Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
19/05/2015 - 21/07/2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Title:
Unnamed
Year:
2018
Report Date:
2015

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rat
Strain:
Crj: CD(SD)
Sex:
female
Details on test animals and environmental conditions:
Reason for selection of test animal: This strain of rat was selected because rats are generally used in toxicity studies and the test facility has abundant experience of using this strain of rats.
Number and age of animals received:4 females aged 7 weeks (for the 3rd group); 7 females aged 8 weeks ( for the 1st and 2nd groups)
Standard body weight range at shipment: Females aged 7 weeks, 140 to 210 g; females aged 8 weeks, 160 to 230 g
Body weight range at receipt: Females aged 7 weeks, 155 to 167 g; females aged 8 weeks, 190 to 207 g
Age at administration: 8 to 9 weeks
Number of groups: 2
Number of animals per group: 3

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
Preparation method: A required amount of the test article was accurately weighed out into a measuring glass, to which the vehicle was added to the prescribed concentration. The mixture in the measuring glass was stirred with a stirrer to dissolve the test article.
Preparation frequency: Immediately before use Dosing solution was placed in light-resistant and airtight
Storage conditions: container, and was not stored.
Precautions in preparation: The test article was handled in a clean bench, and prepared using protective equipment including masks and gloves to avoid inhalation and contact to the eyes, skin and clothing.
Remaining dosing solutions: The remaining dosing solutions were collected as industrial waste for incineration.
Doses:
Dose levels:

1st group: 2000 mg/kg
2nd group: 2000 mg/kg

Reason for dose selection: As the LD50 value of HCFO-1223za, an analogous substance of the test article, exceeds 2000 mg/kg", the dose level for the 1st group was set at 2000 mg/kg. The dose level for the 2nd group was selected based on the mortality by day 3 after administration in the 1st group, according to the procedure shown in Annex 2.
No. of animals per sex per dose:
3
Control animals:
no
Statistics:
Statistical analysis was not conducted. Means and standard deviations were calculated for the body weight and body weight gain.

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
>= 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
Staggering gait was noted 4 hrs after administration in 2 of 3 animals in the 1st group and 1 of 3 animals in the 2nd group, which disappeared by 6 hrs after administration. No abnormalities were noted in any animal from days 1 to 14 after administration.
Body weight:
Body weight increased normally in animals in both the 1st and 2nd groups.
Gross pathology:
No abnormalities were noted in any animal in the 1st or 2nd group.

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
As described above, administration of HCFO-1233yd (Z) at 2000 mg/kg resulted in staggering gait in 3 of 6 animals 4 hrs after administration; however, these changes disappeared by 6 hrs after administration and no changes related to the test article administration were noted in body weight, body weight gain, or necropsy.

On the basis of these results, the LD50 value of HCFO-1233yd (Z) was estimated to be above 2000 mg/kg under the present study conditions. HCFO-1233yd (Z) was classified as Category 5 according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) toxicity categories.
Executive summary:

In an acute oral toxicity study, administration of HCFO-1233yd (Z) at 2000 mg/kg resulted in staggering gait in 3 of 6 animals 4 hrs after administration; however, these changes disappeared by 6 hrs after administration and no changes related to the test article administration were noted in body weight, body weight gain, or necropsy.


On the basis of these results, the LD50 value of HCFO-1233yd (Z) was estimated to be above 2000 mg/kg under the present study conditions. HCFO-1233yd (Z) was classified as Category 5 according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) toxicity categories.