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EC number: 609-496-9 | CAS number: 379685-94-6
- 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:
- From 13 August 2002 to 18 November 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 17th July 1992
- Deviations:
- yes
- Remarks:
- Relative humidity recorded in the animal room was sometimes outside of the target ranges specifiedd in the Study plan. This minor deviation was not considered to have compromised the validity or integrity of the study.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 31st July 1992
- Deviations:
- yes
- Remarks:
- Relative humidity recorded in the animal room was sometimes outside of the target ranges specifiedd in the Study plan. This minor deviation was not considered to have compromised the validity or integrity of the study.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Glycine, N-acetyl-N-[3-(trifluoromethyl)phenyl]valyl-, ethyl ester
- EC Number:
- 609-496-9
- Cas Number:
- 379685-94-6
- Molecular formula:
- C18H23F3N2O4
- IUPAC Name:
- Glycine, N-acetyl-N-[3-(trifluoromethyl)phenyl]valyl-, ethyl ester
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Other: ochre fine powder
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL- Storage condition of test material: room temperaturepH OF TEST ITEM: approximately 5 at the concentration of 10% in purified water, measured at the testing laboratory.
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS - Source: CEGAV, Saint Mars d'Egrenne, France. - Age at study initiation: 2 to 4 months old - Weight at study initiation: 2.8 ± 0.1 kg - Housing: animals were housed individually in polystyrene cages (48.2 cm x 58 cm x 36.5 cm). Each cage was equipped with a food container and a water bottle. - Diet: ad libitum to 110 pelleted diet (UAR, Villemoisson, Epinay-sur-Orge, France). Diet was analysed regularly by the supplier for composition and contaminant levels (dietformula was available in the study report). - Water: ad libitum to drinking water filtered by a FG Millipore membrane (0.22 micron). Bacteriological and chemical analyses of water were performed regularly by extemal laboratories (include detection of possible contaminants (pesticides, heavy metals and nitrosamines)). - Acclimation period: at least five days. ENVIRONMENTAL CONDITIONS - Temperature (°C): 18±3°C - Humidity (%): 30 to 70% - Air changes (per hr): approximately 12 cycles/hour of filtered, non-recycled air. - Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated skin served as control
- Amount / concentration applied:
- TEST MATERIAL - Amount(s) applied (volume or weight with unit): 0.5 g of the test item in its original form
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1 hour, 24, 48 and 72 hours after removal of the dressing. As no persistent irritant reaction was obserevd, the study was ended on day 4.
- Number of animals:
- 3 male rabbits
- Details on study design:
- TEST SITE - Preparation: 24 hours before treatment, both flanks of each animal were clipped using electric clippers and the skin of each animal was examined. Only animals with healthy intact skin were used. Clipping was repeated thereafter on day 3 for two animals of the study. - Area of exposure: no data - Application: As no irritant effects were anticipated, the test item was applied for 4 hours to three animals. A single dose of 0.5 g of the test item in ils original form was placed on a moistened gauze pad, which was then applied to the right flank of the animals for 4 hours. - Type of wrap if used: The test item and the gauze pad were held in contact with the skin by means of an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage. REMOVAL OF TEST SUBSTANCE - Washing (if done): after removal of the dressing any residual test item was wiped off by means of a moistened cotton pad. - Time after start of exposure: 4 hoursOBSERVATION TIME POINTS1 hour, 24, 48 and 72 hours after removal oft he dressing. According to the guidelines followed, the study was ended on day 4 in the absence of persistent irritatant reactions.SCORING SYSTEM:Dermal irritation was evaluated for each animal according to the following scoring scale: Erythema and eschar formation: . no erythema........................................................................................................... 0 . very slight erythema (barely perceptible).............................................................. 1 . well-defined erythema........................................................................................... 2 . moderate to sévère erythema................................................................................. 3 . sévère erythema (beet redness) to slight eschar formation (injuries in depth)...... 4 Oedema formation . no oedema............................................................................................................. 0 . very slight oedema (barely perceptible) ................................................................ 1 . slight oedema (edges of area well-defîned by defmite raising)............................. 2 . moderate oedema (raised approximately 1 millimètre)......................................... 3 . sévère oedema (raised more than 1millimètre and extending beyond area of exposure)..................................................................... 4 Any other lesions were noted.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: a score of 1 was obtained at the 1h observation time point
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: a score of 1 was obtained at the 1h observation time point
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: a score of 1 was obtained at the 1h observation time point
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: a score of 0 was obtained at the 1h observation time point
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: a score of 0 was obtained at the 1h observation time point
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: a score of 0 was obtained at the 1h observation time point
- Irritant / corrosive response data:
- - The readings carried out 1 hour after treatment showed a very slight erythema (grade 1) in all the animals of the study.- The readings carried out 24, 48 and 72 hours after treatment showed that none of the animals presented any lesions.- Individual mean scores for erythema and edema, 24, 48 and 72 hours after treatment were all 0.00 for the three animals.
- Other effects:
- None.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions of this study, the test material is not classified as irritating to the skin according to the Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) and the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) criteria.
- Executive summary:
This GLP-compliant study was performed to assess the potential of the test material to induce skin irritation in vivo, according to OECD Guideline 404 (dated July 17th, 1992) and EU method B.4 of the E.E.C. directive n° 92/69 (dated July 31st, 1992).
Material and methods
0.5 g of the solid test material were applied under semi-occlusive dressing during 4 hours, on a clipped skin area of one flank of 3 male rabbits. Skin reactions were recorded 1 hour and then 24, 48 and 72 hours after removal of the dressing.
Results
A very slight erythema was noted in all animals 1h after removal of the dressing. No dermal lesions were observed in any animal at all the other observation time points. The individual mean scores (24, 48 and 72 hours) of all three animals for erythema and edema were both: 0.0, 0.0 and 0.0.
Conclusion
Under the experimental conditions of this study, the test material is not classified as irritating to the skin according to the Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) and the
Globally Harmonized System of Classification and Labelling of Chemicals (GHS) criteria.
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