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EC number: 402-920-1 | CAS number: 103300-89-6 N-6-TRIFLUORACETYL-L-LYSYL-L-PROLIN; T.F.A. LYS PRO; TFA-LYS-PRO
- 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:
- 1989-11-14 to 1990-02-15
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1981
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 1984
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- N-(N6-trifluoroacetyl-L-lysyl)-L-proline
- EC Number:
- 402-920-1
- EC Name:
- N-(N6-trifluoroacetyl-L-lysyl)-L-proline
- Cas Number:
- 103300-89-6
- Molecular formula:
- C13H20F3N3O4
- IUPAC Name:
- (2S)-1-[(2R)-2-amino-6-(2,2,2-trifluoroacetamido)hexanoyl]pyrrolidine-2-carboxylic acid
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: White russian (Albino)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: Males 9 months
- Weight at study initiation: Males 2.42 - 2.83 kg
- Housing: individually, Stainless steel cages with grating floor, type ASTA, size: 48.5x40x36.5 cm (LxBxH), supplied by ASTA Pharma AG, D-4800 Bielefeld 14
- Diet (e.g. ad libitum): Approx. 120 gram/day x animal Standard diet ssniff K, "Special diet for rabbits", supplied by ssniff Spezialfutter GmbH, D-4770 Soest
- Water (e.g. ad libitum): Water was provided ad libitum in drinking water quality from the Stadtwerke Bielefeld (Municipal Works). An automatic watering system with drinking nipples was used.
- Acclimation period: The animals were kept one day under test conditions before application of the product. Veterinary supervision of the animals was done before start of study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.5 - 22.5
- Humidity (%): 40-55
- Photoperiod (hrs dark / hrs light):12/12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- other: moistened with demineralized water
- Controls:
- other: contralateral non-treated site at the same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g moistened with 0.35 mL demineralized water
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.35 mL demineralized water
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48 and 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: the shorn dorsal skin area between shoulder and sacrum.
- % coverage: (approx. 6.25 cm²)
- Type of wrap if used: (Acrylastic, No. 2408, width 8 cm; supplied by P. Beiersdorf and Co. AG, Hamburg
REMOVAL OF TEST SUBSTANCE
- Washing (if done): After the end of the exposition time remaining test material was gently washed off as far as possible.
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS
1, 24, 48 and 72 hours after removal of the patches for 3 days p. appl.
SCORING SYSTEM: The evaluation of the cutaneous irritation effect at observation times 1, 24, 48 and 72 hours p. appl. was expressed by an irritation index
- Method of calculation: The arithmetical mean values of the individual grades obtained from the skin areas at observation times 1, 24, 48 and
72 hours were calculated - separately for erythema- /eschar and edema formation. The irritation index is represented by the sum of these two mean values.
A corresponding gradation was allocated to this index by the following scheme in a modified method according to Gilman et al..
Index Ranges Gradation
0.0-0.5 non-irritant
0.6-3.0 slightly irritant
3.1-5.0 moderately irritant
5.1-8.0 severely irritant
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal: 1-3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The single application of 0.5 gram ε-trifluoroacetyl-L-lysyl-L-proline to the intact skins of three rabbits caused only very slight changes. Erythema occurred in two animals 24 hours after removal of the patch. The treated skin area showed a very slight erythema (grade 1). The finding had completely disappeared at day 3 of observation.The irritation index is 0.3. ε-trifluoroacetyl-L-lysyl-L-proline therefore is classified as non-irritant in this test system.
- Other effects:
- None
Any other information on results incl. tables
Reaction of the exposed skin |
hours after exposure |
DRAIZE grade
|
||
|
|
Animal number |
||
Erythema and Eschar formation: |
|
|||
|
1 |
0 |
0 |
0 |
|
24 |
0 |
1 |
1 |
|
48 |
0 |
1 |
1 |
|
72 |
0 |
0 |
0 |
Edema |
|
|||
|
1 |
0 |
0 |
0 |
|
24 |
0 |
0 |
0 |
|
48 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item was tested for skin irritation in a study conducted according to OECD guideline 404 (1981). Erythema occurred in two animals 24 hours after removal of the patch. The treated skin area showed a very slight erythema (grade 1). The finding had completely disappeared at day 3 of observation. Systemic-toxic effects did not occur after dermal application of the test substance. The general condition of the test animals was not affected. Therefore, ε-trifluoroacetyl-L-lysyl-L-proline is classified as non-irritant in this test system according to Regulation (EC) No1272/2008 (CLP) and the Globally Harmonized System for Classification and Labelling of Chemicals (GHS).
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