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Diss Factsheets
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EC number: - | CAS number: 37486-69-4
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 31 August 2010 - 29 September 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted under GLP conditions and OECD Guideline 437
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 437: Bovine corneal opacity and permeability (BCOP) test method for identifying occular corosives and severe irritants (adopted September 7, 2009)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Details on test material:
- - Name of test material (as cited in study report): MTDID 21721, TFEE-5
- Substance type: clear colorless liquid
- Physical state: liquid
- Lot/batch no.: TFEE5-276/12/09-1
- Expiration date of the lot/batch: 12 Dec 2012
- Stability under test conditions: stable
- Storage condition of test material: room temperature in the dark under nitrogen
Constituent 1
Test animals / tissue source
- Species:
- other: bovine
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: eyes were obtained from Vitelco, s'Hertogenbosch, The Netherlands
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: 3 corneas were treated with physiological saline (negative control) and three were treated with 10% benzalkonium chloride in physiological saline (positive control)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750 uL per cornea
- Concentration (if solution): undiluted
VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity: - Duration of treatment / exposure:
- 10 +/- 1 min
- Observation period (in vivo):
- corneas were incubated for 120 +/- 10 min following exposure
- Number of animals or in vitro replicates:
- 3 corneas per treatment group
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:
SCORING SYSTEM:
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Mean of three exposures
- Value:
- ca. 0
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: High IVIS: 1, Low IVIS: -1
In vivo
- Irritant / corrosive response data:
- The mean in vitro irritancy score for TFEE-5 was 0.0.
- Other effects:
- none
Any other information on results incl. tables
Mean laboratory historical control irritancy scores for the negative and positive controls were 0.5 and 152, respectively.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of the study, TFEE-5 is not considered an ocular irritant.
- Executive summary:
OBJECTIVE: The corneal irritation and damage potential of TFEE-5 (MTDID 21721, lot TFEE5-276/12/09-1) was tested in the Bovine Corneal Opacity and Permeability assay (BCOP).
METHODS: This study was conducted in compliance with the OECD GLP (1997). The study method was based on OECD 437 (2009), Background Review Document (BRD) prepared by ICCVAM and NICEATM (2006), INVITTOX (UK) protocol no. 124 SOP of Microbiological Associates Ltd. (1999) and Gautheron, P, et al (1992). TFEE-5 was tested as received. Bovine corneas (3 per group) were prepared in cMEM medium, supplemented with 1% FBS and 1% L-glutamine. The corneas were mounted in an O-ring holder and incubated for at least 1 hour at 32 C prior to exposure. Corneas (3 per group) were treated with 0.75 mL of TFEE-5, 10% benzalkonium chloride (positive control) or physiological saline (negative control) and incubated for a 10 minute exposure period at 32 C. At the end of the exposure period, the corneas were rinsed with media and they were then incubated for approximately 120 minutes. Opacity was evaluated prior to treatment and 120 minutes after the exposure period. Permeability was evaluated at 120 minutes after exposure using a fluorescein method. The mean in vitro irritation scores (IVIS) were calculated and a score greater than or equal to 55.1 indicates an ocular corrosive or severe ocular irritant.
RESULTS: The positive and negative controls were within the historical range which indicates the test was valid. The IVIS for TFEE-5 was 0.0.
CONCLUSION: Based on the results of this study, TFEE-5 is not considered an ocular irritant.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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