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EC number: 700-700-2 | CAS number: 1369492-55-6
- 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
- Remarks:
- The study on acute inhalation was conducted solely to comply with a non-EU national registration requirement, and has been provided here in accordance with REACH, Article 22(1)e.
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 21 October 2014 to 10 December 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.2 (Acute Toxicity (Inhalation))
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1300 (Acute inhalation toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- traditional method
- Limit test:
- yes
Test material
- Reference substance name:
- N-[(3E)-11-(dichloromethylidene)tricyclo[6.2.1.0²,⁷]undec-2(7)-en-3-ylidene]hydroxylamine
- EC Number:
- 700-700-2
- Cas Number:
- 1369492-55-6
- Molecular formula:
- C12H13Cl2NO
- IUPAC Name:
- N-[(3E)-11-(dichloromethylidene)tricyclo[6.2.1.0²,⁷]undec-2(7)-en-3-ylidene]hydroxylamine
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Research Models and
Services, Germany GmbH, Sandhofer Weg 7, D-
97633 Sulzfeld
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 9 - 11 weeks old
- Weight at study initiation: males: 366-452g; females: 219-235g
- Fasting period before study: No
- Housing: Animals were grouped by sex (up to 5 animals per cage) in Type III solid floor cages with stainless steel mesh lids.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3°C
- Humidity (%): 30-70%
- Air changes (per hr): 15-20 air exchanges/hour
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Mass median aerodynamic diameter (MMAD):
- 3.71 µm
- Geometric standard deviation (GSD):
- 2.52
- Details on inhalation exposure:
- The animals were exposed, nose-only, to an atmosphere of the test item using a TSE Rodent Exposure System (TSE Systems GmbH, Bad Homburg, Germany). This system comprised of 2 concentric anodised aluminium chambers and a computer control system incorporating pressure detectors and mass flow controllers. Fresh aerosol from the generation system was constantly supplied to the inner plenum (distribution chamber) of the exposure system from where, under positive pressure, it was
distributed to the individual exposure ports. The animals were held in polycarbonate restraint tubes located around the chamber which allowed only the animal’s nares to enter the exposure port. After passing through the animal’s breathing zone, used aerosol entered the outer cylinder from where it was exhausted through a suitable filter system. Atmosphere generation was therefore dynamic. Airflows and relative pressures within the system were constantly monitored and controlled by the computer system thus ensuring a uniform distribution and constant flow of fresh aerosol to each exposure port (breathing zone). The flow of air through each port was at least 0.7 L/min. This flow rate was considered adequate to minimise re-breathing of the test atmosphere as it is about twice the respiratory minute volume of a rat. Homogeneity of the test atmosphere within the test chamber and amongst the exposure ports was not specifically determined during this study. However, chambers of this design have been fully validated and have shown to produce evenly distributed atmospheres in the animals’ breathing zones. - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- 5 mg/L
- No. of animals per sex per dose:
- 10 rats (5 male and 5 female)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
- all animals observed individually at hourly intervals during exposure, as soon as possible following removal from restrains at the end of exposure, 1 hour after exposure and twice daily for 14 days
- Individual bodyweights were recorded prior to treatment on the day of exposure (Day 0) and on Days 1, 3, 7 and 14.
- Necropsy of survivors performed: yes macroscopic examination and special attention given to the respiratory tract.
Results and discussion
- Preliminary study:
- A single sighting exposure was performed prior to the main study with 2 males and 2 females at the target concentration of 5 mg/L. No significant clinical signs were recorded on day of exposure and during whole two weeks of the observation period.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5.01 mg/L air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- All animals survived until the end of the observation period.
- Clinical signs:
- other: No significant clinical signs were recorded on day of exposure and during whole two weeks of the observation period. Wet fur and/or fur staining were recorded in animals on the day of exposure and day following exposure. These observations were considered
- Body weight:
- Normal bodyweight gain was noted for all exposed animals during the observation period. Slight bodyweight loss was noted during period Days 1-3 in some animals from the sighting (1/4) and main groups (3/10).
- Gross pathology:
- No necropsy findings were observed in any animals
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions of this study, no deaths occurred in a group of 10 rats (5/sex) exposed to the mean achieved concentration of 5.01 mg/L for 4 hours. The acute inhalation median lethal concentration of the test item, in CRL: (WI) Wistar strain rats is therefore considered to be greater than 5.01 mg/L.
- Executive summary:
The acute inhalation toxicity of the test substance was assessed in 10 (5 male and 5 female) CRL: (WI) Wistar strain rats according to the OECD guideline 403.
The animals were exposed to the mean achieved concentration of 5.01 mg/L test item during 4 hours using a nose-only exposure system. The animals were observed during 14 days after exposure.
The mean achieved atmosphere concentration was 5.01 mg/L. The MMAD (Mean Mass Aerodynamic Diameter) was 3.71 μm ± 2.52 (GSD [Geometric Standard Deviation]).
No mortality occurred during the course of the study. No significant clinical signs were recorded on day of exposure and during whole two weeks of the observation period. No necropsy findings were observed in any animals exposed to the test substance.
The acute inhalation median lethal concentration of test item, in CRL: (WI) Wistar strain rats is therefore considered to be greater than 5.01 mg/L.
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