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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 December 21, 2015 to December 01, 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report Date:
2016

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

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: 8-10 week old
- Housing: one or two animals per cage
- Diet: ad libitum
- Water: ad libitum
- Temperature (°C): 20.2-22.1 °C
- Humidity (%): 41.0-68.4%
- 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:
Dose Step 1: 2000 mg/kg
Dose Step 2: 2000 mg/kg
No. of animals per sex per dose:
Dose Step 1: Three females
Dose Step 2: Three females

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. All study animals were seen to excrete orange colored urine on the first five days. Hair loss of the forelimb was noted for one assigned study animal (ID No. 0009) on Day 6 and persistent throughout the remainder of the study period.

 In Dose Step 2

All dose animals tolerated the dose well and survived to termination on Day 15. All study animals were seen to excrete orange colored urine on the first three days. Two animals (ID No. 0010 and 0012) were seen to excrete red colored feces and the signs then persisted through the first seven days post dose. One animal (ID No. 0011)exhibited orange stained hair over the dorsalneck area on Day 1 and Day 2. There were no records of animal observations on Day 12 and Day 13.

 

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 CJ302 was 5000 mg/kg. Therefore, CJ302 was Category 5 or Unclassified based on GHS criteria.
Executive summary:

This test using the procedures outlined in the QPS Taiwan Study Plan for T65315002-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 CJ302 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, moribundity, or gross findings reported.The only remarkable clinical signs observed were excretion of orange colored urine in both Dose Step and red feces in Dose Step 2. Hair loss was observed at the forelimb of one study animals in Dose Step 1, but they were not likely dose-related. In absence of mortality, moribund state, or other significant clinical signs of toxicity, these results place CJ302 in the GHS Category 5 or Unclassified, with harmonized LD50 cut-off value at 5,000 mg/kg or Unclassified.