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EC number: 245-082-0 | CAS number: 22564-43-8
- 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:
- 1992-03-10 - 1992-03-24
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Study terminated at day 8 without observation of reversibility.
- GLP compliance:
- yes
Test material
- Reference substance name:
- N-(2-chloroethyl)-N-ethylaniline
- EC Number:
- 245-082-0
- EC Name:
- N-(2-chloroethyl)-N-ethylaniline
- Cas Number:
- 22564-43-8
- Molecular formula:
- C11H16ClN
- IUPAC Name:
- N-(2-chloroethyl)-N-ethylaniline
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: HC:NZW Albino
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Interfauna UK Ltd.
- Age at study initiation: adult
- Weight at study initiation: 3.2 - 3.4 kg
- Housing: individually in stainless steel cages with flat rod bases or plastic cages with perforated bases under standardised conventional conditions. Excrement trays beneath the cages contained low dust-(wood) bedding (type S 8/15). Bedding was regularly spot-checked for contaminants and changed at least twice weekly.
- Diet (e.g. ad libitum): Standard diet ssniff K 4 (Ssniff Spezialdiäten GmbH, Soest/Westfalen), ca. 100-120 g per animal and day, feeding once daily in the morning
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: min. 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21±1.5°C
- Humidity (%): ca. 40-70%
- Air changes (per hr): 12-15 times per hour
- Photoperiod (hrs dark / hrs light): 12 hours, artificial light from 6 to 18 hrs CET, approx. 500 lux
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 500 µL
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 7 d
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6cm² of the flank
- Type of wrap: hypoallergenic Hansamed patch (Beiersdorf No. 2342 PV3), fixed with semiocclusive dressing (Fixomull-Strech Klebevlies, Beiersdorf No. 2239)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): carefully with water
- Time after start of exposure: 4h
SCORING SYSTEM: Draize-grading
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 2
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- within 7 days
- Remarks on result:
- other: Mean value of 2.7 (≥ 2.3 - ≤ 4.0) for erythema/eschar in 2 of 3 tested animals triggering classification as Skin Irrit. 2
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.8
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- within 7 days
- Irritant / corrosive response data:
- Test item is moderately irritating to the skin.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- The study was conducted under GLP according to OECD guideline 404 on the registered substance itself. The method is to be considered scientifically reasonable although it has been terminated at day 8 without observation of reversibility. Hence, the results can be considered as reliable to assess the skin irritating properties of the test substance in rabbits. Scoring according to Draize resulted in mean value of 2.7 (≥ 2.3 - ≤ 4.0) for erythema/eschar in 2 of 3 tested animals triggering classification as Skin Irrit. 2.
- Executive summary:
In a primary dermal irritation study (OECD guideline 404), adult albino HC:NZW rabbits (3 females) were dermally exposed to 500 µL of test substance for 4 hours to 6 cm². Animals then were observed for 7 days. Irritation was scored by the method of Draize.
Erythematous and exsudative reactions were seen. The signs did not prove to be reversible up to day 7. Additionally in the exposed skin areas single rhagades, peeling of epidermis, indurations and necrosis were observed in one and whithish eschar formation in all three animals and in two animals the margin of the exposed area was reddened.
Scoring according to Draize resulted in mean value of 2.7 (≥ 2.3 - ≤ 4.0) for erythema/eschar in 2 of 3 tested animals triggering classification as Skin Irrit. 2.
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