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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 223-445-4 | CAS number: 3896-11-5
- 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
![](https://echa.europa.eu./o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Exposure related observations in humans: other data
Administrative data
- Endpoint:
- exposure-related observations in humans: other data
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
Data source
Reference
- Reference Type:
- publication
- Title:
- OECD HPV Chemical Programme, SIDS Dossier, approved at SIAM 28, 14-17 April 2009
- Author:
- OECD
- Year:
- 2 009
- Bibliographic source:
- https://hpvchemicals.oecd.org/UI/SIDS_Details.aspx?id=56B1CBB4-88AD-496E-87DD-C40C05BC9E9B
Materials and methods
- Type of study / information:
- Occupational exposure to test material measured at production site in Japan
- Endpoint addressed:
- not applicable
- Principles of method if other than guideline:
- Sampling of the test substance was performed during working hours, indoors and outdoors when the possibility of exposure to humans is high. Sampling was done by collecting air from near the mouth of workers. To complete this, workers were asked to repeat the operations for 2 to 6 times before sampling the air. Where possible, air was also sampled from besides the waist.
- GLP compliance:
- no
Test material
- Reference substance name:
- Bumetrizole
- EC Number:
- 223-445-4
- EC Name:
- Bumetrizole
- Cas Number:
- 3896-11-5
- Molecular formula:
- C17 H18 Cl N3 O
- IUPAC Name:
- 2-tert-butyl-6-(5-chloro-2H-benzotriazol-2-yl)-4-methylphenol
- Test material form:
- solid
Constituent 1
Method
- Ethical approval:
- not applicable
- Details on study design:
- Sampling and analytical method: The sample was collected via a glass fiber filter (Toyo Roshi Inc. / GB100R, diameter 37 mm) and filter cassette (SKC / 2-CP, diameter 37 mm) at an aspiration rate of 2.0 L/min. After collection, the glass fiber filter was extracted with 5 mL of dichloromethane by sonication for 30 min. The extracted solution was centrifuged at 3000 rpm for 10 minutes to remove any fibers and the supernatant liquid was analysed by liquid chromatography using a UV detector. LOQ = 0.0058 mg/m³ in air.
- Exposure assessment:
- measured
- Details on exposure:
- TYPE OF EXPOSURE: inhalation exposure
TYPE OF EXPOSURE MEASUREMENT: Area air sampling (near the mouth) and where possible, near the waist
Results and discussion
- Results:
- See table 1.
Occupational exposure to the substance can occur mainly by inhalation and dermal routes at the production and user sites during operations. The atmospheric concentration was measured at one production site in Japan. The monitored data are shown in table 1. It should be noted that operators wear overalls, gloves, helmets, protective eye goggles and a respirator during all operations, minimizing their exposure to the substance.
The air concentration of bumetrizole was in the range < 0.0058 mg/m³ - 0.21 mg/m³. The highest concentration was associated with removal of the product from the centrifuge, with the concentration around the workers mouth reaching 0.21 mg/m³.
Any other information on results incl. tables
Table 1 Measurement results of in-air concentration of bumetrizole during operation
Operation |
Frequency of operation |
Duration of operation |
Sampling time |
n |
Range |
Arithmetic average |
Geometric average |
|||
Minimum (mg/m3) |
Maximum (mg/m3) |
Average (mg/m3) |
S.D. (mg/m3) |
Average (mg/m3) |
S.D. |
|||||
Diazotization and coupling reaction |
1/day |
120 min |
30 min |
2 |
<0.0058* |
<0.0058* |
<0.0058* |
<0.0058* |
||
Reductive reaction/ end check |
1/day |
20 min |
17 min |
6 |
<0.010* |
<0.010* |
<0.010* |
<0.010* |
||
Reductive reaction/ separation |
1/day |
30 min |
30 min |
6 |
0.0085 |
0.043 |
0.020 |
0.017 |
0.015 |
2.2 |
Automatic centrifuge of product |
6/day |
60 min |
30 min |
2 |
<0.0058* |
0.0068 |
0.0063 |
0.0007 |
0.0062 |
1.1 |
Product scraping of centrifuge |
1/day |
10 min |
10 min |
6 |
<0.018* |
0.021 |
0.018 |
0.001 |
0.018 |
1.1 |
Product removal from centrifuge |
6/day |
10 min |
10 min |
6 |
<0.018* |
0.21 |
0.080 |
0.097 |
0.040 |
3.5 |
Carry in to drying process |
6/day |
10 min |
10 min |
6 |
<0.018* |
0.098 |
0.032 |
0.032 |
0.025 |
2.0 |
Product packaging Filling operation |
6/day |
30 min |
26 min |
6 |
0.0083 |
0.052 |
0.030 |
0.016 |
0.026 |
1.9 |
*Limit of determination of the analytical method for the sampling time
Applicant's summary and conclusion
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)