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EC number: 239-018-0 | CAS number: 14940-41-1
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2015-12-14 to 2016-01-30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992-07-17
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The data requirements as laid down in the REACH regulation Annex VII, foresee “the murine local lymph node assay (LLNA) as the first choice method for in vivo testing. Only in exceptional circumstances should another test be used. Justification for the use of another in vivo test (e.g. Guinea pig maximisation test (GPMT)) shall be provided.”
According to the OECD guideline 429 (2010), limitation for not using the LLNA test is the possibility of false positive results due to skin irritation. If a substance has skin irritation properties another in vivo test such as the GPMT test according to OECD guideline 406 (1992) should be considered.
Although the in vivo skin irritation testing in rabbits (according to OECD 404 and GLP) did not reveal irritating properties, a severe conjunctival reaction with a Draize score of up to 3 was received in the in vivo eye irritation testing. Since the skin physiology of the rabbit skin and the conjunctival membrane of the rabbit eye is equivalent, but with the important difference that the conjunctival membrane is lacking the stratum corneum. The stratum corneum consists of several layers of dead corneocytes, which function as a barrier to protect underlying tissue from chemical stress. Since a significant positive response was received for the conjunctivae in the eye irritation assay, one has to assume that the test substance has the intrinsic irritating property for biological membranes, which does not occur in skin with intact protective layer.
It was therefore decided not to perform the in vivo LLNA assay, since irritating properties would have led to a false positive test results. In order to avoid the possibility of a false positive result in the LLNA test, it was decided to conduct the GPMT test (OECD 406, 1992) with triiron bis(orthophosphate) instead of the LLNA.
Test material
- Reference substance name:
- Triiron bis(orthophosphate)
- EC Number:
- 239-018-0
- EC Name:
- Triiron bis(orthophosphate)
- Cas Number:
- 14940-41-1
- Molecular formula:
- Fe.2/3H3O4P or Fe3(PO4)2
- IUPAC Name:
- triiron bis(orthophosphate)
- Test material form:
- solid: particulate/powder
- Details on test material:
- - State of aggregation: light grey powder
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Remarks:
- Crl:(HA)BR
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 4 - 6 weeks old
- Weight at study initiation: 336.1 - 416.7 g
- Housing: housed in groups of up to ten
- Diet (ad libitum): commercial feeding mixture (Mühle Knull, Rostock, Germany)
- Water (ad libitum): tap water (drinking quality, supplemented with 1 g/L vitamin C)
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3 °C
- Relative humidity: 30 - 70 %
- Air changes: 16/hours
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: distilled water
- Concentration / amount:
- 1 %
- Day(s)/duration:
- day 0
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: distilled water
- Concentration / amount:
- 100 %
- Day(s)/duration:
- day 7 (exposure duration: 48 hours)
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: distilled water
- Concentration / amount:
- 100 %
- Day(s)/duration:
- day 22 (exposure duration: 24 hours)
- No. of animals per dose:
- 10 female guinea pigs
- Details on study design:
- The vehicle, distilled water, was selected based on preliminary tests. The test material was not soluble in distilled water and injected as suspension. For topical application the test material ws moistened with distilled water. The preparations of the test material were made immediately prior to each application procedure.
RANGE FINDING TESTS:
The irritation response to intradermal injection of various concentrations of the test substance was examined in three guinea pigs. An area of the flanks was clipped free from hair with electric clippers. Amount of 0.1 mL of the selected test concentrations (5 %; 2.5 %; 1 % and 0.5 % suspensions of the test material in distilled water) were applied by intradermal injection. 24 and 48 hours after injection the animals were examined for signs of irritation according to the Magnusson and Kligman grading scale.
The irritation response to topical treatment of various concentrations of the test substance was examined in three further guinea pigs. The flanks of the animals were clipped. Filter paper fully-loaded with the test substance (100 %; 50 %; 25 % in distilled water) was attached to the skin of the guinea pigs and held in contact by an occlusive dressing for 24 hours. The animals were observed and examined for sings of irritation according to the Magnusson and Kligman grading scale approx. 24 hours and 48 hours after removing the test material.
Resullts:
- intradermal induction: the concentration of 1 % of the test material in distilled water (suspension) was systemically well-tolerated and caused a mild - moderate skin irritation, this concentration was used for the main test.
- topical application (induction): the concentration of 100 % of the test material moistened with distilled water was systemically well-tolerated and did not cuase a skin irritation, this concentration was used for the main test.
- topical application (challenge): a concentration of 100 % of the test material moistened with distilled water was used. This concentration was well-tolerated systemically and did not cause skin irritation.
Please also refer for information on tested doses to the field "Any other information on materials and methods incl. tables" below.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal injection and topical application)
- Site: area of dorsal skin from the scapular region (approx. 4 cm x 6 cm) was clipped free of hair
- Frequency of applications: three pairs of intradermal injections of 0.1 mL volume were given to the animals. Seven days after intradermal induction the test substance was topically applied using filter paper. Because the agent was non-irritating at this concentration, the region was pretreated with 0.5 mL 10 % sodium lauryl sulphate in vaseline for 24 hours. The control animals were treated with vehicle similarly.
- Exposure period: 48 hours (topical application)
- Concentrations:
Intradermal:
i) 0.1 mL 1:1 mixture (v/v) FCA/water
ii) 0.1 mL test substance suspension of 1 % in distilled water
iii) 0.1 mL test substance at the selected concentration formulated in a 1:1 mixture (v/v) FCA/water
The control animals were treated with the vehicle similarly.
Topical application:
100 % finely pulverised test substance moistened with distilled water
The control animals were treated with the vehicle similarly.
B. CHALLENGE EXPOSURE
- No. of exposures: 1 (topical application three weeks after the intradermal induction)
- Exposure period: 24 hours
- Site: flank were cleared of hair of test and control animals
- Concentrations: 100 % finely pulverised test substance moistened with distilled water
- Evaluation (hr after challenge): 24 and 48 hours after removal of the patch
Evaluation according to the Magnusson and Kligman grading scale.
EXAMINATIONS:
- clinical observations: clinical symptoms were recorded over the period of observations
- body weight: at the start and at the end of the test - Challenge controls:
- 5 guinea pigs were used as control animals
Challenge dose: 100 % finely pulverised test substance moistened with distilled water - Positive control substance(s):
- yes
- Remarks:
- hexylcinnamaldehyde (5 % for intradermal induction, 75 % for topical induction and 55 % for challenge)(study conduct: 2015-09-23 to 2015-10-16)
Results and discussion
- Positive control results:
- 90 % of the animals treated with the positive control (55 % hexylcinnamalde hyde in vaseline) showed a skin reaction with numerical grading from 0-1 up to 2 according to Magnusson and Kligman grading scale.
The positive control showed a sensitisation effect and the validity of the test system.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 100 % of the test item moistened with distilled water
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- The animals did not show any visible clinical symptoms over the period of observation. All animals showed the expected body weight development.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100 % of the test item moistened with distilled water
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- The animals did not show any visible clinical symptoms over the period of observation. All animals showed the expected body weight development.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100 % of the test item moistened with distilled water
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- The animals did not show any visible clinical symptoms over the period of observation. All animals showed the expected body weight development.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100 % of the test item moistened with distilled water
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- The animals did not show any visible clinical symptoms over the period of observation. All animals showed the expected body weight development.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 55 % hexylcinnamalde hyde in vaseline
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 55 % hexylcinnamalde hyde in vaseline
- No. with + reactions:
- 9
- Total no. in group:
- 10
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is not a skin sensitiser.
According to Regulation (EC) No 1272/2008 and subsequent adaptations, the substance does not require classification as skin sensitiser.
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