Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Remarks:
Early study, but reporting the main relevant details, No GLP, short report

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report date:
1974

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Remarks:
pre-dates GLP
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of sodium sulphate and trisodium trioxalatoferrate
EC Number:
947-037-7
IUPAC Name:
Reaction mass of sodium sulphate and trisodium trioxalatoferrate

Test animals

Species:
rat
Strain:
other: CFY strain
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS

- Weight at study initiation: 100 -116 g
- Fasting period before study: overnight

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 30 %

MAXIMUM DOSE VOLUME APPLIED: 5,3 to 21,3 ml
Doses:
0 - 1,0 - 1,6 - 2,5 - 4 - 6,4 g /kg
No. of animals per sex per dose:
10
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
ca. 2 300 mg/kg bw
Based on:
test mat.
95% CL:
> 2 000 - < 2 700
Mortality:
Death occurred between 1 and 22 hours after treatment. The lowest fatal dose was 1000 mg/kg bw.
Clinical signs:
Signs of reaction to treatment, observed shortly after dosing, included lethargy, pilo-erection, slight diuresis and slight decrease in respiratory rate. Loss of righting was seen in rats treated at 5 and 6.4g/kg. Rats treated at 6.4 g/kg also showed an increase in salivation.
Body weight:
Body weight showed normal development.
Gross pathology:
Autopsy revealed haemorrohage of the stomach and darkening of the liver in deceased anmals only.

Any other information on results incl. tables

Dose (mg/kg)

Mean Body weight (g)

Mortality (x / n)

Time of death (h)

Dosing

1 week

2 weeks

0

104

177

238

0/10

-

1000

115

152

238

1/10

<20

1600

105

165

226

0/10

-

2500

104

168

232

7/10

<20

4000

101

died

-

10/10

<19

6400

104

died

-

10/10

<20

 

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute median lethal oral dose (LD 50) and its 95% confidence limits to rats of the test item were calculated to be:
2300 (2000 to 2700) mg/kg bodyweight.
Executive summary:

Male rats of the CFY strain in the weight range 100 to 116 g were starved overnight before treatment with the test item. The test material was prepared as a 30% aqueous solution and administered by oral intubation at varying dosage volumes in the test of 5.3 to 21.3 ml/kg bodyweight. Rats dosed with water alone (21.3 ml/kg) served as controls.

During the observation period of 14 days a record was kept of all mortalities and signs of toxicity. All rats that died were examined macroscopically in arn attempt to identify the target organs, and those animals surviving terminally were similarly examined to detect possible residual damage.

From the mortality data recorded the LD 50 and its 95% confidence limits were calculated by the method of Weil C.S. (1952), Biometrics 8, 249.

RESULTS

Signs of reaction to treatment, observed shortly after dosing, included lethargy, pilo-erection, slight diuresis and slight decrease in respiratory rate. Loss of righting was seen in rats lreated at 5 and 6.4 g/kg. Rats treated at 6.4 g/kg also showed an increase in salivation.

Death occurred between 1 and 22 hours after treatment. Autopsy revealed haemorrohage of the stomach and darkening of the liver.

Recovery of survivors as judged by external appearance and behaviour, was apparently complete within 3 days of treatment. Bodyweight increases were depressed during the first week of the observation period but were normal during the second week compared with controls. Autopsy findings were normal.

CONCLUSION

The acute median lethal oral dose (LD 50) and its 95% confidence limits to rats of the test item were calculated to be:

2300 (2000 to 2700) mg/kg bodyweight.