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EC number: 200-644-4 | CAS number: 67-16-3
- 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:
- supporting study
- Study period:
- 05 May 2017
- 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)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- N,N'-[dithiobis[2-(2-hydroxyethyl)-1-methylvinylene]]bis[N-[(4-amino-2-methyl-5-pyrimidinyl)methyl]formamide
- EC Number:
- 200-644-4
- EC Name:
- N,N'-[dithiobis[2-(2-hydroxyethyl)-1-methylvinylene]]bis[N-[(4-amino-2-methyl-5-pyrimidinyl)methyl]formamide
- Cas Number:
- 67-16-3
- Molecular formula:
- C24H34N8O4S2
- IUPAC Name:
- N,N'-[dithiobis[2-(2-hydroxyethyl)-1-methylvinylene]]bis[N-[(4-amino-2-methyl-5-pyrimidinyl)methyl]formamide
- Test material form:
- solid: particulate/powder
- Remarks:
- Pale yellow powder
- Details on test material:
- Batch : 18117240
Dose calculation will not be adjusted to purity
Constituent 1
- Specific details on test material used for the study:
- Batch N°18117240
CAS No.: 67-16-3
Purity: 98.2 %, dose calculation was not adjusted to purity
Appearance: Pale yellow powder
Test animals / tissue source
- Species:
- cattle
- Details on test animals or tissues and environmental conditions:
- Freshly isolated bovine cornea (at least 9 month old donor cattle)
Test system
- Vehicle:
- physiological saline
- Remarks:
- The test item was tested as a 20% suspension (w/v) in saline.
- Amount / concentration applied:
- The test item was tested as a 20% suspension (w/v) in saline.
- Duration of treatment / exposure:
- The incubation time lasted 240 minutes.
- Number of animals or in vitro replicates:
- Negative Control : 3
Positive Control : 3
Test Item : 3
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Remarks:
- Mean IVIS
- Value:
- 0
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
In vivo
- Irritant / corrosive response data:
- Not categorized
Any other information on results incl. tables
Results after 240 Minutes Incubation Time
Test Group |
Opacity value = Difference (t240-t0) of Opacity |
Permeability at 490 nm (OD490) |
IVIS |
Mean IVIS |
Proposedin vitroIrritancy Score |
||
|
|
Mean |
|
Mean |
|
|
|
Negative Control |
0 |
0.00 |
0.079 |
0.078 |
1.19 |
1.17 |
Not categorized |
0 |
0.079 |
1.19 |
|||||
0 |
0.076 |
1.14 |
|||||
Positive Control |
93.00* |
0.177* |
95.66 |
109.92 |
Category 1 |
||
116.00* |
0.181* |
118.72 |
|||||
111.00* |
0.292* |
115.38 |
|||||
5007 TDS HYDRATE SEC |
-1.00* |
0.011* |
-0.84 |
0.00 |
Not categorized |
||
0.00* |
0.006* |
0.09 |
|||||
0.00* |
0.043* |
0.65 |
*corrected values
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In conclusion, according to the current study and under the experimental conditions reported, 5007 TDS HYDRATE SEC is not categorized (GHS).
- Executive summary:
This in vitro study was performed to assess the corneal damage potential of 5007 TDS HYDRATE SEC by means of the BCOP assay using fresh bovine corneae.
After a first opacity measurement of the fresh bovine corneae (t0), the 20% (w/v) suspension in saline (0.9% (w/v) NaCl in deionised water) of the test item 5007 TDS HYDRATE SEC, the positive and the negative controls were applied to corneae fixed in an incubation chamber in horizontal position and incubated for 240 minutes at 32 ± 1 °C. The posterior chamber contained incubation medium. After the incubation phase the test item, the positive, and the negative controls were each rinsed from the corneae and opacity was measured again (t240).
After the opacity measurements permeability of the corneae was determined by measuring spectrophotometrically the transfer of sodium fluorescein after incubation in a horizontal position for 90 minutes at 32 ± 1 °C.
With the negative control (physiological saline) neither an increase of opacity nor permeability of the corneae could be observed.
The positive control (10% (w/v) Benzalkonium chloride in saline) showed clear opacity and distinctive permeability of the corneae corresponding to a classification as serious eye damage (CLP/EPA/GHS (Cat 1)).
Relative to the negative control, the test item 5007 TDS HYDRATE SEC did not cause any increase of the corneal opacity or permeability. The calculated mean in vitro irritancy score was 0.00. According to OECD 437 (see table in chapter 3.8.3) the test item is not categorized (GHS).
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