Zircon, cadmium yellow

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2021-08-26 to 2021-09-10

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2021

Report date:

2021

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

2001-12-17

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

signed 2020-04-22

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Zirconium zircon with encapsulated cadmium sulphide

Cas Number:

72968-34-4

Molecular formula:

ZrSiO4.xCdS 0,03≤x≤0,3

IUPAC Name:

Zirconium zircon with encapsulated cadmium sulphide

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material: Zircon, cadmium yellow
- new EC name: Zirconium zircon with encapsulated cadmium sulphide
- Substance type: inorganic
- Physical state: solid, odourless intense yellow powder
- Storage condition of test material: Keep dry in closed containers.

Specific details on test material used for the study:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature (15-25 ºC, below 70 RH%), protected from light.

Test animals

Species:

rat

Strain:

Wistar

Remarks:

Han

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Toxi-Coop Zrt., H-1122 Budapest, Magyar Jakobinusok tere 4B
- Females nulliparous and non-pregnant: yes
- Rationale for use of males (if applicable)
- Age at study initiation: approx. 10 weeks
- Weight at study initiation: 189 - 199 g
- Fasting period before study: yes, overnight.
- Housing: animals were housed individually (1st treated animal) or in group (2 animals/cage) in T3H polycarbonate cages; wooden chips: “SAFE 3/4-S-FASERN” certified, (J. Rettenmaier & Söhne GmbH & Co.KG, Rosenberg, Germany); nest material: “Sizzle pet” (LBS (Serving Biotechnology) Ltd., Hookwood, Surrey, United Kingdom).
- Diet (ad libitum): standard laboratory rat diet, SM Rat/Mouse, Breeding & Maintenance, 10 mm, autoclavable (manufacturer: ssniff Spezialdiäten GmbH, Soest, Germany).
- Water (ad libitum): tap water
- Acclimation period: at least 8 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20 – 23 °C
- Humidity: 39 – 58 %
- Air changes (per hr): 15 - 20
- Photoperiod (hrs dark / hrs light): 12 / 12, from 6.00 a.m. to 6.00 p.m.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

methylcellulose

Remarks:

in distilled water (1 % solution)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 500 mg/mL
- Justification for choice of vehicle: The selection of the vehicle was made during trial formulations with the test item.
- batch no.: 2005-4320

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

DOSAGE PREPARATION:
The test item was freshly formulated in the vehicle at the appropriate concentration on the day of administration. The formulations were stirred with magnetic stirrer up to finishing the treatment.

CLASS METHOD
- Rationale for the selection of the starting dose: a starting dose level of 5000 mg/kg bw was selected for the following reasons: the study will be used for EU countries implementing CLP regulation as well as for non-EU countries implementing GHS regulation. Furthermore, the test item is a complex inorganic salt which shows low water solubility. As the bioavailability (and thus solubility) of the test item is a key determinant of toxicity, low toxicity was expected, therefore justifying an initial testing at the limit dose of 5000 mg/kg bw.

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

3 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: following the end of the dosage, the animals were observed individually once during the first 30 min., at 1, 2, 3, 4 and 6 hours after the treatment and once daily.
Body weight of the animals was recorded on days 0 (prior to dosing), 7 and 14 (prior to necropsy).
- Necropsy of survivors performed: yes, on day 14, all animals were sacrificed, and subjected to a necropsy and a macroscopic examination.

Statistics:

No statistical analysis could be performed (the method used is not intended to allow a calculation of a precise LD50 value).

Results and discussion

Preliminary study:

Not applicable

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No death occured.

Clinical signs:

other: All animals were symptom-free during the 14-day observation period at a dose level of 5000 mg/kg bw. Yellow coloured faeces were observed in the bedding on Day 1, which is test item related, but considered as not relevant to human health risk assessment.

Gross pathology:

There were no macroscopic changes seen at necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

LD50 (female rats) > 5000 mg/kg bw
According to the Regulation (EC) No 1272/2008 and subsequent adaptations, the substance is not acutely toxic via the oral route.