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Toxicological information

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:
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 401 is followed with deviations.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

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:
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

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): Aluminum Sulfate, Hydrate
- Physical state: not mentioned
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: no data
- Lot/batch No.: no data; the sample was received on July 10, 1975
- Stability under test conditions: no data
- Storage condition of test material: no data

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals 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 levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 - < 5 000 mg/kg bw
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:
- 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, ruffled fur and nearly closed eyes or glossy eyes.
Body weight:
No data
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:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
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 EU criteria.
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 the Directive 67/548/EEC criteria.