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EC number: 205-238-0 | CAS number: 136-30-1
- 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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Sodium dibutyldithiocarbamate
- EC Number:
- 205-238-0
- EC Name:
- Sodium dibutyldithiocarbamate
- Cas Number:
- 136-30-1
- Molecular formula:
- C9H19NS2.Na
- IUPAC Name:
- sodium (dibutylcarbamothioyl)sulfanide
- Details on test material:
- - Name of test material (as cited in study report): sodium dibutyldithiocarbamate (perkacit SDBC liq-w47%)
- Physical state: clear light yellow liquid
- Analytical purity: 46.20% (concentrated aqueous solution)
- Stability under test conditions: stable
- Storage condition of test material: at room temperature in the dark under nitrogen
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: approx. 10-11 weeks old
- Weight at study initiation: +/- 20% of the sex mean
- Fasting period before study: overnight
- Housing: group housing of 3 animals per cage in labeled Macrolon cages (MIV type; height 18 cm) containing sterilized sawdust as bedding material (Litalabo, S.P.P.S., Argenteuil, France) and paper as cage-enrichment (Enviro-dri, Wm. Lillico & Son (Wonham Mill Ltd), Surrey, United Kingdom)
- Diet: pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.7 – 21.5
- Humidity (%): 38 - 73
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: approx. 10% of the total body surface, i.e. approx. 25 cm² for males and 18 cm² for females.
- % coverage: 100
- Type of wrap if used: a dressing, consisting of a surgical gauze patch (Surgy 1D), successively covered with aluminum foil and Coban elastic bandage. A piece of Micropore tape was additionally used for fixation of the bandages in females only.
REMOVAL OF TEST SUBSTANCE
- Washing: tap water for animals at 1000 mg/kg
- Time after start of exposure: 24 hr
TEST MATERIAL
- Amount applied: 2000 mg/kg (1.887 mL/kg) bw and 1000 mg/kg (0.943 mL/kg) bw.
- Constant concentration used: yes
VEHICLE
- Amount applied: 1.887 mL/kg (2000 mg/kg) bw and 0.943 mL/kg (1000 mg/kg) bw. - Duration of exposure:
- 24 hours for 1000 mg/kg bw dose groups; animals at 2000 mg/kg were found dead or were killed in extremis between 2 and 4 hours after application.
- Doses:
- 1000 and 2000 mg/kg bw
- No. of animals per sex per dose:
- For 2000 mg/kg bw: 5/sex/dose; for 1000 mg/kg bw: 3 females/dose
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: for 2000 mg/kg bw, one male and four females died between 2 and 4 hours after application of the test substance, and, subsequently, the remaining female and four males at 2000 mg/kg were killed in extremis. At 1000 mg/kg one female was found dead on Day 1 and the remaining two females at 1000 mg/kg were killed in extremis on Day 8.
- Frequency of observations and weighing: Days 1 (pre-administration) and 8.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- < 1 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: The treated skin of the two animals at 1000 mg/kg that were killed in extremis showed severe effects such as necrosis and a wound and these animals were hypersensitive to touch of the treated skin. The data correspond to 46.2% solution of SDBC.
- Mortality:
- Between 2 and 4 hours after application of the test substance, one male and four females at 2000 mg/kg were found dead and, subsequently, the remaining female and four males at 2000 mg/kg were killed in extremis. One female at 1000 mg/kg was found dead on Day 1 and the remaining two females at 1000 mg/kg were killed in extremis on Day 8.
- Clinical signs:
- other:
- Body weight:
- other body weight observations
- Remarks:
- The two females at 1000 mg/kg that were killed in extremis on Day 8 showed changes in body weight gain over the first week post-treatment which were within the range expected for rats used in this type of study.
- Gross pathology:
- The two females at 1000 mg/kg that were killed in extremis on Day 8 showed isolated or several scab formations in the dorso-lumbar region of the skin at macroscopic post mortem examination. No abnormalities were found at macroscopic post mortem examination of the animals at 2000 mg/kg and 1000 mg/kg that were found dead or killed in extremis on Day 1.
- Other findings:
- The treated skin of the two animals at 1000 mg/kg that were killed in extremis showed severe effects such as necrosis and a wound and these animals were hypersensitive to touch of the treated skin. These signs suggest that treatment with the test substance caused marked pain and distress due to corrosive or irritating properties of the test substance. According to the test guidelines, further testing of the test substance need not be carried out based on these findings. A worst-case approach has been adopted by the study director for classification and labeling of the test substance for acute dermal toxicity.
A worst case Category 1 dermal toxicity classification as proposed by Notox for SDBC (fatal in contact with skin, category 1) seems to be inconsistent with the findings of the study and the results obtained for SDMC.
Based on the observations reported in the study report the systemic dermal LD50 is considered to be around 1.000 mg/kg. Therefore, an assumption that the LD50 for dermal exposure is in the range of 200-1000 mg/kg appears to be justified and in line with the precautionary principle. This leads to a classification Category 3 (toxic by the dermal route).
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- Based on the observations reported in the study report the systemic dermal LD50 is considered to be around 1.000 mg/kg. Therefore, an assumption that the LD50 for dermal exposure is in the range of 200-1000 mg/kg appears to be justified and in line with the precautionary principle. This leads to a classification Category 3 (toxic by the dermal route).
- Executive summary:
Acute dermal toxicity of SDBC as 46.20% solution was studied in an OECD 402, GLP study with rats. Initially, the test substance was administered to five Wistar rats of each sex by a single dermal application at 2000 mg/kg body weight (corresponding to 940 mg/kg bw pure substance) for 2-4 hours after which the animals were found dead or killed in extremis. Based on the mortality at 2000 mg/kg, an additional group of 3 females was treated at 1000 mg/kg bw (corresponding to 490 mg/kg bw pure substance) for 24 hours. One female at 1000 mg/kg was found dead on Day 1 and the remaining two females at 1000 mg/kg were killed in extremis on Day 8. Individual animals at 2000 mg/kg showed general muscle twitching or lethargy at two hours post-treatment. The animal at 1000 mg/kg that died on Day 1 showed lethargy, hunched posture, uncoordinated movements, shallow respiration, piloerection, chromodacryorrhoea and ptosis prior to death. Similar clinical signs were observed between Days 1 and 8 for the two animals at 1000 mg/kg that were killed in extremis on Day 8. In addition, these two animals showed focal erythema, necrosis, scabs, a wound and/or a thickened area in the treated skin-area between Days 2 and 8. The two females at 1000 mg/kg that were killed in extremis on Day 8 showed isolated or several scab formations in the dorso-lumbar region of the skin at macroscopic post mortem examination. No abnormalities were found at macroscopic post mortem examination of the animals at 2000 mg/kg and 1000 mg/kg that were found dead or killed in extremis on Day 1. The dermal LD50 value of SDBC in Wistar rats is considered to be around or slightly below 1000 mg/kg bw for 46.2% aqueous solution of the substance (470 mg/kg bw for pure substance). The treated skin of the two animals at 1000 mg/kg that were killed in extremis showed severe effects such as necrosis and a wound and these animals were hypersensitive to touch of the treated skin. These signs suggest that treatment with the test substance caused marked pain and distress due to corrosive or irritating properties of the test substance. According to the test guidelines, further testing of the test substance need not be carried out based on these findings.
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