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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
An oral and dermal acute toxicity study were available.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- February-March 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 798.1175 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- Guideline comparable to OECD 401.
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Labs. Wilmington, MA, USA
- Age at study initiation: 49-74 days
- Weight at study initiation: 200-300 g
- Fasting period before study: overnight prior to dosing
- Housing: group housed in polycarbonate 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: 18 February To: 4 March 1993 - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 500 mg/ mL corn oil
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: solubility (insoluble in water, saline or natural oils)
- Lot/batch no. (if required): no info
- Purity: no info
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
DOSAGE PREPARATION (if unusual): the test compound (15 g) was mixed continuously with 30 mL corn oil for a good suspension.
Animals were administered 3 fractional doses within a 24-h period. - Doses:
- 5 g/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily, BW weekly
- Necropsy of survivors performed: yes - Statistics:
- Not required.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Remarks on result:
- other: no mortality
- Mortality:
- No.
- Clinical signs:
- other: No signs of toxicity noted. Discolouration (tan) of the fur was seen in 9/10 animals.
- Gross pathology:
- No unusual lesions were noted.
- Other findings:
- Not reported.
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- Because the LD50 is in excess of 5000 mg/kg bw, no classification required according to OECD-GHS.
- Executive summary:
The test substance, Ethylenediaminetetraacetonitrile, was evaluated for its potential to produce death following oral administration (gavage) at a dose of 5 g/kg bw in a group of 5 male and 5 female Sprague-Dawley rats. Based on the absence of mortality, the test substance is defined as nontoxic and does not require classification according to OECD-GHS.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- Study shows LD50 value in excess of 5000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- February-March 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 798.1100 (Acute Dermal Toxicity)
- Principles of method if other than guideline:
- Method used is comparable to OECD 402.
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- 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
- Fasting period before study: no
- Housing: individually using suspended stainless steel cages
- Diet (e.g. ad libitum): ad lib
- Water (e.g. ad libitum): ad lib
- Acclimation period: 6 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: 18 February To: 4 March 1993 - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: ca. 10% of body surface. The test compound was directly applied onto the skin; next 2 single layer gauze
patches were applied that had been moistened with water.
- % coverage: no info
- Type of wrap if used: impervious bandaging
REMOVAL OF TEST SUBSTANCE
- Washing (if done): skin was rinsed with USP water for injection
- Time after start of exposure: immediately after patch removal
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2g/kg
- Concentration (if solution): undiluted
- Constant volume or concentration used: undiluted
- For solids, paste formed: no, patches were moistened (see above)
VEHICLE: not used - Duration of exposure:
- 24 h
- Doses:
- 2 g/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily; BW weekly
- Necropsy of survivors performed: yes - Statistics:
- Not required.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: no mortality
- Mortality:
- No.
- Clinical signs:
- other: Not present.
- Gross pathology:
- No data.
- Other findings:
- None.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- As no levels were tested higher than 2000 mg/kg bw (limit test), but the outcome showed that at 2000 mg/kg bw there was no mortality, no clinical signs and normal body weight gain, there is need it is expeat 5000 mg/kg bw is not known. Therefore, the test
compound was classified in Category V, according to OECD-GHS. - Executive summary:
The test substance, Ethylenediaminetetraacetonitrile, was evaluated for its potential to produce systemic toxicity or death following a 24-h topical application under occlusive conditions at a dose of 2 g/kg in a group of 5 male and 5 female New Zealand White albino rabbits. Based on the absence of mortality, the test substance is defined as non-toxic. As no levels were tested higher than 2000 mg/kg bw (limit test), the outcome at 5000 mg/kg bw is not known. Therefore, the test compound was classified in Category V, according to OECD-GHS.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- LD50 value in excess of 2000 mg/kg bw.
Additional information
The oral LD50 was in excess of 5000 mg/kg bw; the dermal LD50 was higher than 2000 mg/kg bw. Because EDTN is a wet cake and the particle size distribution showed that particles were very large (d10 was 60 µm, d50 119 µm and d90 207 µm), inhalation is not very likely.
Justification for selection of acute toxicity – oral endpoint
Relatively well performed study
Justification for selection of acute toxicity – dermal endpoint
Relatively well performed study
Justification for classification or non-classification
No mortality was seen in the acute dermal toxicity test at 2000 mg/kg bw, and clinical signs and body weight changes were absent. As such no classification is required for acute toxicity (oral and dermal) for both EU-GHS and OECD-GHS.
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