Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
05.2012-08.2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
2-{2-[(2-ethylhexyl)oxy]ethoxy}ethyl prop-2-enoate
Cas Number:
117646-83-0
Molecular formula:
C15H28O4
IUPAC Name:
2-{2-[(2-ethylhexyl)oxy]ethoxy}ethyl prop-2-enoate
Test material form:
liquid
Details on test material:
Test substance name: MI RAMER M1086
Appearance : Clear liquid
Manufacturing date: 2012-03-29
Supplier:Miwon Specialty Chemical Co., Ltd.
Receipt day: 2012-05-23
Deli very amount: 399.223 g(Gross)
Cas No.:117646-83-0
Lot No.:120329JY1
Purit y: 95.55 %
Expiration date: 2013-03-28 (Manufactured after 1 year)
Storage condition: Room temperature [(15 ~ 25)°C

Test animals

Species:
rat
Strain:
other: Crl:CD(SD)
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
Animal speci es (st rai n) : Crl :CD(SD)-Rat
Supplier : ORIENT BIO Co., Ltd. 699-13, Mokdong-ri, Buk-myeon, Gapyeong-gun, Gyeonggi-do, Korea
Number of animals and sex dist incti on at the t ime of recei pt : 14 f emal es
A range of age and body weight at the time of receipt : 8 weeks old, 210.3 g ~ 229.6 g
Number of animal and sex distinction at the time of administration : 3 females for each step
A range of age and body weight at t he time of administration :
9 week olds, 212.2 g ~ 219.8 g (1st step) / 246.2 g ~ 259.3 g (2nd step)
10 week olds, 228.4 g ~ 241.4 g (3rd step) / 240.7 g ~ 246.9 g (4th step)

ENVIRONMENTAL CONDITIONS
The animal facil it y was maintained at (22 ± 3)°C, relative humidity (50 ± 20) %,
air ventilation of 10-15 times/hr, 12 hours light/dark cycle (light during 8:00-20:00) at (150 ~ 600) Lux.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
Vehicle : Corn oil
Manuf actured by : Sigma – Aldrich corporation
Lot No. : MKBF6012V
After the test substance was weighed, it was formulated with corn oil at 30 mg/mL (1st, 2nd step), 200 mg/mL (3rd, 4th step) concentration.
The feed was removed at one day before the administration, but water was supplied.
Formulation was adiministrated only one time by oral gavage at a dose vol ume of 10 mL/kg B.W., using sonde attached to disposable plastic syringe.

Doses:
Starting dose level was selected 300 mg/kg B.W. according to the “OECD Guideline for testing of chemicals, Section 4, TG 423”.
The dose l evel was 300 mg/kg B.W. (1step),2000 mg/kg B.W. (3rd, 4th step) and three animals were used for each step.
The time interval between treatment step was determined by the onset , duration and severity of toxic signs. These steps showed no mortality in the dosed animals.
No. of animals per sex per dose:
Three animals were used for each step.
Control animals:
not specified
Details on study design:
Clinical signs were carefully observed for 4 hours after treatment and then once everyday for 14 days.
Body weight was measured at animal receipt day, animal allocation day, just before treatment and on day 7 and 14 after the administration.
At the end of observation period, all survived animals were sacrificed by bloodletting under ether anesthesia. Necropsy was conducted for all animals and the organs were examined for gross lesions.

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 - < 5 000 mg/kg bw
Mortality:
No death occurred in all animals during the experimental period.
Clinical signs:
Clinical signs related to the test substance were not observed in any animals.
Body weight:
All living animals showed the increase of body weight normally.
Gross pathology:
In all animals, there were no lesions caused by administration of test substance.

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
Based on these results, the MIRAMER M1086 was evaluated to be GHS (Globally Harmonized Classificati on System) Category 5 (2000 mg/kg body weight < LD50< 5000 mg/kg body wei ght) in this study.
Executive summary:

The present study to investigate acute oral toxicity study of MIRAMER M1086 was conducted on the Sprague-Dawley (SD) rats. The test substance was administrated only one time by oral  route at a dose of 300 mg/kg body wei ght (1 step) and 2000 mg/kg body weight (3rd, 4th step). Three animals were used for each step and there were 4 steps in total. Mortality, clinical signs, body weights and necropsy findings were observed for 14 days.

- No mortality was observed in the present study.

- Clinical signs related with the MI RAMER M1086, were not observed in any animal during the observation period.

- All tested animals showed normal gains in body weight.

- In all animals, there were no necropsy fingings caused by administration of test substance.

Based on these results, the MIRAMER M1086 was evaluated to be GHS (Globally Harmonized Classi fication System) Category 5 (2000 mg/kg body weight < LD50 < 5000 mg/kg body weight) in this study.