Zinc dilactate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1996-10-02 to 1996-12-02

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

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)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Zinc dilactate

EC Number:

240-178-9

EC Name:

Zinc dilactate

Cas Number:

16039-53-5

Molecular formula:

C6H10O6Zn

IUPAC Name:

zinc dilactate

Specific details on test material used for the study:

- Date of receipt: 1996-08-12
- Name of the test substance: Puramex Zn (zinc lactate)
- General appearance: fine white powder
- Storage conditions: ambient temperature

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga, Germany
- Age at study initiation: 5-6 weeks old upon arrival
- Weight at study initiation: not specified
- Fasting period before study: prior to dosing, the animals were fasted overnight
- Housing: five animals per cage (stainless steel cages, fitted with wire-screen floor and front)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 to 23 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 50-85
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw

Doses:

500 and 2000 mg/kg bw

No. of animals per sex per dose:

2000 mg/kg bw: 5 males; 5 females
500 mg/kg bw: 5 males, 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: All visible reactions to treatment were recorded including severity, onset and duration. Observations were made within 1 hour and within 4 hours after dosing, and subsequently at least once daily throughout an observation period of 14 days.
- Frequency of weighing: The body weight of each animal was recorded immediately before dosing on day 0 and of the surviving animals on day 3, 7 and 14 of the study.
- Termination of the study: At the end ot the observation period on day 14 of the study, all surviving animals were killed with carbon dioxide and examined for external changes. The abdomen and the thorax of each animal was opened and examined for
gross pathological changes. The animals found dead were also examined for gross pathological changes.

Statistics:

None

Results and discussion

Preliminary study:

A screening was carried out with two males treated with a dose level of 2000 mg kg body weight to check for mortality. Since both animals survived it was decided to continue the study with that dose level.

Effect levels

Sex:

male/female

Dose descriptor:

approximate LD50

Effect level:

> 500 - < 2 000 mg/kg bw

Mortality:

The first two males treated with the 2000 mg/kg bw dose level survived treatment, whereas the other three males and five females were found dead within 3 days after dosing. All five males and five females treated with the 500 mg/kg dose level survived.

Clinical signs:

other: Sluggishness, blepharospasm, piloerection, soiled fur and diarrhoea were generally observed during the first day after dosing.

Gross pathology:

Macroscopic examination of the animals at the end of the observation period did not reveal treatment-related gross alterations.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

In conclusion, the oral LD50 of Puramex Zn is considered to be between 500 and 2000 mg/kg bw; most likely value 1190 mg/kg bw (linear interpolation).

Executive summary:

In an acute oral toxicity study in accordance with OECD 401 the oral LD50 is considered to be between 500 and 2000 mg/kg bw; most likely value 1190 mg/kg bw (linear interpolation).