Reaction mass of Cobaltate(3-), bis[2-[[[3-[2-[1-[[(2-chlorophenyl)amino]carbonyl]-2-(oxo-κO)propyl]diazenyl-κN1]-4-(hydroxy-κO)phenyl]sulfonyl]amino]benzoato(3-)]-, sodium (1:3) and tetrasodium bis[2-[[[3-[[1-[(2-chloroanilino)carbonyl]-2-oxopropyl]azo]-4-hydroxyphenyl]sulphonyl]amino]benzoato(3-)]cobaltate(4-)

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:

1974

Report date:

1974

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:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of Trisodium bis[2-({[3-({1-[(2-chlorophenyl)amino]-3-(hydroxy-kO)-1-oxobut-2-en-2-yl}diazenyl-kN1)-4-(hydroxy-kO)phenyl]sulfonyl}amino)benzoato(3-)]cobaltate(3-) and Trisodium [2-({[3-({1-[(2-chlorophenyl)amino]-3-(hydroxy-kO)-1-oxobut-2-en-2-yl}diazenyl-kN1)-4-(hydroxy-kO)phenyl]sulfonyl}amino)benzoato(3-)][2-({[3-({1-[(2-chlorophenyl)amino]-3-(hydroxy-kO)-1-oxobut-2-en-2-yl}diazenyl-kN2)-4-(hydroxy-kO)phenyl]sulfonyl}amino)benzoato(3-)]cobaltate(3-)

EC Number:

941-792-6

Cas Number:

not given

Molecular formula:

C46H32Cl2CoN8O14S2.3Na

IUPAC Name:

Reaction mass of Trisodium bis[2-({[3-({1-[(2-chlorophenyl)amino]-3-(hydroxy-kO)-1-oxobut-2-en-2-yl}diazenyl-kN1)-4-(hydroxy-kO)phenyl]sulfonyl}amino)benzoato(3-)]cobaltate(3-) and Trisodium [2-({[3-({1-[(2-chlorophenyl)amino]-3-(hydroxy-kO)-1-oxobut-2-en-2-yl}diazenyl-kN1)-4-(hydroxy-kO)phenyl]sulfonyl}amino)benzoato(3-)][2-({[3-({1-[(2-chlorophenyl)amino]-3-(hydroxy-kO)-1-oxobut-2-en-2-yl}diazenyl-kN2)-4-(hydroxy-kO)phenyl]sulfonyl}amino)benzoato(3-)]cobaltate(3-)

Test material form:

solid

Specific details on test material used for the study:

Test Item: FAT 20049/A
Purity: approx. 89 %

Test animals

Species:

rat

Strain:

other: Tif. RAI

Sex:

male/female

Details on test animals or test system and environmental conditions:

The compound was tested on 40 Tif. RAI rats (20 males/20 females), Animals were bred under SPF conditions in the breeding unit of the testing laboratory. They were 6 to 7 weeks old and weighed 160 to 180 g. The males and females were segregated and housed in Macrolon cages (Type 3) in groups of 5 in a room kept at a constant temperature of 22±1 °C and a relative humidity of approximately 50 %. They received water and food (NAFAG, Gossau SG, rat food) ad libitum. The rats were starved during one night before starting dose administration.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

DOSAGE PREPARATION:
The test substance was weighed into an Erlenmeyer flask on a Mettler balance. It was suspended at 20 and 30 % with carboxymethylcellulose 2 % and administered by oral intubation. Before administration the suspension was homogeneously dispersed with an Ultra-Turrax and during administration it was kept stable with a magnetic stirrer.

Doses:

2150, 3590, 4640 and 6000 mg/kg bw

No. of animals per sex per dose:

Five/sex/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration (mortality and clinical signs): 14 d
- Necropsy: Yes; performed on dead and killed animals

Statistics:

The LD50 including the 95 % confidence limits were calculated by probit analysis method (Goulden A (1960), Methods of Statistical Analysis, John Wiley and Sons, 3rd printing, pages 404-408).

Results and discussion

Preliminary study:

not applicable

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

3 934 mg/kg bw

Based on:

test mat.

95% CL:

>= 3 542 - <= 4 368

Mortality:

A dose dependent increase in mortality was observed. No mortality was noted at the lowest dose, 3/10 and 8/10 animals died at the two subsequent intermediate dose levels respectively and all the animals (10/10) died at the highest dose level.

Clinical signs:

other: Within 2 h after treatment, all the animals irrespective of dosage groups showed sedation, dyspnoea, curved position and ruffled fur. Additionally, in the two highest dosage groups diarrhoea was observed. The surviving animals recovered within 8 to 9 d.

Gross pathology:

No substance related gross organ changes were seen.

Other findings:

none

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The oral LD50 of the test substance was found to be 3934 mg/kg bw in rats.

Executive summary:

A study was conducted to evaluate the acute oral toxicity of the test substance (at ca. 89 % purity) following a method comparable to OECD Guideline 401. Four groups of fasted Tif: RAI rats (5/sex/dose) received the test substance at 2150, 3590, 4640 and 6000 mg/kg bw once by oral gavage. All the animals were observed for mortality and clinical signs for an observation period of 14 d. A dose dependent increase in mortality was observed. No mortality was noted at the lowest dose, 3/10 and 8/10 animals died at the two subsequent intermediate dose levels respectively and all the animals died at the highest dose level. Within 2 hours of treatment, the rats in all groups showed sedation, dyspnoea, curved position and ruffled fur. Additionally, diarrhoea was observed in the two highest dose levels. The surviving animals recovered within 8 to 9 d. Macroscopic post-mortem changes were absent. Hence based on the findings of the study, the oral LD50 of the test substance was found to be 3934 mg/kg bw (i.e.ca. 3501 mg a.i./kg bw) in rats.