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EC number: 400-660-3 | CAS number: 111687-36-6 AMMONIUM-EISEN-PDTA; AMMONIUM-IRON-PDTA; COMPLEX OF CHELATING AGENT NO. 1; DISSOLVINE FD-FE-14; DISSOLVINE PD-FE-14; PDTA-FN; RAZ; SEL COMPLEXE D'AGENT CHELATANT KODAK NO. 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 March 1991 - 21 March 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was peformed according to OECD guidelines and GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Ammonium iron(III) trimethylenediaminetetraacetate hemihydrate
- EC Number:
- 400-660-3
- EC Name:
- Ammonium iron(III) trimethylenediaminetetraacetate hemihydrate
- Cas Number:
- 111687-36-6
- Molecular formula:
- Hill formula: C11 H18 Fe N3 O8 CAS formula: C11 H14 Fe N2 O8.H4N
- IUPAC Name:
- iron(3+) ammonium 2-({3-[bis(carboxylatomethyl)amino]propyl}(carboxylatomethyl)amino)acetate hydrate
- Details on test material:
- Name: 1,3-Propylenediaminetetraacetic acid, ferric-ammonium complex (PDTA-FeNH4)
Appearance: fine yellow crystalline powder,
Batch No.: GW-1000
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ranch Rabbits, Crawley Down, Sussex, England
- Age at study initiation: young
- Weight at study initiation: 2.26 - 2.62 kg
- Housing: They were individually housed in suspended stainless steel cages (Type RC10/L) mounted in mobile batteries (Modular Systems and Development Company Limited, London, England). The cages measured 61 x 76 x 46 cm high and were fitted with perforated counter-sunk floor panels. Atray beneath the floor was lined with absorbent crepe paper which was changed regularly.
- Diet (e.g. ad libitum): Animals had free access to a commercially available standard pelleted rabbit diet (S.Q.C. Rabbit Diet, Special Diet Services Limited, Witham, Essex, England).
- Water (e.g. ad libitum): The rabbits had free access to tap water supplied to each cage by an automatic piped system.
- Acclimation period: at least six weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-19
- Humidity (%): 49-62
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: 18 March 1991 - 21 March 1991
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated right flank of the animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): moistened with 0.2 ml distilled water - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: back
- % coverage: 6 cm x 6 cm
- Type of wrap if used: A single dose (0.5 g) was applied directly to the skin and covered by an unmedicated gauze patch (3 x 2 cm) which was held in place on the left test site by strips of Blenderm (3-M Company). Pads of cotton wool and elasticated bandage were used to protect the patches and ensure good contact between the skin and the test material during the four-hour exposure period. The elasticated bandage was held in place by thin strips of waterproof plaster ('Sleek' - T &J Smith and Nephew Li mited) at both edges.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Treatment sites may be gently washed with warm water and dried with paper towels to remove excess test compound adhering to the skin.
- Time after start of exposure: 4 hours
SCORING SYSTEM:
Erythema and eschar formation
0 No erythema
1 Very slight erythema (barely perceptible)
2 Well defined erythema
3 Moderate to severe erythema
4 Severe erythema (beet redness) to slight eschar formation (injuries in depth)
Oedema formation
0 No oedema 0
1 Very slight edema(barely perceptible)
2 Slight edema(edges of the area well defined by definite raising)
3 Moderate edema(raised approximately 1mm)
4 Severe edema( raised more than 1 mm and extending beyond the area of exposure)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24-48-72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No effects observed
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24-48-72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No effects observed
- Irritant / corrosive response data:
- No dermal reaction was observed at the test site of any animal at any time during the 72 hour observation period. The control sites did not show any response to the control procedure.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Not irritating to skin.
- Executive summary:
The potential of 1,3-Propylenediaminetetraacetic acid, ferric-ammonium complex, hereafter referred to as PDTA-FeNH4 to cause inflammatory or corrosive changes upon first contact with skin was assessed by semi-occluded application of 0.5 g of the test material to the closely-clipped dorsa of three New Zealand White rabbits for four hours. Dermal reactions were assessed 1, 24, 48 and 72 hours after removal of the dressings. No dermal response was observed at the test site of any animal at any time during the 72 hour observation. 1.3 Under the conditions of this test, PDTA-FeNH4 was classified as 'non-irritant' to the skin.
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