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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
In an acute oral toxicity study conducted according to OECD TG 401 the LD50 values were above a dose of 5110 mg/kg in male and female rats.
In an acute dermal toxicity study conducted according to OECD TG 402 the LD50 values for male as well as female rabbits were above 2000 mg/kg bw.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1990-01-31 to 1990-04-04
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- 1984
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Bor: WISW (SPFCpb)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: Males 8 weeks Females 8 weeks
- Weight at study initiation: Males 154 - 212 g Females 127 - 131 g
- Fasting period before study: 16 h before treatment
- Housing: individually, Macrolon cages, type II, Bedding: Animal bedding chips, supplied by Jelu-Werk, J. Ehrler, Industriemehle, D-7092 Rosenberg/Württ.
- Diet (e.g. ad libitum): Standard diet ad libitum ssniff R, "Special diet for rats", 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 at least 5 days under test conditions before administration of the test substance. Veterinary supervision of the animals was done before start of study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0 -22.5
- Humidity (%): 40 - 65 (for a short period 25 - 30)
- Photoperiod (hrs dark / hrs light): 12/12
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 237 mg/mL
- Amount of vehicle (if gavage): 21.5 mL/kg
MAXIMUM DOSE VOLUME APPLIED: 21.5 mL/kg
- Doses:
- 5110 mg/kg b.w.
- No. of animals per sex per dose:
- 5
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The body weights were recorded at the beginning and also 7 and 14 days after administration. The animals were continuously observed for the first 4 to 6 hours after administration and then once daily. The nature of the toxicity as well as the onset, the intensity, and the duration of the signs were recorded. Mortality was checked twice daily (a.m. and p.m.), on Saturdays, Sundays, and on national holidays only once.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, other: Mortality - Statistics:
- The LD 50 values were above a dose of 5110 mg/kg in male and female rats, thus no further statistics were performed.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 110 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No Mortality occurred
- Clinical signs:
- other: Signs of toxicity were not observed
- Gross pathology:
- At necropsy of the animals no abnormalities were detected.
- Other findings:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a study conducted according to OECD guideline 401 (1987) the LD 50 values were above a dose of 5110 mg/kg in male and female rats. Thus, the test item does not need to be classified according Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labelling of Chemicals (GHS) with respect to acute oral toxicity.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 110 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1994-01-11 to 1994-03-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- 1992
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rabbit
- Strain:
- other: White russian (Albino)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: Males 11 - 17 months Females 9 - 11 months
- Weight at study initiation: Males 2.33 - 2.79 kg Females 2.75 - 3.39 kg
- Fasting period before study:
- Housing: individually, Stainless steel cages with grating floor, type ASTA, size: 48.5x40x36.5 cm (LxBxH)
- Diet (e.g. ad libitum): Approx. 120 g/day and animal Standard diet, ssniff K, Special diet for rabbits (composition of the diet see attachment 2)
supplied by ssniff Spezialdiaten GmbH, D-59494 Soest
- Water (e.g. ad libitum): Water was provided ad libitum in drinking water quality from the Stadtwerke Halle, using an automatic drinking water system with drinking nipples.
- Acclimation period: The animals were kept at least 5 days under test conditions before substance application after hair clipping. Veterinary supervision of the animals was done before start of the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.0 - 20.0
- Humidity (%): 52 - 67%
- Photoperiod (hrs dark / hrs light): 12/12
- Type of coverage:
- occlusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: shorn skin between shoulder and sacral region
- % coverage: not reported
REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the exposure period bandage and patch were removed and the skin was cleaned from the residual test substance by washing with tapwater as far as possible.
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg moistened with water
VEHICLE
- Amount(s) applied (volume or weight with unit): water - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg b.w.
- No. of animals per sex per dose:
- 5
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were continuously observed for the first 4 to 6 hours after application and then once daily. The nature of the toxicity as well as the onset, the intensity, and the duration of the signs were recorded (1, 2, 4).
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, other: Mortality - Statistics:
- The LD 50 values for male as well as female rabbits were above 2000 mg/kg b.w. (limit test), thus no further statistics were performed.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Not observed
- Clinical signs:
- other: Not observed
- Gross pathology:
- No effects observed
- Other findings:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a study conducted according to OECD guideline 402 (1987) the LD 50 values for male as well as female rabbits were above 2000 mg/kg b.w., thus, the test item does not need to be classified according Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labelling of Chemicals (GHS) with respect to dermal acute toxicity.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
Justification for classification or non-classification
In a study conducted according to OECD TG 401 the LD50 values were above a dose of 5110 mg/kg bw in male and female rats. Thus, the test item does not need to be classified according Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labelling of Chemicals (GHS) with respect to acute oral toxicity.
In a study conducted according to OECD TG 402 the LD50 values for male as well as female rabbits were above 2000 mg/kg bw. Thus, the test item does not need to be classified according Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labelling of Chemicals (GHS) with respect to dermal acute toxicity.
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