Registration Dossier

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:
other: Guideline study, 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

Constituent 1
Chemical structure
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:
other: 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
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
no death occured
Clinical signs:
Hypoactivity and piloerection were observed in all animals on day 1. Recovery was complete in all animals on day 2.
Body weight:
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:
not classified
Remarks:
Migrated information 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.