Aluminium ammonium bis(sulphate)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 2002-09-18 to 2003-03-20

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study performed according to the OECD Guideline No. 423 and in compliance with the GLP, information on the test substance available.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Aluminium ammonium bis(sulphate)

EC Number:

232-055-3

EC Name:

Aluminium ammonium bis(sulphate)

Cas Number:

7784-25-0

Molecular formula:

Al.H3N.2H2O4S

IUPAC Name:

aluminium ammonium bis(sulphate)

Details on test material:

- Name of test material (as cited in study report): Curb Powder, Aluminium ammonium sulfate

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Breeding Facility, jai Research Foundation, India
- Age at study initiation: 10 weeks old at the time of dosing
- Weight at study initiation: 188 to 202 g
- Fasting period before study: No data
- Housing: 3 animals per cage in polypropylene cages covered with stainless steel grid top. Autoclaved clean rice husk was used as the bedding material.
- Diet (e.g. ad libitum): ad libitum; rat pellet diet (Amrut brand) manufactured by Pranav Agro Industries Limited, Pune, Mahashtra, India
- Water (e.g. ad libitum): ad libitum in a polypropylene water bottle with a stainless steel nozzle. The drinking water was filtered through Aquagard water filter system.
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 to 25 °C
- Humidity (%): 67%
- Air changes (per hr): 18 air changes per hour
- Photoperiod (hrs dark / hrs light): 12h artificial light / 12 h darkness

IN-LIFE DATES: No data

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

distilled

Details on oral exposure:

VEHICLE
- Concentration in vehicle: no data
- Amount of vehicle (if gavage): a dose volume of 10mL/kg bw was calculated for each rat
- Justification for choice of vehicle: no data
- Lot/batch no. (if required): not required
- Purity: no data, distilled water

MAXIMUM DOSE VOLUME APPLIED: no data

DOSAGE PREPARATION (if unusual): not required

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6 female

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Deaths and overt signs of toxicity were recorded at 30 minutes, 1, 2, 3, 4 hours and once thereafter oral intubation on the day of dosing. Then, the animals were observed twice per day for the duration of the observation period. The animals were weighing prior the treatment (day 0) and on days 7 and 14 after the administration of the test substance.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight. At the end of 14 day observation period, a gross pathological examination was performed for all animals, consisting of an external examination and opening of abdominal and thoracic cavities.

Statistics:

No data

Results and discussion

Preliminary study:

No data

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

At the dose level of 2000 mg Aluminium ammonium sulfate / kg bw, no mortality was observed.

Clinical signs:

other: All animals were found normal after dosing and during the observation period.

Gross pathology:

External examination of the animals did not reveal any abnormality or lesion of pathological significance
Internal examination revealed lesions in lungs (consolidation / hepatisation) and uterus (hydrometra).
Above recorded lesions were spontaneous / incidental in nature and unrelated with test subtance administration.

Other findings:

No additional data

Any other information on results incl. tables

Table 7.2.1/2: Mean Body Weights

 

Dose (mg / kg bw)	Sex	Number of Animals	Mean Body Weights (g)			Mean Per cent Body Weight Change
			0 day	7 days	14 days	7 days	14 days
2000	Female	3	192±6	222± 6	238± 16	15.4± 0.4	23.6± 8.1
		3	196± 6	220± 20	233± 27	12.1± 27	18.9± 11.4

Values are mean± standard deviation

Table 7.2.1/3: External and Internal Examinations

Rat n°	External examination	Internal examination
1	NAD	Lungs : Partial hepatisation Uterus : Bilateral hydrometra (+)
2		NAD
3		NAD
4		Uterus : Hydrometra (+)
5		NAD
6		Lungs : Consolidation (++)

NAD: No Abnormalities Detected

(+): Mild

(++): Moderate

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the test conditions, aluminium ammonium sulfate is not classified according to the criteria of the Annex VI to the CLP Regulation and to the 67/548/EEC Directive.

Executive summary:

In an acute toxic class method study, Aluminium ammonium sulfate was administered by gavage to 6 female Wistar rats at a single dose of 2000 mg/kg bw. This study was performed in compliance with Good Laboratory Practices and according to OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method).

Deaths and overt signs of toxicity were recorded at 30 minutes, 1, 2, 3, 4 hours and once thereafter oral intubation on the day of dosing. Then, the animals were observed twice per day for the duration of the observation period. The animals were weighing prior the treatment (day 0) and on days 7 and 14 after the administration of the test substance.

At the end of 14 day observation period, a gross pathological examination was performed for all animals, consisting of an external examination and opening of abdominal and thoracic cavities.

At the dose level of 2000 mg Aluminium ammonium sulfate / kg bw, all animals were found normal after dosing and during the observation period. There was a normal increase in the body weight of all treated animals and no mortality was observed. The gross pathological examination revealed no anormality due to the test substance.

Therefore, the acute oral lethal dose (LD₅₀) of Aluminium ammonium sulfate is > 2000 mg / kg bw .

Under the test conditions, aluminium ammonium sulfate is not classified according to the criteria of the Annex VI to the Regulation N° 1272/2008 and to the 67/548/EC Directive.

This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.