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EC number: 283-041-9 | CAS number: 84539-53-7
- 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
Four acute skin irritation/corrosion studies and four eye irritation studies were performed in rabbits generally according to the OECD Guideline No. 404. Application of EDDHMA-Fe to the rabbit skin or eye was evaluated as not irritating in all four studies.
Four eye irritation studies, performed according to OECD Guideleine 405 with the test item FeNaEDDHA in rabbits, showed that the test substance does not cause eye irritation. Application of EDDHMA-FeNa/K to the rabbit eye was evaluated as not irritating in all four studies.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April 1987 - May 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Relatively well reported study; 3 days of observation instead of 14 days.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Principles of method if other than guideline:
- - sex of rabbits is unknown
- no initial and confirmatory test - GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Rosemead Rabbits, Waltham Abbey, Essex, England
- Age at study initiation: 3 months old
- Weight at study initiation: 2.76 - 2.89 kg
- Housing: individually housed in suspended stainless steel cages
- Diet (e.g. ad libitum): free access (to S.Q.C. Rabbit Diet, Special Diet Services Limited, Witham, Essex, England)
- Water (e.g. ad libitum): free access to tap water
- Acclimation period: at least 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 (range 15 - 23)
- Humidity (%): 55 (range 40 - 70)
- Air changes (per hr): 15 complete air changes per hour without re-circulation
- Photoperiod (hrs dark / hrs light): 12 hours of artificial light per day
IN-LIFE DATES: From: April 28, 1987 To: May 1, 1987 - Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- other: moistened with 0.2 ml distilled water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): not applicable (moistened with 0.2 ml distilled water - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 3 days (1 hour, 24, 48 and 72 hours after patch removal)
- Number of animals:
- 3 rabbits
- Details on study design:
- TEST SITE
- Area of exposure: gauze patch was 3 x 2 cm
- % coverage: no info
- Type of wrap if used: The rabbit was securely restrained by a technician. Two test sites (6 x 6 cm) were marked on either side of the clipped area of dorsum and moistened by direct application of 0.2 ml distilled water per test site. A single dose (0.5 g) was impregnated onto an unmedicated gauze patch (3 x 2 cm) and was held in place on the left test site by strips of Blenderm (3-M Company). The right test site, acting as a control, was covered by a similar semi-occlusive dressing but otherwise remained untreated. 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.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The dressings were removed after four hours exposure. Where necessary, the treatment sites were gently washed with warm water and dried with paper towels to remove excessive amounts of test material adhering to the skin.
- Time after start of exposure: 4 hours
SCORING SYSTEM: see below - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24/48/72 h after patch removal
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24/48/72 h after patch removal
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- No other dermal irritation response was observed in any animal.
- Other effects:
- No.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Based on the results of the present study, it was concluded that Bolikel FE induced practically no skin irritation, so the test material is classified as non-irritant to the skin. Reversibility of the slight skin effect in one animal occurs.
- Executive summary:
A primary dermal irritation study was conducted on three male white rabbits using test substance Bolikel FE. The method is equivalent to OECD Guideline 404 (acute Dermal Irritation/Corrosion). The study is designed and performed according to Good Laboratory Practice Standards.
Each animal received 0.5 g test material. A single 4 -hour, semi-occluded application of the test material to the intact skin produced immediately after patch removal very slight erythema at the test site of one animal. This effect disappeared after 24 hours after patch removal. Necrosis and ulceration were not reported.
Based on the results of the present study, it was concluded that Bolikel FE induced practically no skin irritation, so the test material is classified as non-irritant to the skin. Reversibility of the slight skin effect in one animal occurs.
Reference
Summary of dermal lesions on clipped and intact skin (following 4-h application).
no. |
Effect |
Hour |
Days after application |
Mean score erythema 24/48/72 h |
Mean score oedema 24/48/72 h |
|||||
1 |
1 |
2 |
3 |
7 |
14 |
|||||
523M |
Erythema/ eschar Oedema |
0 0 |
0 0 |
0 0 |
0 0 |
- - |
- - |
0 |
0 |
|
524M |
Erythema/ eschar Oedema |
1 0 |
0 0 |
0 0 |
0 0 |
- - |
- - |
0 |
0 |
|
525M |
Erythema/ eschar Oedema |
0 0 |
0 0 |
0 0 |
0 0 |
- - |
- - |
0 |
0 |
|
Mean Group |
0 |
0 |
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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Relatively well reported study. Observation period 8 days instead of 21 days.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- observation period of 8 days instead of 21 days; sex unknown
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Froxfield S.P.F. Rabbits, Broadway Farm, Froxfield, Hampshire, England
- Age at study initiation: at least 3 months old
- Weight on arrival: 2.29-2.38 kg
- Weight at study initiation: 3.08-3.67 kg
- Housing: individually in suspended stainless steel cages
- Diet (e.g. ad libitum): free access (to S.Q.C. Rabbit Diet, Special Diet Services Limited, Witham, Essex, England)
- Water (e.g. ad libitum): free access to tap water
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 (range 15 - 23)
- Humidity (%): 55 (range 40 - 70)
- Air changes (per hr): 15 complete air changes per hour without re-circulation
- Photoperiod (hrs dark / hrs light): 12 hours artificial light per day
IN-LIFE DATES: From: May 11, 1987 To: May 19, 1987 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: other eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g test material
- Concentration (if solution): not applicable - Duration of treatment / exposure:
- Single application (the eyelids were gently held together for one second and then released. The left eye remained untreated).
- Observation period (in vivo):
- 8 days (1 hour, 24, 48 and 72 hours and on Day 8)
- Number of animals or in vitro replicates:
- 3 rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: see below (additionally an assessment was made for the pain response)
TOOL USED TO ASSESS SCORE: ophthalmoscope and fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24/48/72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24/48/72 hours
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24/48/72 hours
- Score:
- 1.78
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24/48/72 hours
- Score:
- 0.22
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Irritant / corrosive response data:
- No
- Other effects:
- No
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Based on the results of the present study, it was concluded that the test compound, Bolikel FE, induced a reversible very slight eye irritation. So the test material was a ‘non-irritant’ to the eye and therefore not classifiable according to OECD-GHS.
- Executive summary:
A study was conducted to assess the irritancy potential of Bolikel FE to the eye of three New Zealand Albino rabbits. The study was performed according to OECD Guideline 405 (Acute Eye Irritation/Corrosion) and also according to Good Laboratory Practice Standards.
A single application of 0.1 g of the test material to the right eye of the rabbit produced redness of the conjunctivae, slight chemosis and iridial congestion were observed amongst all three animals during the first 24 hours. Translucency of up to one-quarter of the cornea was also apparent in one rabbit at the one hour examination. Only injection of the conjunctival blood vessels was observed at the 72-hour examination and all ocular lesions had resolved by Day 8.
Based on the results of the present study, it was concluded that the test compound, Bolikel FE, induced a reversible very slight eye irritation. So the test material was a ‘non-irritant’ to the eye and therefore not classifiable according to OECD-GHS.
Reference
Summary of ocular lesions
Anim. No. |
Effect |
Hours |
Days after application |
Mean score cornea Days 1/2/3 |
Mean score iritis Days 1/2/3 |
Mean score redness Days 1/2/3 |
Mean score chemosis Days 1/2/3 |
||||
1 |
1 |
2 |
3 |
8 |
14 |
||||||
504M |
Cornea Iris Redness Chemosis |
2 1 1 1 |
0 1 2 0 |
0 0 2 1 |
0 0 1 0 |
0 0 0 0 |
- - - - |
0 |
0.33 |
1.67 |
0.33 |
511M |
Cornea Iris Redness Chemosis |
0 1 2 0 |
0 0 2 0 |
0 0 2 0 |
0 0 1 0 |
0 0 0 0 |
- - - - |
0 |
0 |
1.67 |
0 |
512M |
Cornea Iris Redness Chemosis |
0 1 2 1 |
0 1 2 1 |
0 1 2 0 |
0 0 2 0 |
0 0 0 0 |
- - - - |
0 |
0.67 |
2 |
0.33 |
Mean all anim. |
0 |
0.33 |
1.78 |
0.22 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
Four acute skin irritation/corrosion studies in albino rabbits were performed to determine the irritant or corrosive potency of the test substance EDDHMA-Fe on the albino rat skin.These tests were generally based on the OECD Guideline 404 (Acute Dermal Irritation/Corrosion) and were performed on 3 -6 rabbits, checked for normal skin conditions. The studies showed that EDDHMA-Fe does not cause skin irritation.
Eye irritation
Four eye irritation studies were performed according to the OECD Guideline 405 (Acute Eye Irritation/Corrosion) with the test item EDDHMA-Fe. The test was performed on 3 -6 rabbits. An amount of 0.1 g (three studies) or 37 mg (corresponding to a volume of 0.1 mL (one study)) of the test item was placed into the conjunctival sac of one of the eyes of each animal; the other eye served as control. The animals were checked daily for systemic symptoms and mortality. The studies showed that the test substance does not cause eye irritation as none of the animals achieved a mean score leading to classification according to GHS.
Justification for selection of skin irritation / corrosion endpoint:
One key (GLP) study and three supporting studies (two GLP studies and one older study)
Justification for selection of eye irritation endpoint:
One key (GLP) study and three supporting studies (two GLP studies and one older study)
Justification for classification or non-classification
Based on the results of four eye irritation studies and four skin irritation studies the test substance EDDHMA-Fe is not classified and labelled as an eye or skin irritant according to Regulation 1272/2008/EC (CLP).
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