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Toxicological information

Acute Toxicity: oral

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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:
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

Reference
Name:
Unnamed
Type:
Constituent
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

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals 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:
One male animal showed severe respiratory distress.
Body weight:
not specified
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.