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EC number: - | 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 March 2012 and 08 May 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was performed according to OECD guideline and GLP. There were no significant deviations.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
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))
- Principles of method if other than guideline:
- 1. The relative humidity (animal room) increased above the target values on two separate occasions during the course of the study.
2. Two samples are outside 20% (Lower) of the mean achieved atmosphere concentration.
These deviations did not influence the outcome of the study. - GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Ltd, Oxon, UK
- Age at study initiation: eight to twelve weeks
- Weight at study initiation: 200g to 350g
- Fasting period before study: No
- Housing: The animals were housed in groups of five by sex in solid-floor polypropylene cages with stainless steel lids, furnished with softwood flakes (Datesand Ltd., Cheshire, UK) and provided with environmental enrichment items: wooden chew blocks and cardboard "fun tunnels" (Datesand Ltd., Cheshire, UK).
- Diet/water (e.g. ad libitum): With the exception of the exposure period, free access to mains drinking water and food (Harlan 2014C Rodent Diet, Harlan Laboratories UK Ltd, Oxon, UK) was allowed throughout the study. The diet, drinking water, bedding and chew blocks are routinely analysed and are considered not to contain any contaminants that could reasonably be expected to affect the purpose or integrity of
the study.
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.62 - 22.42°C
- Humidity (%): 38.27 -77.98%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To:
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: see attached picture.
- Exposure chamber volume: 30 litres (dimensions: 28 cm diameter x 50 cm high).
- Method of holding animals in test chamber: During the day of exposure, each rat was individually held in a tapered, polycarbonate restraining tube fitted onto a single tier of the exposure chamber and sealed by means of a rubber '0' ring. Only the nose of each animal was exposed to the test atmosphere.
- Source and rate of air: Compressed air. The chamber flow rate was maintained at 60 L/min providing 120 air changes per hour.
- Method of conditioning air: Compressed air was supplied by means of an oil free compressor and passed through a water trap and respiratory quality filters before it was introduced to the nebuliser.
- System of generating particulates/aerosols: glass concentric jet nebuliser (Radleys, Saffron Walden, Essex, UK) located at the top of the exposure chamber. The nebuliser was connected to a plastic syringe (covered in foil to protect the test item from light) attached to an infusion pump, which provided a continuous supply of test item formulation under pressure, and to a metered compressed air supply.
- Method of particle size determination: The particle size of the generated atmosphere inside the exposure chamber was determined three times during the exposure period using a Marple Personal Cascade Impactor (Westech IS Ltd, Beds., UK).
- Treatment of exhaust air: The extract from the exposure chamber passed through a 'scrubber' trap and was connected with a high efficiency filter to a metered exhaust system.
- Temperature, humidity, pressure in air chamber: The temperature and relative humidity inside the exposure chamber were measured by an electronic thermometer/humidity meter (Hanna Instruments Ltd, Beds., UK) located in a vacant port in the animals' breathing zone of the chamber and recorded every thirty minutes throughout the four-hour exposure period.
TEST ATMOSPHERE
- Brief description of analytical method used: HPLC was used. During the characterisation phase of the study the test atmosphere was sampled twice and filter samples were then submitted for chemical analysis to determine if the original test item was similar to the composition of the airborne test item.
Prior to the inhalation phase of the study, the non-volatile component of the test item was determined by adding a small, known amount of test item to glass fibre filters and recording their weights. The filters were then dried in a desiccator between 19 and 21°C for approximately 24 hours and then weighed again. The difference in the two weights was taken as the volatile content of the test item and the non-volatile component was calculated as a percentage. The mean non-volatile component of the batch used during the formal exposure was found to be 21.52% (n=10).
- Samples taken from breathing zone: yes
TEST ATMOSPHERE (if not tabulated)
- Particle size distribution:
Cascade impactor data:
Impactor Stage Cut Point Amount Collected (mg) per Sample Number
Number (µm) 1 2 3 Mean Amount Collected (mg)
3 9.7 0.01 0.07 0.02 0.03
4 6.7 0.07 0.10 0.11 0.09
5 3.8 0.45 0.69 0.38 0.51
6 1.8 0.66 0.77 0.52 0.65
7 0.94 0.56 0.74 0.47 0.59
8 0.46 0.13 0.13 0.09 0.12
Back-up Filter<0.46 0.04 0.00 0.00 0.01
Total Mean Amount of Test Item Collected 2.00
Calculation
Cut Point Log10 Mean Cumulative Amount Less Than Cut Point
(µm) Cut Point (mg) (0/0) Probit
9.7 0.987 1.97 98.5 7.17
6.7 0.826 1.88 94.0 6.56
3.8 0.580 0.37 68.5 5.48
1.8 0.255 0.72 36.0 4.64
0.94 -0.027 0.13 6.50 3.49
0.46 -0.337 0.01 0.500 2.42
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 2.47/1.92 - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- 5.64 mg/L
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Clinical Signs
All animals were observed for clinical signs at hourly intervals during exposure, immediately on removal from the restraining tubes at the end of exposure, one hour after termination of exposure and subsequently once daily for up to fourteen days. Any evidence of overt toxicity was recorded at each observation.
Bodyweight
Individual bodyweights were recorded on arrival, prior to treatment on the day of exposure and on Days 1, 3, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed:
Necropsy
At the end of the fourteen day observation period the animals were killed by intravenous overdose of sodium pentobarbitone. All animals were subjected to a full external and internal examination, and any macroscopic abnormalities were recorded. The respiratory tract was subjected to a detailed macroscopic examination for signs of irritancy or local toxicity.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5.64 mg/L air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- No mortality occured
- Clinical signs:
- other: Signs of hunched posture and pilo-erection are commonly seen in animals for short periods on removal from the chamber following 4-Hour inhalation studies. Wet fur is commonly recorded both during and for a short period after exposure. These observations a
- Body weight:
- All males and four female animals exhibited bodyweight losses on the first day postexposure. All male animals subsequently exhibited reasonable bodyweight gains throughout the remainder of the recovery period. In contrast, three female animals .exhibited slight bodyweight losses or showed no bodyweight gain from Days 1 to 3 postexposure. Reasonable bodyweight development was noted in all female animals during the remainder of the recovery period.
- Gross pathology:
- With the exception of one instance of dark patches on the lungs, no macroscopic abnormalities were detected amongst animals at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- No deaths occurred in a group of ten rats exposed to a mean achieved atmosphere concentration of 5.64 mg/L for four hours. It was therefore considered that the acute inhalation median lethal concentration (4 hr LC50) of Complexation products of sodium
tartrate with iron trichloride, in the RccHan™ : WIST strain rat, was greater than 5.64 mg/L. - Executive summary:
Introduction.
A study was performed to assess the acute inhalation toxicity of the test item. The method used was designed to be compatible with that described in the OECD Guidelines for Testing of Chemicals (2009) No. 403 "Acute Inhalation Toxicity" and with Method B2 (Inhalation) of Commission Regulation (EC) No. 440/2008.
Methods.
A group of ten RccHan™ : WIST strain rats (five males and five females) was exposed to an aerosol atmosphere. The animals were exposed for four hours using a nose only exposure system, followed by a fourteen day observation period.
Results.
The mean achieved atmosphere concentration was as follows:
Atmosphere Concentration
Mean Achieved (mg/L) 5.64
Standard Deviation 0.71
Nominal (mg/L) 18.5
The characteristics of the achieved atmosphere were as follows:
Mean Achieved Atmosphere Concentration (mg/L) 5.64
Mean Mass Median Aerodynamic Diameter (µM) 2.47
Inhalable Fraction (% < 4 µM) 77.2
Geometric Standard Deviation 1.92
Clinical Observations.
No deaths occured. Common abnormalities noted during the study included increased respiratory rate, hunched posture, pilo-erection and wet fur. From Days 5 to 7 post-exposure the animals recovered and all animals in the study appeared normal after day 7 post-exposure.
Bodyweight.
All males and four female animals exhibited bodyweight losses on the first day post-exposure. All male animals subsequently exhibited reasonable bodyweight gains throughout the remainder of the recovery period. In contrast, three female animals exhibited slight bodyweight losses or showed no bodyweight gain from Days 1 to 3 postexposure. Reasonable bodyweight development was noted in all female animals during the remainder of the recovery period.
Necropsy.
With the exception of one instance of dark patches on the lungs, no macroscopic abnormalities were detected amongst animals at necropsy.
Conclusion.
No deaths occurred in a group of ten rats exposed to a mean achieved atmosphere concentration of 5.64 mg/L for four hours. It was therefore considered that the acute inhalation median lethal concentration (4 hr LC50) of Complexation products of sodium tartrate with iron trichloride, in the RccHan™ : WIST strain rat, was greater than 5.64 mg/L.
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