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EC number: 700-597-4 | CAS number: 1215841-86-3
- 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
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- Solubility in organic solvents / fat solubility
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- Flash point
- Auto flammability
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- 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
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- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
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- Nanomaterial aspect ratio / shape
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- Endpoint summary
- Stability
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- 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:
- 2011-06-03 to 2011-06-18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study; GLP study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- (2002)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Version / remarks:
- 1998
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- (1r,4r)-N1,N1,N4,N4-tetrakis(2-hydroxyethyl)cyclohexane-1,4-dicarboxamide
- EC Number:
- 700-597-4
- Cas Number:
- 1215841-86-3
- Molecular formula:
- C16H30N2O6
- IUPAC Name:
- (1r,4r)-N1,N1,N4,N4-tetrakis(2-hydroxyethyl)cyclohexane-1,4-dicarboxamide
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- CAS name: 1,4-Cyclohexanedicarboxamide, N1,N1,N4,N4-tetrakis(2-hydroxyethyl)-, trans
Chemical characterization: Trans-N,N,N',N'-Tetrakis(2-hydroxyethyl)-cyclohexyl-1,4-diamide
Characteristics: Whitish, solid, powder, hydroscopic
Contents:
91.53 % Trans-N,N,N',N'-Tetrakis(2-hydroxyethyl)-cyclohexyl-1,4-diamide
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
- Source: LPT, Laboratory of Pharmacology and Toxicology, Löhndorf (Germany)
- Sex: male
- Age: approx. 5.5 - 6.5 months
- Weight at study initiation: 2.5 kg to 2.6 kg
- Housing: single
- Diet: ad libitum, ssniff K-H (ssniff Spezialdiäten GmbH, 59494 Soest, Germany)
- Water: ad libitum, tap water
- Acclimatisation period: at least 20 days
- Controls: untreated skin surrounding the application area
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +/- 3 °C
- Humidity (%): 30% - 70%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 hour light/12 hour dark cycle
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 500 mg/patch and animal
1000 mg of the test item were mixed with 0.5 mL aqua ad iniectabilia , 750 mg of this paste were applied per animal (500 mg test item/animal) - Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- Postexposure period: 72 hours (Because no effects have been observed the period of observation is not 14 days but 72 hours.)
- Number of animals:
- 3
- Details on study design:
- ADMINISTRATION/EXPOSURE
- Preparation of test substance: 1000 mg of the test item were mixed with 0.5 mL aqua ad iniectabilia , 750 mg of this paste were applied per animal
(500 mg test item/animal)
- Area of exposure: dorsal area of trunk, shaved 24 hours in advance, approx. 6 cm2
- Vehicle: aqua ad iniectabilia
- Concentration: 500 mg test substance
- Occlusion: gauze patch held in place by semi-occlusive non-irritating tape dressing
- Washing:
EXAMINATIONS
- Examination time points: 60 minutes, 24, 48, 72 hours,
- Scoring system: Draize (0-4 possible scores each for erythema/eschar and for edema)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- AVERAGE SCORE
- Erythema: 0
- Edema: 0 - Other effects:
- no other effects
Any other information on results incl. tables
Findings Examination Skin irritation scores
of the skin schedule
animal no.
1 2 3
E/Oe E/Oe E/Oe
500 mg substance/patch/animal
erythema and
eschar formations/before dosing 0/0 0/0 0/0
oedema formation
time after removal
of the patch
(4-hour exposure)
60 min 0/0 0/0 0/0
24 hours 0/0 0/0 0/0
48 hours 0/0 0/0 0/0
72 hours 0/0 0/0 0/0
0 no pathological findings
E erythema and eschar formations
Oe oedema
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: EC Regulation 1272/2008
- Conclusions:
- According to the EC Regulation 1272/2008 and subsequent regulations on classification, labelling and packaging of substances and mixtures, trans-N1,N1,N4,N4-Tetrakis(2-hydroxyethyl)1,4-cyclohexanedicarboxamide was n o n - i r r i t a t i n g to skin, hence, no labelling is required.
- Executive summary:
The purpose of this study was to examine trans-N1,N1,N4,N4-Tetrakis(2-hydroxyethyl)1,4-cyclohexanedicarboxamide for acute dermal irritation/corrosion properties in rabbits (patch test), according to OECD guideline 404, EC method B.4.and OCSPP guideline 870.2500.
Under the present test conditions, none of the three male rabbits exposed for 4 hours to 500 mg trans-N1,N1,N4,N4-Tetrakis(2-hydroxyethyl)1,4-cyclohexanedicarboxamide/patch (semi-occlusive conditions) showed any skin reaction. There were no systemic intolerance reactions. Therefore, the test item was non-irritating to skin, hence no labelling is required.
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