Ferrate(4-), hexakis(cyano-C)-, Et 2-[6-(ethylamino)-3-(ethylimino)-2,7-dimethyl-3H-xanthen-9-yl]benzoate copper(2+) salts

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

June 1975

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Justification for type of information:

Data is from study report.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: As mentioned below

Principles of method if other than guideline:

The acute oral toxicity study was conducted in rats by using test chemical

GLP compliance:

not specified

Test type:

other: not specified

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Ferrate(4-), hexakis(cyano-C)-, Et 2-[6-(ethylamino)-3-(ethylimino)-2,7-dimethyl-3H-xanthen-9-yl]benzoate copper(2+) salts

EC Number:

235-469-2

EC Name:

Ferrate(4-), hexakis(cyano-C)-, Et 2-[6-(ethylamino)-3-(ethylimino)-2,7-dimethyl-3H-xanthen-9-yl]benzoate copper(2+) salts

Cas Number:

12237-63-7

Molecular formula:

C34H31N8O3Cu3Fe

IUPAC Name:

ferrate(4-), hexakis(cyano-C)-, Et 2-[6-(ethylamino)-3-(ethylimino)-2,7-dimethyl-3H-xanthen-9-yl]benzoate copper(2+) salts

Test material form:

solid: particulate/powder

Details on test material:

- Name of substance:ferrate(4-), hexakis(cyano-C)-, Et 2-[6-(ethylamino)-3-(ethylimino)-2,7-dimethyl-3H-xanthen-9-yl]benzoate copper(2+) salts
- Common name: Pigment red 169
- Substance type: UVCBs-organometallic
- Physical state: solid
- Appearance : Red powder
-Molecular weight: 1218.7 g/mol
Molecular formula: C66H70CuFeN10O6

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 6-7 weeks
- Weight at study initiation: 190 g. (male) and 151 g. (female)
- Fasting period before study: 18 hours
- Housing: Rats were caged singly and kept in a room maintained at a constant temperature
- Diet (e.g. ad libitum): A commercial pelleted diet (Oakes Special Diet with added Vit. E) was fed, ad libitum
- Water (e.g. ad libitum): Water was available at all times.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21±2°C.
- Photoperiod (hrs dark / hrs light): Animals were subjected to 12 hours artificial light and 12 hours darkness in each 24 hour period.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 25% w/v suspension
- Amount of vehicle (if gavage): 20 ml/kg

DOSAGE PREPARATION (if unusual):25% w/v suspension of the compound in a 50% aqueous solution of polyethylene glycol was administered

Doses:

20 ml/kg (Equivalent to 5g/kg. compound)

No. of animals per sex per dose:

Total = 10 (5 male and 5 female)

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Deaths and clinical symptoms were recorded.
- Necropsy of survivors performed: yes, at the end of the observation period surviving animals were killed by exsanguination under ether anaesthesia and an autopsy performed.

Statistics:

not specified

Results and discussion

Preliminary study:

not specified

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other:

Remarks:

Mortality observed

Mortality:

Two male died at 164 and 175 hours respectively after administration of the compound.

Clinical signs:

other: One male animal showed severe respiratory distress.

Gross pathology:

At autopsy no changes in organs or tissues caused by the administration of the test compound were seen.

Other findings:

not specified

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Conclusions:

The acute oral toxicity dose (LD50) value was considered to be >5000 mg/kg bw, when male and female Sprague-Dawley rats were treated with test chemical via oral gavage route.

Executive summary:

The acute oral toxicity study was conducted by using test chemical in 10 male and female Sprague-Dawley rats at the dose concentration of 5000 mg/kg bw. A 25% w/v suspension of the compound in a 50% aqueous solution of polyethylene glycol (vehicle) was administered as a single dose by gavage to rats which had been fasted for 18 hours, at a dose rate of 20ml/kg. (Equivalent to 5g/kg. compound).  After administration of the compound, the animals were observed for 14 days. Deaths and clinical symptoms were recorded. At the end of the observation period surviving animals were killed by exsanguination under ether anaesthesia and an autopsy performed. Two male died at 164 and 175 hours respectively after administration of the compound. One male animal showed severe respiratory distress.At autopsy no changes in organs or tissues caused by the administration of the test compound were seen. Therefore, LD50 value was considered to be >5000 mg/kg bw, when male and female Sprague-Dawley rats were treated with test chemical via oral gavage route. This toxicity value does not fall in the range of classification within the EU CLP regulation and thus the substance is not considered to be classified in the toxic category.