of weighing: day 0, 3, 7, 14
- Frequency of observations: All visible reactions to treatment were recorded, including type, severity, onset and duration. Observations were made within 1 hour and within 4 houes after dosing, and subsequently at least once daily throughout an observation period of 14 days.
- Necropsy of survivors performed: yes

Results and discussion

Preliminary study:
The study was started with treatment of three females with a 2000 mg/kg body weight dose level. Since all females survived the first days after treatment, it was decided to continue treatment with 3 males dosed with the 2000 mg/kg dose level.
Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks:
Aluminium-L-lactate
Remarks on result:
other: no animal died
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 183.4 mg/kg bw
Based on:
element
Remarks:
Al3+
Remarks on result:
other: no animal died
Mortality:
female 0/3 animals died
male 0/3 animals died
Clinical signs:
other: No abnormal clinical signs were observed.
Gross pathology:
Gross pathological examinations at 14 days p. a. (terminal necropsy) revealed no test substance dependent findings.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)
Conclusions:
Aluminium-L-lactate is practically nontoxic based on the oral LD50 (males/females) in rats of greater than 2000 mg/kg body weight (corresponding to 183.4 mg Al3+/kg bw).
Executive summary:

In an acute oral toxicity study (limit test, according to OECD guideline 423, adopted March 22, 1996), 3 male and 3 female Wistar rats were given a single oral dose of Aluminium-L-lactate in water of 2000 mg/kg bw (corresponding to 183.4 mg Al3+/kg bw, considering an amount of 9.17% Aluminium in Aluminium-L-lactate) and observed for 14 days.

No animal died in this study. No clinical signs or effects on body weight were observed. Gross pathological examinations at 14 days p.a. (terminal necropsy) revealed no test substance-dependent findings.

Oral LD50 Males and Females > 2000 mg/kg bw