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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 214-686-6 | CAS number: 1185-57-5
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Justification for type of information:
- Data is from experimental study report.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: the OECD [C(81) 30 (final)]
- Principles of method if other than guideline:
- The purpose of the study was to evaluate the acute eye irritation and/or corrosive effects on the eye following the application of the test article.
- GLP compliance:
- no
Test material
- Reference substance name:
- Ammonium iron(III) citrate
- EC Number:
- 214-686-6
- EC Name:
- Ammonium iron(III) citrate
- Cas Number:
- 1185-57-5
- Molecular formula:
- C6H8O7.xFe.xH3N
- IUPAC Name:
- Ammonium iron (III) citrate
- Details on test material:
- - Name of test material (IUPAC name): 2-Hydroxypropane-1,2,3-tricarboxylate, ammonium iron (3+) salt
- Common name: Ferric ammonium citrate
- Molecular formula: C6H8O7.xFe.xH3N
- Molecular weight: 264.9979 g/mol
- Smiles notation: N.[Fe+3].OC(=O)CC(O)(CC(=O)O)C(=O)O
- InChl: 1S/C6H8O7.Fe.H3N/c7-3(8)1-6(13,5(11)12)2-4(9)10;;/h13H,1-2H2,(H,7,8)(H,9,10)(H,11,12);;1H3/q;+3;
- Substance type: Organic
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Details on test animal
TEST ANIMALS
- Source: Conelli S.n,c., Via Milano. 61 - 28041 ARONA (Novara - Italy) and received on January 7,1998 (shipping slip No. 00001, dated Itinerary 7,1998).
- Age at study initiation: 2 - 3 months old
- Weight at study initiation: 2.5 - 2.8 kg.
- Fasting period before study:Not specified
- Housing: housed in room T05C
- Diet (e.g. ad libitum): The animals were fed a diet coded "2 RB 15 GLP Certificate" produced by the Charles River ltalia's feed licensec Mucedola S.r.l., Seflimo Milanese. ad libitum.
- Water (e.g. ad libitum): municipal water, ad libitum
- Acclimation period: Not specified
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 2
- Humidity (%):50% ± 15
- Air changes (per hr): approximately 20 air changes per hour (filtered on HEPA 99.97%).
- Photoperiod (hrs dark / hrs light): The room was illuminated by artificial lighting with a 12-hour circadian cycle (7 a.m. - 7 p.m.).
IN-LIFE DATES: From: To: March 3 - March 6,1998
Test system
- Vehicle:
- not specified
- Controls:
- yes
- Amount / concentration applied:
- 0.1 ml / animal
- Duration of treatment / exposure:
- single dose
- Observation period (in vivo):
- 1, 24, 48 and 72 hours after the test article application.
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- Details on study design
TEST SITE
- Area of exposure: the conjunctival sac of the right eye of each animal
REMOVAL OF TEST SUBSTANCE
- Washing (if done): At 24 hours a washout was performed.
- Time after start of exposure: 1, 24, 48 and 72 hours
SCORING SYSTEM: as mentioned in table 1
TOOL USED TO ASSESS SCORE: After the 24-hour reading, the cornea was examined after instillation of one drop of 1% sodium fluorescein and successive washing out with sterile saline solution.
other : Both eyes of each experimental animal selected for the study were examined within 24 hours of testing. Only animals without eye irritation, ocular defects or pre-existing corneal injury were used.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Slight redness of the conjunctivae (grade 1) was the only finding in all rabbits at the observation carried out 1 hour after treatment. No signs of ocular irritancy were subsequently observed. Negative results were obtained at the fluorescein staining performed 24 hours after the test article application .
- Other effects:
- Neither mortality nor adverse general clinical modifications were seen during the study.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not irritating
- Conclusions:
- Negative results were obtained at the fluorescein staining performed 24 hours after the test article application. Neither mortality nor adverse general clinical modifications were seen during the study. Thus, the test was considered to be non-irritant when administered to New Zealand White rabbits as a single ocular application.
- Executive summary:
An acute ocular irritation study of test chemical was conducted in the male New Zealand White rabbit (3 animals) in accordance with the OECD [C(81) 30 (final)].
Both eyes of each experimental animal selected for the study were examined within 24 hours of testing. Only animals without eye irritation, ocular defects or pre-existing corneal injury were used.
About 0.1 ml of the test article was placed in the conjunctival sac of the right eye of each animal, after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about 3-4 seconds in order to prevent loss of the material. The other eye (the left eye), remaining untreated, served as control. At 24 hours a washout was performed.
Observations were performed at 1, 24, 48 and 72 hours after the test article application. After the 24-hour reading the cornea was examined after instillation of one drop of 1% sodium fluorescein and successive washing out with sterile saline solution. Inspections for mortality and general clinical signs were made once a day.
Slight redness of the conjunctivae (grade 1) was the only finding in all rabbits at the observation carried out 1 hour after treatment. No signs of ocular irritancy were subsequently observed.
Negative results were obtained at the fluorescein staining performed 24 hours after the test article application. Neither mortality nor adverse general clinical modifications were seen during the study. Thus, the test was considered to be non-irritant,when administered to New Zealand White rabbits as a single ocular application.
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.