Tripotassium hexacyanoferrate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

02 December - 20 December, 1983

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Limited information about substance identity and no GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

(deleted in december 2002)

Deviations:

yes

Remarks:

Not all clinical examinations performed (body weight, necropsy), but considered not to have affected the outcome of the study.

GLP compliance:

no

Remarks:

performed before GLP was in place in the EU

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Tetrasodium hexacyanoferrate

EC Number:

237-081-9

EC Name:

Tetrasodium hexacyanoferrate

Cas Number:

13601-19-9

Molecular formula:

C6FeN6.4Na

IUPAC Name:

tetrasodium hexacyanoferrate

Test material form:

solid

Details on test material:

- Physical appearance: light yellow powder

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelman, D-4791 Borchen
- Age at study initiation: males: 56 days; females: 66 days
- Weight at study initiation: males: 144-166 g; females: 139-153 g
- Fasting period before study: 16 hours
- Housing: One animal per cage in Makrolon Type II cages
- Diet (e.g. ad libitum): standard diet (ALTROMIN®)
- Water: Free access to water
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2
- Humidity (%): 50 - 60
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 237 mg/mL

MAXIMUM DOSE VOLUME APPLIED: 21.5 mL/kg

Doses:

5110 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Not indicated
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, mortality

Statistics:

Calculation LD50 determined with Probitanalyse (1952) (if required).

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 110 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred during the study.

Clinical signs:

other: In all animals diarrhoea was observed on the first day (day 1) after application.

Gross pathology:

No data

Other findings:

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In an acute oral toxicity study with male and female rats, performed equivalent or similar to OECD 401 guideline, the LD50 was calculated to be >5110 mg/kg.

Executive summary:

In an acute oral toxicity study, performed comparable to OECD test guideline 401, male and female rats were exposed to 5110 mg/kg via gavage. No deaths occurred during the study. In all animals diarrhoea was observed on the first day (day 1) after application. The LD50 was determined to be >5110 mg/kg.