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Description of key information

Sulphide precipitate (OECD 423) LD50 > 2000 mg/kg bw/d

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
September 11, 2020 - October 2, 2020
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes
Specific details on test material used for the study:
Test Item Zinc chlorohydroxy sulphate and copper sulphide, precipitation
Lot No. 20190601
CAS No. n.a.
EINECS-No. n.a.
Molecular Formula n.a.
Molecular Weight n.a.
Purity 100 % (UVCB)
Appearance n.a.
Homogeneity Homogenous
Composition Elements: 9.9 % P, 5.9 % Cl, 8.8 % Cu, 42 % Zn, 2.3 % Cd,
Minerals: 70–80 % Zinc Chloride Sulphate Hydroxide Hydrate, (Zn12(OH)15(SO4)3Cl3xH2O), 10–15% Copper Sulphide (CuS), ˂10% Sodium Sulphate (Na2SO4), ˂10% Sodium Chloride (NaCl)
Production Date n.a.
Expiry Date December 31, 2025
Storage Room temperature (20±5°C)
Test Item Handling and Storage According to SPP: M0001-01, Test and Reference Substances
Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Institue of Experimental Pharmacology and Toxicology, Center of Experimental Medicine of the Slovak Academy of Sciences, Dobrá Voda, Slovak Republic
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: Young adult animals (approximately 8-12 weeks old)
- Weight at study initiation:
- Fasting period before study: overnight before dosing
- Housing:The animals will be housed in plastic cages suspended on stainless steel racks, up to 3 animals per cage, in a room equipped with central air-conditioning. The sanitation will be performed according to standard operation procedures.
- Diet (e.g. ad libitum): A standard laboratory food KKZ-P/M (UEFT CEM SAS) will be available ad libitum. The certificate of analysis will be included in the raw data.
- Water (e.g. ad libitum): The animals will receive tap water for human consumption. Supply of drinking water will be unlimited. The quality of drinking water is periodical monitored (including microbiological control) and recorded; certificate of analysis will be included in raw data.
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±2°C
- Humidity (%): 55±10%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12-hour light/12-hour dark
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:


CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: TThe starting dose can be selected from the fixed dose levels of 5, 50, 300, and 2000 mg/kg body weight. Available information indicated that the test item was likely to be non-toxic regarding acute toxicity therefore we chose a dose of 2000 mg of Zinc chlorohydroxy sulphate and copper sulphide, precipitation per kg body weight to be used as a starting dose. In the first step, one group of 3 females was dosed. The test item in limit dose did not cause mortality for 48 hours and therefore, in a second step, another 3 females were treated at the same dose level.
Doses:
2000 mg Zinc chlorohydroxy sulphate and copper sulphide, precipitation/kg body weight was used as a starting dose
No. of animals per sex per dose:
In the first step, one group of 3 females was dosed. The test item in limit dose did not cause mortality for 48 hours and therefore, in a second step, another 3 females were treated at the same dose level.
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days.

- Frequency of observations and weighing: The animals will be observed individually immediately after the administration of the test item and then 0.5, 1, 2 and 4 hours later. Each animal will be inspected daily for the next 14 days. Individual weights of animals will be determined shortly before the test item is administered and at least weekly thereafter.

- Necropsy of survivors performed: yes

- Other examinations performed: clinical signs, body eight, gross necropsy
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed during the study.
Clinical signs:
No signs of intoxication, change of health, nor any other adverse reactions during 24 hours and 14-days observation period at limit dose of 2000 mg/kg body weight was observed. Animals No 1-3 exhibit slight piloerection after 2 hours from administration and went to normal behavior in 2 hours.
Body weight:
The body weight gain shown by the animals over the study period was considered to be similar to that expected for normal untreated animals of the same age and strain.
Gross pathology:
No abnormalities were found at macroscopic post mortem examination of the animals.
Interpretation of results:
GHS criteria not met
Conclusions:
The oral LD50 value of Zinc chlorohydroxy sulphate and copper sulphide, precipitation in Wistar rats was established to exceed 2000 mg/kg body weight.


Executive summary:

The purpose of the study was to evaluate the potential toxic effect of the test item “Zinc chlorohydroxy sulphate and copper sulphide, precipitation” when administered as a single oral dose to Wistar rats.

The procedure according to OECD Guideline 423 Acute Toxic Class (ATC) method was used. A limit dose of 2000 mg/kg body weight was used as a starting dose. Available information indicated that the test item is likely to be non-toxic regarding acute toxicity, therefore, a limit dose of2000 mg/kg body weight was used as a starting dose.

In the first step, one group of 3 females was dosed. The test item at this dose did not cause death in the next 48 hours and therefore another 3 females were treated at the same dose level. The test item Zinc chlorohydroxy sulphate and copper sulphide, precipitation administered to 6 females Wistar rats at a limit dose of 2000 mg/kg did not induce signs of intoxication, change of health, nor any other adverse reactions during 14-days observation period. During necropsy we did not observe any macroscopic findings in all Animals at this dose level. The LD50 of the test item “Zinc chlorohydroxy sulphate and copper sulphide, precipitation” is greater than 2000 mg/kg body weight after single oral administration to Wistar rats.

Based on Annex 2d Test Procedure with a Starting Dose of 2000 mg/kg body weight of OECD Guideline 423 it can be concluded that the test item Zinc chlorohydroxy sulphate and copper sulphide, precipitation is classified in GHS Category 5 – Unclassified. Limit test with dose of 5000 mg/kg body weight was not conducted.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The purpose of the study was to evaluate the potential toxic effect of the test item “Zinc chlorohydroxy sulphate and copper sulphide, precipitation” when administered as a single oral dose to Wistar rats.

The procedure according to OECD Guideline 423 Acute Toxic Class (ATC) method was used. A limit dose of 2000 mg/kg body weight was used as a starting dose. Available information indicated that the test item is likely to be non-toxic regarding acute toxicity, therefore, a limit dose of2000 mg/kg body weight was used as a starting dose.

In the first step, one group of 3 females was dosed. The test item at this dose did not cause death in the next 48 hours and therefore another 3 females were treated at the same dose level. The test item Zinc chlorohydroxy sulphate and copper sulphide, precipitation administered to 6 females Wistar rats at a limit dose of 2000 mg/kg did not induce signs of intoxication, change of health, nor any other adverse reactions during 14-days observation period. During necropsy we did not observe any macroscopic findings in all Animals at this dose level. The LD50of the test item “Zinc chlorohydroxy sulphate and copper sulphide, precipitation” is greater than 2000 mg/kg body weight after single oral administration to Wistar rats.

Based on Annex 2d Test Procedure with a Starting Dose of 2000 mg/kg body weight of OECD Guideline 423it can be concluded that the test item Zinc chlorohydroxy sulphate and copper sulphide, precipitation is classified in GHS Category 5 – Unclassified. Limit test with dose of 5000 mg/kg body weight was not conducted.

Justification for classification or non-classification

The substance is not classified for acute toxicity according to the CLP Regulation No. 1272/2008.