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EC number: 927-442-5 | CAS number: 15651-72-6
- 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
Endpoint summary
Administrative data
Description of key information
- Skin irritation: not irritating by analogy with FeNaEDTA (CAS 15708-41-5)
- Eye irritation: not irritating by analogy with FeNaEDTA (CAS 15708-41-5)
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- July 2007
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well conducted study according to GLP (as the data is used in a read-across approach, a maximal reliability score of 2 was attributed).
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: LPT, 24601 Löhndorf, germany
- Age at study initiation: 3-5 months
- Weight at study initiation: 1.8 - 2.3 kg
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: 20 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/- 3°C
- Humidity (%): 30-70%
- Air changes (per hr): 60 per hour
- Photoperiod (hrs dark / hrs light):12/12
IN-LIFE DATES: From: 2. To: 6.July 2007 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg/animal - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm²
- % coverage:
- Type of wrap if used: gauze patch
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no - Irritation parameter:
- erythema score
- Basis:
- animal: one animal
- Time point:
- other: 1 hour
- Score:
- 1
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- Very slight erythema (grade 1) was observed in one animal at 1 h after removal of the patch. There were no further skin reactions and no systemic adverse effects.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- The test iterm is not irritating to the skin.
- Executive summary:
In a skin irritation study according to OECD guideline 404 a dose of 500 mg FeNaEDTA was applied to the shaved skin of three male rabbits for 4 hours. Very slight erythema was noted for one animal at 1 hour after patch removal. No other skin effects or systemic effects were noted during the observation period of 72h.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- July 2007
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well conducted study according to GLP (as the data is used in a read-across approach, a maximal reliability score of 2 was attributed).
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: LPT germany
- Age at study initiation: 4-5 months
- Weight at study initiation: 2.2-2.4
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: 20 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-3°C
- Humidity (%): 30-70%
- Air changes (per hr): 60
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 4. To: 12.July 2007 - Vehicle:
- unchanged (no vehicle)
- Irritant / corrosive response data:
- Under the present test conditions a single administration of 100 mg FeNaEDTA per animal into the conjunctival sac of the right eye of three rabbits caused the following effects:
Corneal opacity (grad 1) was observed in animal no. three 24 hours to 6 days after instillation.
The fluorescein test performed 24 hours after instillation revealed corneal staining in animal no. 3 (up to 1/4 of the surface).
Conjunctival redness (grad 1) was observed in animal no. one 60 minutes, in animal no. two 60 minutes to 48 hours and in animal no. three 24 hours to 4 days after instillation.
In addition, secretion was observed in all 3 animals 1 hour after instillation.
The irises were not affected by instillation of the test item.
There were no systemic intolerance reactions. - Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Although the test item induced slight irritation, no classification is needed according to OECD-GHS.
- Executive summary:
An eye irritation study with three male Himalyan rabbits according to OECD guideline 405 and GLP was performed.
A single administration of 100 mg FeNaEDTA per animal into the conjunctival sac of the right eye of three rabbits caused the following effects:
Corneal opacity (grade 1) was observed in animal no. three 24 hours to 6 days after instillation.
The fluorescein test performed 24 hours after instillation revealed corneal staining in animal no. 3 (up to 1/4 of the surface).
Conjunctival redness(grade 1) was observed in animal no. one 60 minutes, in animal no. two 60 minutes to 48 hours and in animal no. three 24 hours to 4 days after instillation. In addition, secretion was observed in all 3 animals 1 hour after instillation.
Irises were not affected by instillation of the test item.
There were no systemic intolerance reactions.
Reference
Time after administration |
C O R N E A |
I R I S |
C O N J U N C T I V A E |
C H E M O S I S |
|
Opacity |
|
Redness |
|
|
A n i m a l n o. : 1 / 2 / 3 |
|||
before dosing |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
60 minutes |
0/0/0 |
0/0/0 |
1/1/0 |
0/0/0 |
24 hours |
0/0/1 |
0/0/0 |
0/1/1 |
0/0/0 |
48 hours |
0/0/1 |
0/0/0 |
0/1/1 |
0/0/0 |
72 hours |
0/0/1 |
0/0/0 |
0/0/1 |
0/0/0 |
4 days |
-/-/1 |
-/-/0 |
-/-/1 |
-/-/0 |
5 days |
-/-/1 |
-/-/0 |
-/-/0 |
-/-/0 |
6 days |
-/-/1 |
-/-/0 |
-/-/0 |
-/-/0 |
7 days |
-/-/0 |
-/-/0 |
-/-/0 |
-/-/0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
There is no data available on the test item, but the skin irritation and eye irritation potential of EDTAFeHNa was assessed by analogy with FeNaEDTA (CAS 15708-41-5):
In a skin irritation study according to OECD guideline 404 a dose of 500 mg FeNaEDTA (CAS 15708-41-5) was applied to the shaved skin of three male rabbits for 4 hours. Very slight erythema was noted for one animal at 1 hour after patch removal. No other skin effects or systemic effects werenoted during the observation period of 72h.
An eye irritation study with three male Himalyan rabbits according to OECD guideline 405 and GLP was performed. A single administration of 100 mg FeNaEDTA per animal into the conjunctival sac of the right eye of three rabbits caused the following effects:
Corneal opacity (grade 1) was observed in animal no. three 24 hours to 6 days after instillation.
The fluorescein test performed 24 hours after instillation revealed corneal staining in animal no. 3 (up to 1/4 of the surface).
Conjunctival redness (grade 1) was observed in animal no. one 60 minutes, in animal no. two 60 minutes to 48 hours and in animal no. three 24 hours to 4 days after instillation. In addition, secretion was observed in all 3 animals 1 hour after instillation.
Irises were not affected by instillation of the test item.
There were no systemic intolerance reactions.
The key studies (recently performed according to current guidelines and GLP) did result in very slight skin and slight eye irritation; these slight irritation effects do not require classification. Supporting studies show signs of slight to moderate irritation but do not justify classification.
Justification for selection of skin irritation / corrosion endpoint:
Well conducted study according to GLP
Justification for selection of eye irritation endpoint:
Well conducted study according to GLP
Justification for classification or non-classification
Based on the classification criteria of Annex VI Directive 67/548/EEC or UN/EU GHS, the low level of dermal and ocular irritation (by analogy with FeNaEDTA, CAS 15708-41-5) results in no classification of EDTAFeHNa for skin and eye irritation.
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