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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 202-615-1 | CAS number: 97-88-1
- 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: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 08-26-92 / 12-21-93
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- yes
- Remarks:
- No macroscopic examination was performed at sacrifice
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Butyl methacrylate
- EC Number:
- 202-615-1
- EC Name:
- Butyl methacrylate
- Cas Number:
- 97-88-1
- Molecular formula:
- C8H14O2
- IUPAC Name:
- butyl methacrylate
- Details on test material:
- - Name of test material (as cited in study report): n-Butyl Methacrylate
- Physical state: liquid
Two batches were used:
- Lot/batch No.: H19845
- Analytical purity: 99.56%
- Purity test date: no data
- Expiration date of the lot/batch: no data
- Lot/batch No.: H19924
- Analytical purity: 99.49%
- Purity test date: no data
- Expiration date of the lot/batch: no data
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Inc., Kingston, New York, USA
- Age at exposure initiation :eight to ten weeks
- Weight at study initiation: male rats weighed 214 to 355 grams and female rats weighed from 171 to 232 grams
- Housing: either singly or in pairs (sexes separate) in 8" x 14" x 8" suspended, stainless steel, wire-mesh cages
- Diet (e.g. ad libitum): Purina Certified Rodent Chow© #5002
- Water (ad libitum): tap water from the Wilmington Suburban Water Corporation
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 2
- Humidity (%): 50 ± 10
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- inhalation
- Type of inhalation exposure:
- nose/head only
- Vehicle:
- other: unchanged (no vehicle)
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
During exposure, all rats were restrained in perforated, stainless steel or polycarbonate cylinders with conical nose pieces. The restrainers were inserted into the face plate of a 29-L cylindrical glass exposure chamber so that only the nose of each rat extended into the chamber.
Chamber airflow was set and recorded at the beginning of the four-hour exposure period. Chamber airflow ranged from 25 to 47 L/min, chamber temperature ranged from 21 to 25°C, chamber relative humidity ranged from 37 to 61%, and oxygen concentration was 21%..
Test atmospheres containing BMA aerosol were generated using a Spraying Systems or a Solo-Sphere Nebulizer. The test substance was either metered into the Spraying Systems nebulizer using a Harvard Apparatus Model 22 Infusion Pump or Fluid Metering Inc. Model RP G-150 Fluid Displacement Pump or placed in the reservoir of the Solo-Sphere Nebulizer. Filtered, high-pressure air introduced into the nebulizer swept the resulting atmosphere into the 29-L glass exposure chamber. The chamber concentration of BMA was controlled by varying the feed rate of test substance to the Spraying Systems nebulizer or varying the airflow to the Solo-Sphere nebulizer.
TEST ATMOSPHERE
The atmospheric concentrations of the test chemicals were determined at approximately 30-minute intervals during the exposures by gravimetric analysis and gas chromatography.
TEST ATMOSPHERE (if not tabulated)
- Particle size distribution:
One sample to determine particle size distribution (mass median aerodynamic diameter and percent particles less than 10 um diameter) was taken during each exposure with a Sierra® Series 210 cyclone preseparator/cascade impactor and a vacuum pump calibrated to a constant airflow.
About halfway through the 24 mg/1 experiment, it was noted that the aerosol distribution appeared to be non-uniform from the front to the back of the exposure chamber. The position of the chamber baffle was altered to attain a more homogeneous-appearing aerosol concentration. In addition, the rats were repositioned to compensate for the possible non-uniform chamber aerosol distribution. - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- 13.8, 18.2, 23.9, 26.6, 28.6, 36.0 mg/L
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- Each group of rats was observed for mortality during the exposure and observed for mortality and clinical signs of toxicity immediately after being removed from the restrainers following exposure. During a 13- or 14-day post-exposure period, surviving rats were observed each day for mortality. Surviving rats were weighed and observed daily for clinical signs of toxicity. At the end of the recovery period, all surviving rats were sacrificed by carbon dioxide asphyxiation and discarded.
- Statistics:
- The LC50 was calculated using the method of Finney.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- other: Approximate lethal concentration
- Effect level:
- 29 mg/L air
- Exp. duration:
- 4 h
- Mortality:
- Deaths occurred at BMA atmospheric concentrations of 29 mg/l or greater, see the table below.
In the 36 mg/l group, no rats died during exposure. Three female rats were found dead on test day 2.
In the 29 mg/l group, one male and one female rat died during exposure. Two male rats and two female rats were found dead on test day 2.
All rats in the 13.8, 18, 24, 27 mg/l survived the exposure and recovery period. - Clinical signs:
- other: In the 36 mg/l group, following exposure, clinical observations included discharge, corneal opacity (one rat), gasping, irregular respiration, lethargy, lung noise, weakness, and wet fur. Diarrhea, hunched posture, and ruffled and stained fur developed du
- Body weight:
- In the 36 mg/1 group, rats showed sporadic slight body-weight losses throughout the recovery period.
In the 29 mg/1 group, rats showed severe body-weight losses on test day 2. All surviving male rats generally gained body-weight during the rest of the recovery period. All surviving female rats had sporadic body-weight gain with slight to moderate body weight losses during the recovery period.
Following exposure at 13.8, 18, 24, 27 mg/l, rats showed slight to severe body-weight losses on test day 2, and sporadic slight body-weight losses during the remainder of the recovery period. - Gross pathology:
- No data
Any other information on results incl. tables
SUMMARY OF BMA CHAMBER CONCENTRATIONS AND ASSOCIATED RAT MORTALITY
TOTAL ATMOSPHERIC CONCENTRATION (mg/L) |
N |
AEROSOL/* VAPOR (%) |
VAPOR CONCENTRATION |
AEROSOL CONCENTRATION |
MORTALITY |
|
||||||
(#DEATHS/#EXPOSED) |
||||||||||||
MEAN |
ST.DEV. |
RANGE |
MEAN |
ST.DEV. |
MEAN |
ST.DEV. |
MALES |
FEMALES |
|
|||
13.8 |
0.94 |
12-15 |
8 |
25 /75 |
10 |
0.68 |
3.5 |
0.36 |
0/5 |
0 /5 |
|
|
18 |
3.6 |
9.8-22 |
8 |
43 /57 |
10 |
0.36 |
7.9 |
3.3 |
0/5 |
0 /5 |
|
|
24 |
2.0 |
20-27 |
8 |
56 /44 |
10 |
0.42 |
13 |
2.3 |
0/5 |
0 /5 |
|
|
27 |
2.2 |
23-29 |
8 |
62 /38 |
10 |
2.1 |
17 |
2.5 |
0/5 |
0 /5 |
|
|
29 |
0.98 |
26-30 |
8 |
66 /34 |
9.8 |
0.29 |
19 |
0.75 |
3/5 |
3 /5 |
|
|
36 |
1.5 |
34-38 |
8 |
67 /33 |
12 |
0.66 |
24 |
1.2 |
0/5 |
3 /5 |
|
* Aerosol/vapor ratios were calculated using the mean aerosol and vapor concentrations for each exposure.
SUMMARY OF BMA CHAMBER ENVIRONMENTAL CONDITIONS AND PARTICLE SIZE DISTRIBUTION
TOTAL CHAMBER CONCENTRATION (MG/L) |
AIRFLOW (L/MIN) |
N |
TEMPERATURE RANGE(°C) |
N |
HUMIDITY RELATIVE RANGE |
N |
OXYGEN (%) |
N |
MASS MEDIAN AERODYNAMIC DIAMETER (µm) |
GEOMETRIC STANDARD DEVIATION |
PERCENT PARTICLES <10 pm |
13.8 |
25 |
1 |
21- 24 |
4 |
41- 44 |
3 |
21 |
3 |
4.5 |
1.8 |
81 |
18 |
25 |
1 |
23- 25 |
4 |
41- 47 |
3 |
21 |
3 |
6.0 |
2.6 |
71 |
24 |
24 |
1 |
23- 24 |
4 |
60- 61 |
3 |
21 |
3 |
3.9 |
2.3 |
87 |
27 |
35 |
1 |
22- 23 |
4 |
45- 59 |
3 |
21 |
3 |
6.7 |
1.9 |
74 |
29 |
44 |
1 |
22- 23 |
4 |
37- 45 |
3 |
21 |
3 |
8.0 |
2.1 |
62 |
36 |
47 |
1 |
23- 25 |
4 |
40- 45 |
3 |
21 |
3 |
8.3 |
2.1 |
61 |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: other: REGULATIONS REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 December 2008
- Conclusions:
- In a valid guideline study, groups of five rats exposed to atmospheres containing BMA aerosol and vapour in air for 4 hours. Exposure concentrations were 14, 18, 24, 27, 29 or 36 mg/l. Deaths occurred at 29 mg/l (4901 ppm) or greater BMA in air. The approximate lethal concentration was 29 mg/l.
- Executive summary:
In an OECD 403 and GLP study with acceptable restriction (no macroscopic observation at sacrifice), six groups of five male and five female Sprague-Dawley rats each were exposedfor a single, four-hour period to atmospheres containing a mixture of n-BMA aerosol and vapor in air. Aerosol concentrations were determined by gravimetric analysis and vapor concentrations were determined by gas chromatography. During a 14-day recovery period, rats were weighed and observed for clinical signs of toxicity. Rats were exposed to 13.8, 18, 24, 27, 29, or 36 mg/l of BMA and the aerosol MMADs were 4.5, 6.0, 3.9, 6.7, 8.0 or 8.3 µm, respectively. Deaths occurred following exposure to n-BMA at concentrations of 29 mg/l or greater. Some important effects of exposure included slight to severe weight loss and signs of respiratory tract irritation. Surviving rats had an overall weight gain by the end of the recovery period.Under the conditions of this study, it was not possible to calculate the LC50. The approximate lethal concentration for n-BMA was 29 mg/l.
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.