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Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from authoritative database

Data source

Reference
Reference Type:
other: Authoritative database
Title:
Single Dose Oral Toxicity study of the given test chemical in rats
Author:
J-CHECK
Year:
2010
Bibliographic source:
J-CHECK , 2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
Single oral administration toxicity test using test chemical rat.
GLP compliance:
not specified
Test type:
other: Acute Oral Toxicity
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- IUPAC Name: Disperse Red 206
- Smiles: CCN(CCO)c1ccc(N=NC2=N{+}(C)(.O{-}C(C)=O)c3ccc(OC)cc3S2)cc1
- Molecular formula : C21H26N4O4S
- Substance type: Organic
- Physical state: reddish brown odorless powder
- Purity: 97.65%

Test animals

Species:
rat
Strain:
Sprague-Dawley
Remarks:
(Crj: CD (SD) IGS)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Japan Co., Ltd.
- Age at study initiation: 4 week old
- Weight at study initiation: The weight range on the administration day was 112 to 127 g for males and 101 to 110 g for
females.
- Fasting period before study: Animals were fasted for about 17 to 18 hours
- Housing: Bracket type metal wire mesh floor cage was divided into groups of 3 or less, after grouping they were kept individually.
- Diet (e.g. ad libitum): solid feed
- Water (e.g. ad libitum): drinking water freely using automatic water supply equipment.
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 to 23 ° C.
- Humidity (%): 50 to 70%
- Air changes (per hr): ventilation frequency of 10 to 15 times/hour
- Photoperiod (hrs dark / hrs light): an illumination time of 12 hours (lighting from 8:00 to 20:00)

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
methylcellulose
Remarks:
0.5% methyl cellulose aqueous solution
Details on oral exposure:
VEHICLE
- Amount of vehicle (if gavage): 10 mL/kg
Doses:
0 and 2000 mg/kg bw
No. of animals per sex per dose:
Total = 10 animals
(5 male and 5 female)
Control animals:
yes
Remarks:
5 male and 5 female
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: The life and death, appearance, behavior and the like of the animals were observed consecutively from immediately after administration on the administration day (0 day after administration) until 1 hour after administration and at 1 hour interval from 2 hours to 6 hours after administration. From day 1 to day 14 post administration, observation was carried out once a day until the autopsy day.
The body weight was measured at 0 (before administration on the administration day), 1, 3, 5, 7, 10 and 14
days after administration (autopsy day), and the body weight gain and the body weight gain rate from day 0 to the 14th day after administration.
- Necropsy of survivors performed: yes, on the 14th day after administration, after observing the external surface table, animals were exsanguinated under ether anesthesia and killed by lethality, and the whole body organs and tissues were observed macroscopically.
Statistics:
Bartlett 's test for body weight, body weight gain and body weight gain rate was conducted and equi-dispersibility was analyzed. In the case of equi-variance, it is analyzed by one-way analysis of variance and in case of unequal variance it is analyzed by Kruskal-Wallis's test method. As a result of the analysis of the Kruskal-Wallis method, when significant difference was observed, it was analyzed by Mann-Whitney U-test method. In the test between the control group and the test substance-administered group, the significance level was set to 5% in each case.

Results and discussion

Preliminary study:
In the dose setting test, the test chemical was orally administered to Crj: CD (SD) IGS rats of 3 male and 3 female rats, respectively. As a result, no death was observed, so the OECD Test Method
Guideline (401) 2000 mg/kg and a control group to which only the solvent was administered. The number of animals in one group was 5 for both males and females, and grouping was performed by stratified random extraction method based on the body weight the day before administration.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
Dead cases were not observed in both males and females.
Clinical signs:
No abnormality was observed in both males and females.
Body weight:
There was no significant difference between the 2000 mg/kg group and the control group in both males and females.
Gross pathology:
No abnormal findings were observed in both males and females.
Other findings:
not specified

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Conclusions:
The acute oral toxicity dose (LD50) was considered to be >2000 mg/kg bw, when 5 male and 5 female per group Sprague-Dawley (Crj: CD (SD) IGS) rats were treated with the given test chemical via oral gavage route.
Executive summary:

The acute oral toxicity study was conducted by using the given test chemical in 5 male and 5 female per group of Sprague-Dawley (Crj: CD (SD) IGS) ratsat the dose concentration of 2000 mg/kg bw.

The given test chemical was dissolved in 0.5% methyl cellulose aqueous solution and administered as 10 mL/kg via oral route. A control group to which only the solvent was administered.

In the dose setting test, the test chemical was orally administered to Crj: CD (SD) IGS rats of 3 male and 3 female rats, respectively. As a result, no death was observed, so the OECD Test Method Guideline (401) 2000 mg/kg and a control group to which only the solvent is present was administered. The number of animals in one group was 5 for both males and females, and grouping was performed by stratified random extraction method based on the body weight the day before administration.

The life and death, appearance, behavior and the like of the animals were observed consecutively from immediately after administration on the administration day (0 day after administration) until 1 hour after administration and at 1 hour interval from 2 hours to 6 hours after administration. From day 1 to day 14 post administration, observation was carried out once a day until the autopsy day.

The body weight was measured at 0 (before administration on the administration day), 1, 3, 5, 7, 10 and 14 days after administration (autopsy day), and the body weight gain and the body weight gain rate from day 0 to the 14th day after administration.

Necropsy of survivors performed. On the 14th day after administration, after observing the external surface table, animals were exsanguinated under ether anesthesia and killed by lethality, and the whole body organs and tissues were observed macroscopically.

Bartlett’s test for body weight, body weight gain and body weight gain rate was conducted and equi-dispersibility was analyzed. In the case of equi-variance, it is analyzed by one-way analysis of variance and in case of unequal variance it is analyzed by Kruskal-Wallis's test method. As a result of the analysis of the Kruskal-Wallis method, when significant difference was observed, it was analyzed by Mann-Whitney U-test method. In the test between the control group and the test substance-administered group, the significance level was set to 5% in each case.

Dead cases were not observed in both males and females. No abnormality was observed in both males and females. There was no significant difference between the 2000 mg/kg group and the control group in both males and females. No abnormal findings were observed in both males and females.

Under the condition of this, the LD50 value was considered to be >2000 mg/kg bw, when 5 male and 5 female per group Sprague-Dawley (Crj: CD (SD) IGS) rats were treated with the given test chemical via oral gavage route.