Antimony nickel titanium rutile

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

GLP compliance:

yes

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Antimony nickel titanium rutile

EC Number:

701-459-6

Cas Number:

8007-18-9

Molecular formula:

Ni(x/3)Sb(2x/3)Ti(1-x)O2 0,1≤x≤0,3

IUPAC Name:

Antimony nickel titanium rutile

Test material form:

solid

Specific details on test material used for the study:

- Batch No.: 4879

Test animals

Species:

rat

Strain:

other: Crj; CD(SD) IGS

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: SD rats (SPF, Crj: CD (SD) IGS) produced by Atsugi Breeding Center, Charles River Laboratories Japan, Inc.
- Age at study initiation: Five-weeks-old male and female rats.
- Weight at study initiation: males weighed 138 to 152 g (mean: 145.0 g); females weighed 125 to 136 g (mean: 129.4 g).
- Fasting period before study: Yes, 17 to 18 hours before administration.
- Housing: Male and female rats were housed separately in bracket cages with metal wire-mesh flooring (300 w x 410 d x 200 h mm). Each cage housed one or three rats during quarantine and acclimation, and one rat after grouping.
- Diet: The rats took freely CRF-1, or gamma-irradiated solid feed produced by Oriental Yeast Co., Ltd., using metal diet feeders except for 17 to 18 hours before and about four hours after administration.
- Water: The rats drank tap water of Sapporo freely from automatic water feeders.
- Acclimation period: All animals were subjected to eight days of quarantine and acclimation. General condition was checked once a day, and body weight was checked twice a day. During the period of quarantine and acclimation, no abnormality was found in the animals.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 3 (measured 22 to 24)
- Humidity (%): 55 ± 10 (measured 51 to 58)
- Air changes (per hr): 10 to 15
- Photoperiod (hrs dark / hrs light): 12/12 (with artificial lights from 8 a.m. to 8 p.m.)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Carmellose sodium

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 1% carmellose sodium solution
- Lot no.: lot No. 9813

Doses:

0, 2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: at least once daily
- Necropsy of survivors performed: yes

Statistics:

Bartlett’s test was applied to body weight, body weight increase, and body weight increasing rate to analyze equality of variance. The check items were analyzed by the one-way analysis of variance in case of equal variance and by the Kruskal-Wallis test in case of unequal variance. If the one-way analysis variance indicated a significant difference, the treatment group was compared with the control by the Dunnett’s test. If the Kruskal-Wallis test indicated a significant difference, the treatment group was compared with the control by the Mann-Whitney U test. In comparison with the control, averages and standard deviations of the groups were used, and a critical rate of 5 % or less was regarded statistically significant.

Results and discussion

Preliminary study:

In the preliminary test, 2000 mg/kg of the test substance was administered in a single dose to three each of male and female Crj: CD (SD) IGS rats, and no death was observed. In accordance with the result of the preliminary test, only doses of 2000 mg/kg bw, or the limit dose specified by OECD Guidelines for the Testing of Chemicals (401) were used, and 1 % carmellose sodium solution as control.

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

not observed

Clinical signs:

other: not observed

Gross pathology:

In the control group, one male had unilateral yellowish white patches on the kidney and another male had unilateral pyelectasis, while females had no abnormality. In the 2000 mg/kg group, no abnormality was found for both males and females.

Other findings:

On day 1, all rats of the 2000 mg/kg group discharged yellow feces. On day 2 and on, no abnormality was found for both males and females.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met