Aluminium sulphate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

No data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Only raw data were reported, details on test materials are missing. Guideline 401 is followed with deviations.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

No data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Only raw data were reported, details on test materials are missing. Guideline 402 is followed with deviations.

Reason / purpose for cross-reference:

reference to same study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

: only 2 males and 2 females tested

Principles of method if other than guideline:

Not applicable.

GLP compliance:

no

Remarks:

pre-GLP

Test type:

standard acute method

Limit test:

yes

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

No data

Type of coverage:

not specified

Vehicle:

not specified

Details on dermal exposure:

No data

Duration of exposure:

24 hours

Doses:

5000 mg/kg

No. of animals per sex per dose:

2 males and 2 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations: daily; weighing: at start and end of the test
- Necropsy of survivors performed: yes

Statistics:

No data

Preliminary study:

Not applicable.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred following treatment and during the observation period at the 5000 mg/kg dosage level.

Clinical signs:

other: Clinical observation data at the 5000 mg/kg dosage: - Males: mild/moderate erythema. Both appear normal 2 days after treatment. - Females: moderate and severe erythema, small areas of haemorrhaging in places where large chunks of compound were pressed int

Gross pathology:

Animals autopsied in the 5000 mg/kg group showed no gross abnormalities, with the exception of 1 male animal which had pale lungs.

Other findings:

See Table below (Table 7.2.3/1)

Table 7.2.3/1: results on deaths, clinical and necropsy observations:

Date	Sex	Dose (mg/kg)	# deaths	Total # animals	Clinical observations	Necropsy observations
15July1976	M	5000	0	2	After unwrapping: - Mild/moderate erythema Day 2: - Appear normal	One animal with pale lungs, other animal showed no gross abnormalities
15July1976	F	5000	0	2	Day 1: - Moderate and severe erythema - Small areas of haemorrhaging in places where large chunks of compound were pressed into the skin Day 2: - Appear normal	No gross abnormalities

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions of this study, the Single Dose Acute Dermal LD50 of Aluminum Sulfate, Hydrate applied to the skin for 24 hours, is greater than 5000 mg/kg bw. Therefore the test material was not classified according to Regulation EC No.1272/2008 (CLP) and to the GHS.

Executive summary:

In an acute dermal toxicity study performed with some equivalence to OECD Guideline 402 but not in compliance with GLP, groups (2/sex/dose) of New Zealand White rabbits were tested with a single dermal application of Aluminum Sulfate, Hydrate at 5000 mg/kg bw for 24 hours. Animals were then observed for mortality, clinical signs for 14 days and were all sacrificed for macroscopic examination.

No mortality occurred. All rabbits exhibited normal appearance and behaviour on day 2. However, some skin irritation such as erythema and haemorrhaging were observed.The gross necropsy showed no significant gross changes, with the exception of 1 male animal which had pale lungs.

The Single Dose Acute Dermal LD50 of Aluminum Sulfate, Hydrate applied to the skin for 24 hours, is greater than 5000 mg/kg bw. Therefore the registered substance was not classified according to the Annex VI of the Regulation EC No.1272/2008 (CLP) and to the GHS.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

: not always a 14 day observation period.

Principles of method if other than guideline:

Not applicable.

GLP compliance:

no

Remarks:

pre-GLP

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Reference substance 006

Cas Number:

17927-65-0

Molecular formula:

Al2 (SO4)3, x H2O

Test material form:

not specified

Details on test material:

- Name of test material (as cited in study report): Aluminum Sulfate, Hydrate
- the sample was received on July 10, 1975

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

No data

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

other: water or Tween 80 with water

Details on oral exposure:

No data

Doses:

- 2000 mg/kg
- 5000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days (not always a 14 day observation period.)
- Frequency of observations and weighing: observations: daily
- Necropsy of survivors performed: yes

Statistics:

No data

Results and discussion

Preliminary study:

Not relevant

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 - < 5 000 mg/kg bw

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

< 5 000 mg/kg bw

Mortality:

- No animals died following treatment or during the observation period at the 2000 mg/kg dosage.
- All animals died during the observation period at the 5000 mg/kg dosage. Deaths occurred on the first or second day.

Clinical signs:

other: - All rats generally exhibited normal appearance and behaviour following treatment and during the observation period at the 2000 mg/kg dosage. - Clinical observation data at the 5000 mg/kg dosage: The most frequently observed changes included depression,

Gross pathology:

- Animals in the 2000 mg/kg group with water as a vehicle showed no gross abnormalities.
- The observed changes of the gross necropsies performed on animals which died during the observation period included very red lung edges and swollen stomach.

Other findings:

See table below (Table 7.2.1/1)

Any other information on results incl. tables

Table 7.2.1/1: Results on deaths, clinical and necropsy observations:

Date	Sex	Dose (mg/kg)	Vehicle	# deaths	Total # animals	Clinical observations	Necropsy observations
8July1976	M	5000	Tween 80 + H2O	5	5	Day 1: - Restless - Ruffled fur - Lying in one place - Occasionally readjust positions - React to touch + sound Day 2: - Remaining rat sits in one place, wobbling slightly - Head rests on floor - Eyes sunken + glossy - Fur ruffled	Day 2: - Lung edges very red - Stomach swollen; content reddish - Yellow liquid filled mouth during necropsy
18June1976	F	2000	Tween 80 + H2O	0	5	Appear normal
13July1976	F	5000	Tween 80 + H2O	5	5	Day 1: - Mild to severe depression - Slower reacting to sound + touch - Ruffled fur - Walking uncoordinated - Eyes partially closed - Huddled in a pile - Mild lacrimation - 1 animal died Day 2: - Other animals died
03August1976	F	2000	H2O	0	5	Appear normal	No gross abnormalities

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

Under the test conditions of this study, the acute oral median lethal dose to rats of Aluminum sulphate, hydrate was found to be greater than 2000 mg/kg body weight and less than 5000 mg/kg bw. Based on these results, the registered substance is not classified according to the Regulation (EC) N° 1272-2008 (CLP) and classified in classified in category 5 according to the GHS.

Executive summary:

In an acute oral toxicity study performed with some equivalence to OECD Guideline 401 but not in compliance with GLP, groups (5/sex/dose) of Sprague Dawley rats were given Aluminum sulphate, hydrate at 2000 mg/kg in water or in Tween 80/water to females and 5000 mg/kg in Tween 80/water to males and females.

Animals were then observed for mortality, clinical signs for 14 days in most cases and were all sacrificed for macroscopic examination.

No mortality occurred in all ten females dosed at the 2000 mg/kg level. No clinical changes were observed generally at this dose level. All ten animals at 5000 mg/kg bw died with deaths occurring on the first or second day. Clinical signs of toxicity included depression and ruffled fur. Necropsy findings showed very red lung edges and/or swollen stomach.

 

The acute oral LD50 for Aluminum sulphate, hydrate was found to be greater than 2000 mg/kg bodyweight and less than 5000 mg/kg bw for females. For males the LD50 is less than 5000 mg/kg. Based on these results, the registered substance was not classified according to the Regulation (EC) N° 1272-2008 (CLP) and classified in category 5 according to the GHS.