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EC number: 233-149-7 | CAS number: 10045-86-0
- 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:
- 10th October 2011 - 17 November 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 436 (Acute Inhalation Toxicity: Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Iron orthophosphate
- EC Number:
- 233-149-7
- EC Name:
- Iron orthophosphate
- Cas Number:
- 10045-86-0
- Molecular formula:
- FePO4
- IUPAC Name:
- iron(3+) phosphate
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 (UK) Ltd.
- Age at study initiation:
approximately eight to twelve weeks old
- Weight at study initiation:
200g to 350g.
- Fasting period before study:
Not applicable
- Housing:
The animals were housed in solid-floor polypropylene cages with stainless steel lids, furnished with softwood flakes and provided with environmental enrichment items: wooden chew blocks and cardboard “fun tunnels”
- Diet:
ad libitum
- Water:
ad libitum
- Acclimation period:
at least five days
ENVIRONMENTAL CONDITIONS
- Temperature:
19 - 25°C
- Humidity:
30 - 70 %
- Air changes (per hr):
at least fifteen changes per hour
- Photoperiod (hrs dark / hrs light):
twelve hours continuous light and twelve hours darkness
IN-LIFE DATES:
From: 26 October 2011 To: 17 November 2011
Administration / exposure
- Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Mass median aerodynamic diameter (MMAD):
- 2.96 µm
- Geometric standard deviation (GSD):
- 3.22
- Remark on MMAD/GSD:
- Inhalable Fraction (% <4 µm) 60.2
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus:
a SAG 410 Solid Aerosol Generator (TOPAS GmbH, Dresden, Germany) plus cylindrical exposure chamber
- Exposure chamber volume:
approximately 30 litres
- Method of holding animals in test chamber:
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 ‘O’ ring. Only the nose of each animal was exposed to the test atmosphere.
- Source and rate of 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 SAG 410. 60 L/min providing 120 air changes per hour
- Method of conditioning air:
water trap and respiratory quality filters
- System of generating particulates:
SAG 410 Solid Aerosol Generator , a particle separator was introduced before the aerosol entered the exposure chamber in order to remove large particles and thereby increase the inhalable portion of the generated aerosol.
- Method of particle size determination:
Marple Personal Cascade Impactor .
- Treatment of exhaust air:
filtered
- Temperature, humidity, pressure in air chamber: temperature and relative humidity inside the exposure chamber were measured by an electronic thermometer/humidity meter 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:
glass fibre filters (Gelman type A/E 25 mm) placed in a filter holder. The holder was temporarily sealed in a vacant port in the exposure chamber in the animals’ breathing zone and a suitable, known volume of exposure chamber air was drawn through the filter using a vacuum pump (Gravimetric).
- Samples taken from breathing zone:
yes
VEHICLE
- Composition of vehicle (if applicable):
Not applicable
- Concentration of test material in vehicle:
Not applicable
- Justification of choice of vehicle:
Not applicable
- Lot/batch no. (if required):
Not applicable
- Purity: Not applicable
TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: tabulated
- MMAD (Mass median aerodynamic diameter: 9.93 µm
CLASS METHOD (if applicable)
- Rationale for the selection of the starting concentration: Not applicable. - Analytical verification of test atmosphere concentrations:
- no
- Remarks:
- Gravimetric only
- Duration of exposure:
- 4 h
- Concentrations:
- Mean Achieved (mg/L) 5.05
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 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 fourteen days. Individual 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: clinical signs. - Statistics:
- Data evaluations included the relationship, if any, between the animals’ exposure to the test material and the incidence and severity of all abnormalities including behavioural and clinical observations, necropsy findings, bodyweight changes, mortality and any other toxicological effects.
Using the mortality data obtained, an estimate of the acute inhalation median lethal concentration (LC50) of the test material was made.
Results and discussion
- Preliminary study:
- Not applicable
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5.05 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- No deaths occurred in a group of six rats exposed to a mean achieved atmosphere concentration of 5.05 mg/L for four hours
See Appendix 3 Mortality Data in the overall remarks section. - Clinical signs:
- other: Common abnormalities noted during the study included increased respiratory rate, hunched posture, pilo-erection and wet fur. See Appendix 4 Individual Clinical Observations(Day of Exposure) and Appendix 5 Individual Clinical Observations (Recovery Peri
- Body weight:
- All animals exhibited bodyweight losses or showed no bodyweight gain on the first day post-exposure. All animals exhibited reasonable bodyweight developments throughout the remainder of the recovery period. With the exception of one female animal which showed no bodyweight gain from Days 3 to 7 post-exposure. See Appendix 6.
Appendix 6 Individual Bodyweights in the overall remarks section. - Gross pathology:
- No macroscopic abnormalities were detected amongst animals at necropsy.
- Other findings:
- Not applicable.
Any other information on results incl. tables
Exposure Chamber Concentration
The test atmosphere was sampled seventeen times during the exposure period and the actual concentration of the test item calculated. The mean values obtained were:
Atmosphere Concentration |
||
Mean Achieved (mg/L) |
Standard Deviation |
Nominal (mg/L) |
5.05 |
0.11 |
9.22 |
The chamber flow rate was maintained at 60 L/min providing 120 air changes per hour.The theoretical chamber equilibration time (T99) was 3 minutes (Silver, 1946). However,Test atmospheres were generated for a total of 24 minutes prior to animal insertion to ensure test item concentration was being achieved.
Particle Size Distribution
The particle size analysis of the atmosphere drawn from the animals’ breathing zone, was as follows:
Mean Achieved Atmosphere Concentration (mg/L) |
Mean Mass Median Aerodynamic Diameter (µm) |
Inhalable Fraction (% <4 µm) |
Geometric Standard Deviation |
5.05 |
2.96 |
60.2 |
3.22 |
Mortality Data
The mortality data are given in Appendix 3 and are summarised as follows:
Mean Achieved Atmosphere Concentration |
Deaths |
||
Male |
Female |
Total |
|
5.05 |
0/3 |
0/3 |
0/6 |
Appendix1 Exposure Chamber Atmosphere Concentrations
Duration of Exposure (minutes) |
Net Weight of Sample (mg) |
Volume of Air Sampled (L) |
Chamber Flow Rate (L/min) |
Atmosphere Concentration (mg/L) |
5 |
10.04 |
2 |
60 |
5.02 |
15 |
9.94 |
2 |
60 |
4.97 |
30 |
10.11 |
2 |
60 |
5.06 |
45 |
10.04 |
2 |
60 |
5.02 |
60 |
9.91 |
2 |
60 |
4.96 |
75 |
10.26 |
2 |
60 |
5.13 |
90 |
10.11 |
2 |
60 |
5.06 |
105 |
10.11 |
2 |
60 |
5.06 |
120 |
10.25 |
2 |
60 |
5.13 |
135 |
10.16 |
2 |
60 |
5.08 |
150 |
10.71 |
2 |
60 |
5.36 |
165 |
9.85 |
2 |
60 |
4.93 |
180 |
10.06 |
2 |
60 |
5.03 |
195 |
9.75 |
2 |
60 |
4.88 |
210 |
9.78 |
2 |
60 |
4.89 |
225 |
10.31 |
2 |
60 |
5.16 |
238 |
10.12 |
2 |
60 |
5.06 |
Mean achieved atmosphere concentration (mg/L) =5.05
Standard deviation =0.11
Nominal concentration:
Test item used (g) |
146 |
Air Flow (L/min) |
60 |
Total Generation Time (mins) |
264 |
Nominal Concentration (mg/L) |
9.22 |
[1]= Test atmospheres were generated for a total of 24 minutes prior to animal insertion to ensure test item concentration was being achieved.
Appendix2 Particle Size Distribution
Cascade Impactor Data
Impactor Stage Number |
Cut Point (µm) |
Amount Collected (mg) per Sample Number |
Mean Amount Collected (mg) |
||
1 |
2 |
3 |
|||
3 |
8.8 |
0.33 |
0.29 |
0.04 |
0.22 |
4 |
5.8 |
0.45 |
0.50 |
0.10 |
0.35 |
5 |
3.6 |
0.38 |
0.37 |
0.20 |
0.32 |
6 |
1.9 |
0.59 |
0.62 |
0.33 |
0.51 |
7 |
0.79 |
0.11 |
0.14 |
0.34 |
0.20 |
8 |
0.33 |
0.14 |
0.12 |
0.15 |
0.14 |
Back-up Filter |
<0.33 |
0.04 |
0.06 |
0.20 |
0.10 |
Total Mean Amount of Test Item Collected |
1.84 |
Calculation
Cut Point (µm) |
Log10 Cut Point |
Mean Cumulative Amount Less Than Cut Point |
||
(mg) |
(%) |
Probit |
||
8.8 |
0.945 |
1.62 |
88.0 |
6.18 |
5.8 |
0.763 |
1.27 |
69.0 |
5.50 |
3.6 |
0.556 |
0.95 |
51.6 |
5.04 |
1.9 |
0.279 |
0.44 |
23.9 |
4.29 |
0.79 |
-0.102 |
0.24 |
13.0 |
3.88 |
0.33 |
-0.482 |
0.10 |
5.44 |
3.40 |
Results
Mean Mass Median Aerodynamic Diameter (MMAD) =2.96µm
Geometric Standard Deviation (GSD) =3.22
Predicted amount less than 4 µm =60.2%
Appendix 3 Mortality Data
Mean Achieved Atmosphere Concentration (mg/L) |
Sex |
Deaths During Exposure |
Deaths Post Exposure (1 Hour) |
Deaths During Day of Observation |
Total Deaths |
|||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8-14 |
|||||
5.05 |
Male |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/6 |
Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Appendix 4 Individual Clinical Observations(Day of Exposure)
Mean Achieved Atmosphere Concentration (mg/L) |
Animal Number and Sex |
Hours During Exposure |
On Removal From Chamber |
One Hour Post-Exposure |
||
1 |
2 |
3 |
||||
5.05 |
1 Male |
Wf Ri |
Wf Ri |
Wf Ri |
Wf H P Ri |
Wf H P Ri |
2 Male |
Wf Ri |
Wf Ri |
Wf Ri |
Wf H P Ri |
Wf H P Ri |
|
3 Male |
Wf Ri |
Wf Ri |
Wf Ri |
Wf H P Ri |
Wf H P Ri |
|
4 Female |
Wf Ri |
Wf Ri |
Wf Ri |
Wf H P Ri |
Wf H P Ri |
|
5 Female |
Wf Ri |
Wf Ri |
Wf Ri |
Wf H P Ri |
Wf H P Ri |
|
6 Female |
Wf Ri |
Wf Ri |
Wf Ri |
Wf H P Ri |
Wf H P Ri |
Appendix 5 Individual Clinical Observations (Recovery Period)
Mean Achieved Atmosphere Concentration (mg/L) |
Animal Number and Sex |
Days Post Exposure |
|||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 - 14 |
||
5.05 |
1 Male |
H Ri |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 Male |
H Ri |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3 Male |
H Ri |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
4 Female |
H Ri |
Ri |
Ri |
Ri |
0 |
0 |
0 |
0 |
|
5 Female |
H Ri |
Ri |
Ri |
Ri |
0 |
0 |
0 |
0 |
|
6 Female |
H Ri |
Ri |
Ri |
Ri |
0 |
0 |
0 |
0 |
Appendix 6 Individual Bodyweights.
Mean Achieved Atmosphere Concentration (mg/L) |
Animal Number and Sex |
Bodyweight (g) on Day: |
Increment (g) During Days: |
|||||||||
-8 |
0 |
1 |
3 |
7 |
14 |
-8-0 |
0-1 |
1-3 |
3-7 |
7-14 |
||
5.05 |
1 Male |
215 |
257 |
250 |
260 |
276 |
299 |
42 |
-7 |
10 |
16 |
23 |
2 Male |
223 |
274 |
264 |
268 |
289 |
318 |
51 |
-10 |
4 |
21 |
29 |
|
3 Male |
215 |
278 |
278 |
287 |
303 |
333 |
63 |
0 |
9 |
16 |
30 |
|
4 Female |
191 |
202 |
198 |
199 |
199 |
205 |
11 |
-4 |
1 |
0 |
6 |
|
5 Female |
202 |
218 |
217 |
222 |
227 |
239 |
16 |
-1 |
5 |
5 |
12 |
|
6 Female |
199 |
212 |
208 |
213 |
217 |
224 |
13 |
-4 |
5 |
4 |
7 |
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008
- Conclusions:
- No deaths occurred in a group of six rats exposed to a mean achieved atmosphere concentration of 5.05 mg/L for four hours. It was therefore considered that the acute inhalation median lethal concentration (4 hr LC50) of IP 27 Iron orthophosphate, in the RccHanTM : WIST strain rat, was greater than 5.05 mg/L (Globally Harmonised Classification System – Unclassified). This study is considered to be scientifically justified for use as a key study under Regulation (EC) No. 1907/2006 and the results are appropriate for the purposes of classification and labelling in accordance with Regulation (EC) No. 1272/2008 (EU CLP).
- Executive summary:
Introduction.
A study was performed to assess the acute inhalation toxicity of the test item. The method used was compatible with that described in the OECD Guidelines for Testing of Chemicals (2009) No. 436 “Acute Inhalation Toxicity – Acute Toxic Class Method”.
Methods.
A group of six RccHanTM: WIST strain rats (three males and three females) was exposed to a dust 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)
Standard Deviation
Nominal (mg/L)
5.05
0.11
9.22
The characteristics of the achieved atmosphere were as follows:
Mean Achieved Atmosphere Concentration (mg/L)
Mean Mass Median Aerodynamic Diameter (µm)
Inhalable Fraction
(% <4 µm)
Geometric Standard Deviation
5.05
2.96
60.2
3.22
The mortality data were summarised as follows:
Mean Achieved Atmosphere Concentration (mg/L)
Deaths
Male
Female
Total
5.05
0/6
0/6
0/6
Clinical Observations.
Common abnormalities noted during the study included increased respiratory rate, hunched posture, pilo-erection and wet fur. Animals recovered to appear normal from Days 2 to 5 post-exposure.
Bodyweight.
All animals exhibited bodyweight losses or showed no bodyweight gain on the first day post-exposure. All animals exhibited reasonable bodyweight developments throughout the remainder of the recovery period. With the exception of one female animal which showed no bodyweight gain from Days 3 to 7 post-exposure.
Necropsy.
No macroscopic abnormalities were detected amongst animals at necropsy.
Conclusion.No deaths occurred in a group of six rats exposed to a mean achieved atmosphere concentration of5.05mg/L for four hours. It was therefore considered that the acute inhalation median lethal concentration (4 hr LC50) of IP 27 Iron orthophosphate, in the RccHanTM: WIST strain rat, was greater than 5.05mg/L (Globally Harmonised Classification System – Unclassified).
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