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Diss Factsheets
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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- 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 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF Japanese test guidelines (2000)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
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
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Details on test animals:
Young adult animals (approx. 11 weeks).
Body weight variation <20% of the sex mean.
Identificatin by 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: 19.1 —22.6°C), a relative humidity of 30-70% (actual range: 35 - 72%) 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
Group housing of 3 animals per sex per cage in labelled Macrolon cages (type IV; height 18 cm.) containing purified sawdust as bedding material (Woody Clean bedding, Tecnilab—BMl BV, Someren, The Netherlands) and paper as cage-enrichement (Enviro—dri, BMI, Helmond, The Netherlands).
Certificates of analysis were examined and then retained in the NOTOX archives. Acclimatisation period was at least 5 days before start of treatment under laboratory conditions.
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.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Propylen glycol (specific gravity 1,036)
- Remarks:
- The vehicle was selected based on trial formulations at NOTOX
- Doses:
- single dosage of 2000 mg/kg (10 ml/kg) body weight on day 1
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Statistics:
- No statistical analysis was performed (the method used is not intented to allow the calculation of a precise LD50 value)
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No mortality occurred.
- Clinical signs:
- Hunched posture, uncoordinated movements were noted among the animals on day 1. In one animal tremor was noted on day 1 and on day 13 chromodacryorrhoea was noted in one animal.
- Body weight:
- The mean body weight gain shown by the animals over the study period was considered to be similar to that expected of normal untreated animals of the same age and strain.
The incidence of slight body weight loss or reduced body weight gain between days 8 and 15 in individual animals were considered not indicative of toxicity, based on the absence of any corroborative findings in these animals. - Gross pathology:
- In one animal lobe infraportalis (diaphragmatic hernia) and enlarged mandibular lymph nodes at both sides were noted at macroscopic post mortem examination. Macroscopic post mortem examination of the surviving animals at termination did not reveal any abnormalities.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Does not have to be classified
No obligatory labelling requirement for oral toxicity
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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