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EC number: 227-290-3 | CAS number: 5766-67-6
- 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
A skin and eye irritation test were available.
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:
- February 1993
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data on batch no. is given; no data on the composition of the test compound. Limited reported study comparable to guideline/standard
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4470 (Acute Dermal Irritation)
- Principles of method if other than guideline:
- Comparable to OECD 404; deviations: 6 animals rather than 3, occlusive rather than semi-occlusive application.
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Eastern Rabbit Breeding Lab, Taunton, MA, USA
- Age at study initiation: 10-12 weeks
- Weight at study initiation: 2-3 kg
- Housing: individually in suspended stainless steel cages
- Diet (e.g. ad libitum): ad lib
- Water (e.g. ad libitum): ad lib
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±1
- Humidity (%): 30-70
- Air changes (per hr): 10-13
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 19 To: 22 February 1993 - Type of coverage:
- occlusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g (ground to a fine powder)
- Concentration (if solution): undiluted
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 30-60 min, 1, 2 and 3 days
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 1 square inch (2.5 x 2.5 cm)
- % coverage: no info
- Type of wrap if used: impervious non-irritating bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): stated that the skin was wiped to remove any residual test material
- Time after start of exposure: immediately upon patch removal
SCORING SYSTEM:
EVALUATION OF SKIN REACTIONS
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
Oedema formation
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well-defined by
definite raising) 2
Moderate oedema (raised approximately 1 mm) 3
Severe oedema (raised more than 1 mm and
extending beyond area of exposure) 4 - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable as there were no dermal reactions at all
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- No signs of dermal reactions or other toxicity.
- Other effects:
- All 6 animals showed BW gain.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- There were no dermal reactions at all; therefore no classification is needed according to OECD-GHS.
- Executive summary:
The test substance, Ethylenediaminetetraacetonitrile, was evaluated for its potential to produce Primary Dermal Irritation after a single 4 -h topical, occlusive, application to the skin of a group of 3 male and 3 female New Zealand White Rabbits. No dermal reactions were noted up to 72 h after application. The test substance is considered a non-irritant, and does not need classification according to OECD-GHS.
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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- February 1993
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data on batch no. is given; no data on the composition of the test compound. Limited reported study comparable to guideline/standard (max reliability score can be 2).
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4500 (Acute Eye Irritation)
- Principles of method if other than guideline:
- Comparable to OECD 405.
- GLP compliance:
- yes
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Eastern Rabbit Breeding Lab, Taunton, MA, USA
- Age at study initiation: 10-12 weeks
- Weight at study initiation: 2-3 kg
- Housing: individually in suspended stainless steel cages
- Diet (e.g. ad libitum): ad lib
- Water (e.g. ad libitum): ad lib
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±1
- Humidity (%): 30-70
- Air changes (per hr): 10-13
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 17 To: 20 February 1993 - Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): it had been indicated that 0.1 mL was used after grinding to a fine powder.
- Concentration (if solution): undiluted
VEHICLE: not used - Duration of treatment / exposure:
- single application
- Observation period (in vivo):
- 1, 24, 48 and 72 h
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): 0.9% NaCl for injection
- Time after start of exposure: 24 h
SCORING SYSTEM:
CORNEA
Degree of Opacity (most dense area used)
No opacity 0
Scattered or diffuse areas, details of iris clearly visible 1
Easily discernible translucent areas, details of iris slightly obscured 2
Nacreous areas, no details of iris visible, size of pupil barely discernible 3
Opaque cornea, iris not discernible 4
IRIS
Normal 0
Folds above normal, congestion, swelling, circumcorneal injection
(any or all of these or combination of any thereof), iris still reacting to light
(sluggish reaction is positive) 1
No reaction to light, haemorrhage, gross destruction (any or all of these) 2
CONJUNCTIVAE
Redness (refers to palpebral and bulbar conjunctivae excluding cornea and iris)
Vessels normal 0
Vessels definitely injected above normal 1
More diffuse, deeper crimson red, indiviual vessels not easily discernible 2
Diffuse beefy red 3
Chemosis
No swelling 0
Any swelling above normal (includes nictitating membrane) 1
Obvious swelling with partial eversion of lids 2
Swelling with lids about half closed 3
Swelling with lids more than half closed 4
TOOL USED TO ASSESS SCORE: fluorescein and han held slit-lamp - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable as there were no changes
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable as there were no changes
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24/48/72 h
- Score:
- 0.06
- Max. score:
- 3
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable as there were no changes
- Irritant / corrosive response data:
- Slight redness was observed in 4/6 and moderate redness in 2/6 animals 1 h after exposure. Slight redness was still seen in one
animal 24 h after application. Slight discharge was seen in 3/6 animals. All treated eyes appeared normal 2 days after application. - Other effects:
- No other signs of toxicity were noted; all animals exhibited BW gain.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Although slight to moderate redness was observed 1 h and 24 h after application, there is no need for classification according to
OECD-GHS. - Executive summary:
A study was performed to assess the irritancy potential of the test material, Ethylenediaminetetraacetonitrile, to the eye of the New Zealand White rabbit. The method used essentially followed that described in the OECD Guidelines for Testing of Chemicals No. 405. A single application of the test material to the eye of six rabbits produced minimal to moderate redness and slight discharge. All treated eyes appeared normal 48 hours after treatment. Although the test material induced minimal irritation, there is no need for classification as an irritant according to OECD-GHS.
Reference
Summary of ocular changes
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 |
7 |
21 |
||||||
30586 |
Cornea Iris Redness Chemosis |
0 0 1 0 |
0 0 0 0 |
0 0 0 0 |
0 0 0 0 |
- - - - |
- - - - |
0 |
0 |
0 |
0 |
30587 |
Cornea Iris Redness Chemosis |
0* 0 1 0 |
0* 0 0 0 |
0* 0 0 0 |
0 0 0 0 |
- - - - |
- - - - |
0 |
0 |
0 |
0 |
30588 |
Cornea Iris Redness Chemosis |
0 0 2 0 |
0* 0 1 0 |
0 0 0 0 |
0 0 0 0 |
- - - - |
- - - - |
0 |
0 |
0.33 |
0 |
30589 |
Cornea Iris Redness Chemosis |
0 0 1 0 |
0 0 0 0 |
0 0 0 0 |
0 0 0 0 |
- - - - |
- - - - |
0 |
0 |
0 |
0 |
30590 |
Cornea Iris Redness Chemosis |
0* 0 2 0 |
0 0 0 0 |
0 0 0 0 |
0 0 0 0 |
- - - - |
- - - - |
0 |
0 |
0 |
0 |
30591 |
Cornea Iris Redness Chemosis |
0 0 1 0 |
0 0 0 0 |
0 0 0 0 |
0 0 0 0 |
- - - - |
- - - - |
0 |
0 |
0 |
0 |
Mean all anim. |
0 |
0 |
0.06 |
0 |
* discharge (any amount different from normal)
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
No dermal reactions were noted in the skin irritation test. A single application of the test material to the eye of six rabbits produced minimal to moderate redness and slight discharge. All treated eyes appeared normal 48 hours after treatment.
Justification for selection of skin irritation / corrosion endpoint:
Relatively well performed study
Justification for selection of eye irritation endpoint:
Relatively well performed study
Justification for classification or non-classification
No classification for skin irritation is required due to the absence of dermal reactions. Although the test material induced minimal irritation, there is no need for classification as an irritant according to EU and OECD-GHS.
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.
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