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EC number: 606-946-6 | CAS number: 221640-14-8
- 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:
- from February to April 2004
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 24 April 2002
- Deviations:
- yes
- Remarks:
- - exposure time 24 hrs instead of 4 hrs; number of animals 6 instead of 3 animals
- Principles of method if other than guideline:
- A combined study on acute dermal toxicity and on local tolerance was used to assess skin irritation/corrosion. The study design and reporting deviates from the current OECD TG 404, however, the study is considered sufficient for assessment of this endpoint.
- GLP compliance:
- yes
Test material
- Reference substance name:
- n.a.
- Molecular formula:
- n.a.
- IUPAC Name:
- n.a.
- Reference substance name:
- Carbamic acid [(1S)-,2-[(2-aminoethyl)amino]-1-[(4-ethoxyphenyl)methyl]ethyl]-,phenylmethyl ester, dihydrochloride (9Cl)
- IUPAC Name:
- Carbamic acid [(1S)-,2-[(2-aminoethyl)amino]-1-[(4-ethoxyphenyl)methyl]ethyl]-,phenylmethyl ester, dihydrochloride (9Cl)
- Reference substance name:
- benzyl[(2S)-1-[(2-aminoethyl)amino]-3-(4-ethoxyphenyl)propan-2-yl]carbamate dihydrochlorid
- EC Number:
- 606-946-6
- Cas Number:
- 221640-14-8
- Molecular formula:
- C21 H29 N3 O3 . 2 Cl H
- IUPAC Name:
- benzyl[(2S)-1-[(2-aminoethyl)amino]-3-(4-ethoxyphenyl)propan-2-yl]carbamate dihydrochlorid
- Test material form:
- solid
impurity 1
impurity 2
impurity 3
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Han:WIST (SPF)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Schering AG, Germany
- Mean weight at study initiation: 287-314 g (males) or 198-205 g (females)
- Housing: 1 animal per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: >= 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 23
- rel. Humidity (%): 48 - 57
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- other: 9 mg NaCl ad 1 mL, aqua p.i.
- Controls:
- other: the untreated skin served as control
- Amount / concentration applied:
- 79.2 - 125.8 mg (= 400 mg/kg bw doese group animals)
400.0-590.2 mg/animal (= 2000 mg/kg bw dose group animals) - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 14 days
- Number of animals:
- 3 males and 3 females
- Details on study design:
- TEST SITE
- Area of exposure: 4 x 9 cm (approximately 10% of the body surface area of a rat)
- % coverage: 10%
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no removal
OBSERVATION TIME POINTS
(indicate if minutes, hours or days) 1, 24, 48, and 72h; total observation period 14 days
SCORING SYSTEM: According to Amendment of the Directive 67/548/EEC, Annex V, B.4. Acute toxicity (Skin irritation) in the version of the Directive 92/69/EEC, dated 31 Jul 1992.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1-#6
- Time point:
- 24/48/72 h
- Score:
- 3.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal: #1- #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
Any other information on results incl. tables
At the dose of 2000 mg/kg the animals showed primary and secondary efflorescences.
|
| Animal number and sex | |||||
Location (finding) | Time-point after end of exposure | 27M | 28M | 29M | 30F | 31F | 32F |
Reddening and scrab formation | 1 h | 0 | 0 | 0 | 1 | 1 | 1 |
24 h | 4 | 4 | 4 | 1 | 4 | 4 | |
48 h | 4 | 4 | 4 | 1 | 4 | 4 | |
72 h | 4 | 4 | 4 | 1 | 4 | 4 | |
Individual mean values: |
| 4 | 4 | 4 | 1 | 4 | 4 |
Mean value of all animals |
| 3.5 | |||||
| |||||||
Swellings | 1 h | 0 | 0 | 0 | 0 | 0 | 0 |
24 h | 0 | 0 | 0 | 0 | 0 | 0 | |
48 h | 0 | 0 | 0 | 0 | 0 | 0 | |
72 h | 0 | 0 | 0 | 0 | 0 | 0 | |
Individual mean values: |
| 0 | 0 | 0 | 0 | 0 | 0 |
Mean value of all animals |
| 0 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- A combined study on acute dermal toxicity and on local tolerance was conducted . The study design and reporting deviates from the current OECD TG 404, however, the study was considered sufficient for assessment of skin irritation/corrosion. After a single dermal administration of the test substance for 24 hours to male and female rats at a dose of 2000 mg/kg local irritation was described for 6/6 animals. Following grading at 24, 48 and 72 hours after patch removal a mean value of 3.5 for erythema/eschar was calculated. All animals were without local findings within 14 days.
- Executive summary:
In a primary dermal irritation study similar to OECD TG 404, young adult Wistar rats, female and male (3/sex) were dermally exposed to 79.2 - 125.8 mg or 400.0-590.2 mg/ animal of Z-Triamine Dihydrochloride in physiological saline for 24 hours. Animals then were observed for 14 days. Irritation was scored by the method according to Amendment of the Directive 67/548/EEC, Annex V, B.4. Acute toxicity (Skin irritation) in the version of the Directive 92/69/EEC, dated 31 Jul 1992..
At the dose of 2000 mg/kg the animals showed primary and secondary efflorescences.. These irritations lasted 14 days. In this study, the test item is considered a dermal irritant.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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