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EC number: 224-314-4 | CAS number: 4303-67-7
- 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:
- 28 May 2014 to 28 May 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted in compliance with OECD GLP (1997) and OECD Guideline 437 (2013).
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 13999
- IUPAC Name:
- MTDID 13999
- Test material form:
- other: Liquid
- Details on test material:
- - Name of test material (as cited in study report): MTDID 13999
- Substance type: Pure active substance
- Physical state: Liquid
- Analytical purity: 99.0%
- Purity test date: 11 March 2014
- Lot/batch No.: Batch 529783
- Expiration date of the lot/batch: 23 September 2016
Constituent 1
Test animals / tissue source
- Species:
- other: Not applicable
- Strain:
- other: No applicable
- Details on test animals or tissues and environmental conditions:
- No applicable: in vitro test on Bovine corneas.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Corneas were exposed to negative and positive controls.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750 uL - Duration of treatment / exposure:
- The corneas were exposed to the test article for 10 minutes at 32 degrees C.
- Observation period (in vivo):
- After exposure, the corneas were observed for possible pH effects. They were then incubated for 120 minutes. After the incubation period, the opacity of the
- Number of animals or in vitro replicates:
- 0
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): The corneas were washed with Minimum Essential Medium after exposure.
- Time after start of exposure: 10 minutes
SCORING SYSTEM: The opacity and permeability of each cornea was measured.
TOOL USED TO ASSESS SCORE: An opacitometer was utilized to measure the opacity of each cornea and sodium fluorescein was used to determine permeability.
Results and discussion
In vivo
Results
- Irritation parameter:
- other: In Vitro Irritation Score (IVIS)
- Basis:
- mean
- Time point:
- other: 10 minutes
- Score:
- ca. 12
- Max. score:
- 13
- Reversibility:
- other: Not applicable
- Irritant / corrosive response data:
- The mean opacity score was 7 (range 6-7) and the mean permeability score was 0.300 (range 0.252-0.376). The mean in vitro irritation score (IVIS) was 12.0 after 10 minutes.
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Irritating to eyes (CLP Category 2A) Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results of the test and OECD 437 (2013), MTDID 13999 is a possible eye irritant, but is not corrosive to eyes (IVIS = 12.0).
- Executive summary:
The ocular corrosion potential of MTDID 13999 (clear yellowish liquid, Purity 99.0% CASRN 4303-67-7, Batch 529783) 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 (2013), 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 13999 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 OECD 437 (2013). For MTDID 13999, the mean IVIS = 12 after 10 minutes. The mean opacity score was 7 (range 6-7) and the mean permeability score was 0.300 (range 0.252-0.376). The pH of the rinsing medium was not altered by the test substance. Based on the results of the test and OECD 437 (2013), MTDID 13999 is a possible eye irritant, but is not corrosive to eyes (IVIS = 12.0).
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