zinc hexacyanocobaltate(III), tertiary butyl alcohol/polypropylene glycol complex

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:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

(1987)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

425-240-7

EC Name:

-

Molecular formula:

C28H42O8Cl2Co2N12Zn4

IUPAC Name:

Zinc hexacyanocobaltate(III), tertiary butyl alcohol/polypropylene glycol complex

Test animals

Species:

rat

Strain:

other: Crl: CD.BR

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Ltd, Margate, UK
- Age at study initiation: approx. 5-7 weeks old
- Weight at study initiation: males 156-171 g, females 142-147 g
- Fasting period before study: from approx. 18 hours prior to dosing until 4 hours after dosing
- Housing: in groups of up to 5 rats in suspended stainless steel mesh cages (55x34x20 cm)
- Diet and water: ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25°C
- Humidity (%): 40-70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 1% aqueous methyl cellulose

Details on oral exposure:

Administration volume: 20 ml/kg
VEHICLE: methyl cellulose, prepared for administration as a 1% m/v suspension in water

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

-Preliminary test: A preliminary investigation was conducted using two female fasted rats dosed with the test substance at 200 mg/kg bw. No death occurred.
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Treated rats were observed closely for clinical signs of reaction to treatment. Clinical signs were recorded frequently on Day 1 and regularly for the remainder of the study (at least twice daily on Days 2, 3 and 4 and once daily from the fifth to last day of the observation period). Rats were weighed on the day before dosing, and on Day 1 (day of dosing), 8 and 15.
- Necropsy of survivors performed: yes

Statistics:

Determination of the acute median lethal oral dose (LD50).

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No animal died following a single oral administration of the test substance at 2000 mg/kg bw.

Clinical signs:

Three females showed some loss of hair from Day 2 to Day 6. There were no other clinical signs of reaction to treatment.

Body weight:

All rats achieved body weight gains during the first and second weeks of the study.

Gross pathology:

Necropsy on Day 15 revealed no macroscopic changes.

Applicant's summary and conclusion

Executive summary:

A standard acute toxicity testing according to OECD TG 401 was performed on 5 male and 5 female rats, receiving each a single dose of 2000 mg/kg test substance in 1% aqueous methyl cellulose. No mortalities, effects on body weight gain or findings at necropsy were observed. Three female rats showed some loss of hair from Day 2, but this was no longer apparent after Day 6. Therefore the LD50 was found to be > 2000 mg/kg bw.