Ferrate(4-), hexakis(cyano-C)-, methylated 4-[(4-aminophenyl)(4-imino-2,5-cyclohexadien-1-ylidene)methyl]benzenamine copper(2+) salts

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

April 1974

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Data is from study report.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1974

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: As mentioned below

Principles of method if other than guideline:

Acute oral toxicity of test chemical in rats.

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Ferrate(4-), hexakis(cyano-C)-, methylated 4-[(4-aminophenyl)(4-imino-2,5-cyclohexadien-1-ylidene)methyl]benzenamine copper(2+) salts

EC Number:

235-468-7

EC Name:

Ferrate(4-), hexakis(cyano-C)-, methylated 4-[(4-aminophenyl)(4-imino-2,5-cyclohexadien-1-ylidene)methyl]benzenamine copper(2+) salts

Cas Number:

12237-62-6

Molecular formula:

[C24N3H28] Cu2Fe(CN)6

IUPAC Name:

ferrate(4-), hexakis(cyano-C)-, methylated 4-[(4-aminophenyl)(4-imino-2,5-cyclohexadien-1-ylidene)methyl]benzenamine copper(2+) salts

Test material form:

solid

Details on test material:

IUPAC name: ferrate(4-), hexakis(cyano-C)-, methylated 4-[(4-aminophenyl)(4-imino-2,5-cyclohexadien-1-ylidene)methyl]benzenamine copper(2+) salts
Substance type: Organic
Physical state: Solid
Molecular Formula: [C24N3H28] Cu2Fe(CN)6
Molecular Weight: 697.54 g/mol

Test animals

Species:

rat

Strain:

other: Tif. RAI

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 6 to 7 weeks old
- Weight at study initiation: 160 to 180 g.
- Fasting period before study: The rats were starved during one night before starting the treatment.
- Housing: The males and females were segregated and housed in Macrolon cages. (Type 3) in groups of 5 in a room.
- Diet (e.g. ad libitum): They received water and food (NAFAG, Gossau SG, rat food) ad libitum.
- Breeding : The compound was tested on 50 Tif. RAI rats (25 males/25 females), bred under SPF conditions in our own breeding unit.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±1 °C
- Humidity (%): a relative humidity of approximately 50 %

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

2 %

Details on oral exposure:

DOSAGE PREPARATION:
Test chemical was weighed into an Erlenmeyer flask on a Mettler balance. It was suspended at 10 and 30 % with carboxymethylcellulose 2 % and administered by oral intubation. Before treatment the suspension was homogeneously dispersed with an Ultra-Turrax and during treatment it was kept stable with a magnetic stirrer.

Doses:

Doses: 1000; 3170; 3590; 4640 and 6000 mg/kg

No. of animals per sex per dose:

1000 mg/kg: 5 males and 5 females
3170 mg/kg: 5 males and 5 females
3590 mg/kg: 5 males and 5 females
4640 mg/kg: 5 males and 5 females
6000 mg/kg: 5 males and 5 females

Control animals:

no

Details on study design:

No data

Statistics:

No data

Results and discussion

Preliminary study:

No data

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 6 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality was observed

Mortality:

No mortality was observed.

Clinical signs:

other: Symptoms: Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, exophthalmus, curved position and ruffled fur. These symptoms became more accentuated as the dose was increased.

Gross pathology:

Autopsy: Dead and killed animals: No substance related gross organ changes were seen.

Other findings:

The surviving animals had recovered within 6 to 7 days. They were killed and autopsied after an observation period of 7 days.

Any other information on results incl. tables

Table:

Dose mg/kg	Concentration % of formulation	No. of animals		Died within
				2 hrs.		24 hrs.		48 hrs.		7 days
		Male	Female	Male	Female	Male	Female	Male	Female	Male	Female
1000	10	5	5	0	0	0	0	0	0	0	0
3170	30	5	5	0	0	0	0	0	0	0	0
3590	30	5	5	0	0	0	0	0	0	0	0
4640	30	5	5	0	0	0	0	0	0	1	0
6000	30	5	5	0	0	0	0	0	0	0	3

No higher doses were possible.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Conclusions:

The acute oral LD50 of test chemical in rats of both sexes observed over a period of 7 days is >6000 mg/kg.

Executive summary:

The acute oral toxicity study was conducted by using test chemical in groups of 10 male and female Tif. RAI rats at the dose concentration of 1000; 3170; 3590; 4640 and 6000 mg/kg bw dissolved in CMC (carboxymethyl cellulose). Test chemical was weighed into an Erlenmeyer flask on a Mettler balance. It was suspended at 10 and 30 % with carboxymethylcellulose 2 % and administered by oral intubation. Before treatment the suspension was homogeneously dispersed with an Ultra-Turrax and during treatment it was kept stable with a magnetic stirrer. Animals were observed for mortality, clinical signs and gross necropsy. No mortality was observed. Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, exophthalmus, curved position and ruffled fur. These symptoms became more accentuated as the dose was increased. The surviving animals had recovered within 6 to 7 days. They were killed and autopsied after an observation period of 7 days. No substance related gross organ changes were seen in dead and killed animals. Hence, LD50 value was considered to be >6000mg/kg bw, when groups of 10 male and female Tif. RAI rats were treated with Pigment Violet 27 vai oral gavage route. Thus the substance is considered to be not classified in the toxic category.