Registration Dossier
Registration Dossier
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EC number: 218-566-4 | CAS number: 2184-11-4
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2014-11-28~2014-12-12
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- GLP compliance:
- yes
- Test type:
- up-and-down procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Tetrasodium 7,7'-[[6-(morpholin-4-yl)-1,3,5-triazine-2,4-diyl]diimino]bis[4-hydroxy-3-[(4-methoxy-2-sulphonatophenyl)azo]naphthalene-2-sulphonate]
- EC Number:
- 218-566-4
- EC Name:
- Tetrasodium 7,7'-[[6-(morpholin-4-yl)-1,3,5-triazine-2,4-diyl]diimino]bis[4-hydroxy-3-[(4-methoxy-2-sulphonatophenyl)azo]naphthalene-2-sulphonate]
- Cas Number:
- 2184-11-4
- Molecular formula:
- C41H36N10O17S4.4Na
- IUPAC Name:
- tetrasodium 7,7'-[[6-(morpholin-4-yl)-1,3,5-triazine-2,4-diyl]diimino]bis[4-hydroxy-3-[(4-methoxy-2-sulphonatophenyl)azo]naphthalene-2-sulphonate]
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report):Everdirect SH05(DR224)
- Substance type:Powder
- Composition of test material, percentage of components:68.89%
- Lot/batch No.:4501
- Expiration date of the lot/batch:2016-10-31
- Storage condition of test material:Refrigeration (5 ± 3℃)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Doses:
- 5 g/kg b.w.
- No. of animals per sex per dose:
- Five male and five female
- Control animals:
- no
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
Any other information on results incl. tables
Table 1 : Body weight of the rats
Animal I.D. |
Dosing volume (mL) |
Body weight (g) |
Weight changes (g) |
|||
Day 1 |
Day 7 |
Day 14 |
||||
Male |
|
|||||
01 |
8.5 |
211.1 |
288.7 |
352.6 |
+141.5 |
|
02 |
8.6 |
214.4 |
285.1 |
330.3 |
+115.9 |
|
03 |
8.3 |
207.0 |
279.1 |
323.5 |
+116.5 |
|
04 |
8.8 |
219.2 |
307.2 |
371.4 |
+152.2 |
|
05 |
8.0 |
198.2 |
270.3 |
320.3 |
+122.1 |
|
Female |
|
|||||
06 |
6.4 |
159.1 |
184.2 |
200.3 |
+41.2 |
|
07 |
6.8 |
167.9 |
204.8 |
235.3 |
+67.4 |
|
08 |
6.7 |
165.8 |
206.6 |
224.5 |
+58.7 |
|
09 |
6.3 |
157.5 |
183.7 |
197.5 |
+40.0 |
|
10 |
6.2 |
154.3 |
180.6 |
200.8 |
+46.5 |
|
Table 2 : Clinical observation of the rats
Animal I.D. |
Clinical sign observation |
|||||||||||||||
30 mins |
4 hours |
D2 |
D3 |
D4 |
D5 |
D6 |
D7 |
D8 |
D9 |
D10 |
D11 |
D12 |
D13 |
D14 |
||
Male |
|
|||||||||||||||
01 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
|
02 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
|
03 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
|
04 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
|
05 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
|
Female |
|
|||||||||||||||
06 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
|
07 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
|
08 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
|
09 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
|
10 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
|
Table 3 : Results of gross necropsy examination
Animal I.D. |
Dose |
Gross lesion |
|
Male |
|
||
01 |
5 g/kg b.w. |
No significant lesion founded |
|
02 |
No significant lesion founded |
||
03 |
No significant lesion founded |
||
04 |
No significant lesion founded |
||
05 |
No significant lesion founded |
||
Female |
|
||
06 |
5 g/kg b.w. |
No significant lesion founded |
|
07 |
No significant lesion founded |
||
08 |
No significant lesion founded |
||
09 |
No significant lesion founded |
||
10 |
No significant lesion founded |
||
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test dose of this study was 5 g/kg b.w.. Result showed that all treated rats survived till the end of the study and there was no significant gross lesions founded during the gross necropsy examination.
- Executive summary:
According to OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure), the median lethal dose (LD50) of test article was greater than 5 g/kg b.w..
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