Cobaltate(1-), bis[2-(3-chlorophenyl)-2,4-dihydro-4-[[2-hydroxy-5-(methylsulfonyl)phenyl]azo]-5-methyl-3H-pyrazol-3-onato(2-)]-, hydrogen, compd. with [1R-(1α,4aβ,10aα)]-1,2,3,4,4a,9,10,10a-octahydro-1,4a-dimethyl-7-(1-methylethyl)-1-phenanthrenemethanamine (1:1)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

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:

1973

Report date:

1973

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

Observation period was only eight days long. No gross necropsy was performed.

GLP compliance:

no

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

Cobaltate(1-), bis[2-(3-chlorophenyl)-2,4-dihydro-4-[[2-hydroxy-5-(methylsulfonyl)phenyl]azo]-5-methyl-3H-pyrazol-3-onato(2-)]-, hydrogen, compd. with [1R-(1α,4aβ,10aα)]-1,2,3,4,4a,9,10,10a-octahydro-1,4a-dimethyl-7-(1-methylethyl)-1-phenanthrenemethanamine (1:1)

EC Number:

243-855-7

EC Name:

Cobaltate(1-), bis[2-(3-chlorophenyl)-2,4-dihydro-4-[[2-hydroxy-5-(methylsulfonyl)phenyl]azo]-5-methyl-3H-pyrazol-3-onato(2-)]-, hydrogen, compd. with [1R-(1α,4aβ,10aα)]-1,2,3,4,4a,9,10,10a-octahydro-1,4a-dimethyl-7-(1-methylethyl)-1-phenanthrenemethanamine (1:1)

Cas Number:

20506-24-5

Molecular formula:

C34 H26 Cl2 Co N8 O8 S2 . C20 H31 N . H

IUPAC Name:

(2Z,2'Z)-7,7'-bis(3-chlorophenyl)-15,15'-dimethanesulfonyl-5,5'-dimethyl-9,9',11,11'-tetraoxa-2,2',3,3',6,6',7,7'-octaaza-10-cobalta-10,10'-spirobi[tricyclo[10.4.0.0⁴,⁸]hexadecane]-1(12),1'(12'),2,2',4(8),4'(8'),5,5',13,13',15,15'-dodecaen-10-uide; [1,4a-dimethyl-7-(propan-2-yl)-1,2,3,4,4a,4b,8a,9,10,10a-decahydrophenanthren-1-yl]methanaminium

Test animals

Species:

rat

Strain:

other: RAI strain

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 115 - 145 g
- Fasting period before study: yes, fasted overnight
- Housing: groups of five animals per sex in macrolon cages (size 3)
- Diet: ad libitum, standard diet (NAFAG)
- Water: ad libitum, tap water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±1
- Humidity (%): 55±5:
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 15, 20, 25, 35, 40, 45 %

Doses:

3000, 4000, 5000, 7000, 8000, 9000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 8 days
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight

Statistics:

The LD50 was calculated by the method of Miller-Tainter (Proc. Soc. Exp. Biol. Med. 57, 261, 1944).

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: ±574 mg/kg bw (CL)

Mortality:

No mortality was observed in the lowest dosing group. 4/10 animals died in the 4000 mg/kg bw dosing group until study day 4. 5/10, 8/10 and 19/20 animals died at 5000, 7000 and 8000 mg/kg bw. All animals died in the highest dosing group.

Clinical signs:

other: In the two lowest dosing group sedation and brown stained extremities and feces was observed. Additionally reduction of spontaneous motility, ataxia, diarrhoea and ruffed fur was observed in the higher dosing groups.

Gross pathology:

No gross necropsy was performed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met