Disodium hexatitanate

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

13 August 2012 - 25 October 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2015

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 436 (Acute Inhalation Toxicity: Acute Toxic Class Method)

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

Disodium hexatitanate

EC Number:

815-182-4

Cas Number:

12058-75-2

Molecular formula:

Na2Ti6O13

IUPAC Name:

Disodium hexatitanate

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: IC96
- Expiration date of the lot/batch: 24 March 2014

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at ambient temperature

Description: White powder
Purity: 100%

Test animals

Species:

rat

Strain:

other: Crl:CD (SD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
In the initial consignment of animals, 4 male and 4 female Crl:CD (SD) rats were received from Charles River (UK) Ltd. The rats were ordered at 56 to 84 days of age and within a weight range of ±20% of the mean bodyweight for each sex. The animals were allowed to acclimatise to the conditions described below for 6 days before treatment commenced. For those animals selected for this study, their age at the start of treatment was 62 to 90 days and their bodyweights were in the range of 330 to 351 g for males and 230 to 238 g for females.

Each animal room was supplied with filtered fresh air, which was passed to atmosphere and not re-circulated. The temperature and relative humidity controls were maintained within the range of 19 to 23°C and 40 to 70% respectively. Artificial lighting was controlled to give a cycle of 12 hours continuous light and 12 hours continuous dark per 24 hours.

The animals were housed three of one sex per cage. The cages were made of a polycarbonate body with a stainless steel mesh lid. Wood shavings (Lignocel 3/4) were used as bedding and were sterilised by autoclaving and changed at appropriate intervals each week. Cages, food hoppers and water bottles were changed at appropriate intervals.

Whilst in the home cage, animals were allowed free access to a standard rodent diet (Rat and Mouse No. 1 Maintenance Diet). This diet contained no added antibiotic or other chemotherapeutic or prophylactic agent. Potable water taken from the public supply was freely available via polycarbonate bottles fitted with sipper tubes.

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

not specified

Vehicle:

air

Mass median aerodynamic diameter (MMAD):

3.7 µm

Geometric standard deviation (GSD):

2.6

Analytical verification of test atmosphere concentrations:

not specified

Duration of exposure:

4 h

No. of animals per sex per dose:

1 test group, which consisted of 3 male and 3 female animals

Control animals:

no

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

5.2 mg/L air

Based on:

test mat.

Exp. duration:

4 h

Mortality:

There were no unscheduled deaths

Clinical signs:

other: The clinical sign of test substance staining to the snout and jaw was observed in 2/3 males and 2/3 females immediately after the exposure, this sign was no longer evident at 1 hour post dose. In addition wet fur was observed in all animals immediately af

Body weight:

There were slight bodyweight losses in the individual bodyweights of both sexes on the day following the exposure, recovery from any loss was observed at the next weighing occasion, Day 4, after which growth continued for the remainder of the study.

Gross pathology:

The macroscopic examination performed after a single administration followed by a 14-day observation period revealed enlargement and pallor to the tracheobronchial lymph node of a single female (Animal 6B). The nature and incidence of the other finding (pelvic dilatation of the right kidney of male 1B) were consistent with the commonly seen background of macroscopic changes.

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

Under the conditions of this study the LC50 (4-hour) of Terracess DSR is in excess of 5.20 mg/L for male and female rats.
Terracess DSR is included in Category 5 or unclassified according to the Globally Harmonised System