reaction mass of: pentasodium bis[6-anilino-3,5'-disulfonatonaphthalene-2-azobenzene-1,2'-diolato]cobaltate(III);tetrasodium [6-anilino-3,5'-disulfonatonaphthalene-2-azobenzene-1,2'-diolato][6-anilino-5'-sulfamoyl-3-sulfonatonaphthalene-2-azobenzene-1,2'-diolato]cobaltate(III);trisodium bis[6-anilino-5'-sulfamoyl-3-sulfonatonaphthalene-2-azobenzene-1,2'-diolato]cobaltate(III)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

2001

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

444-290-0

EC Name:

-

Cas Number:

508202-43-5

Molecular formula:

Not applicable

IUPAC Name:

tricobalt(3+) dodecasodium tris(2-[2-(2-oxido-5-sulfamoylphenyl)diazen-1-yl]-6-(phenylamino)-3-sulfonatonaphthalen-1-olate) tris(2-[2-(2-oxido-5-sulfonatophenyl)diazen-1-yl]-6-(phenylamino)-3-sulfonatonaphthalen-1-olate)

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
-Source: RCC Ltd, Biotechnology and Animal Breeding Division CH-4414 Füllinsdorf / Switzerland
-Age at study initiation:
Males: 9 weeks
Females: 13 weeks
-Weight at study initiation:
♂ (235.9 - 249.5) g
♀ (178.1 - 188.7) g
-Housing: In groups of three per sex in Makrolon type-4 cages with wire mesh tops and standard softwood bedding (“Lignocer” Schill AG, CH-4132 Muttenz/Switzerland).
-Diet: Pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet, batch no. 34/02 and 57/02, ad libitum. The animals were fasted for 18 to 19 hours before the treatment.
-Water: Community tap water from Füllinsdorf, ad libitum.
-Acclimatization: under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.

ENVIRONMENTAL CONDITIONS
-Temperature: 22 ± 3 °C
-Humidity: 30-70 %
-Air changes: 10-15 air changes per hour
-Photoperiod: 12 hours cycle dark/light with fluorescent light
-other: music during the light period.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Remarks:

(PEG 300)

Details on oral exposure:

The dose formulations were made shortly before each dosing occasion using a magnetic stirrer.
The test item was weighed into a tared glass beaker on a suitable precision balance and the vehicle added (weight:volume). Homogeneity of the test item in the vehicle was maintained during adminlstration using a magnetic stirrer. The application volume was 10 ml/kg body weight.
-Justification for choice of vehicle: the vehicle was chosen after a non-GLP solubility trial which was performed before the study initiation date.

Doses:

2000 mg/kg b.w.

No. of animals per sex per dose:

3 per sex per dose

Control animals:

no

Details on study design:

-Duration of observation period following administration: 14 days
-Frequency of observations:
i) Mortality: daily during acclimatizatlon and twice daily during days 1-15
ii) Body weights: on test days 1 (prior to administration), 8 and 15.
iii) Clinical sígns: daily during acclimatizatlon and at approximately 1, 2, 3 and 5 hours after administration on test day 1. Once daily during days 2-15.
-Necropsy of survivors performed: yes
All animals were killed at the end of the observation period by an intraperitoneal Injection of Vetanarcol at a dose of al least 2.0 ml/kg body weight (equivalent to at least 324 mg sodium pentobarbitone/kg body weight) and discarded after macroscopic examinations were performed. No organs or tissues were retained.

Statistics:

No statistical analysis was used.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred during the study.

Clinical signs:

other: No clinical signs were observed during the course of the study.

Gross pathology:

No macroscopic findings were recorded at necropsy.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified according to the CLP Regulation (EC 1272/2008)

Conclusions:

The LD50 (rat)was found to be greater than 2000 mg/kg body weight.

Executive summary:

The substance was tested for acute administration by oral route according to the OECD guideline 423 and the EU method B.1 tris of theDirective 96/54/EEC. Three male and three femal Wistar rats were treated with test substance by oral gavage administration at a dosage of 2000 mg/kg body weight. The test item was diluted in vehicle (PEG 300) at a concentration of 0.2 g/ml and administered at a volume dosage of 10 ml/kg. The animals were examined daily during the acclimatization period and mortality, viability, body weghts and clinical signs were recorded during the observation period of 14 days. All animals were necropsied and examined macroscopically.

No deaths and no clinical signs were observed during the course of the study. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were recorded at necropsy.

The LD50 (rat, oral) was found to be greater than 2000 mg/kg body weight.