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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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2004
- Reliability:
- 1 (reliable without restriction)
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 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 2002
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- Draft 2001
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Version / remarks:
- 2003
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
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
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- Age and bodyweight: Young adult animals (approx. 10 weeks old) were selected. Body weight variation was within +/- 20% of the sex mean.
Identification: Tail mark.
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: 19.1 - 21 .7°C), a relative humidity of 30-70% (actual range: 32 — 88%) 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 fluctuations were considered not to have affected the study integrity.
Accommodation
Individual housing in labelled Macrolon cages (type l; height 12.5 cm) containing purified sawdust as bedding material (Woody-Clean type 3/4; Tecnilab-BMI BV, Someren , The Netherlands). Certificates of analysis were examined and then retained in the NOTOX archives.
The acclimatisation period was at least 5 days before the start of treatment under laboratory conditions. Animals were group housed in polycarbonate cages (Macrolon II type; height 15 cm) during the acclimatisation period.
Diet
Free access to standard pelleted laboratory animal diet (from Altromin (code VRF 1), Lage, Germany). Certificates of analysis were examined and then retained in the NOTOX archives.
Water
Free access to tap-water. Certificates of quarterly analysis were examined and then retained in the NOTOX archives.
Results of analysis for ingredients and/or contaminants of diet, sawdust, and water were assessed and did not reveal any findings that were considered to have affected study integrity.
Study design: in vivo (LLNA)
- Vehicle:
- methyl ethyl ketone
- Remarks:
- Vehicle was selected based on trial formulations performed at NOTOX
- Concentration:
- Vehicle control, 5%, 25% and 50% of test substance concentration
- No. of animals per dose:
- 5
- Details on study design:
- Three groups of five animals were treated with three test substance concentrations respectively. One group of five animals was treated with vehicle.
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 1
- Variability:
- SD = 0
- Test group / Remarks:
- Vehicle control
- Parameter:
- SI
- Value:
- 1
- Variability:
- SD = 0.7
- Test group / Remarks:
- 5% test substance
- Parameter:
- SI
- Value:
- 1.3
- Variability:
- SD = 1.0
- Test group / Remarks:
- 25% test substance
- Parameter:
- SI
- Value:
- 0.6
- Variability:
- SD = 0.7
- Test group / Remarks:
- 50% test substance
- Cellular proliferation data / Observations:
- Induction phase
No irritation was observed in any of the animals examined.
Macroscopy
The majority of nodes were equal in size. No other macroscopic abnormalities of the nodes were noted.
Body Weights
Body weights and body weight gain of experimental animals remained in the same range as controls over the study period. The slight body weight loss, noted in some animals, was considered not toxicologically significant.
Radioactivity Measurements
Mean DPM/animal values for the experimental groups treated with test substance concentrations 5, 25 and 50% were 316, 395 and 196 respectively. The mean DPM/animal value for the vehicle control group was 311.
Toxicity I Mortality
No mortality occurred and no symptoms of systemic toxicity were observed in the animals of the main study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The SI values calculated for the substance concentrations 5, 25 and 50% were 1.0, 1.3 and 0.6 respectively. There was no indication that the test substance could elicit an SI >= 3.
Based on these results and according to the recommendations made in the test guidelines (OECD No.429, EC B.42 and EPA OPPTS 870.2600), V182675 should not be regarded as a skin sensitiser.
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 does not have to be classified for sensitisation by skin contact.
- EC criteria for classification and labelling requirements for dangerous substances and preparations (Council Directive 67/548/EEC), V182675 does not have to be classified and has no obligatory labelling requirement for sensitisation by skin contact.
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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