Bis(D-gluconato-O1,O2)zinc

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1985

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Bis(D-gluconato-O1,O2)zinc

EC Number:

224-736-9

EC Name:

Bis(D-gluconato-O1,O2)zinc

Cas Number:

4468-02-4

Molecular formula:

C12H22O14Zn

IUPAC Name:

bis(D-gluconato-O1,O2)zinc

Test material form:

solid: particulate/powder

Details on test material:

- Appearance : White cristalline powder:
- Batch number: 1700001575
- Manufacturing date: 10.08.2017
- Expiry date: 09.08.2020

Specific details on test material used for the study:

The test compound "zinc gluconate granular" was supplied by the sponsor.
The sample is a white fine granular.
Storage at normal room-temperature, in darkness.

Test animals

Species:

rat

Strain:

Wistar

Remarks:

Substrain : SPF TNO ; Color : white

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Firma Winkelmann, Versuchstierzucht, 4791 Borchen 1, Gartenstraße 300
- Weight at study initiation: male = 194,1 - 219,2 g ; female = 146,5 - 183,0 g
- Housing: Collection caging (Cage type: Macrolon type III/max. 5 rats)
- Diet : ad libitum (Pellets, 2.4 cm large, 1.0 cm diameter ; Producer: Ssniff Versuchstierdiäten GmbH 4770 Soest/Westfalen ; composition detailed in the report)
- Water : ad libitum (Aqua fontana as for human consumption)
- Acclimation period: About 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 2°C
- Humidity (%): 50 - 85 %
- Photoperiod (hrs dark / hrs light): 12 hours daily, from 7.00 a.m. - 7.00 p.m. with fluorescent light, 120 Lux

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 0.5%
- Justification for choice of vehicle: standard vehicle

MAXIMUM DOSE VOLUME APPLIED: 5.0 g/kg (volume = 0.73 to 0.91ml at maximum dose)

CLASS METHOD
- Rationale for the selection of the starting dose: highest dose following the range finding study

Doses:

5.0g/kg (only one dose applied according to the range finding study results).

No. of animals per sex per dose:

2 groups of fasted 5 male and 5 female rats.

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of weighing: The body weights are recorded at day 0 (beginning of the experiment) and at day 14 (terminal necropsy) on the surviving animals.
- Frequency of observations: Records were made according to the following intervals: ca. 20', 1 h, 2 + 3 h, 6 h, 24/48 h, 7/14 days p.a.
- Necropsy of survivors performed: yes
- Other examinations performed: Necropsies performed on all animals at termination exhibited no gross pathological findings.

Results and discussion

Preliminary study:

This preliminary study (range finding) showed no mortalities.
Pairs of two female rats were employed in a preliminary range finding study. The dosages of the single oral administration were 2,5 g/kg and 5,0 g/kg.
In the light of the range finding results and in accordance with the OECD-guidelines, the following dosage was used for the definitive study: 5 g/kg

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality observed

Clinical signs:

Any signs of reaction were recorded during the 14-day observation period. At the tested dosage the sample did not induce any clinical-toxicological symptoms.

The evaluation of the clinical-toxicological signs (a modified Irvin-Screening) is done individually and depends on the nature of the signs. If the symptoms persist to the same degree for a longer period of time, this is noted in the corresponding protocoIs .
Only a change of symptoms is recorded. Records were made according to the following intervals: ca. 20', 1 h, 2 + 3 h, 6 h, 24/48 h, 7/14 days p.a.

Body weight:

Body weight changes after the observation period showed a normal weight gain :
mean initial body weight = 132.31g
mean terminal weight = 217.93g

Gross pathology:

No gross pathology observed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The determination of the oral LD50 is > 5g/kg.

Executive summary:

The objective of this study was to determine the acute median lethal dosage of "zinc gluconate granular" after its single oral application to rats in accordance with the OECD guidelines.

The acute oral toxicity was investigated in 2 groups of fasted 5 male and 5 female rats of the WISW-strain. Any signs of reaction and mortalities were recorded during the 14-day observation period, animals which died and those killed terminally were subjected to necropsy. In the tested dosage the sample did not induce any clinical-toxicological symptoms. Post-dosing weight gains (2 week values) of all animals did not show essential differences. No mortali ties were observed. Nothing abnormal was found in the animals necropsied on day 14. The determination of the oral LD50 is > 5g/kg.