2-Ethylhexan-1-ol, ethoxylated, esters with acrylic acid

Acute Toxicity: oral

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

Test material information

Constituent 1

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:

other: Clinical signs related to the test substance were not observed in any animals.

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.