Titanium nitride

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Experimental phase: 30 April 2018 to 17 May 2018. Report issued: 18 July 2018.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Titanium nitride

EC Number:

247-117-5

EC Name:

Titanium nitride

Cas Number:

25583-20-4

Molecular formula:

NTi

IUPAC Name:

titanium nitride

Test material form:

solid: nanoform

Specific details on test material used for the study:

FORM AS APPLIED IN THE TEST

Test item dosing formulations (w/w) were homogenised to visually acceptable levels at appropriate concentrations to meet dose level requirements. The dosing formulations were kept at room temperature until dosing. The dosing formulations were stirred until and during dosing.

No adjustment was made for specific gravity of the vehicle and no correction was made for the purity/composition of the test item.

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: Approximately 9 weeks old
- Weight at study initiation: 151 to 174g
- Housing: On arrival and following assignment to the study, animals were group housed (up to 3 animals of the same sex and same dosing group together) in polycarbonate cages(height 18 cm.) containing sterilised sawdust as bedding material equipped with water bottles.
- Diet (e.g. ad libitum): ad libitum except overnight (for a maximum of 20 hours) prior to dosing and 3-4 hours after adminstration
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 24°C
- Humidity (%): 40 to 70%
- Air changes (per hr): Ten or greater air changes per hour with 100% fresh air (no air recirculation).
- Photoperiod (hrs dark / hrs light): 12-hour light/12-hour dark

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Justification for choice of vehicle: Trial preparations were performed at the Test Facility to select the suitable vehicle and to establish a suitable formulation procedure.

ADMINISTRATION OF THE TEST ITEM
A single dose of test item was administered to the appropriate animals by oral gavage on study Day 1, using a syringe with a plastic gavage cannula attached. The dose volume for each animal was based on the body weight measurement prior to dosing. A dose volume of 20 mL/kg body weight was used for each dose.

Doses:

2000 mg/kg

No. of animals per sex per dose:

6 (dosed stepwise as two groups of 3)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: Post-dose observations were performed at periodic intervals on the day of dosing (at least three times) and once daily thereafter.
- Fequency weighing: Animals were weighed individually on Day 1 (predose), 8 and 15. A fasted weight was recorded on the day of dosing.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There was no mortality during the study.

Clinical signs:

other: Hunched posture and/or piloerection were noted for the animals on Days 1 and/or 2.

Gross pathology:

No abnormalities were found at macroscopic post mortem examination of the animals.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The oral LD50 value of Titanium Nitride (Nanoform) in Wistar rats was considered to be greater than 2000 mg/kg body weight.

Executive summary:

Introduction

The objective of this study was to determine the acute oral toxicity of Titanium Nitride (Nanoform). The study was carried out in compliance with the method described in OECD No.423 (2001) "Acute Oral Toxicity, Acute Toxic Class Method"

Method

Titanium Nitride (Nanoform) was administered by oral gavage to two consecutive groups of three female Wistar rats at 2000 mg/kg body weight. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (Day 15).

 

Results

No mortality occurred.

 

Hunched posture and/or piloerection were noted for the animals on Days 1 and/or 2.

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.

 

No abnormalities were found at macroscopic post mortem examination of the animals.

 

The oral LD50 value of Titanium Nitride (Nanoform) in Wistar rats was determined to be in excess of 2000 mg/kg body weight.

 

Conclusion

The oral LD50 value of Titanium Nitride (Nanoform) in Wistar rats was considered to be greater than 2000 mg/kg body weight.