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EC number: 616-081-6 | CAS number: 743423-33-8
- 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 vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 1992
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Version / remarks:
- August 1998
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF guidelines
- Version / remarks:
- 2000
- GLP compliance:
- yes
Test material
- Reference substance name:
- sodium;2-hexadecylsulfanyl-1H-benzimidazole-5-sulfonate
- EC Number:
- 616-081-6
- Cas Number:
- 743423-33-8
- Molecular formula:
- C23 H37 N2 Na O3 S2
- IUPAC Name:
- sodium;2-hexadecylsulfanyl-1H-benzimidazole-5-sulfonate
- Reference substance name:
- 1-hexadecyl-2-hexadecylsulfanyl-benzimidazole-5-sulfonate sodium salt
- Molecular formula:
- C39 H69 N2 Na O3 S2
- IUPAC Name:
- 1-hexadecyl-2-hexadecylsulfanyl-benzimidazole-5-sulfonate sodium salt
- Reference substance name:
- N,N-dimethylacetamide
- EC Number:
- 204-826-4
- EC Name:
- N,N-dimethylacetamide
- Cas Number:
- 127-19-5
- Molecular formula:
- C4H9NO
- IUPAC Name:
- N,N-dimethylacetamide
- Reference substance name:
- Ethyldiisopropylamine
- EC Number:
- 230-392-0
- EC Name:
- Ethyldiisopropylamine
- Cas Number:
- 7087-68-5
- Molecular formula:
- C8H19N
- IUPAC Name:
- N-ethyl-N-isopropylpropan-2-amine
- Test material form:
- solid: particulate/powder
- Remarks:
- off-white powder with lumps
- Details on test material:
- Traces of 1-bromohexadecane
Constituent 1
impurity 1
impurity 2
impurity 3
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- Source: Charles River Deutschland, Kisslegg, Germany
- Details on test animals or tissues and environmental conditions:
- Age and body weight: The animal used within the study was at least 6 weeks old and its body weight was at least 1.0 kg.
Identification Earmark.
Conditions
Animals were housed in a controlled environment, in which optimal conditions were considered to be approximately 15 air changes per hour, a temperature of 21.0 +- 3.0°C (actual range: 19.9 - 22.0°C), a relative humidity of 30-70% (actual range: 50 — 81%) and 12 hours artificial fluorescent light and 12 hours darkness per day.
Cleaning procedures in the room might have caused the temporary fluctuations above the optimal maximum level of 70% for relative humidity. Based on laboratory historical data, these fluctuatlons were considered not to have affected the study integrity.
Accommodation
individually in labelled cages with perforated floors (Scanbur, Denmark, dimensions: 56x44x37.5 cm). Acclimatisation period was at least 5 days before start of treatment under laboratory conditions.
Diet
Standard laboratory rabbit diet (Charles River Breeding and Maintenance Diet for Rabbits, Altromin, Lage, Germany) approx. 100 g. per day. Certificates of analysis were examined and retained in the NOTOX archives. in addition, hay (BMI, Helmond, the Netherlands) was provided at least three times a week.
Water
Free access to tap—water. Certificates of quarterly analysis were examined and retained in the NOTOX archives. Results of analysis for ingredients and/or contaminants of diet and water were assessed and did not reveal any findings that were considered to have affected study integrity.
Test system
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- Substance was ground to a powder using mortar and pestle prior to weighing
- Amount / concentration applied:
- 59,7 mg in a volume approximately 1 ml
- Observation period (in vivo):
- 1, 24, 48 and 72 hours after instillation
- Number of animals or in vitro replicates:
- 1
- Details on study design:
- All available data relevant to the potential eye irritation/corrosivity of the substance indicated that no severe effects were to be expected. No severe reactions were noted in the skin irritation study (Notox Project 407756). An in-vitro test was considered, but a negative test result was anticipated that still had to be confirmed in an in-vivo study. Since no severe harm for the animals was to be expected, this in-vivo eye irritation study was performed and was started by treatment of a single rabbit (sentinel).
A health inspection was performed prior to commencement of treatment, to ensure that the animal was in a good state of health. Special attention was paid to the eyes, which were free from any abnormality.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- >= 1 - <= 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within:
- Remarks:
- 72 hours
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- >= 1 - <= 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within:
- Remarks:
- 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- >= 2 - <= 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within:
- Remarks:
- 72 h
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- >= 2 - <= 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within:
- Remarks:
- 72 h
- Irritation parameter:
- conjunctivae score
- Remarks:
- Discharge
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- >= 1 - <= 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within:
- Remarks:
- 72 h
- Irritation parameter:
- other: epithelial damage %
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- >= 75 - <= 95
- Max. score:
- 95
- Reversibility:
- not fully reversible within:
- Remarks:
- 72 h
- Other effects:
- Decreased elasticity of the eyelids was noted at 24 and 48 hours after instillation of the test substance.
Gray discoloration (signs of necrosis) of eyelids and sclera were noted 48 and 72 hours after
Any other information on results incl. tables
Colouration / Remnants
No staining of (peri) ocular tissues by the test substance was observed and no test substance remnants were seen.
Toxicity / Mortality
No symptoms of systemic toxicity were observed in the animal during the test period and no mortality occurred.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Based on the degree and persistence of the corneal injury, it was concluded that ocular corrosion had occurred by instillation of V182675 into the rabbit eye in the animal.
Based on these results and according to the:
- OECD Harmonized Integrated Hazard Classification System for Human Health and Environmental Effects of Chemical Substances (OECD, 1998), V182675 should be classified as: having irreversible effects on the eyes (Class 1).
- EC criteria for classification and labelling requirements for dangerous substances and preparations (Council Directive 67/548/EEC), V182675 should be labelled as: risk of serious damage to eyes (R 41).
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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