Reaction mass of Cobaltate(2-), [2-[[[4-hydroxy-3-[[2-oxo-1-[(phenylamino)carbonyl]propyl]azo]phenyl]sulfonyl]amino]benzoato(3-)][2-[[2-hydroxy-5-[(phenylamino)sulfonyl]phenyl]azo]-3-oxo-N-phenylbutanamidato(2-)]-, disodium and Cobaltate(3-), bis[2-[[[4-hydroxy-3-[[2-oxo-1-[(phenylamino)carbonyl]propyl]azo]phenyl]sulfonyl]amino]benzoato(3-)]-, trisodium and sodium bis[2-[[2-hydroxy-5-[(phenylamino)sulphonyl]phenyl]azo]-3-oxo-N-phenylbutyramidato(2-)]cobaltate(1-)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Remarks:

source of read across

Adequacy of study:

key study

Study period:

From September the 13th to October the 04th, 1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

adopted February 24, 1987

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Similar Substance 01

IUPAC Name:

Similar Substance 01

Test animals

Species:

rat

Strain:

Wistar

Remarks:

Hanlbm: WIST (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd. Wölferstrasse 4 4414 Füllinsdorf / Switzerland.
- Age at study initiation: males 8 weeks; females 10 weeks.
- Weight at study initiation: males: 189.2 - 209.6 g; females: 173.6 - 185.2 g
- Fasting period before study: overnight fasting period prior to application.
- Housing: groups of five in Makrol on type-4 cages with autoclaved standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz).
- Diet: a pelleted standard Kliba 343, Batch no. 65/95 rat maintenance diet ("Kuba", Klingentalmuehle AG, CH-4303 Kaiseraugst) available ad libitum.
- Water: community tap water from Füllinsdorf, available ad libitum.
- Acclimation period: one week under laboratory conditions, after health examination.

ENVIRONMENTAL CONDITIONS
- Temperature: 21-23 °C
- Humidity: 42-79 %
- Air changes: 10-15 air changes per hour
- Photoperiod: 12 hours artificial fluorescent light (approx. 100 Lux) / 12 hours dark (light period between 6.00 a.m. to 6.00 p.m.), music during the light period.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

- Volume dose:10 ml/kg
- Preparation of test article: the test article, previously reduced with a mortar was placed into a glass beaker on a tared Mettler PM 480 balance, and the vehicle (bi-distilled water) was added. Homogeneity of the test article in the vehicle was maintained during treatment using a magnetic stirrer. The preparation was made shortly before dosing.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 males and 5 females

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of mortality / viability recording: four times during test day 1 and daily during days 2-15.
- Frequency of observation: each animal was examined for changes in appearance and behaviour four times during day 1 and once daily during days 2-15. All abnormalities were recorded.
- Frequency of weighing: on test day 1 (pre-administration), 8 and 15.
- Necropsy of survivors performed: yes. At the end of the observation period all animals were anesthetized by intraperitoneal injection of NARCOREN at a dose of at least 2.0 ml/kg body weight (equivalent to at least 320 mg sodium pentobarbitone/kg body weight) and sacrificed by exsanguination. The animals were examined macroscopically.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

There were no deaths as a result of treatment with the test article.

Clinical signs:

Diarrhoea was observed in 2 males from test day 1 to 5 and in all females from test day 1 to 4. No other clinical signs were observed during the observation period.

Body weight:

The body weight of the animals was within the normal range for rats of this strain and age.

Gross pathology:

No organ abnormalities were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:

other: not classified, according to the CLP Regulation (EC) No 1272/2008

Conclusions:

LD50 (male and female) > 2000 mg/kg bw

Executive summary:

The acute toxicty of the substance by oral route was investigated in accordance with the OECD guideline 401. The test article was administered to a group of 5 male and 5 female rats by oral gavage, at a single dose of 2000 mg test article/kg body weight.  

There were no deaths as a result of treatment with the test article. Diarrhea was observed in 2 males from test day 1 to 5 and in all females from test day 1 to 4. No other clinical signs were observed during the observation period.  

The body weight of the animals was within the normal range for rats of this strain and age.  

No organ abnormalities were observed at necropsy.  

The mean lethal dose after single oral administration to rats of both sexes, observed over a period of 14 days, could not be estimated. Hence, the LD50 resulted to be greater than 2000 mg/kg.

Conclusion

LD50 (male and female) > 2000 mg/kg bw