Reaction mass of Cobaltate(1-), bis[6-(amino-κN)-5-[2-[2-(hydroxy-κO)-4-nitrophenyl]diazenyl-κN1]-N-methyl-2-naphthalenesulfonamidato(2-)]-, sodium (1:1) and disodium [6-amino-5-[(2-hydroxy-4-nitrophenyl)azo]-N-methylnaphthalene-2-sulphonamidato(2-)][6-amino-5-[(2-hydroxy-4-nitrophenyl)azo]naphthalene-2-sulphonato(3-)]cobaltate(2-)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 14 April 1994 to 28 April 1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

The minimum relative humidity in the animal room during the week beginning 18-April 1994 was 36% and The minimum relative humidity in the animal room during the week beginning 25- APR-1994 was 39%.

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: Directive 92/69/EEC, B.l. "Acute Toxicity-Oral", July 31, 1992

Deviations:

yes

Remarks:

The minimum relative humidity in the animal room during the week beginning 18-April 1994 was 36% and The minimum relative humidity in the animal room during the week beginning 25- APR-1994 was 39%.

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: U. S. Environmental Protection Agency, Code of Federal Regulations 40, Part 798, Health Effects Testing Guidelines, Subpart B - General Toxicity Testing, Section 798.1175 "Acute Oral Toxicity"; Revised as of July 01, 1992

Deviations:

yes

Remarks:

The minimum relative humidity in the animal room during the week beginning 18-April 1994 was 36% and The minimum relative humidity in the animal room during the week beginning 25- APR-1994 was 39%.

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: Testing Methods for New Chemical Substances according to the Revised Japanese Chemical Substance Law (March 31, 1987).

Deviations:

yes

Remarks:

The minimum relative humidity in the animal room during the week beginning 18-April 1994 was 36% and The minimum relative humidity in the animal room during the week beginning 25- APR-1994 was 39%.

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of Cobaltate(1-), bis[6-(amino-κN)-5-[2-[2-(hydroxy-κO)-4-nitrophenyl]diazenyl-κN1]-N-methyl-2-naphthalenesulfonamidato(2-)]-, sodium (1:1) and disodium [6-amino-5-[(2-hydroxy-4-nitrophenyl)azo]-N-methylnaphthalene-2-sulphonamidato(2-)][6-amino-5-[(2-hydroxy-4-nitrophenyl)azo]naphthalene-2-sulphonato(3-)]cobaltate(2-)

EC Number:

943-062-2

Molecular formula:

not available

IUPAC Name:

Reaction mass of Cobaltate(1-), bis[6-(amino-κN)-5-[2-[2-(hydroxy-κO)-4-nitrophenyl]diazenyl-κN1]-N-methyl-2-naphthalenesulfonamidato(2-)]-, sodium (1:1) and disodium [6-amino-5-[(2-hydroxy-4-nitrophenyl)azo]-N-methylnaphthalene-2-sulphonamidato(2-)][6-amino-5-[(2-hydroxy-4-nitrophenyl)azo]naphthalene-2-sulphonato(3-)]cobaltate(2-)

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

None

Specific details on test material used for the study:

Identification : IRGALAN BLAU 3GL ROH FEUCHT (FAT 20'036/F)
Description : Lumpy black powder
Batch number : 1
Identification : 097911-1
CAS·Nr : 075314-27-1
Purity: ca 97.7%
Expiry date: July 1999
Storage conditions: In the original container at room temperature away from direct sunlight.

Test animals

Species:

rat

Strain:

other: Rat, 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.
- Weight at study initiation for males: 197.6 - 213.4 g.
- Weight at study initiation for females: 177.6 - 188.5 g.
- Age at study initiation: 8 for males and 10 for females
- Identification: By unique cage number and corresponding color-coded spots on the tail.
- Randomozation: Randomly selected at the time of delivery into groups of five.
- Acclimatization: One week under laboratory conditions, after health examination. Only animals without any visual signs of illness were used for the study.

Conditions:
Standard Laboratory Conditions.
Air-conditioned with 10-15 air changes per hour, a continuously monitored environment with a temperature of 22 ± 2 °C, a relative humidity between 36-58%, 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.

Accommodation:
Groups of five in Makrolon type-4 cages (size: 33 x 55 x 20 cm) with standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz).

Diet:
Pelleted standard Kliba 343, Batch no.73/94 rat maintenance diet ("Kuba", Klingentalmuehle AG, CH-4303 Kaiseraugst) available ad libitum (except for the overnight fasting period prior to application).

Water:
Community tap water from Füllinsdorf, available ad libitum.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

Bidistilled water

Details on oral exposure:

VEHICLE: Bidistilled water

TREATMENT:
The animals received a single dose of the test article on a mg/kg body weight basis by oral gavage following fasting for 16 to 22 hours, but with free access to water. Food was provided again approximately 3 hours after dosing.

MAXIMUM DOSE VOLUME given: 10 ml/kg body-weight

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 15 days
- Mortality: Four times during test day 1 and daily during days 2-15.
- Frequency of observations and weighing: On test day 1 (pre-administration), 8 and 15.
- Clinical signs: Each animal was examined for changes in appearance and behaviour four times during day 1, and once daily for surviving animals during days 2-15. All abnormalities were recorded
- Necropsy of survivors performed: Necropsies were performed by experienced prosectors. At the end of the observation period all animals were anesthetized by intraperitoneal injection of NARCOREN (Rhone Merieux GmbH, D-88471 Laupheim) at a dose of at least 2.0 ml/kg body weight and sacrificed by exsanguination. The animals were examined macroscopically.

Statistics:

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

Results and discussion

Preliminary study:

None

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No moratlity was observed.

Clinical signs:

No clinical signs of toxicity were observed during the observation period.

Body weight:

The rate of body weight gain of the animals during the observation period was not affected by treatment with the test article.

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 acute oral LD50 of FAT-20036/F in rats of both sexes observed over a period of 14 days is greater than 2000 mg/kg bw.

Executive summary:

The test article IRGALAN BLAU 3GL ROH FEUCHT (FAT 20'036/F) was tested for acute oral toxicity according to OECD Guideline 401. FAT 20036/F was administered to a group of 5 male and 5 female rats by oral gavage, at the single maximal dose of 2000 mg test article/kg bw.

There were no deaths observed as a result of treatment with the test article. No clinical signs of toxicity were observed during the observation period. There was no effect on body weight gain during the observation period. No organ abnormalities were observed at necropsy.

Based on the above findings, the mean lethal dose (LD50) of IRGALAN BLAU 3GL ROH FEUCHT (FAT 20'036/F) was found to be greater than 2000 mg/kg bw.