Reaction mass of ammonium sulphate and potassium sulfate and sodium sulphate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

no data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Post exposure observation period only 7 days, no further information on purity, limited documentation.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1969

Report date:

1969

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

BASF Test.
In principle, the methods described by OECD TG 401 were used.

GLP compliance:

no

Remarks:

pre-GLP study

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Ammonium sulphate

EC Number:

231-984-1

EC Name:

Ammonium sulphate

Cas Number:

7783-20-2

Molecular formula:

H8N2O4S

IUPAC Name:

diammonium sulfate

Details on test material:

- Name of test material (as cited in study report): ammonium sulfate
- Analytical purity: chemically pure
No further data

Test animals

Species:

rat

Strain:

other: Gassner

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Gassner
- Weight at study initiation: mean weights: 131-148 g

ENVIRONMENTAL CONDITIONS: no data
No further data

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 30%

Doses:

2500, 3200, 4000, 5000, 6400 mg/kg bw

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 7 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, gross pathology

Statistics:

The LD50 was calculated according to the method described by Litchfield-Wilcoxon.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

4 250 mg/kg bw

95% CL:

3 788 - 4 769

Mortality:

Mortality and time of death(s) per dose group:
- 6400 mg/kg bw: 12 died within the first hour, 2 within 24 hours, 4 within 48 hours; in total, 18/20 died within 7 days.
- 5000 mg/kg bw: 8 died within the first hour, 1 within 24 hours, 1 within 48 hours; in total 11/20 died within 7 days.
- 4000 mg/kg bw: 7 died within 24 hours, and 2 within 48 hours; in total, 9/20 died within 7 days.
- 3200 mg/kg bw: 1 animal died within the first hour, 1 within 24 hours, 2 within 48 hours; in total, 4/20 died within 7 days.
- 2500 mg/kg bw: no deaths occurred.

Clinical signs:

other: - 4000-6400 mg/kg bw: immediately after application staggering, abdominal and lateral position, partly dorsal position, apathy, laboured and irregular breathing. On the next day, secretion out of eyes and mouth, reddened eyes and nose. In the post-exposur

Gross pathology:

At necropsy, fluid in the thoracic cavity was observed in some animals. In three animals, the stomach was filled with liquid, and bloody mouth and forelegs were noted. No pathological findings were noted.

Applicant's summary and conclusion

Executive summary:

In an acute oral toxicity study, a 30% aqueous solution of the test substance was administered by gavage. Groups of 10 rats/sex received doses of 6400, 5000, 4000, 3200, and 2500 mg/kg bw and were observed for 7 days.

Mortality was 18/20, 101/20, 9/20, 4/20, and 0/20 in the groups given 6400, 5000, 4000, 3200, and 2500 mg/kg bw, respectively. All deaths occurred within 48 hours after dosing. Clinical signs of toxicity were observed in all but the lowest dose group and comprised staggering, abdominal/lateral/dorsal position, apathy, laboured/irregular breathing, secretion out of the eyes and mouth, redness of the eyes and nose. All surviving animals were normal by day 2 post dose. At necropsy, fluid in the thoracic cavity was observed in a few animals. In three animals, the stomach was filled with liquid, and bloody mouth and forelegs were noted. No pathological findings were noted with regard to the inner organs.

The LD50 was 4250 (3788 - 4769) mg/kg bw.