Trizinc dicitrate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from 5 March 1991 to 28 March 1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study was conducted according to the appropriate OECD test guideline and in compliance with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Trizinc dicitrate

EC Number:

208-901-2

EC Name:

Trizinc dicitrate

Cas Number:

546-46-3

Molecular formula:

C6H8O7.3/2Zn

IUPAC Name:

trizinc dicitrate

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Ltd, Manston, Kent, UK
- Age at study initiation: 5-8 wk
- Weight at study initiation: 143-161 g (males); 143-154 g (females)
- Fasting period before study: overnight
- Housing: 5/solid floor polypropylene cge, with sawdust bedding
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22
- Humidity (%): 37-69
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 h/12 h

IN-LIFE DATES: within period 5-28 March 1991

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/ml

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw

Doses:

2000 mg/kg bw

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: observation for death or overt toxicity at 0.5, 1, 2 and 4 h, then daily to day 14; body weights on days 0, 7, 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight.

Statistics:

None required.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No deaths recorded. See table 1.

Clinical signs:

other: No overt clinical toxicity. See table 1.

Gross pathology:

No abnormalities detected.

Other findings:

None.

Any other information on results incl. tables

Table 1: Number of animals dead and with evident toxicity

Dose (mg/kg bw)	Mortality (dead/total)			Number with evident toxicity (no./total)
	Male	Female	Combined	Male	Female	Combined
2000	0/5	0/5	0/10	0/5	0/5	0/10

 

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

A reliable study conducted in compliance with the standard guideline and in accordance with GLP, found the LD50 to be greater than 2000 mg/kg bw in male and female rats. This value would indicate low acute toxicity by the oral route.