Sodium bis[N-(2-chlorophenyl)-2-[[2-hydroxy-5-(N-methylsulphamoyl)phenyl]azo]-3-oxobutyramidato(2-)]cobaltate(1-)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

20 September 1995 - 26 October 1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

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)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sodium bis[N-(2-chlorophenyl)-2-[[2-hydroxy-5-(N-methylsulphamoyl)phenyl]azo]-3-oxobutyramidato(2-)]cobaltate(1-)

EC Number:

274-503-0

EC Name:

Sodium bis[N-(2-chlorophenyl)-2-[[2-hydroxy-5-(N-methylsulphamoyl)phenyl]azo]-3-oxobutyramidato(2-)]cobaltate(1-)

Cas Number:

70247-74-4

Molecular formula:

C34H30Cl2CoN8O10S2.Na

IUPAC Name:

sodium bis[N-(2-chlorophenyl)-2-[[2-hydroxy-5-(N-methylsulphamoyl)phenyl]azo]-3-oxobutyramidato(2-)]cobaltate(1-)

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

None

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material:
9
- Expiration date of the lot/batch:
June 2000

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
In the original container at room temperature away from direct sunlight.
- Stability under test conditions:
Stable under stated storage condition;
expiration date: JUN-2000
- Stability of the test substance in the solvent/dispersant/vehicle/test medium:
Unknown in bi-distilled water, therefore is excluded from the statement of compliance.

Test animals

Species:

rat

Strain:

Wistar

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
- Housing:Groups of five in Makrol on type-4 cages with autoclaved standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz).
- Diet:Pelleted standard Kliba 343, Batch no. 65/95 rat maintenance diet ("Kuba", Klingentalmuehle AG, CH-4303 Kaiseraugst) available ad libitum (except for the overnight fasting period prior to dosing). Results of analyses for contaminants are included in the report.
- Water: Community tap water from Füllinsdorf, available ad libitum. Results of bacteriological, chemical and contaminant analyses are included in the report.
- Acclimation period: One week under laboratory conditions, after health examination.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23
- Humidity (%): 42-79
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light):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.

In-life phase: 20-SEP-1995 to 04-0CT-1995

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

bi-distilled water

Details on oral exposure:

VEHICLE
- Concentration in vehicle:10 ml/kg

Doses:

2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, mortality

Statistics:

The LOGIT-Model could not be used as no deaths occurred.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

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

Clinical signs:

other: 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.

Gross pathology:

No organ abnormalities were observed at necropsy.

Other findings:

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The median lethal dose (LD50) of FAT 20035/D in Wistar rats of both sexes is greater than 2000 mg/kg body weight.

Executive summary:

The test article FAT 20035/D was administered to a group of 5 male and 5 female Wistar rats by oral gavage, at a single dose of 2000 mg test article/kg body weight according to OECD guideline 401 and EU method B.1. Based on the study results, 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. So, the mean lethal dose (LD50) of FAT 20035/D after single oral administration to Wistar rats of both sexes, observed over a period of 14 days, is greater than 2000 mg/kg.