Trisodium bis[4-[4,5-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-3-methyl-5-oxo-1H-pyrazol-1-yl]benzene-1-sulphonato(3-)]ferrate(3-)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From July 14, 1981 to September 7, 1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

Acid Brown 098

IUPAC Name:

Acid Brown 098

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 100 - 180 g
- Fasting period before study: 18 hours after and 4 hours before administration of test item
- Diet: UAR D-04, ad libitum
- Water: deionised water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24 ± 1 °C
- Humidity (%): 65 ± 5 %
- Photoperiod (hrs dark / hrs light): 12 hour cycle dark/light

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: suspension 1% with CMC and 2% with water
- Amount of vehicle (if gavage): 40 ml/kg

Doses:

4000, 8000, 16000 mg/kg

No. of animals per sex per dose:

5 per sex per doses

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 16 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 4 800 mg/kg bw

Based on:

act. ingr.

Effect levels 3

Sex:

male/female

Dose descriptor:

LD0

Effect level:

ca. 4 000 mg/kg bw

Based on:

act. ingr.

Mortality:

For concentrations above 4000 mg/kg

Clinical signs:

No signs of toxicity

Gross pathology:

At highest dose one of the surviving rats presents the kidneys of pale colour

Applicant's summary and conclusion

Interpretation of results:

other: Not classified according to the CLP Regulation (EC n. 1272/2008)

Conclusions:

The substance shows a LD50 =16000 mg/kg b.w.

Executive summary:

The substance has been tested for acute toxicity by oral route according to a method similar to the one described by OECD Guideline 401; 30 Wistar rats are tested with the substance at concentration of 4000, 8000 and 16000 mg/kg by gavage, 10 animals per dose.

During the study the following rates of mortality were observed:

At the dose of 4000 mg/kg no mortality was observed and at the dose of 8000 mg/kg bw one rat were found dead. At the highest dose tested 5 rats died.

Results

LD50 = 16000 mg/kg bw