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EC number: 260-976-0 | CAS number: 57834-33-0
Endpoint summary
Administrative data
Description of key information
Acute toxicity: via oral route
The LD50 of the test substance
was greater than 2000 mg/kg B.W. (OECD TG423).
Acute toxicity: via dermal route
The LD50 of the test substance was greater than 2000 mg/kg B.W. (OECD TG402).
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From August 29, 2016 to January 04, 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- 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: about 8 week old
- Housing: two animals per cage
- Water: ad libitum
- Acclimation period: at least 7 days
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 55 ± 15%
- Photoperiod (hrs dark / hrs light): 12-hrs dark / 12-hrs light cycle - Route of administration:
- oral: gavage
- Vehicle:
- water
- Doses:
- 2000 mg/kg B.W.
- No. of animals per sex per dose:
- For Group 1: Three female
For Group 2: Three female - Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Clinical signs:
- other:
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to OECD 423 test method, the LD50 of Eversorb EP4 was greater than 2000 mg/kg B.W.. Therefore, Eversorb EP4 was Category 5 based on GHS criteria. According to CLP, category 5 is not used. The test substance is not classified.
- Executive summary:
This test using the procedures outlined in the SuperLab for M62-151100165001EN 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 Eversorb EP4 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 Eversorb EP4 was greater than 2,000 mg/kg.
Reference
Table 1. Body weight of the rats in the study period
Animal I.D. |
Dosing volume (mL) |
Body weight (g) |
Weight changes (g) |
|
Day 1 |
Day 14 |
|||
Group 1 |
||||
01F |
2.1 |
206.6 |
237.9 |
+31.3 |
02F |
2.1 |
208.6 |
241.7 |
+33.1 |
03F |
2.1 |
208.6 |
244.2 |
+35.6 |
Group 2 |
||||
04F |
2.2 |
210.8 |
242.4 |
+31.6 |
05F |
2.2 |
217.2 |
257.0 |
+39.8 |
06F |
2.2 |
217.8 |
259.6 |
+41.8 |
Table 2. Clinical observation of the rats
Animal I.D. |
Clinical sign observation |
||||||||||||||
30 mins |
4 hrs |
D2 |
D3 |
D4 |
D5 |
D6 |
D7 |
D8 |
D9 |
D10 |
D11 |
D12 |
D13 |
D14 |
|
Group 1 |
|||||||||||||||
01F |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
02F |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
03F |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Group2 |
|||||||||||||||
04F |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
05F |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
06F |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N: Normal.
D2-D14: Day 2-Day 14 in the study period.
Table 3. Results of gross necropsy examination
Animal I.D. |
Dose |
Gross lesion |
Group 1 |
||
01F |
2,000 mg/kg B.W. |
No significant lesion founded |
02F |
No significant lesion founded |
|
03F |
No significant lesion founded |
|
Group 2 |
||
04F |
2,000 mg/kg B.W. |
No significant lesion founded |
05F |
No significant lesion founded |
|
06F |
No significant lesion founded |
|
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From November 07, 2016 to January 25, 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes
- 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 7-8 weeks old (males); about 9-10 weeks old (females)
- Housing: Animals were individually housed with bedding and an enrichment toy.
- Acclimation period: 6 Days
- Temperature (°C): 21 ± 2 °C
- Humidity (%): 50 ± 20%
- Photoperiod: 12 hrs dark / 12 hrs light - Type of coverage:
- occlusive
- Vehicle:
- water
- Remarks:
- Water for Injection (WFI)
- Duration of exposure:
- 24 hours
- Doses:
- 2,000 mg/kg B.W.
- No. of animals per sex per dose:
- For Group 1: six male and six female
For Group 2: six male and six female - Control animals:
- yes, concurrent vehicle
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Clinical signs:
- other:
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to OECD 402 test method, the LD50 of Eversorb EP4 was greater than 2000 mg/kg B.W.. Therefore, Eversorb EP4 was Category 5 based on GHS criteria. According to CLP, category 5 is not used. The test substance is not classified.
- Executive summary:
This test using the procedures outlined in the QPS study for T65316017-GN and OECD 402 (OECD, 1987). Six male and six female Sprague-Dawley rats for each group were used in test. For Dose Group 2, 12 Sprague-Dawley ratsweredermally dosed with 2000 mg/kg B.W. of Eversorb EP4. 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 Eversorb EP4 was greater than 2,000 mg/kg B.W..
Reference
Table 1. Clinical Observations
Dose (mg/kg) |
0 |
2000 |
Group |
1 |
2 |
Red lacrimation |
||
Male |
1/6 |
1/6 |
Female |
0/6 |
0/6 |
Red hair stain on nose |
||
Male |
5/6 |
5/6 |
Female |
3/6 |
5/6 |
Skin laceration on neck |
||
Male |
0/6 |
1/6 |
Female |
0/6 |
0/6 |
Skin scab/scar on neck/back |
||
Male |
1/6 |
1/6 |
Female |
0/6 |
0/6 |
Skin swelling on thorax |
||
Male |
0/6 |
0/6 |
Female |
0/6 |
1/6 |
Table 2. Body Weight and Body Weight Gains
Dose (mg/kg) |
0 |
2000 |
Group |
1 |
2 |
Male |
||
Body weight (g) |
||
D1 |
253 |
253 |
D15 |
343 |
349 |
Weight gain |
||
Absolute (g) |
+90 |
+96 |
Relative to D1 (%) |
+36% |
+38% |
Female |
||
Body weight (g) |
||
D1 |
233 |
230 |
D15 |
266 |
262 |
Weight gain |
||
Absolute (g) |
+33 |
+32 |
Relative to D1 (%) |
+14% |
+14% |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
Acute toxicity: via oral route
A total of 6 female Sprague-Dawley rats were orally dosed withEversorb EP4in 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 ofEversorb EP4was greater than 2,000 mg/kg.
Acute toxicity: via dermal route
Six male and six femaleSprague-Dawley rats for each group were used in test.For Dose group 2, 12Sprague-Dawley ratsweredermally dosed with 2000 mg/kg B.W. ofEversorb EP4. 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 ofEversorb EP4was greater than 2,000 mg/kg B.W..
Justification for classification or non-classification
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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