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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin 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 guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- The purpose of the study was to evaluate the acute dermal irritation and/or corrosive effects on skin 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
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system 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 - 2.8kg.
- Fasting period before study:
- 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 2- March 5, 1998
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Remarks:
- intact
- Vehicle:
- not specified
- Controls:
- yes
- Amount / concentration applied:
- 0.5 ml/site
- Duration of treatment / exposure:
- 3 minutes, 1 hour and 4 hours
- Observation period:
- Observations were performed immediately and 72 hours after the 3-minute and the 1-hour exposure period in the first rabbit and at 1, 24. 48 and 72 hours after the 4-hour exposure period (all rabbits).
- Number of animals:
- 3 female
- Details on study design:
- Details on study design
TEST SITE
- Area of exposure: the trunk
- % coverage: approximately 6 cm2
- Type of wrap if used: The application area was covered with a gauze patch loosely held in contact with the skin by an impermeable, non-irritant, hypoallergenic tape (occlusive patch).
REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual substance was removed with water
- Time after start of exposure: 1, 24. 48 and 72 hours after
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 3 minutes, 1 hour and 4 hours (for single rabbit ) and after 1, 24. 48 and 72 hours (all rabbits)
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No changes were seen at any test article application site. No clinical signs, either general or local (at the application sites), were noted in any rabbit.
- Other effects:
- not specified
Any other information on results incl. tables
Table 1:
Grading of Skin Reaction |
1. Erythema and Eschar Formation No erythema....................................................................................... 0 Very slight erythema (barely perceptible)............................................. 1 Well defined erythema........................................................................ 2 Moderate to severe erythema.............................................................3 Severe erythema (beet redness) to slight Eschar formation (injuries in depth)..................................................... 4 Maximum possible = 4
|
2. edema Formation No oedema......................................................................................... 0 Very slight edema (barely perceptible)................................................. 1 Slight edema (edges of area well defined by definite raising)................. 2 Moderate edema (raised approximately 1 mm...................................... 3 Severe edema (raised more than 1 mm and extending Beyond area of exposure)....................................................................4 Maximum possible = 4
|
Evaluation of results: the dermal irritation was evaluated in conjunction with the nature and reversibility or otherwiseofthe responsesobserved. |
RESULTS:
Table 2: Observation of single rabbit
Exposure period: 3 minutes
Erythema And Eschar
Obs. wade at |
42F (animal No.) |
3minutes |
0 |
72 hours |
0 |
Edema
3 minutes |
0 |
72 hours |
0 |
Exposure period: 1hour
ErythemaAnd Eschar
Obs. made at |
42F (animal No.) |
1 hour |
0 |
72 hours |
0 |
Edema
1 hour |
0 |
72 hours |
0 |
Table 3: obervation of all rabbits
Exposure period:4 hours
Erythema And Eschar
Obs. made at |
42F |
46F |
48F |
60 minutes |
0 |
0 |
0 |
24 hours |
0 |
0 |
0 |
48 hours |
0 |
0 |
0 |
72 hours |
0 |
0 |
0 |
Edema
Obs. made at |
42F |
46F |
48F |
60 minutes |
0 |
0 |
0 |
24 hours |
0 |
0 |
0 |
48 hours |
0 |
0 |
0 |
72 hours |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: Not irritating
- Conclusions:
- Neither mortality nor adverse general clinical modifications were seen during the study. Thus, the test material was considered to be non-irritant when administrated to rabbits by dermal route.
- Executive summary:
An acute dermal irritation study of test chemical was conducted in the female New Zealand White rabbit (3 animals) in accordance with EEC Guidelines (B.4) and OECD Guidelines (404).
0.5 ml of the test article were applied on the intact skin of the trunk to a small area (approximately 6 cm2) of skin. The application area was covered with a gauze patch loosely held in contact with the skin by an impermeable, non-irritant, hypoallergenic tape (occlusive patch). At the end of each exposure period, residual substance was removed with water. Adjacent areas of untreated skin of each animal served as control for the test.
Observations were performed immediately and 72 hours after the 3-minute and the 1-hour exposure period in the first rabbit and at 1, 24. 48 and 72 hours after the 4-hour exposure period (all rabbits). Inspections for mortality and general clinical signs were made once a day.
No changes were seen at any test article application site. No clinical signs, either general or local (at the application sites), were noted in any rabbit. Thus, the test material was considered to be non-irritant when administrated to rabbits by dermal route.
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