Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from February 2004 to April 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 24 February 1987
- Deviations:
- yes
- Remarks:
- - 3 instead of 5 animals/sex used
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
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)
- Sex:
- male/female
- 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
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- other: 9 mg NaCl ad 1 mL aqua p.i.
- Details on dermal exposure:
- TEST SITE
- Area of exposure: The test substance was applied on a piece of gauze covering approximately 10% (4 x 9 cm) of the animal body surface under occlusive conditions for 24 hours.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No washing
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): A paste consisting the original compound (group 2: 79.2-125.8 mg, group 3: 400.0-590.2 mg) and 0.9% (w/v) sodium chloride (group 2: 0.05-0.075 mL, group 3: 0.30-0.35 mL)
was administered.
- Constant volume or concentration used: yes
- For solids, paste formed: yes
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.05 mL to 0.35 mL - Duration of exposure:
- 24 hours
- Doses:
- 400, 2000 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
General findings:
All alterations of the baseline condition of the animals were recorded. All animals were checked four times on administration day and once daily on the following days up to day 14 of the test.
Local findings:
All alterations of the skin at the administration sites of all animals were recorded according to the scoring system recommended by the EU (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.). The application sites were evaluated 1, 24, 48 and 72 h after removal of the patches and then once daily until day 14 of the test.
Body weight
Body weight was determined at the start (day 1), on day 8 and at the end of the study (day 14).
- Necropsy of survivors performed: yes; the animals were sacrificed 14 days post administration by inhalation of carbon dioxide and after occurrence of death a complete postmortem examination was performed on each animal.
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All treated animals survived at both doses.
- Clinical signs:
- other: no clinical findings at both doses.
- Gross pathology:
- Autopsy revealed no compound-related findings.
Any other information on results incl. tables
Dose [mg/kg] | Sex | Findings | Numberof animals with findings/number of surviving animals | ||||||||||||
Days after administration(hours after removal of the patches) | |||||||||||||||
2 (1) | 3 (24) | 4 (48) | 5 (72) | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | |||
400 | M | without findings | 3/3 | 3/3 | 3/3 | 3/3 | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. |
F | without findings | 3/3 | 3/3 | 3/3 | 3/3 | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | |
M | Pustules spotty |
| 2/3 |
|
|
|
|
|
|
|
|
|
|
| |
Pustules, plain |
| 1/3 |
|
|
|
|
|
|
|
|
|
|
| ||
Scab formation, spotty |
| 1/3 | 1/3 | 1/3 | 1/3 | 2/3 | 2/3 | 1/3 | 1/3 | 1/3 | 1/3 |
|
| ||
Scab formation, plain |
|
|
| 1/3 | 1/3 | 1/3 | 1/3 | 1/3 | 1/3 | 1/3 | 1/3 |
|
| ||
2000 | Scab formation, total treated area |
| 2/3 | 2/3 | 1/3 | 1/3 |
|
|
|
|
|
|
|
| |
without findings | 3/3 | 0/3 | 0/3 | 0/3 | 0/3 | 0/3 | 0/3 | 1/3 | 1/3 | 1/3 | 1/3 | 3/3 | 3/3 | ||
F | Reddening. sporadic, punctiform | 3/3 | 3/3 | 3/3 | 3/3 | 2/3 | 2/3 | 1/3 | 1/3 | 1/3 | 1/3 | 1/3 |
|
| |
Scab formation, spotty |
| 2/3 | 2/3 | 2/3 | 1/3 | 1/3 | 1/3 | 1/3 |
|
|
|
|
| ||
Skin defect -only outside of the treated area |
|
|
|
|
|
|
| 2/3 | 2/3 | 2/3 | 1/3 | 2/3 |
| ||
without findings | 0/3 | 0/3 | 0/3 | 0/3 | 1/3 | 1/3 | 2/3 | 0/3 | 0/3 | 0/3 | 1/3 | 1/3 | 3/3 |
M = male
F = female
n.d. = not detected
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- A single dermal administration of the test substance to male and female rats at 400 mg/kg and 2000 mg/kg was tolerated without mortalities, compound-related clinical findings, sustained effects on body weight gain and gross pathological findings. According to OECD TG 402 the dermal LD50 of the test substance is therefore > 2000 mg/kg body weight.
- Executive summary:
In an acute dermal toxicity study similar to OECD TG 402 (adopted 24 February 1987), groups of young adult Wistar rats (3/sex) were dermally exposed to Z-Triamine Dihydrochloride in physiological saline for 24 hours at doses of 400 and 2000 mg/kg bw. Animals then were observed for 14 days.
Dermal LD50 Combined = > 2000 mg/kg bw
The test item is of low Toxicity based on the combined LD50 value of > 2000 mg/kg bw.
The treatment was tolerated without mortalities, compound-related clinical findings, effects on body weight gain and gross pathological findings. Local effects were observed only for the 2000 mg/kg bw treatment group.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
Although ECHA is providing a lot of online material in your language, part of this page is only in English. More about ECHA’s multilingual practice.
Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
the-echa-website-uses-cookies
find-out-more-on how-we-use-cookies