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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From November 22, 2016 to June 06, 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2017

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes
Test type:
acute toxic class method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
- Source: BioLASCO Taiwan Co., Ltd (Taipei, Taiwan)
- Age at study initiation: 9-10 week old
- Housing: one or two animals per cage
- Diet: ad libitum
- Water: ad libitum
- Photoperiod (hrs dark / hrs light): 12-hrs dark / 12-hrs light cycle

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
Water for injection (WFI)
Doses:
2000 mg/kg b.w.
No. of animals per sex per dose:
three

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

Respectively, the mortalities andclinical observations in Dose Step 1 and 2 as below:

In Dose Step 1

No mortality occurred within the first three days post-dose. All dose animals tolerated the dose well and survived to termination on Day 15. Two animals (ID No. 0001 and 0003) were seen the excretion of feces of unusual color (deep pink), watery or unformed at 4 hours post dose. Animal ID No. 0001 also excreted watery brown feces at 0.5 hour post dose. Deep pink-stained skin over feet or tail was noted for all animal.

In Dose Step 2

All dose animals tolerated the dose well and survived to termination on Day 15. One animal (ID No. 0004) was seen the excretion of feces of unusual color (deep pink), watery or unformed was seen at 4 hours post dose. Deep pink-stained skin over feet or tail was noted for two animals (ID No. 0004 and 0005). Other observations include the hair loss of the forelimbs for one animal (ID No. 0006). The small amount of hair loss was first observed on Day 1 and persistent to study completion.

 

In Dose Step 1 and 2, body weights increased throughout the study period and gross examination at termination revealed no remarkable changes or lesions in all dose animals.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
According to OECD 423 test method a, the harmonized LD50 cut-off value of CR SB32N2 was 5000 mg/kg. Therefore, CR SB32N2 was Category 5 or Unclassified based on GHS criteria.
Executive summary:

This test using the procedures outlined in the QPS Taiwan Study Plan for T65316015-GN which is based on the SOP for the OECD 423 and OECD 423 (OECD, 2002). A total of 6 female Sprague-Dawley rats were orally dosed with CR SB32N2 in two dose steps of three animals each, at 2000 mg/kg b.w. for both Dose Step 1 and Dose Step 2. All animals in the two dose steps tolerated the test article well with increasing body weights and no mortality or moribundity reported. The remarkable clinical signs observed were excretion of deep pink feces in both dose steps on Dosing Day 1 and deep pink discoloration of the tail. Isolated instances of forelimb hair loss was also noted for one animal in Dose Step 2. In absence of mortality, moribund state, or other significant clinical and gross signs of toxicity, these results place CR SB32N2 in the GHS Category 5 or Unclassified, with harmonized LD50 cut-off value at 5,000 mg/kg or Unclassified.