Zinc bis(benzenesulphinate)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From April 3 to 19, 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Version / remarks:

2008

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

2001

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Zinc bis(benzenesulphinate)

EC Number:

246-148-1

EC Name:

Zinc bis(benzenesulphinate)

Cas Number:

24308-84-7

Molecular formula:

C12H10O4S2Zn

IUPAC Name:

zinc bis(benzenesulphinate)

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: SPF breeding, VELAZ s.r.o., Lysolajské údolí 15/53, 165 00 Prague 6, Czech Republic, RČH CZ 11760500
- Age at study initiation: 8 weeks
- Housing: animal room with monitoring conditions – 3 animals of one sex in one plastic breeding cage
- Diet: ad libitum
- Water: ad libitum
- Fasting period before study: 20 hours
- Acclimation period: 12 days

ENVIRONMENTAL CONDITIONS
- Temperature: room temperature 22 ± 3 °C, permanently monitored
- Humidity: 30 – 70 %, permanently monitored
- Photoperiod: light period 12-hour light/12 hour dark

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

VEHICLE
- Amount of vehicle: 1 ml/100 g bw
- Lot/batch no.: 8001526002
- Purity: pharmaceutical quality

DOSAGE PREPARATION: immediately before administration

CLASS METHOD
- Rationale for selection of starting dose: starting dose of 300 mg/kg, according to guideline

Doses:

300 mg/kg , 2000 mg/kg, 2000 mg/kg

No. of animals per sex per dose:

3 female/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days

- Necropsy of survivors performed: yes, on day 15

- Body weight: animals were weighed before application, at the 8th day of study and at the 15th day, before euthanasia of animals. Average body weight in a group was calculated from individual body weights. Body weight increments were calculated from body weight at the start of the study, the first week and at the end of the study

- Clinical examination: after application the animals were observed individually: twice the first day (30 minutes and 3 hours after application); twice the second day (in the morning and in the afternoon) and daily thereafter for 14 days. Observations included changes in skin and fur, eyes, visible mucous membranes, behaviour of animals, somatomotor activity, reactions to stimuli, and presence of lacrimation, salivation and discharge from nostrils, function of respiratory, digestive and urogenital system. The results of the observations were recorded on special data sheets.

- Pathological examination: all test animals survived to the end of study were sacrificed on the 15th day and gross necropsy was carried out. Nutritious status, body surface, body foramina, thoracic, abdominal and cranial cavity were evaluated. All gross macroscopic changes of organs and tissues were recorded on special data sheets.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Mortality:

None.

Clinical signs:

other: No clinical signs of intoxication.

Gross pathology:

No pathologic changes.

Applicant's summary and conclusion

Interpretation of results:

other: not classified according to the CLP Regulation (EC 1272/2008)

Conclusions:

LD50 > 2000 mg/kg

Executive summary:

Method

Acute toxic effects of test substance were investigated after a single oral dose, following EU method B.1 tris. Test substance was given in olive oil by gavage, to 3 groups of 3 female Wistar rats.

The dosing was performed sequentially: group 1 - first step using a starting dose of 300 mg/kg bw, group 2 - second step using a higher dose of 2000 mg/kg and group 3 – third step using the same dose of 2000 mg/kg.

Results

Test substance administered at dose of 2000 mg/kg caused no death of animals. No clinical signs of intoxication were detected during whole study and no pathologic macroscopic changes were diagnosed during pathological examination.     

Accordingly, LD50 value of test substance for female rats was higher than 2000 mg/kg bw.