Reaction mass of sodium sulphate and trisodium trioxalatoferrate

Endpoint summary

Description of key information

The oral LD50 in rats was found to be 2300 mg/kg bw after gavage administration. The dermal LD50 in rats was found to be greater than 5000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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

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

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

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

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.

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

 

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 300 mg/kg bw

Quality of whole database:

reliable with restrictions

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size

other:

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

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

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

no

Remarks:

pre-dates GLP

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

other: CFY strain

Sex:

male

Details on test animals or test system and environmental conditions:

no data

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: dorso-lumbar region
- Type of wrap if used: Al foil + waterproof plaster

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm (40-50°C} dilute soap solution
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume): 6,7 mL/kg
- Concentration: 75 % suspension
- Constant volume or concentration used: yes
- For solids, paste formed: yes

Duration of exposure:

24 h

Doses:

5 000 mg/kg bw

No. of animals per sex per dose:

10

Control animals:

yes, concurrent vehicle

Key result

Sex:

male

Dose descriptor:

LD0

Effect level:

>= 5 000 mg/kg bw

Mortality:

None

Clinical signs:

other: shortly after dosing slight lethargy. One rat showed slight erythema on the fourth day of treatment only. This rat and another were observed to have small, raised, brown nodules on areas on the treated sites on the day after treatment only

Gross pathology:

Autopsy findings were normal

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute median lethal percutaneous dose (LD 50 ) to male rats of the test item was found to be: greater than 5000 mg/kg bodyweight.

Executive summary:

Ten male rats were treated with The test item at a dosage level of 5 g/kg bodyweight.

There were no mortalities. Signs of reaction to treatment, observed shortly after dosing, consisted of slight lethargy only, which persisted for three days. One rat showed slight erythema on the fourth day of treatment only. This rat and another were observed to have small, raised, brown nodules on areas on the treated sites on the day after treatment only. Bodyweight increases were normal compared with the controls. Autopsy findings were normal.

CONCLUSION: The acute median lethal percutaneous dose (LD 50 ) to male rats of gold 4 N was found to be: greater than 5000 mg/kg bodyweight.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

reliable with restrictions

Justification for classification or non-classification

No classification

The oral LD50 in rats was found to be 2300mg/kg bw after gavage administration. The dermal LD50 in rats was found to be greater than 5000 mg/kg bw.