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Diss Factsheets
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EC number: 247-361-2 | CAS number: 25952-53-8
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- N'-(ethylcarbonimidoyl)-N,N-dimethylpropane-1,3-diamine monohydrochloride
- EC Number:
- 247-361-2
- EC Name:
- N'-(ethylcarbonimidoyl)-N,N-dimethylpropane-1,3-diamine monohydrochloride
- Cas Number:
- 25952-53-8
- Molecular formula:
- C8H17N3.ClH
- IUPAC Name:
- N-[3-(dimethylamino)propyl]-N'-ethylcarbodiimide hydrochloride
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- Crl: KBL (NZW)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, 97633 Sulzfeld, Germany,
- Age at study initiation: 19 to 30 weeks
- Weight at study initiation: > 2 Kg
- Housing: Semi-barrier in an air conditioned room. Housed in ABS plastic rabbit cages.
- Diet (e.g. ad libitum): Free access to autoclaved hay and Altromin maintenance diet for rabbits.
- Water (e.g. ad libitum): Free access to tap water.
- Acclimation period: At least 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3°C
- Humidity (%): 55 +/- 10%
- Air changes (per hr): At least 10
- Photoperiod (hrs dark / hrs light): Artificial light (12 hours light/dark cycle)
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Remarks:
- Aqua ad injectionem
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of the test item was applied.
VEHICLE
- Amount(s) applied (volume or weight with unit): Only used to ensure good contact with the test substance and skin. - Duration of treatment / exposure:
- Applied over a 4 hour period
- Observation period:
- Up to 14 days after patch removal
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: Left side of dorsal area
- % coverage: approximately 6 cm3
- Type of wrap if used: the gauze used was held in place with non-irritating tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed with tap water after 4 hours of exposure
OBSERVATION TIME POINTS
(indicate if minutes, hours or days): 1, 24, 48 and 72 hours after patch removal.
SCORING SYSTEM:
- Method of calculation: Scoring and grading as per standard system in relevant OECD guideline.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- >= 1 - <= 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 11 days
- Remarks on result:
- other: max score seen in study refers to whole observation period.
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- >= 2 - <= 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 9 days
- Remarks on result:
- other: max score seen in study refers to whole observation period.
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- > 0 - <= 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: max score seen in study refers to whole observation period.
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- >= 1 - <= 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 4 days
- Remarks on result:
- other: max score seen in study refers to whole observation period.
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- >= 1 - <= 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: max score seen in study refers to whole observation period.
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- >= 1 - <= 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 5 days
- Remarks on result:
- other: max score seen in study refers to whole observation period.
- Irritant / corrosive response data:
- The first animal showed irritation effects (erythema and oedema) immediately after patch removal. The subsequent observations revealed signs of irritation (erythema, oedema and eschar formation) within 10 days after removing the patch. Eschar formation was also observed in isolation on day 8.
The examination of the test site showed irritant effects 1 hour after the patch removal in Animal No. 2 (oedema) and animal No. 3 (oedema and erythema). Subsequent observations revealed signs of irritation (erythema, oedema eschar formation and desquamation) within the maximum of the prolonged observation period of 14 days. Eschar formation was observed in animal Nos. 2 and 3 up until Day 13 and 14 of the observation period, respectively. - Other effects:
- Minor skin inflammation observed as a result of the adhesive dressing in the first animal. There were also no significant bodyweight changes during the contact and observation period and no relevant clinical signs.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- Under the conditions of the study, the dermal application of the test substance showed irritant but not corrosive effects. The changes were not reversible within the maximum observation period of 14 days in one animal.
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