Reaction mass of sodium sulphate and trisodium trioxalatoferrate

Acute Toxicity: oral

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

Test material information

Constituent 1

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:

other: 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 i

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.