Sodium bis[4-hydroxy-3-[(2-hydroxy-1-naphthyl)azo]benzenesulphonamidato(2-)]cobaltate(1-)

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:

other: GLP Guideline Study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sodium bis[4-hydroxy-3-[(2-hydroxy-1-naphthyl)azo]benzenesulphonamidato(2-)]cobaltate(1-)

EC Number:

261-204-5

EC Name:

Sodium bis[4-hydroxy-3-[(2-hydroxy-1-naphthyl)azo]benzenesulphonamidato(2-)]cobaltate(1-)

Cas Number:

58302-43-5

Molecular formula:

C32H22CoN6O8S2.Na

IUPAC Name:

sodium [4-(hydroxy-kappaO)-3-{[2-(hydroxy-kappaO)-1-naphthyl]diazenyl}benzenesulfonamidato(2-)][4-hydroxy-3-{[2-(hydroxy-kappaO)-1-naphthyl]diazenyl}benzenesulfonamidato(2-)]cobaltate(1-)

Details on test material:

- Name of test material (as cited in study report): Eukesolar Rubine EB Liquid - dried
- Physical state: Solid / dark red
- Analytical purity:
HPLC fingerprint:
87.0 area-% (268 nm) sum of all peaks: 99.4 area-%
90.1 area-% (552 nm) sum of all peaks: 100.2 area-%
(For details see analytical report No.: 14L00142)
- Lot/batch No.: Dye powder sample 14/076 from Material no. 52631478; batch no. M-R/G
- Stability under test conditions: The stability under storage conditions over the study period was guaranteed by the sponsor, and the sponsor holds this responsibility.
- Storage condition of test material: Room temperature

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, Germany
- Age at study initiation: Young adult animals (female animals approx. 10 weeks)
- Weight at study initiation: Animals of comparable weight (± 20% of the mean weight)
- Fasting period before study: Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum.
- Housing: Single housing
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: Acclimatization period of at least 5 days before the beginning of the experimental phase

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +- 3°C
- Humidity (%): 30 – 70%
- Air changes (per hr): Approx. 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20 g/100 mL
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: Aqueous preparation corresponds to the physiological medium.

MAXIMUM DOSE VOLUME APPLIED: 10 mL/ kg bw

Doses:

2000 mg/kg

No. of animals per sex per dose:

6 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: A check for any dead or moribund animals was made at least once each workday; these records are archived by Bioassay. Clinical signs for each animal were recorded several times on the day of administration and at least once during each workday thereafter. Individual body weights shortly before administration (day 0), weekly thereafter and on the last day of observation.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology

Statistics:

N/A

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality was observed

Mortality:

No mortality occurred in both test groups.

Clinical signs:

other: All animals of the first 2000 mg/kg bw test group showed impaired general state and piloerection from hour 2 until hour 3 after administration. In one of these animals the same findings were noted again at hour 5. No clinical signs were noted in the secon

Gross pathology:

There were no macroscopic pathological findings in the animals sacrificed at the end of the observation period (6 females).

Any other information on results incl. tables

Under the conditions of this study the median lethal dose of Eukesolar Rubine EB Liquid; dried after oral administration was found to be greater than 2000 mg/kg bw in rats.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met