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EC number: 820-015-3 | CAS number: 129874-15-3
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 11, 2016 to December 07, 2016. 24 hour exposure.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Cuprate(4-), [μ-[[7,7'-[[6-[(2-hydroxyethyl)amino]-1,3,5-triazine-2,4-diyl]diimino]bis[4-(hydroxy-κO)-3-[[2-(hydroxy-κO)-5-sulfophenyl]azo-κN1]-2-naphthalenesulfonato]](8-)]]di-, tetrasodium
- EC Number:
- 820-015-3
- Cas Number:
- 129874-15-3
- Molecular formula:
- C37H22Cu2N10O17S4.4Na
- IUPAC Name:
- Cuprate(4-), [μ-[[7,7'-[[6-[(2-hydroxyethyl)amino]-1,3,5-triazine-2,4-diyl]diimino]bis[4-(hydroxy-κO)-3-[[2-(hydroxy-κO)-5-sulfophenyl]azo-κN1]-2-naphthalenesulfonato]](8-)]]di-, tetrasodium
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Everdirect SH12
- Substance type: Powder
- Composition of test material, percentage of components: 69.96 %
- Lot/batch No.: 3506
- Storage condition of test material: Ambient
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Source: BioLASCO Taiwan Co. Ltd.
- Age at study initiation: about 7 weeks old
- Housing: Male and female rats were fed, respectively. Two rats per cage in an autoclaved polyethylene cage.
- Acclimation period: 7 Days
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 55 ± 15%
- Photoperiod: 12 hrs dark / 12 hrs light
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- olive oil
- Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg B.W.
- No. of animals per sex per dose:
- For male: six
For female: six - Control animals:
- yes, concurrent vehicle
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- no indication of skin irritation up to the relevant limit dose level
Any other information on results incl. tables
Table 1. Body weight of the rats in the study period
Group |
Animal I.D. |
Dosing volume (mL) |
Body weight (g) |
Weight chenges(g) |
|
Day 1 |
Day 14 |
||||
Control |
01M |
0.6 |
284.0 |
337.7 |
+53.7 |
02M |
0.6 |
286.1 |
336.1 |
+50.0 |
|
03M |
0.6 |
289.5 |
362.1 |
+72.6 |
|
04M |
0.6 |
294.9 |
374.2 |
+79.3 |
|
05M |
0.6 |
297.6 |
360.0 |
+62.4 |
|
06M |
0.6 |
292.3 |
386.0 |
+93.7 |
|
Test |
07M |
0.6 |
284.8 |
340.0 |
+55.2 |
08M |
0.6 |
286.3 |
345.0 |
+58.7 |
|
09M |
0.6 |
291.7 |
340.0 |
+48.3 |
|
10M |
0.6 |
295.1 |
350.0 |
+54.9 |
|
11M |
0.6 |
295.5 |
340.0 |
+44.5 |
|
12M |
0.6 |
295.2 |
360.0 |
+64.8 |
|
Control |
13F |
0.4 |
206.2 |
241.7 |
+35.5 |
14F |
0.4 |
211.8 |
251.1 |
+39.3 |
|
15F |
0.4 |
216.4 |
239.4 |
+23.0 |
|
16F |
0.4 |
214.7 |
254.8 |
+40.1 |
|
17F |
0.4 |
218.1 |
267.5 |
+49.4 |
|
18F |
0.4 |
219.7 |
260.4 |
+40.7 |
|
Test |
19F |
0.4 |
211.0 |
246.3 |
+35.3 |
20F |
0.4 |
213.1 |
252.6 |
+39.5 |
|
21F |
0.4 |
214.6 |
241.1 |
+26.5 |
|
22F |
0.4 |
214.6 |
258.7 |
+44.1 |
|
23F |
0.4 |
219.2 |
265.1 |
+45.9 |
|
24F |
0.4 |
221.3 |
256.2 |
+34.9 |
|
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 |
|
01M |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
02M |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
03M |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
04M |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
05M |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
06M |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
07M |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
08M |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
09M |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
10M |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
11M |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
12M |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
13F |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
14F |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
15F |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
16F |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
17F |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
18F |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
19F |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
20F |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
21F |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
22F |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
23F |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
24F |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
DX: Day X in the study period
N: Normal
Table 3. Results of gross necropsy examination
Animal I.D. |
Dose |
Gross lesion |
01M |
─ |
No significant lesion founded |
02M |
No significant lesion founded |
|
03M |
No significant lesion founded |
|
04M |
No significant lesion founded |
|
05M |
No significant lesion founded |
|
06M |
No significant lesion founded |
|
07M |
2000 mg/kg B.W. |
No significant lesion founded |
08M |
No significant lesion founded |
|
09M |
No significant lesion founded |
|
10M |
No significant lesion founded |
|
11M |
No significant lesion founded |
|
12M |
No significant lesion founded |
|
13F |
─ |
No significant lesion founded |
14F |
No significant lesion founded |
|
15F |
No significant lesion founded |
|
16F |
No significant lesion founded |
|
17F |
No significant lesion founded |
|
18F |
No significant lesion founded |
|
19F |
2000 mg/kg B.W. |
No significant lesion founded |
20F |
No significant lesion founded |
|
21F |
No significant lesion founded |
|
22F |
No significant lesion founded |
|
23F |
No significant lesion founded |
|
24F |
No significant lesion founded |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to OECD 402 test method, the LD50 of Everdirect SH12 was greater than 2000 mg/kg B.W.. Therefore, Everdirect SH12 was Category 5 based on GHS criteria.
- Executive summary:
This test using the procedures outlined in the SuperLab for M62-151100081001EN which is based on the SOP (SOPP-342) for the OECD 402 and OECD 402 (OECD, 1987). Six male and six female Sprague-Dawley rats for each group were used in limit test. For Test group, 12Sprague-Dawley ratsweredermally dosed with 2000 mg/kg B.W. of Everdirect SH12. All animals tolerated the test article well with increasing body weights and no mortality or gross lesions findings reported. In absence of mortality or other significant clinical signs of toxicity, LD50 of Everdirect SH12 was greater than 2,000 mg/kg B.W..
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