Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 08.04.1999-29.06.1999
- 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 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- 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 / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Animals
Sex. species, strain: male New Zealand White rabbits.
Reason for this choice: species generally accepted by regulatory authorities for this type of study.
Breeder. Elevage Cunicole de Val de Sel1e, 80160 Prouzel, France.
Number of animals: 3
Identification: the animals were identified individually with a metal ear tag.
Weight: on the day of treatment, the animals had a mean body weight ± standard deviation of 2.7 ±0.2kg.
Acclimatization: at least 5 days before the beginning of the study.
Environmental conditions
The conditions in the animal room were set as follows:
· temperature: 18 ± 3°C
· relative humidity: 30 to 70%
. light/dark cycle: 12 hlI2 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 were verified and calibrated at regular intervals.
The animals were housed individually in polystyrene cages (48.2 cm x 58 cm x 36.5 cm).
Each cage was equipped with a food container and a water bottle.
Food and water
During the study. the animals had free access to 112 C pelleted diet (UAR. 91360 Villemoissonsur-Orge, France).
Each batch of food was analysed by the supplier for composition and contaminant levels.
The diet formula is presented in appendix 2.
Drinking water filtered by a FG Millipore membrane (0.22 micron) was provided ad libitum.
Bacteriological and chemical analyses of the water and diet, including the detection of possible contaminants (pesticides, heavy metals and nitrosamines), are perfonned regularly by external laboratories.
The results of these analyses are archived at err.
No contaminants were known to have been present in the diet, drinking water or bedding material at levels which may be expected to have interfered with or prejudiced the outcome of the study.
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 0.1 ml
- Observation period (in vivo):
- Eyes were examined approximately 1 hour, 24, 48 and 72 hours after administration of the test substance
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- The study design was established according to available infonnation on the test substance and according to the OECD (No. 405) and EC (92169/EEC. 8.5) guidelines.
As possible irritant effects were anticipated, the test substance was administered to a single animal (No. 768) in the first instance.
Since the test substance was not severely irritant on this first animal, it was then evaluated on two other animals (Nos. 769 and 770).
Administration of the test substance
A single dose of 0.1 mt of the undiluted test substance was instilled into the conjunctival sac of the left eye after gently pulling the lower lid away from the eyeball.
The lower and upper eyelids were held together for about one second to avoid any loss of test substance. The right eye, which remained untreated, served as control.
The eyes were not rinsed after administration of the test substance.
OCULAR EXAMINATIONS
The eyes were examined approximately 1 hour, 24, 48 and 72 hours after administration of the
test substance.
Following the OEeD and EC guidelines:
• when there was no evidence of irritation after 72 hours, the study was ended.
• when there was persistent ocular irritation after 72 hours, the observation period was extended
to a maximum of 21 days (until day 22) in order to detennine the progress of the lesions and
their reversibility.
• when severe irritant effects were observed, the animals were killed on humane grounds.
Any change in the animals'behaviour was noted.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 h
Any other information on results incl. tables
- Irreversible damage to cornea, iris, conjunctiva 21 days after exposure in at least one animal
- Mean Draize score in 2 of 3 animals:
- Reversible adverse effects on cornea, iris, conjunctiva
- Mean Draize score in 2 of 3 animals:
- Reversible in 21 days
- Reversible in 7 days
Classification of eye irritation studies according GHS-criteria
Substance: Butyldiglycol methacrylate BDGMA CAS: 7328-22-5
Internal No.: LITSU 12-0039
Date/Expert: 12-11-02/Am
Animal No. |
Corneal opacity/Hornhauttrübung[Scores]
|
Mean Draize score |
Reversibility [scores] |
Hazard category |
|||
after 24 h |
after 48 h |
after 72 h |
in 7 days |
in 21 days |
|
||
1 |
0 |
0 |
0 |
0 |
n.d. |
n.d. |
|
2 |
0 |
0 |
0 |
0 |
n.d. |
n.d. |
|
3 |
0 |
0 |
0 |
0 |
n.d. |
n.d. |
|
|
|
|
|
|
|
|
none |
|
|
|
|
|
|
|
|
Animal No. |
Iritis/Regenbogenhautentzündung[Scores]
|
Mean Draize score |
Reversibility [scores] |
Hazard category |
|||
after 24 h |
after 48 h |
after 72 h |
in 7 days |
in 21 days |
|
||
1 |
0 |
0 |
0 |
0 |
n.d. |
n.d. |
|
2 |
0 |
0 |
0 |
0 |
n.d. |
n.d. |
|
3 |
0 |
0 |
0 |
0 |
n.d. |
n.d. |
|
|
|
|
|
|
|
|
none |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Animal No. |
Conjunctiva redness (erythem) /Bindehautrötung[Scores]
|
Mean Draize score |
Reversibility [scores] |
Hazard category |
|||
after 24 h |
after 48 h |
after 72 h |
in 7 days |
in 21 days |
|
||
1 |
1 |
0 |
0 |
0.33 |
n.d. |
n.d. |
|
2 |
1 |
1 |
0 |
0.66 |
n.d. |
n.d. |
|
3 |
1 |
0 |
0 |
0.33 |
n.d. |
n.d. |
|
|
|
|
|
|
|
|
none |
|
|
|
|
|
|
|
|
Animal No. |
Conjunctiva chemosis /Bindehautödem[Scores]
|
Mean Draize score in 2 of 3 animals |
Reversibility [scores] |
Hazard category |
|||
after 24 h |
after 48 h |
after 72 h |
in 7 days |
in 21 days |
|
||
1 |
1 |
0 |
0 |
0.33 |
n.d. |
n.d. |
|
2 |
1 |
1 |
0 |
0.66 |
n.d. |
n.d. |
|
3 |
1 |
1 |
0 |
0.66 |
n.d. |
n.d. |
|
|
|
|
|
|
|
|
none |
Classification: Hazard Category |
none |
n.d. = no data
Classification Criteria for serious Eye Damage/Eye Irritation
Category 1
corneal opacity≥ 3
iritis ≥ 1,5
Category 2
corneal opacity≥1
iritis≥1
redness≥2
chemosis≥2
Subcategory 2A
Subcategory 2B
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- In an eye irritation study acc. OECD 405 3 rabbits were exposed to 0.1 ml Butyldiglycol methacrylate. Mean scores calculated for each animal over 24, 48 and 72 hours were 0.33, 0.66 and 0.66 for chemosis, 0.33, 0.66 and 0.33 for redness of the conjunctiva, 0.0, 0.0 and 0.0 for iris lesions and 0.0, 0.0 and 0.0 for corneal opacity.
The irritations were fully reversible within 72 hours.
Butyldiglycol is not classified acc. EU-GHS criteria. - Executive summary:
In an eye irritation study acc. OECD 405 3 rabbits were exposed to 0.1 ml Butyldiglycol methacrylate. Mean scores calculated for each animal over 24, 48 and 72 hours were 0.33, 0.66 and 0.66 for chemosis, 0.33, 0.66 and 0.33 for redness of the conjunctiva, 0.0, 0.0 and 0.0 for iris lesions and 0.0, 0.0 and 0.0 for corneal opacity. The irritations were fully reversible within 72 hours.
Butyldiglycol is not classified acc. EU-GHS criteria.
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.