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Acute Toxicity: oral

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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 oxide yellow
EC Number:
EC Name:
Antimony nickel titanium oxide yellow
Cas Number:
Molecular formula:
(Ti, Sb, Ni) O2
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:
not observed
Body weight:
no abnormalities 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