Chrome tungsten titanium buff rutile

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2021-08-05 to 2021-08-2021

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 2020-11-06.

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Chrome tungsten titanium buff rutile

EC Number:

269-054-2

EC Name:

Chrome tungsten titanium buff rutile

Cas Number:

68186-92-5

Molecular formula:

Cr(2x/3)W(x/3)Ti(1-x)O2 0,05≤x≤0,25

IUPAC Name:

tungsten(6+) titanium(4+) dichromium(3+) octaoxidandiide

Test material form:

solid: particulate/powder

Details on test material:

- Test item identification: Chrome tungsten titanium buff rutile
- C.I. name: Pigment Yellow 163
- Substance type: inorganic pigment
- Storage conditions: At room temperature, under moisture protection

Specific details on test material used for the study:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at + 10 to +25 °C, keep dry in closed containers.

Test animals

Species:

rat

Strain:

Crj: CD(SD)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, 97633 Sulzfeld, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: approx. 9 weeks
- Weight at study initiation: 183 - 186 g
- Fasting period before study: yes, approximately 16 hours before administration.
- Housing: during the 14-day observation period the animals were kept in groups of 3 animals in MAKROLON cages (type III plus); bedding material: granulated textured wood (Granulat A2, J. Brandenburg, 49424 Goldenstedt, Germany).
- Diet (ad libitum): commercial diet, ssniff® R/M-H V1534 (supplier: ssniff Spezialdiäten GmbH, 59494 Soest, Germany)
- Water (ad libitum): tap water
- Acclimation period: at least 14 adaptation days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 °C ± 3 °C
- Humidity: 55 % ± 10 %
- Photoperiod (hrs dark / hrs light): 12 / 12; rooms were lit (about 150 lux at approx. 1.50 m room height).

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Hydroxypropylmethylcellulose (0.8 %)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 500 mg/mL
- Batch no.: DTR459964

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

DOSAGE PREPARATION: test item was suspended in the vehicle.

CLASS METHOD
- Rationale for the selection of the starting dose: a starting dose of 5000 mg/kg bw has been selected for the following reasons: the study will be used for EU countries implementing the CLP regulation as well as for non-EU countries implementing the GHS regulation. Furthermore, the test item shows a low water solubility. As the bioavailability (and thus solubility) of the test item is a key determinant of toxicity, low toxicity is 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: observations were performed before and immediately, 5, 15, 30 and 60 min, as well as 2, 3, 6 and 24 hours after administration. All surviving animals were observed for a period of 14 days.
Individual body weights were recorded before administration of the test item and thereafter in weekly intervals up to the end of the study and at death.
- Necropsy of survivors performed: yes
At the end of the experiments, all surviving animals were sacrificed, dissected and inspected macroscopically.

Statistics:

No statistical analysis was 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 premature death was noted.

Clinical signs:

other: Under the present test conditions, animals treated orally with a single dose of 5000 mg test item/kg bw, revealed no signs of toxicity during the 14-day recovery period.

Gross pathology:

Macroscopic examination did not reveal any test item-related findings.

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.