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EC number: 259-587-9 | CAS number: 55310-46-8
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-compliance OECD guideline study, no restrictions, adequate for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Sodium dibenzyldithiocarbamate
- EC Number:
- 259-587-9
- EC Name:
- Sodium dibenzyldithiocarbamate
- Cas Number:
- 55310-46-8
- Molecular formula:
- C15H15NS2.Na
- IUPAC Name:
- sodium (dibenzylcarbamothioyl)sulfanide
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany.
- Age at study initiation: approx. 9 weeks old
- Weight at study initiation: 17-22 g
- Housing: One per cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21±3°C
- Humidity (%): 30-70% R.H.
- Air changes: 15 air changes per hour
- Photoperiod: 12 hrs dark / 12 hrs artificial fluorescent light
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- 25 μl/ear of 0%, 25%, 50% and 100% in DMF (dimethylformamide) on three consecutive days
- No. of animals per dose:
- 12 females (three groups of four females each group).
(females were nulliparous and non-pregnant). - Details on study design:
- RANGE FINDING TESTS:
- Irritation: not irritant
- Lymph node proliferation response: No necropsy was performed
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Criteria used to consider a positive response: Calculation of the Stimulation Index (SI). The SI is the ratio of the DPM/node/group against the DPM/node of the negative control group. If the results indicate a SI ≥ 3, the test substance may be regarded as a skin sensitiser, based on the test guideline and recommendations done by ICCVAM (NIH publication; No 99-4494, February 1999).
TREATMENT PREPARATION AND ADMINISTRATION:
INDUCTION - Days 1, 2 and 3
Experimental animals:
The dorsal surface of both ears was epidermally treated with the test substance concentration, approximately the same time each day.
Vehicle control animals:
The control animals were treated the same as the experimental animals, except that, instead of the test substance, the vehicle was administered.
TREATMENT - Day 6:
All animals:
Each animal was injected via the tail vein with 0.25 ml of sterile phosphate buffered saline (PBS) containing 20 μCi of 3H-methyl thymidine (Amersham Pharmacia Biotech, NOTOX Substance 105624).
After approximately five hours, all animals were killed by intra peritoneal injection with an overdose of pentobarbital and the draining (auricular) lymph node of each ear were excised and pooled for each group in 3 ml PBS. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- No statistical analysis was performed.
Results and discussion
- Positive control results:
- The SI value calculated for the positive control (10% HCA in DMF) were 2.63.
Note: The SI = 2.63 value, as calculated for the 10% HCA positive control group, is relatively low, but considered sufficiently high to indicate that the assay as performed at NOTOX is able to identify possible skin sensitisers.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: The SI values calculated for the test substance concentrations 25%, 50% and 100% were 0.77, 0.47 and 0.53 respectively. The results are applicable for 16.9% aqueous solution of the substance.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: DPM/node values for the experimental groups treated with test substance concentrations of 25%, 50% and 100% were 217, 133 and 148 respectively. The DPM/node value for the vehicle control group was 281.
Any other information on results incl. tables
RADIOACTIVITY MEASUREMENTS
GROUP# |
INDUCTION |
NODES |
DPM/GROUP |
DPM/NODE |
1 |
Vehicle Control (DMF*) |
8 |
2244 |
281 |
2 |
25% test substance in DMF |
8 |
1733 |
217 |
3 |
50% test substance in DMF |
8 |
1060 |
133 |
4 |
100% test substance |
8 |
1179 |
148 |
#. Four females each group
*. Vehicle: Dimethylformamide.
Applicant's summary and conclusion
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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