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EC number: 815-855-2 | CAS number: 440667-78-7
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- ethyl (2S)-3-[3,5-diamino-4-(4-methoxyphenoxy)phenyl]-2-acetamidopropanoate
- Cas Number:
- 440667-78-7
- Molecular formula:
- C20H25N3O5
- IUPAC Name:
- ethyl (2S)-3-[3,5-diamino-4-(4-methoxyphenoxy)phenyl]-2-acetamidopropanoate
- Test material form:
- solid: particulate/powder
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- Species: Mice CBA/CaOlaHsd
Source: Anlab, Praha, Czech Republic
Number and Sex of Animals: 28 females
Age at First Dose: 9-10 weeks; female animals were non-pregnant and nulliparous
Animal Health: The health condition of animals and skin integrity was examined by a veterinarian before initiation of the study. Animals were healthy, without visible symptoms of disease.
Acclimation: The animals were acclimated to the conditions identical to the condition during the experiment 5 days prior to the start of treatment. The acclimation was performed according to standard operation procedure ŠPP/EZ V001.
Housing Condition: The animals were housed in TECNIPLAST cages from the Tecniplast Company, in Conventional animal room No: B2-608. 5 females were housed per cage. The room temperature was within the range of 20-24oC, relative humidity was within the range of 40-60%. The animals were subjected to a 12-hour light/ 12-hour dark cycle. The sanitation was performed according to SOP ŠPP/EZ/V005.
Diet : A laboratory food for mice V1534-000 R/M-H (Ssniff) was served ad libitum. The certificate of analysis is included in the raw data.
Water: The animals received tap water for human consumption ad libitum. The water from the local mains was monitored for quality by testing for the microbiological and chemical quality by Waterworks Bratislava quarterly. Bottles were exchanged and cleaned once a week. The quality of drinking water is periodical monitored (including microbiological control) and recorded; certificate of analysis is included in raw data.
Bedding: Sterilized bedding from JRS Lignocel®. Hygienic animal bedding, sterilized sawdust.
The cages were cleaned once a week. The cages were emptied and cleaned with water and detergent. After cleaning they were dried and then immersed in disinfectant. The cage racks were cleaned in the rooms every week manually with water and detergent.
Animals Identification: Each animal was marked by code on the tail base in accordance with SOP: ŠPP/TOX/V002 to identify the animal individually. Each cage was marked with a coloured cage card. Each cage was affixed with a cage card containing pertinent animal and study information.
Justification for the Choice of Species: The CBA/Ca mice are the standard experimental rodent of choice and recommended by OECD Guideline No. 429.
Randomisation: Before the treatment animals were randomized based on body weights to treatment groups.
Study design: in vivo (LLNA)
- Vehicle:
- dimethyl sulphoxide
- Concentration:
- The doses were selected from the concentration series 100 %, 50 %, 25 %, 10 %, 5 %, 2.5 % etc. according to OECD Guideline No. 429.
The starting concentration was determined according to Pre-screen test results.
Number of animals:
Pre-screen test:
Group Group name No. animals ID number Cage number
1 L-TDOM 100 % (w/v) 1 1 1
2 L-TDOM 50 % (w/v) 1 1 2
3 L-TDOM 25 % (w/v) 1 1 3
Legend: L-TDOM - L-Tyrosine, N-acetyl-3,5-diamino-O-(4-methoxyphenyl)-, ethyl ester
Main study:
Group Group name No. animals ID number Cage number
1 Negative Control 5 1-5 1
2 Positive Control 5 6-10 2
3 L-TDOM 10 % (w/v) 5 11-15 3
4 L-TDOM 25 % (w/v) 5 16-20 4
5 L-TDOM 50 % (w/v) 5 21-25 5
Legend: L-TDOM - L-Tyrosine, N-acetyl-3,5-diamino-O-(4-methoxyphenyl)-, ethyl ester - No. of animals per dose:
- 5
- Details on study design:
- Day 1:
Each animal was identified, and the body weight was recorded. To the dorsum of each ear 25 µL of the appropriate dilution of the test item, positive control or the vehicle alone was applied.
Days 2 and 3:
The application procedure carried out on day 1 was repeated.
Days 4 and 5:
No treatment.
Day 6:
The body weight of each animal was recorded. 250 μL of sterile phosphate-buffered saline (PBS) containing 20 μCi (7.4×105 Bq) of tritiated (3H)-methyl thymidine was injected into all test and control mice via the tail vein.
Five hours later, the animals were sacrificed. The draining auricular lymph nodes from each ear was excised and pooled in PBS for each experimental group (pooled treatment group approach). - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 1.96
- Test group / Remarks:
- 50% group
- Key result
- Parameter:
- SI
- Value:
- 0.94
- Test group / Remarks:
- 25% group
- Key result
- Parameter:
- SI
- Value:
- 0.78
- Test group / Remarks:
- 10% group
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The skin sensitization potential of L-Tyrosine, N-acetyl-3,5-diamino-O-(4-methoxyphenyl)-, ethyl ester
was evaluated by LLNA method, which basic underlying principle is that sensitizers induce a primary proliferation of lymphocytes in the auricular lymph nodes draining the site of chemical application.
In the present study, the test item was applied to the dorsum of each ear of five female mice (CBA/CaOlaHsd) per group over three consecutive days, at three concentrations (10 %, 25 % and 50 % w/v). All animals survived throughout the test period without showing any clinical signs of toxicity. Calculated SI values in treated groups remained under the value of 3, which is the threshold to consider the substance as a sensitizer. Therefore, it was not possible to calculate an EC3 value.
These results demonstrate that the test item L-Tyrosine, N-acetyl-3,5-diamino-O-(4-methoxyphenyl)-, ethyl ester was not a skin sensitizer under the test conditions of this study - Executive summary:
The skin sensitizing potential of L-Tyrosine, N-acetyl-3,5-diamino-O-(4-methoxyphenyl)-, ethyl ester was assessed using the murine local lymph node assay. Based on the results of this study, L-Tyrosine, N-acetyl-3,5-diamino-O-(4-methoxyphenyl)-, ethyl ester is not considered a skin sensitizer under the conditions of this LLNA study.
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