Chromate(2-), [2,4-dihydro-4-[(2-hydroxy-4-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulfonato(3-)]-, disodium

Acute Toxicity: oral

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:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Principles of method if other than guideline:

not applicable

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Chromate(2-), [2,4-dihydro-4-[(2-hydroxy-4-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulfonato(3-)]-, disodium

EC Number:

274-386-6

EC Name:

Chromate(2-), [2,4-dihydro-4-[(2-hydroxy-4-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulfonato(3-)]-, disodium

Cas Number:

70209-87-9

Molecular formula:

C32H21CrN10Na2O11S

IUPAC Name:

Disodium-[2,4-dihydro-4-[(2-hydroxy-4-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulfonato(3-)]-chromate(2-)

Test material form:

solid - liquid: suspension

Details on test material:

- Name of test material (as cited in study report): FAT 20060/B
- Analytical purity: Approx. 82 %

Test animals

Species:

rat

Strain:

other: Tif: RAIf (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

Healthy random bred animals raised on the premises of the testing laboratory were used for the study. They were kept at a room temperature of 22±1 °C, at a relative humidity of 55±5 % and on a 10 h light cycle day. They received ad libitum rat food - NAFAG, Gossau SG - and water. Prior to treatment the animals were adapted to our laboratories for a minimum of 4 d and the initial body weight ranged from 160 to 180 g. During the treatment and observation period the animals were housed in groups of 5 in Macrolon cages (type 3). Animals were fasted overnight before treatment.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Remarks:

(PEG 400)

Details on oral exposure:

The test substance was suspended with PEG 400. Before treatment the suspension was homogeneously dispersed with an Ultra-Turrax and during treatment it was kept stable with a magnetic stirrer. The concentrations of the test substance in the vehicle were 5, 10, 10, and 30 % which correspond to the dose levels of 600, 1000, 2150 and 4640 mg/kg bw respectively.

Doses:

600, 1000, 2150 and 4640 mg/kg bw

No. of animals per sex per dose:

5/sex/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 d
- Frequency of observations: Animals observed for mortality at 1, 24, and 48 h and weekly thereafter.
- Necropsy of survivors performed: Yes, animals were submitted at random to a necropsy whenever they died, survivors at the end of the observation period.
- Other examinations performed: clinical signs

Statistics:

LD50 including 95 % confidence limits were calculated by the logit model.

Results and discussion

Preliminary study:

not applicable

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 717 mg/kg bw

Based on:

test mat.

95% CL:

1 271 - 2 433

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 408 mg/kg bw

Based on:

act. ingr.

Mortality:

A dose dependent increase in the rate of mortality was observed. No mortality was noted at the lowest dose, 2 and 6 deaths were noted in the two subsequent intermediate dose levels respectively and the highest mortality of 10 animals was recorded at the highest dose level.

Clinical signs:

other: Within 2 h after treatment the animals in all dosage groups showed dyspnoea, curved position, diarrhoea and ruffled fur. With the exception of the animals in the lowest dose level, sedation was also observed. Diarrhoea became more accentuated as the dose

Gross pathology:

No test substance related gross organ changes were observed.

Other findings:

none

Any other information on results incl. tables

none

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The oral LD50 of the test substance was found to be 1717 (1271-2433) mg/kg bw (i.e. ca. 1408 mg a.i./kg bw)

Executive summary:

A study was conducted to evaluate the acute oral toxicity of the test substance (at ca. 82 % purity) following a method comparable to OECD Guideline 401. Four groups of fasted Tif: RAI rats (5/sex/dose) received the test substance at 0, 600, 1000, 2150 and 4640 mg/kg bw once by oral intubation. Animals were observed for mortality and clinical signs for a period of 14 d. At the end of this period, animals were sacrificed and autopsied. No mortality was noted at the lowest dose, 2/10 and 6/10 animals died in the two subsequent intermediate dose levels and mortality of 10/10 animals was recorded at the highest dose level. All the animals across dose groups showed sedation (except lowest dose level), dyspnoea, curved position, diarrhoea and ruffled fur within 2 h of test substance administration. Diarrhoea became more pronounced with increment in dose. The surviving animals recovered within 9 -12 d. Under the study conditions, the oral LD50 of the test substance was found to be 1717 (1271-2433) mg/kg bw (i.e. ca. 1408 mg a.i./kg bw).