2-(2-butoxyethoxy)ethyl methacrylate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1999-04-09 - 1999-06-30

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-(2-butoxyethoxy)ethyl methacrylate

EC Number:

230-813-8

EC Name:

2-(2-butoxyethoxy)ethyl methacrylate

Cas Number:

7328-22-5

Molecular formula:

C12H22O4

IUPAC Name:

2-(2-butoxyethoxy)ethyl 2-methylprop-2-enoate

Test material form:

liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Species, strain: rat, Sprague-Dawley ICO: OFA-SD (lOPS Caw).
Reason for this choice: rodent species generally accepted by regulatory authorities for this type of study.
Breeder: Iffa Credo, 69210 L'Arbresle, France.
Number and sex: one group of ten animals (five males and five females).
Age/weight: on the day of treatment, the animals were approximately 6 weeks old, and had a
mean body weight ± standard deviation of 196 ± 8 g for the males and 163 ± 7 g for the females.
Acclimatization: at least 5 days before the beginning of the study.
Identification of the animals: the animals were identified individually by earmarks or earnotches.

Environmental conditions
During the acclimatization period and throughout the study, the conditions in the animal room were set as follows:
· temperature: 21 ± 2°C
· relative humidity: 30 to 70%
· light/dark cycle: 12 h/12 h
· ventilation: approximately 12 cycles/hour of filtered, non-recycled air.
The temperature and relative humidity were under continuous control and recording. The records were checked daily and filed. In addition to these
daily checks, the housing conditions and corresponding instrumentation and equipment are verified and calibrated at regular intervals.
The animals were housed in polycarbonate cages (48 cm x 27 cm x 20 cm). Each cage contained four to seven animals of the same sex during the
acclimatization period and five rats of the same sex during the treatment period.
Each cage contained dust-free sawdust (SICSA, 94142 Alfortville, France).
Bacteriological and chemical analyses of the sawdust, including the detection of possible contaminants (pesticides, heavy metals), are performed regularly by external laboratories.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Fasting of the animals
The animals were fasted for an overnight period of approximately 18 hours before dosing, but had free access to water.
Food was given back approximately 4 hours after administration of the test substance.
Administration of the test substance
A preliminary test was conducted on a reduced number of animals in order to define the range of doses to be tested. The results of this preliminary test, not included in the report, enabled us to perform a limit test by administering 2000 mg/kg of the test substance to one group of
ten animals (five males and five females).
The test substance was administered undiluted, taking into consideration its specific gravity (0.96 glml).
The administration was performed in a single dose by oral route using a metal gavage tube fitted to a 1 ml plastic syringe (0.01 ml graduations).
The volume administered to each animal was adjusted according to body weight determined on
the day of treatment
Chronology of the study
The single administration was performed on 9 April 1999 in the morning (day 1) and was

Doses:

2000 mg/kg

No. of animals per sex per dose:

One group of ten animals (five males and five females).

Control animals:

no

Details on study design:

CLINICAL EXAMINATIONS
Clinical signs and mortality
The animals were observed frequently during the hours following administration of the test substance, for detection of possible treatment-related
clinical signs. Thereafter, observation of the animals was made at least once a day until day 15.
Type, time of onset and duration of clinical signs were recorded for each animal individually.
Time of death was recorded individually, in terms of the number of hours or days after dosing.

Body weight
The animals were weighed individually just before administration of the test substance on day 1 and then on days 8 and 15.
The body weight gain of the treated animals was compared to that of CIT control animals with the same initial body weight.

NECROPSY
On day 15, all animals were killed by carbon dioxide asphyxiation and a macroscopic examination was performed.
After opening the thoracic and abdominal cavities, a macroscopic examination of the main organs (digestive tract, heart, kidneys, liver, lungs,
pancreas, spleen and any other organs with obvious abnormalities) was performed.
In case of macroscopic lesions, organ samples were taken and preserved in 10% buffered formalin.

Results and discussion

Preliminary study:

A preliminary test was conducted on a reduced number of animals in order to define the range of doses to be tested. The results of this preliminary test, not included in the report, enabled to perform a limit test by administering 2000 mg/kg of the test substance to one group of ten animals (five males and five females).

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

no death occured

Clinical signs:

other: Hypoactivity and piloerection were observed in all animals on day 1. Recovery was complete in all animals on day 2.

Body weight:

other body weight observations

Remarks:

The body weight gain of the treated animals was similar to that of historical control animals.

Gross pathology:

Macroscopic examination of the main organs of the animals revealed no apparent abnormalities.

Any other information on results incl. tables

Dose (mg/l)	Time	Animals		Mortality	Clinical signs
		Males	Females
2000	30 min	01-02-03-04-05-06	06-07-08-09-10	No	None
	1h-2h-4h	01-02-03-04-05-06	06-07-08-09-10	No	Hypoactivity, piloerection
	D2 to D15	01-02-03-04-05-06	06-07-08-09-10	No	None

Individual and mean body weight and weekly body weight change

Dose mg/kg	Volume ml/kg	Sex	Animals	Days
				1	(1)	8	(1)	15
2000	2.09	Male	01	207	61	268	34	302
			02	187	67	254	52	306
			03	200	74	274	34	308
			04	191	70	261	45	306
			05	193	83	276	54	330
			M	196	71	267	44	310
			SD	8	8	9	10	11
2000	2.09	Female	01	168	43	211	15	226
			02	151	44	195	16	211
			03	163	43	206	24	230
			04	164	45	209	20	229
			05	167	37	204	25	229
			M	163	42	205	20	225
			SD	7	3	6	5	8

(1)   = Body weight gain

M = Mean

SD = Standard deviation

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

LD50 > 2000 mg/kg

Executive summary:

In an acute oral toxicity study according to OECD guideline 401 (adopted February, 24 1987), one group of fasted, ca.. 6 weeks old, Sprague Dawley rats (5/sex) were given a single oral dose of Butyldiglycol methacrylate at doses of 2000 mg/kg bw and observed for 14 days.

No deaths occurred at 2000 mg/kg. Hypoactivity and piloerection were observed in all animals on day 1. Recovery was complete in all animals on day 2.

LD50: > 2000 mkg bw

NOTE: Any of data in this dataset are disseminated by the European Union on a right-to-know basis and this is not a publication in the same sense as a book or an article in a journal. The right of ownership in any part of this information is reserved by the data owner(s). The use of this information for any other, e.g. commercial purpose is strictly reserved to the data owners and those persons or legal entities having paid the respective access fee for the intended purpose.