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EC number: 212-786-4 | CAS number: 869-24-9
- 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:
- 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline and GLP compliant study with good documentation.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-chloroethyldiethylammonium chloride
- EC Number:
- 212-786-4
- EC Name:
- 2-chloroethyldiethylammonium chloride
- Cas Number:
- 869-24-9
- Molecular formula:
- C6H14ClN.ClH
- IUPAC Name:
- 2-chloroethyldiethylammonium chloride
- Details on test material:
- - Name of test material (as cited in study report): P5524
- Substance type: Powder
- Physical state: white powder
- Analytical purity: 102%
- Purity test date: 4. 1. 1990
- Lot/batch No.: 861201
- Storage condition of test material: room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd., Maston, Sandbach, Cheshire, U.K.
- Weight at study initiation: 2.19 - 2.26 kg/animal
- Housing: individually in suspended metal cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 - 22°C
- Humidity (%): 49 - 67%
- Air changes (per hr): 15 cycles/hour
- Photoperiod (hrs dark / hrs light): 12/12 hours
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: clipped
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg of the test substance were placed on a moistered gauze pad which was then applied to the right flank (application for 4 hours) or the left flank (application for 3 minutes) - Duration of treatment / exposure:
- 4 hours
- Observation period:
- approximately 1 hours, 24, 48, and 72 hours after removal of dressing
- Number of animals:
- three animals
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Four hours after application the corset and patches were removed from each animal and any residual test material removed by gentle swabbing with cotton wool soaked in distilled water.
SCORING SYSTEM:
Draize J.H. (1959) Association of Food and Drug Officials of the United States, Austin, Texas, "The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics"
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 1 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: haemorrhage of the dermal capilaries
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 d
- Remarks on result:
- other: haemorrhage of the dermal capilaries
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 48 and 72 h
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: evaluation of erythema not possible due to other adverse reactions, hardened dark brown/black-coloured scab, blanching, moderate erythema surrounding scab
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 7 days
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: evaluation of erythema not possible due to other adverse reactions, hardened dark brown/black-coloured scab
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 14 days
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: evaluation of erythema not possible due to other adverse reactions, scab lifting at edges to reveal dried blood
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 1 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: haemorrhage of the dermal capilaries
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: haemorrhage of the dermal capillaries, reaction extends beyond treatment site, blanching
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 48 and 72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: blanching
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 7 days
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: evaluation of erythema not possible due to other adverse reactions, hardened dark brown/black-coloured scab, dried blood
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 14 days
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: evaluation of erythema not possible due to other adverse reactions, sunken hardened dark brown/black-coloured scab resembling a crater
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 1 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: haemorrhage of the dermal capillaries
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: haemorrhage of the dermal capillaries, blanching
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 7 days
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: evaluation of erythema not possible due to other adverse reactions, hardened dark brown/black-coloured scab, blanching
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 14 days
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: evaluation of erythema not possible due to other adverse reactions, scab lifting at edges to reveal dried blood
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 1, 24, and 48 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 72 hours, 7 and 14 days
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: evaluation of oedema not possible due to the degree of thickening/ scabbing
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 1, 24, 48, and 72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 7 and 14 days
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: evaluation of oedema not possible due to the degree of thickening/ scabbing
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 1, 24, and 48 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: At 7 and 14 days: evaluation of oedema not possible due to the degree of thickening/ scabbing
- Irritant / corrosive response data:
- Well-defined or moderate erythema with moderate to severe oedema was noted during the study. Other adverse reactions noted were haemorrhage of the dermal capillaries, hardened dark brown/black-coloured scab, moderate erythema surrounding scab, blanching, dried blood, scab lifting at edges to reveal further dried blood and sunken hardened dark brown/black-coloured scab resembling a crater. At some treated skin sites the reaction extended beyond the treatment site. Reactions were indicative of corrosion.
Applicant's summary and conclusion
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Executive summary:
The acute dermal irritation of P5524- which contains 102% DEC - to rabbit (New Zealand White) was determined in a GLP compliant test according to OECD 404 and EU Method B.4 (Coles 1990). Since the study was performed under GLP and according the guideline and based on the good documentation the study was awarded with Klimisch 1. For the acute dermal irritation testing in 3 rabbits (2 males and one female, approx. weight of 2.19 - 2.26 g on day of application) 500 mg test item moistened with water was administered to the clipped skin. Application was performed for 4 hours.
The skin were examined according Draize J.H. (1959). Well-defined or moderate erythema with moderate to severe oedema was noted during the study. Other adverse reactions noted were haemorrhage of the dermal capillaries, hardened dark brown/black-coloured scab, moderate erythema surrounding scab, blanching, dried blood, scab lifting at edges to reveal further dried blood and sunken hardened dark brown/black-coloured scab resembling a crater. At some treated skin sites the reaction extended beyond the treatment site. Reactions were indicative of corrosion.
It can be concluded that under the experimental conditions the test substance is corrosive when administered by dermal route to rabbits.
According to the classification criteria laid down in the Commission Directive 93/21/EEC the test item required to be classified as corrosive to the skin.
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