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EC number: 855-027-8 | CAS number: 2409921-75-9
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From January 4, 2019 to September 16, 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 2-Naphthalenesulfonic acid, 7-amino-4-hydroxy-, coupled with diazotized 2-amino-5-[[2-(sulfooxy)ethyl]sulfonyl]benzenesulfonic acid and diazotized dehydrochlorinated 2-amino-4-[[4-[(2-chloroethyl)sulfonyl]-1-oxobutyl]amino]benzenesulfonic acid, sodium salts
- EC Number:
- 833-951-2
- Cas Number:
- 2246977-27-3
- Molecular formula:
- C8H11NO9S3.C10H9NO4S.C12H17ClN2O6S2.Na
- IUPAC Name:
- 2-Naphthalenesulfonic acid, 7-amino-4-hydroxy-, coupled with diazotized 2-amino-5-[[2-(sulfooxy)ethyl]sulfonyl]benzenesulfonic acid and diazotized dehydrochlorinated 2-amino-4-[[4-[(2-chloroethyl)sulfonyl]-1-oxobutyl]amino]benzenesulfonic acid, sodium salts
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- - Source: BioLASCO Taiwan Co., Ltd (Taipei, Taiwan)
- Age at study initiation: 8~12 week old
- Housing: two animals per cage
- Diet: ad libitum
- Water: ad libitum
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 55 ± 15%
- Frequency of ventilation: 10~15 times/hour
- Photoperiod (hrs dark / hrs light): 12-hrs dark / 12-hrs light cycle
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Doses:
- 2000 mg/kg b.w.
- No. of animals per sex per dose:
- Three
- Details on study design:
- 1. Test article was prepared to aqueous solution of 200 mg/mL in RO water. The dosage was 2,000 mg/kg BW.
2. After fasted overnight, the test article was administered in a single dose by gavage using a stomach tube.
3. First, three rats at group 1 were administered and observed for 48 hours. Group 2 were administered depending on the mortality results in the group 1.
3.1 If group 1 has <=1 out of three rats die, the same dose is administered to three rats in group 2 and their mortality rate is observed again.
3.2 If group 1 has >1 out of three rats die, a smaller dose is administered to three rats in group 2.
4. After the test article has been administered, food was withheld for a further 3 hours. Animals are observed individually after dosing at the 30 minutes and 4 hours, and continuous observation to day14.
5. Test item:
5.1 Record toxicity symptoms, time of their occurrence, duration, and rehabilitation details.
5.2 Mortality rate: The rate should be carefully observed and its condition should be recorded (once a day) for 14 days after the application of the test article.
5.3 Body weight: Individual weight of animals in day 1, in weekly intervals thereafter, and at the time of death or sacrifice.
5.4 Anatomical pathology and macropathology: A;; rats that survived the test should be checked for anatomical pathology and macropathology
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50 cut-off
- 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 in the study period
| Group | Animal ID | Dosing Volumn (mL) | Body weight (g) Day1 Day7 Day14 |
Weight changes (g) | ||
| 1 | 01F | 1.9 | 182.4 | 207.0 | 217.1 | +34.7 |
| 1 | 02F | 2.0 | 196.3 | 233.2 | 249.6 | +53.3 |
| 1 | 03F | 2.1 | 207.1 | 244.1 | 268.2 | +61.1 |
| 2 | 04F | 2.1 | 202.2 | 239.7 | 252.7 | +50.5 |
| 2 | 05F | 2.0 | 192.0 | 233.9 | 233.7 | +41.7 |
| 2 | 06F | 1.9 | 187.4 | 219.3 | 229.4 | +42.0 |
aWeight change = body weight (day 14)-body weight (day 1).
Table 2. Clinical observation of the rats
| Group | Animal ID | Clinical sign observation a | ||||||||||||||
| 30 mins | 4 hours | D2 b | D3 | D4 | D5 | D6 | D7 | D8 | D9 | D10 | D11 | D12 | D13 | D14 | ||
| 1 | 01F | N c | N | N | N | N | N | N | N | N | N | N | N | N | N | N |
| 1 | 02F | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N |
| 1 | 03F | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N |
| 2 | 04F | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N |
| 2 | 05F | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N |
| 2 | 06F | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N |
aClinical sign observation including: skin, hair, eyes, activity, circulatory system, respiratory system, digestive system and urinary system.
bD X: Day X of test.
cN: Normal.
Table 3. Results of gross necropsy examination
| Group | Animal ID | Dose | Gross lesion |
| 1 | 01F | 2,000 mg/kg BW | No significant lesion founded |
| 02F | No significant lesion founded | ||
| 03F | No significant lesion founded | ||
| 2 | 04F | 2,000 mg/kg BW | No significant lesion founded |
| 05F | No significant lesion founded | ||
| 06F | No significant lesion founded |
aGross lesion including: appearance, subcutis, abdomen, reproductive system, spleenm pancreas, liver, stomach, intestines, mesemteric lymph node, kidney, urinary bladder, adrenal, thorax, thymus, heart, lung, oral cavity, salivary gland, lymph nodes, muscles, esophagus, trachea and other.
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- According to OECD 423 test method, the LD50 of CR SB33 was greater than 2000 mg/kg B.W.. Therefore, CR SB33 was Category 5 based on GHS criteria.
- Executive summary:
This test using the procedures outlined in the SuperLab for MZ6-181200026 which is based on the SOP (SOPP-341) for the OECD 423 and OECD 423 (OECD, 2001). A total of 6 female Sprague-Dawley rats were orally dosed with CR SB33 in three animals each group, at 2000 mg/kg b.w. for both Group 1 and Group 2 in limit test. 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 CR SB33 was greater than 2,000 mg/kg.
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