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EC number: 219-350-2 | CAS number: 2422-88-0
- 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:
- 08 November 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Version / remarks:
- 26 July 2013
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Tributyl-2-thiourea
- EC Number:
- 219-350-2
- EC Name:
- Tributyl-2-thiourea
- Cas Number:
- 2422-88-0
- Molecular formula:
- C13H28N2S
- IUPAC Name:
- 1,1,3-tributylthiourea
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): Tri butyl thiourea
- Appearance: Clear pale to medium brown liquid
- Storage conditions: At room temperature
Constituent 1
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent vehicle
- yes, concurrent positive control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 750 μl per cornea
NEGATIVE CONTROL
- Amount applied: 750 µl of physiological saline per cornea
POSITIVE CONTROL
Amount applied: 750 µl 99.9% ethanol per cornea - Duration of treatment / exposure:
- 10 minutes
- Number of animals or in vitro replicates:
- Test item: 3
Negative control: 3
Positive control: 3 - Details on study design:
- TEST SITE
- Isolated bovine cornea
REMOVAL OF TEST SUBSTANCE
- Washing: yes, with cMEM (Eagle’s Minimum Essential Medium, Life Technologies)
- Time after start of exposure: 10 minutes
SCORING SYSTEM:
- After exposure the cornea is thoroughly rinsed to remove the test substance followed by incubation for 120 ± 10 minutes in cMEM. Then, corneas were incubated in sodium-fluorescein solution for 90 ± 5 minutes (both incubations at 32 ± 1°C).
- The mean opacity and mean permeability values (OD490) were used for each treatment group to calculate an in vitro score:
In vitro irritancy score (IVIS) = mean opacity value + (15 x mean OD490 value).
TOOL USED TO ASSESS SCORE:
- opacitymeter and microplate reader
DATA EVALUATION:
A test substance that induces an IVIS ≤ 3 is not classified for eye irritancy (UN GHS: no category);
A test substance that induces an IVIS > 55 is defined as a corrosive or severe irritan (UN GHS: catgegory 1);
For a test substance that induces an IVIS >3 and ≥ 55, no prediction on irritant potency can be made.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Mean of 3 replicates
- Value:
- 0.8
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- (-0.2)
- Positive controls validity:
- valid
- Remarks:
- (50.2)
- Other effects / acceptance of results:
- - The result was based on the mean value of the individual scores (-0.7, 0.6 and 2.4)
- One of the negative control eyes was excluded from the analysis since the IVIS was >3 due to an opacity value of 3.1 which was just outside the historical control data range of -2.9-3.0. However, since the other 2 eyes completely met the acceptance criteria and the test item results were not influenced by this result, the deviation does not affect the study outcome.
- The acceptability criteria were met, therefore the study is considered valid.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the outcome of a Bovine Corneal Opacity and Permeability test (BCOP) performed according to OECD gudieline and GLP principles, it is concluded that Tri butyl thiourea is not irritant or corrosive for the eye.
- Executive summary:
A Bovine Corneal Opacity and Permeability test (BCOP) was performed with Tri butyl thiourea according to OECD guideline 437 and GLP principles. Tri butyl thiourea was applied undiluted (750 µL/ cornea, n=3). The mean in vitro irritancy score of the positive control (ethanol) was 50, and the mean in vitro irritancy score of the negative control (physiological saline) was 0.9. It was therefore concluded that the test conditions were adequate and that the test system functioned properly. Tri butyl thiourea did not induce ocular irritation through opacity or permeability, resulting in a mean in vitro irritancy score of 0.8 after 10 minutes of treatment. Since Tri butyl thiourea induced an IVIS ≤ 3, no classification is required for eye irritation or serious eye damage.
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