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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
Endpoint summary
Administrative data
Description of key information
The test item was tested for skin irritation in a study conducted according to OECD TG 404. Erythema occurred in two rabbits 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.
In an eye irritatio/corrosion study conducted according to OECD TG 405 ε-trifluoroacetyl-L-lysyl-L-proline was applied into the conjunctival sac of three rabbits eyes. The animals were examined after 1, 24, 48 and 72 h, and only a slight hyperemia was detected in two animals which was fully reversible within 72 h.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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
- 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
- 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
- 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 - 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
- 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).
Reference
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 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1989-11-16 to 1990-03-22
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 1984
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- other: White russian (Albino)
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: Males 7 - 8 months, female 7 months
- Weight at study initiation: Males 2.36; 2.54 kg, female 2.89 kg
- Housing: individually in 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), using an automatic drinking water system with drinking nipples.
- 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 - 23.0
- Humidity (%): 40 - 55
- Photoperiod (hrs dark / hrs light): 12/12
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of the same animal served as control
- Amount / concentration applied:
- - Amount(s) applied (volume or weight with unit):0.07 or 0.055 g
- Duration of treatment / exposure:
- single exposure
- Observation period (in vivo):
- 1, 24, 48, 72 hours and 4 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): The eye was not rinsed
SCORING SYSTEM: Signs of irritation on the cornea, iris, and conjunctiva were assessed quantitatively and qualitatively using the DRAIZE scale (1, 2, 4 - 6). In addition, attention was paid to the occurrence of further reactions on the eye (e.g. corrosive effect) and to clinical symptoms (systemic toxic effects).
TOOL USED TO ASSESS SCORE: The treated eye was examined using a Cliptrix pencil light (supplied by Varta, Hannover, No. 645). - Irritation parameter:
- cornea opacity score
- Basis:
- animal: 1-3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal: 1-3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 4 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis 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 conjunctiva of two animals reacted with hyperemia (grade 1) from day 1 to day 2 or 3 of observation. Immediately after application slight discharge or discharge with moistening of lids and hair just adjacent to lids (grade 1 or 2) were observed and had completely disappeared after 24 or 72 hours. In the cornea and in the iris no alterations were detected. There were no systemic toxic effects after conjunctival application of the test substance.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a study conducted according to OECD guideline 405 (1987) ε-trifluoroacetyl-L-lysyl-L-proline was applied into the conjunctival sac of three rabbits eyes. The animals were examined after 1, 24, 48 and 72 h, and only a slight hyperemia was detected in two animals which was fully reversible within 72 h.
ε-trifluoroacetyl-L-lysyl-L-proline therefore 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).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
The test item was tested for skin irritation in a study conducted according to OECD TG 404. 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).
In a study conducted according to OECD TG 405 ε-trifluoroacetyl-L-lysyl-L-proline was applied into the conjunctival sac of three rabbits eyes. The animals were examined after 1, 24, 48 and 72 h, and only a slight hyperemia was detected in two animals which was fully reversible within 72 h. 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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