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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:
accepted calculation method

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)
Deviations:
yes
Remarks:
Post exposure observation period only 7 days
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

Constituent 1
Chemical structure
Reference substance name:
Ammonium sulphate
EC Number:
231-984-1
EC Name:
Ammonium sulphate
Cas Number:
7783-20-2
Molecular formula:
H3N.1/2H2O4S
IUPAC Name:
Monochloramine generated from ammonium sulphate and a chlorine source
Test material form:
solid: crystalline

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 male and 1o females per group
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
Key result
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:
- 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-exposure observation days the animals were without clinical symptoms.
- 3200 mg/kg bw: No symptoms on the application day. The next day, reddened eyes and nose, and irregular breathing were noted. Later without clinical signs.
- 2500 mg/kg bw: No clinical signs noted.
Gross pathology:
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.

Applicant's summary and conclusion