Trisodium 5-[[4-chloro-6-[(o-tolyl)amino]-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(2-sulphonatophenyl)azo]naphthalene-2,7-disulphonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2009-Nov-18

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Test guideline 3

Qualifier:

according to guideline

Guideline:

OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)

GLP compliance:

no

Remarks:

Testing was performed outside the EU to meet non-EU regulatory requirements

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Trisodium 5-[[4-chloro-6-[(o-tolyl)amino]-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(2-sulphonatophenyl)azo]naphthalene-2,7-disulphonate

EC Number:

300-504-3

EC Name:

Trisodium 5-[[4-chloro-6-[(o-tolyl)amino]-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(2-sulphonatophenyl)azo]naphthalene-2,7-disulphonate

Cas Number:

93941-05-0

Molecular formula:

C26H20ClN7O10S3.3Na

IUPAC Name:

trisodium 5-[[4-chloro-6-[(o-tolyl)amino]-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(2-sulphonatophenyl)azo]naphthalene-2,7-disulphonate

Details on test material:

- Name of test material (as cited in study report): Evercion Red P-4BN
- Substance type: Powder
- Composition of test material, percentage of components: 75-80 %
- Lot/batch No.: R6108507
- Storage condition of test material: Ambient

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

5 male and 5 female Sprague-Dawley rats about 5 weeks old were obtained from the supplier. The rat quarantined for 2 weeks and acclimated to the condition of the animal room for at least 5 days prior to the test.

Environmental conditions:
Temperature: 22±4°C
Relative humidity: 40-70%
Light cycle: 12 hours light/dark

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Doses:

2000 mg/ kg bw

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

Limit test: The test article was administered to the rats by oral gavage with gastric tube at a dose of 2,000 mg/kg bw. Individual body weight of the treated rats was measured on day 1, day 8 and day 15.
After dosing of the test article, all treated rats were observed individually 2 a day by veterinarian for a total of 14 days.
During the observation period, the mortality of the rats, toxic reaction after dosing, time of onset and length of period were recorded. Any found dead or moribund rats in the interim would be examined by gross necropsy.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Any other information on results incl. tables

All the treated rats survived till the end of the study.

All the survival rats were subjected to gross necropsy examination on day 15. Results indicated that there were no significant gross lesions founded.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

After application of the test article, all treated rats survived till the end of the study. The body weight of the rats was increased normally during the observation period and the result of the gross necropsy examination showed that there were no significant gross lesions founded.
According to the above findings, the median lethal dose (LD50) of the substance was greater than 2,000 mg/kg under the condition designed for this study.

Executive summary:

This study was conducted to investigate the acute oral toxicity of the substance (Specimen no. 90077902). 5 males and 5 females Sprague-Dawley rats in the study were housed in Yang-Ming University Laboratory Animal Quarters. The test article was administered to the rats by oral gavage at a dose of 2,000 mg/kg bw. After application of the test article, the rats were observed for mortality and sign of toxicity for 14 days. Results showed all treated rats survived till the end of the study. The body weight of the rats was increased normally during the observation period. At the end of the study, all treated rats were subjected to gross necropsy, and the examination showed that there were no significant gross lesions founded.

According to the findings of the study, the median lethal dose (LD50) of the substance was more than 2,000 mg/kg bw under the condition designed for this study.