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EC number: 230-813-8 | CAS number: 7328-22-5
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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:
- 1 999
- 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
- 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
Constituent 1
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
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