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)

Endpoint summary

Description of key information

In an acute oral toxicity study in rats an oral LD50 of 5000 mg/kg bw was determined. (BASF, 1973)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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

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

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

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).

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.

Interpretation of results:

GHS criteria not met

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

Non GLP study. Meets generally accepted scientific standards.

Additional information

Acute oral toxicity

In a study according to internal standard procedures similar to OECD guideline 401, the acute oral toxicity of the test substance following a single oral administration in RAI rats was investigated (BASF, 1973). Groups of 10 fasted animals (5/sex/dose) were exposed to 3000, 4000, 5000, 7000, 8000, 9000 mg/kg bw of test substance diluted in carboxymethylcellulose (CMC) 0.5% and tap water. The animals were then observed for 8 days.

No mortality was observed in the lowest dosing group. 4/10, 5/10, 8/10 and 19/20 animals died at 4000, 5000, 7000 and 8000 mg/kg bw. All animals died in the highest dosing group. Observed clinical signs included sedation, brown stained extremities and feces, reduction of spontaneous motility, ataxia, ruffed fur and diarrhoea. No gross necropsy was performed.

A LD50 of 5000 ± 574 mg/kg bw was determined.

Justification for selection of acute toxicity – oral endpoint
Non GLP study. Meets generally accepted scientific standards.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available study is considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance does not need to be classified and labelled for acute oral toxicity under Directive 67/548/EEC, as amended for the 31st time in Directive 2009/2/EC.

 

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance does not need to be classified and labelled for acute oral toxicity under Regulation (EC) No 1272/2008, as amended for the sixth time in Regulation (EC) No 605/2014.