Cobaltate(3-), bis[4-[4-[[4-[4-[[5-(aminosulfonyl)-2-hydroxyphenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]phenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulfonato(3-)]-, trisodium

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

September/October, 1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

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:

not specified

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

Cobaltate(3-), bis[4-[4-[[4-[4-[[5-(aminosulfonyl)-2-hydroxyphenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]phenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulfonato(3-)]-, trisodium

EC Number:

278-140-9

EC Name:

Cobaltate(3-), bis[4-[4-[[4-[4-[[5-(aminosulfonyl)-2-hydroxyphenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]phenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulfonato(3-)]-, trisodium

Cas Number:

75214-72-1

Molecular formula:

C52H40CoN18Na3O16S4

IUPAC Name:

Cobaltate(3-), bis[4-[4-[[4-[4-[[5-(aminosulfonyl)-2-hydroxyphenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]phenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulfonato(3-)]-, trisodium

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River U.K. Limited, Margate, Kent, England
- Females: vergin
- Age at study initiation: approximately four to six weeks
- Weight at study initiation: from 73 to 93 g
- Housing: in groups in metal cages with wire mesh floors
- Diet (e.g. ad libitum): Access to a standard laboratory rodent diet prevented approximately 18 ± 2 h prior to and 4 h after dosing; the batch of diet used for the study was analysed for certain chemical and microbiological contaminants
- Water: ad libitum
- Acclimation period: for a minimum period of four days prior to the start of the study
- Identification: each animal at each dose level was identified by cage number and ear punching.

ENVIRONMENTAL CONDITIONS
- Temperature: 22-20 °C, recorded daily on a maximum and minimum thermometer
- Humidity: not controlled but remained at a mean of 48 % RH recorded daily on a wet and dry bulb hygrometer
- Air changes: approximately 15 air changes/h
- Lighting: controlled by means of a time switch to a 12 h light/dark cycle.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: aqueous methyl cellulose (1 %)

Details on oral exposure:

The test substance was prepared as a 40 w/v suspension in the vehicle and dosed at a volume not exceeding 37.5 ml/kg. The test sample was prepared freshly on the day of dosing.

Doses:

5 g/kg bw

No. of animals per sex per dose:

Main study:
- control group: 5 males and 5 females
- treatment group: 5 males and 5 females
Preliminary study:
- control group: 5 males and 5 females
- low-dose group: 5 males and 5 females
- high-dose group: 2 males and 2 females

Control animals:

yes

Remarks:

A vehicle control group of five male and five female rats was treated with aqueous methyl cellulose (1 %) at the same dose volume as the test group.

Details on study design:

TREATMENT PROCEDURE
Administration of test sample:
A rubber catheter was used. The concentration of test substance in the vehicle was the same for all dosage levels. The dosed volume was varied to achieve the necessary dosage levels. Control animals were dosed with aqueous methyl cellulose (1 %) at 12.5 ml/kg bw.

OBSERVATION
Animals were observed soon after dosing; then at hourly-intervals for the remainder of Day 1. On subsequent days the animals were observed once in the morning and once at the end of the experimental day (this was approximately 11.30 a.m. on Saturday and Sunday). Clinical signs were recorded at each observation.
The animals on both the preliminary and main studies were observed for 14 days after dosing.
The following were recorded:
- Approximate time of death of individual rats.
- The nature, severity, approximate time of onset and duration of each toxic sign.
- Individual bodyweights on Days 1, 8 and 15.

POST MORTEN EXAMINATION
Surviving animals were killed on Day 15. All animals that died during the study and those killed on Day 15 were subjected to a macroscopic post mortem examination. The macroscopic appearance of abnormal organs was recorded.

Results and discussion

Preliminary study:

Control group: 0 % mortality; 5 male and 5 female animals survived
Low-dose group: 0 % mortality; 5 male and 5 female animals survived
High-dose group: 100 % mortality; 2 male and 2 female animals died

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no mortalities.

Clinical signs:

Signs of reaction to treatment observed shortly after dosing in treated rats at 5 g/kg included pilo-erection and abnormal body carriage (hunched posture). These signs were accompanied by abnormal gait (waddling) in three males and three females, by diarrhoea in one male and two females and by lethargy in one male and three females.
Pilo-erection only was observed in the controls.
Recovery of all treated rats, as judged, by external appearance and behaviour, was apparently complete within seven days of dosing.

Body weight:

The bodyweight gains of male rats treated at 5 g/kg were very slightly depressed during the second week of observation compared to the controls. Bodyweight gains of female treated rats were normal throughout the two-week observation period compared to the controls.

Gross pathology:

Terminal autopsy findings were normal.

Applicant's summary and conclusion

Interpretation of results:

other: not classified according to CLP Regulation (EC) no. 1272/2008

Conclusions:

The LD50 (rat, oral) of the test item was found to be greater than 5000 mg/kg bw.

Executive summary:

The acute oral toxicity of the test item was evaluated in an experimental study according to an internal method, similar to the OECD Guideline 401. Based on the results of a preliminary study, five male and five female Sprague-Dawley rats were administered 5 g/kg bw in aqueous methyl cellulose (1 %) by oral gavage. A vehicle control group of five males and five females was treated with aqueous methyl cellulose. Clinical signs and mortality were recorded during an observation period of 14 days. Thereafter, all animals were subjected to a macroscopic examination.

No mortalities were observed in the treatment or control group. Terminal autopsy findings were normal. Clinical signs among treatment animals included pilo-erection and abnormal body carriage (hunched posture), accompanied by abnormal gait (waddling) in three males and three females, by diarrhoea in one male and two females and by lethargy in one male and three females. Pilo-erection only was observed in some control animals. All treated animals recovered within seven days of dosing. The median lethal dose (LD₅₀) of the test item to rats is therefore greater than 5000 mg/kg bw.