Reaction products of sodium glucoheptonate with zinc sulfate and sodium hydroxide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

22.06.2016 - 12.07.2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

issued by the Government of India, Department of Science and Technolog; National Good Laboratory Practice (GLP) Compliance Monitoring Authority (NGCMA)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction products of sodium glucoheptonate with zinc sulfate and sodium hydroxide

EC Number:

946-329-1

Molecular formula:

Not specified (UVCB substance).Molecular formula of the main substance:C14H30O22SZn2

IUPAC Name:

Reaction products of sodium glucoheptonate with zinc sulfate and sodium hydroxide

Test material form:

solid

Remarks:

microgranulat

Details on test material:

- State of aggregation: solid (microgranulare)
- appearance: odorless pale brown

Specific details on test material used for the study:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Keep container tightly closed in a cool and well ventilated place.

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Animal Breeding Facility, Jai Research Foundation
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 10 - 11 weeks
- Weight at study initiation: 170.2 -196.2 g
- Fasting period before study: Rats were fasted overnight prior to dosing until three hours post-dosing.
- Housing: 3 rats per cage. Polypropylene rat cages covered with stainless steel grid top were used. Autoclaved clean rice husk was used as the bedding material.
- Diet: ad libitum (Teklad Certified Global HIgh Fiber Rat/Mice Feed (Envigo, USA))
- Water: ad libitum (UV sterilized water filtered through Reverse Osmosis water filtration system)
- Acclimation period: minimum of 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 23 °C
- Humidity (%): 57 - 67 %
- Air changes (per hr): minimum 15 air changes/hour
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

Reverse Osmosis (RO) Water

Details on oral exposure:

The actual dose formulation was prepared using RO water as vehicle. Required quantity were mixed in RO water and the final volume was made up to 10 mL. Gavage solution were prepared freshly prior to dosing on all the occasions.
Individual dose volume was adjusted according to body weight. All rats were dosed by oral gavage (day 0) using a BD 1 mL disposable syringe. Rats were fasted overnight prior to dosing until three hours post-dosing.

Doses:

2000 mg/ kg bw

No. of animals per sex per dose:

Two sets of 3 female rats, each.

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Rats were observed for signs of toxicity and mortality at 0.5, 1, 2, 3, 4 and 6 hours post-administration on the day of dosing. Subsequently, rats were observed twice a day for morbidity and mortality for 14 days following oral dosing. The clinical signs were recorded once a day. Individual body weight was recorded prior to dosing on day 0 and on days 7 and 14.
- Necropsy of survivors performed: yes. All rats were euthanised by carbon dioxide asphyxiation.
- Other examinations performed: gross pathology examiation, consisting of external examination and opnening of the abdominal and thoracic cavities.

Statistics:

not reported

Results and discussion

Preliminary study:

not applicable

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed in rats treated with 2000 mg test material /kg bw.

Clinical signs:

other: No clinical sign was observed in all rats treated with 2000 mg test material /kg bw.

Gross pathology:

In absence of any pathological lesions in terminally sacrificed rats, it is concluded that the test item did not produce any treatment related effect at the dose level used in the present study.

Applicant's summary and conclusion

Interpretation of results:

other: EU GHS (CLP) criteria not met

Conclusions:

The LD50 is >2000 mg/kg bw. Based on the results of this study, an indication of the classification of the test material is as follows: EU GHS (CLP) criteria not met.

Executive summary:

In an oral toxicity study (OECD 423), two sets of fasted Wistar rats (3 femals/set) (10 - 11 weeks) were given a single oral dose of 2000 mg test material /kg bw and observed for 14 days. The conducted study was in compliance with GLP (GLP certificate issued by the Government of India, Department of Science and Technolog; National Good Laboratory Practice (GLP) Compliance Monitoring Authority (NGCMA). There were no treatment-related mortality, clinical signs and changes in body weight or necropsy findings observed so the LD50 is >2000 mg/kg bw. Based on the results of this study, an indication of the classification of the test material is as follows: EU GHS (CLP) criteria not met.