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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 939-549-4 | CAS number: -
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 10 May - 6 Sept 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Version / remarks:
- adopted 2009
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.2 (Acute Toxicity (Inhalation))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayer Heatlh Care - Bayer Pharma AG, Experimental Toxicology - Inhalation, Wuppertal, Germany
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Reference substance 001
- Cas Number:
- 28182-81-2
- Molecular formula:
- Unspecified (UVCB substance)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan-Nederland, Netherlands (Hsd Cpb:WU (SPF) wistar strain)
- Age at study initiation: 2 months
- Weight at study initiation: males: 178 - 187 g; females: 168 - 183 g
- Housing: singly in conventional Makrolon Type IIIH cages
- Diet: standard fixed-formula diet (KLIBA 3883), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 40 - 60
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Plexiglas exposure restrainers (TSE, Bad Homburg)
- Method of holding animals in test chamber: 20 rats in each inhalation chamber segment
- Source and rate of air: Dry conditioned air, 15 L/min
- Method of conditioning air: Compressed air was supplied by Boge compressors and was conditioned (free from water dust and oil) automatically by a VIA compressed air dryer.
- System of generating particulates/aerosols: Under dynamic conditions the targeted concentrations were achieved by atomization using the nozzle-baffle system and inhalation chamber. For atomization a binary nozzle and conditioned compressed air was used (15 L/min). The representative dispersion pressure was approximately 600 kPa. The test article was fed into the nozzle system using a digitally controlled pump.
- Method of particle size determination: Cascade impactor
- Treatment of exhaust air: The exhaust air was purified via filter systems.
- Temperature, humidity: mean temperatures from 20.7 to 22°C, 5% relative humidity
TEST ATMOSPHERE
- Brief description of analytical method used: Measurements were carried out using a RAS-2 real-time aerosol photometer.
- Samples taken from breathing zone: yes
TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: The particle size distribution was analyzed using a BERNER critical orifice cascade impactor.
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 1.8 µm/~1.6 - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- 0.235, 0.284, 0.314 mg/L
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were made several times on the day of exposure and daily thereafter, body weights were determined before exposure and on days 1, 3 and 7 and weekly thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: Reflexes were tested (visual placing response, grip strength on wire mesh, abdominal muscle tone, corneal and pupillary reflex, pinnal reflex, righting reflex, tail-pinch response, startle reflex with respect to behavioral changes stimulated by sounds (finger snapping) and touch (back); rectal temperatures were determined shortly after cessation of exposure. - Statistics:
- Analysis of variance (ANOVA) was used for statistical evaluation.
Calculation of LC50 was performed according to Rosiello et al. (1977; Rosiello, Essigmann and Wogan, Tox and Environ. Health, 3, pp797) as modified by Pauluhn (1983). It is based on the maximum likelihood method of Bliss (1983; Q.J.Pharm.Pharmacol., 11, pp192).
Results and discussion
- Preliminary study:
- Based on previous experience with this class of isocyanates the likely LC50 could be anticipated and a preliminary study was relinquished.
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LC50
- Effect level:
- 0.264 mg/L air
- Based on:
- test mat.
- 95% CL:
- >= 0.241 - <= 0.291
- Exp. duration:
- 4 h
- Sex:
- female
- Dose descriptor:
- LC50
- Effect level:
- > 0.314 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- No animal died in the lowest dose group of 0.235 mg/L. 4 male animals and 2 female animals of the middle dose group (0.284 mg/L) died during the first day following application. In the highest dose group (0.314 mg/L) all male ainmals died within one day, but only 1 female animal died.
- Clinical signs:
- other: Almost all treated animals showed bradypnoea, labored and irregular breathing patterns, reduced motility, atony, high-legged and uncoordinated gait, tremor, ungroomed hair-coat, piloerection, cyanosis, serous nasal discharge and encrustations of nose and
- Body weight:
- Treated animals showed reduced body weights as compared to control animals.
- Gross pathology:
- Necropsy of animals that died during the study revealed nasal/muzzle with red encrustations, nostrils with foamy content/discharge, lung less collapsed with foamy whitish content in trachea, hydrothorax, abdomen bloated and discoloration/bloodless appearance of parenchymatous organs.
Necropsy of surviving animals at the end of the study period did not reveal any abnormal finding compared to control. - Other findings:
- - Other observations: All treated animals showed significantly reduced rectal temperatures (hypothermia). A battery of reflex measurements was made on the first post-exposure day. ln comparison to the rats of the control group, rats of groups 2-4 exhibited impaired reflexes. Male animals of the low dose group showed a reduced tonus, impaired righting reflex and one animal each landed on side or back during drop method. Each one male animal from the mid dose group showed reduced grip strength (vertical and horizontal) and reduced tonus. One male animal was slightly uncoordinated.
Female animals from low dose showed reduced tonus (3/5), impaired righting reflex (2/5) and one female was slightly uncoordinated. Female animals from the mid dose group showed reduced vertical (1/5) and horizontal (3/5) grip strength, reduced tonus (1/5) and 2/5 animals were slightly uncoordinated. 4/5 female animals from the high dose group showed reduced tonus and one animal impaired righting reflex and another one was slightly uncoordinated.
Any other information on results incl. tables
Table 1. Table for acute inhalation toxicity.
Target concentration |
Toxicological results* |
Duration of clinical signs |
Time of death |
Mortality (%) |
Rectal Temperature (°C) |
Males |
|||||
0 |
0/0/5 |
--- |
--- |
0 |
38.0 |
0.235 |
0/5/5 |
Day 0-3 |
--- |
0 |
29.7** |
0.284 |
4/5/5 |
Day 0-5 |
Day 0-1 |
80 |
29.6** |
0.314 |
5/5/5 |
Day 0-1 |
Day 1 |
100 |
28.3** |
Females |
|||||
0 |
0/0/5 |
--- |
--- |
0 |
38.5 |
0.235 |
0/5/5 |
Day 0-10 |
--- |
0 |
29.5** |
0.284 |
2/5/5 |
Day 0-9 |
Day 1 |
40 |
30.1** |
0.314 |
1/5/5 |
Day 0-5 |
Day 1 |
20 |
29.2** |
LC50 = 0.264 mg/L air |
**significant different from control value, p<0.01
* first number = number of dead animals, second number = number of animals with clinical sings,third number = number of animals used
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.