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EC number: 941-221-0 | CAS number: 203929-12-8
- 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:
- 16 January 2014 to 16 January 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted in compliance with OECD GLP regulations.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- MTDID 30531
- IUPAC Name:
- MTDID 30531
- Test material form:
- other: Liquid
- Details on test material:
- - Name of test material (as cited in study report): MTDID 30531
- Substance type: Mono-constituent
- Physical state: Liquid
- Analytical purity: 98.6%
- Purity test date: 03 August 2012
- Lot/batch No.: 41260127919/ Lot 2
- Storage condition of test material: At room temperature in the dark
- Other:
Constituent 1
Test animals / tissue source
- Species:
- other: in vitro
- Strain:
- other: not applicable
- Details on test animals or tissues and environmental conditions:
- Not applicable: in vitro method
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: in vitro method: positive (10% w/v Benzalkonium Chloride) and negative (physiological saline) controls were utlilized.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.75 mL - Duration of treatment / exposure:
- Corneas were incubated with the test article for 10 minutes at 32 degrees C.
- Observation period (in vivo):
- Following the 10 minute exposure, the corneas were rinsed and incubated in cell culture medium for 120 minutes. Opacity readings were conducted following the 120 minute incubation. The corneas were then placed in Na-fluorescein medium and incubated for 90 minutes. Following the indubations, permeability was measured.
- Number of animals or in vitro replicates:
- None, in vitro method.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Following the 10 minute exposure, the corneas were rinsed in cell culture
- Time after start of exposure: 10 minutes
SCORING SYSTEM: Opacity and permeability readings were normalized to the negative control values.
TOOL USED TO ASSESS SCORE: opacitometer, microplate reader for sodium fluorescein permeability reading.
Results and discussion
In vivo
Results
- Irritation parameter:
- other: in vitro irritation score (IVIS)
- Basis:
- mean
- Time point:
- other: 10 minute exposure
- Score:
- ca. -1
- Irritant / corrosive response data:
- Based on the results of the study, the test article is not an irritant to the cornea (IVIS = -1.0)
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results of the study, the test article is not an irritant to the cornea (IVIS = -1.0)
- Executive summary:
The corneal irritation and damage potential of the test article (Clear colorless liquid, Batch: 41260127919/Lot 2) was tested in the Bovine Corneal Opacity and Permeability test (BCOP test). The study was performed in compliance with OECD GLP (98) 17 (1997). The test method was based on OECD no. 437 (2009), EC No. 440/2008 B. 47 (2010), OTWG- ICCVAM-NICEATM (2006), INVITTOX 127 (2006), and Gautheron, P. et al. 18: 442-449 (1992). Corneas were prepared in cell culture medium and incubated at 32 C for at least 1 hour prior to exposure. Corneas (3/group) were treated with 0.75 mL of undiluted MTDID 30531 test material and incubated in a horizontal position for 10 minutes at 32 C. A positive control (10% w/v Benzalkonium Chloride) and a negative control (physiological saline) were tested in parallel with the test material. At the end of the exposure period, the corneas were rinsed and incubated in fresh cell culture medium for 120 +/- 10 minutes at 32 C. Opacity was evaluated using an opacitometer after the 2 hour post-exposure incubation. Following opacity readings, the cell culture medium was replaced with Na-fluorescein medium and incubated for approximately 90 minutes at 32 C. Following the 90 minute Na-fluorescein exposure, permeability was measured. The mean in vitro irritation score (IVIS) was calculated and the scores were classified according to protocol defined categories. For the test article, the mean IVIS = -1.0 after 10 minutes. The mean opacity score was -1 and the mean permeability score was -0.001 (range -0.007 to 0.007). Controls performed as expected. No pH effect of the test substance was observed on the rinsing medium. Based on the results of the study, the test article is not an irritant to the cornea (IVIS = -1.0).
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