Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
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 Type:
study report

Materials and methods

Test guideline
according to guideline
OECD Guideline 401 (Acute Oral Toxicity)
not specified
GLP compliance:
Limit test:

Test material

Constituent 1
Chemical structure
Reference substance name:
Antimony nickel titanium rutile
EC Number:
Cas Number:
Molecular formula:
Ni(x/3)Sb(2x/3)Ti(1-x)O2 0,1≤x≤0,3
Antimony nickel titanium rutile
Test material form:
Specific details on test material used for the study:
- Batch No.: 4879

Test animals

other: Crj; CD(SD) IGS
Details on test animals or test system and environmental conditions:
- 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.

- 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
other: Carmellose sodium
Details on oral exposure:
- Concentration in vehicle: 1% carmellose sodium solution
- Lot no.: lot No. 9813

0, 2000 mg/kg bw
No. of animals per sex per dose:
Control animals:
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: at least once daily
- Necropsy of survivors performed: yes
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
Dose descriptor:
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
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