Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2018
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report Date:
2018

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Qualifier:
according to
Guideline:
other: OECD Guidelines for Testing of Chemicals, Section 4, OECD Publishing. DOI: 10.1787/9789264071001-en.
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Remarks:
Light yellow solid (powder)

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
Animals were fasted overnight prior to dosing orally. The dosing volume was calculated based on the individual body weight on D1 before dosing. Three females were dosed of 2000 mg/kg first, and then three more females were administered at 5 days later since no mortality was observed on the first three animals. Total 6 animals were administered test article at dose level of 2000 mg/kg. After the test article administration, food was withheld for a further 3 to 4 hours.
No. of animals per sex per dose:
Animals were fasted overnight prior to dosing orally. The dosing volume was calculated based on the individual body weight on D1 before dosing. Three females were dosed of 2000 mg/kg first, and then three more females were administered at 5 days later since no mortality was observed on the first three animals. Total 6 animals were administered test article at dose level of 2000 mg/kg. After the test article administration, food was withheld for a further 3 to 4 hours.

Results and discussion

Preliminary study:
Treated animals were observed by detailed clinical examinations at 0.5 and 4 hours after dosing on D1, and once weekly starting from the dosing day to the day before necropsy. Other days, exception of Day 6, cage-side observation was conducted. The clinical observation on Day 6 for ID#1, 2, 3 was not conducted. All animals were normal on Day 5 and Day 7. The one day data missing did not have impact on the outcome of study.
Effect levels
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
0
Body weight:
Body weight was recorded on animals treated with test article, prior to the start of dosing (D1), D8, at the end of the study period (D15).

Any other information on results incl. tables

Mortality and moribundity

Mortality and moribundity of animals were checked twice daily from Days 1 to 15 except necropsy day on which mortality and moribundity were checked only once before necropsy.

Clinical observations

Treated animals were observed by detailed clinical examinations at 0.5 and 4 hours after dosing on D1, and once weekly starting from the dosing day to the day before necropsy. Other days, exception of Day 6, cage-side observation was conducted. The clinical observation on Day 6 for ID#1, 2, 3 was not conducted. All animals

were normal on Day 5 and Day 7. The one day data missing did not have impact on the outcome of study.

Body weights

Body weight was recorded on animals treated with test article, prior to the start of dosing (D1), D8, at the end of the study period (D15).

Gross necropsy

[SOP: CTPS-TE00449]

Gross necropsy was performed on all rats at the end of study (D15). The rats were euthanized by carbon dioxide exposure followed by exsanguinations and necropsied. The external surface of the body and all organs/tissues in the thoracic and abdominal cavities were examined.

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
A single oral dose of “Chiguard® GA403” (Lot no.: S323B185001) was given to six female rats at 2000 mg/kg, none animal was found dead.
Executive summary:

“Chiguard® GA403” (Lot no.: S323B185001) in GHS system and the harmonized LD50 cut-off values are classified to category 5/unclassified and 5000 mg/kg, respectively.