Zirconium zircon with encapsulated cadmium selenium sulphide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2000-11-22 to 2000-12-06

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1987-02-24

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

signed 2000-08-02

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Zirconium zircon with encapsulated cadmium selenium sulphide

EC Number:

701-413-5

Cas Number:

102184-95-2

Molecular formula:

ZrSiO4.y[CdS(x)Se(1-x)] 0,5≤x≤0,95 0,03≤y≤0,25

IUPAC Name:

Zirconium zircon with encapsulated cadmium selenium sulphide

Test material form:

solid: particulate/powder

Details on test material:

Substance name: "Einschlusspigment 270337"
Appearance: red powder

Test animals

Species:

rat

Strain:

other: Crl: CD® BR

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland GmbH, Sandhofer Weg 7, D-97633 Sulzfeld
- Age at start of adaptation: males: 34 days; females: 43 days
- Weight at study initiation: males: 171 - 193 g; females: 162 - 178 grams
- Fasting period before study: feeding was discontinued approx. 16 hours before administration; only tap water was then available ad libitum
- Housing: during the 14-day observation period the animals were kept in groups of 2 -3 animals in MAKROLON cages (type III); bedding material: granulated textured wood (Granulate A2, J. Brandenburg, D-49424 Goldenstedt)
- Diet (ad libitum, except for fasting period before study): Altromin 1324 (ALTROMIN GmbH, D-32791 Lage/Lippe
- Water (ad libitum): drinking water
- Acclimation period: at least 5 adaptation days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 °C ± 3 °C (maximum range)
- Relative humidity: 55 % ± 15 % (maximum range)
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 0.8 % hydroxypropyl-methylcellulose gel

Details on oral exposure:

VEHICLE
- Source: Synopharm, Barsbüttel
- Batch no.: MM 96 100 910

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 males / 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: observations were performed before and immediately, 5, 15, 30 and 60 min, as well as 3, 6 and 24 hours after administration. During the follow-up period, clinical signs were observed at least once a day until all symptoms subsided , thereafter each working day. Observations on mortality were made at least once daily with appropriate actions taken to minimize loss of animals during the study. Individual body weights were recorded before administration of the substance and thereafter in weekly intervals up to the end of the study, and at death. Changes in weight were calculated and recorded.
- Necropsy of survivors performed: yes, at the end of the experiments all surviving animals were sacrificed, dissected and inspected macroscopically. All pathological changes were recorded. From animals which survive 24 hours or longer a microscopic examination of all organs which showed evident lesions was performed, if necessary. Autopsy and macroscopic inspection of animals which died prematurely were carried out as soon as possible after exitus.

Statistics:

The LD50 could not be calculated because no lethality occurred in this limit test.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

other: Under the present test conditions a single oral administration of 2000 mg Inclusion Pigment/kg bw to rats revealed no toxic symptoms.

Gross pathology:

No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

LD50 (male and female rats) > 2000 mg/kg bw
According to the Regulation (EC) No 1272/2008 and subsequent adaptations, the substance is not acutely toxic via the oral route.