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EC number: 620-365-5 | CAS number: 9016-72-2
- 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:
- 2010/03/03 to 2010/06/04
- 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:
- 2021
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Commission Regulation (EC) No. 440/2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 17th December 2001
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- polymeric zinc 1,2-propylenebis(dithiocarbamate)
- EC Number:
- 620-365-5
- Cas Number:
- 9016-72-2
- IUPAC Name:
- polymeric zinc 1,2-propylenebis(dithiocarbamate)
- Test material form:
- solid
- Remarks:
- Powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
The acclimatization period was at least 5 days. The organisms were given tap water, ad libitum, and the weight at dosing was 323-363 g males and 201-226 g females.
The animals were housed in polycarbonate cages with stainless steel lid (48 cm x 27 cm x 20 cm). Each cage contained one to seven animals of the same sex during the acclimation period and three rats of the same sex and group during the treatment period. Each cage contained autoclaved sawdust.
The environmental conditions for temperature was 22 ± 2°C, humidity (30 to 70%), air changes (per hr): Approximately 12 and photoperiod (hrs dark / hrs light): 12
IN-LIFE DATES: 12 to 31 March 2010
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other:
- Remarks:
- 0.5% (w/v) Methylcellulose/0.4% (w/v) Tween 80 in purified water.
- Details on oral exposure:
- The test item was administered once, using a metal gavage tube fitted to a 5 mL plastic syringe (0.2 mL graduations). The quantity of the test item administered to each animal was adjusted according to the body weight recorded on the day of dosing.
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw - Doses:
- 5, 50, 300 or 2000 mg/kg body weight.
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- Three males and three females were used for each step. The dose-level to be used as the starting dose-level was selected from one of four fixed levels, 5, 50, 300 or 2000 mg/kg body weight. The dose-level have been selected in agreement with the Sponsor, based on the results of a previous non GLP study, in which the acute oral LD50 of the test item was higher than 2000 mg/kg.
Therefore, the test item was administered to 3 males and 3 females at the dose-level of 2000 mg/kg then in agreement with the Sponsor, the dose-level was carried out on 3 males and 3 females to confirm the results. - Statistics:
- The data did not warrant statistical analysis.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50 cut-off
- Effect level:
- 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- The dose of 2000 mg/kg bw induced no mortality.
- Clinical signs:
- other: other: No clinical signs were observed.
- Gross pathology:
- No abnormalities were observed at gross necropsy.
Any other information on results incl. tables
Table one
Doses, mortality /clinical signs/ animals treated
Dose (mg/kg bw) | Toxicological results* | Occurrence of signs | Mortality (%) | |
2 000 (1st) | Males 0/0/3 | Females 0/0/3 | - | 0 |
2 000 (2nd) | Males 0/0/3 | Females 0/0/3 | - | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The objective of this study was to evaluate the toxicity of the test item, Propineb, following a single oral administration in rats according to OECD (No. 423, 17th December 2001) and Commission Regulation (EC) (No. 440/2008, B.1tris, 30 May 2008) guidelines. The test item was administered by oral route (gavage) to 2 groups of six fasted Sprague-Dawley rats (three males and three females) at the dose-level of 2000 mg/kg under a dosage-volume of 10 mL/kg. The acute oral LD50 cut-off of propineb in the rat was found to be 5000 mg/kg bw, the oral LD50 of the test item Propineb was higher than 2000 mg/kg in rats.
- Executive summary:
The objective of this study was to evaluate the toxicity of the test item, Propineb, following a single oral administration in rats according to OECD (No. 423, 17th December 2001) and Commission Regulation (EC) (No. 440/2008, B.1tris, 30 May 2008) guidelines. The study was conducted in compliance with the principles of Good Laboratory Practice Regulations.
The test item was administered by oral route (gavage) to 2 groups of six fasted Sprague-Dawley rats (three males and three females) at the dose-level of 2000 mg/kg under a dosage-volume of 10 mL/kg. The test item was prepared in 0.5% (w/v) Methylcellulose/0.4% (w/v) Tween 80 in purified water.
Mortality, clinical signs and body weight gain were checked for a period of up to 14 days following the single administration of the test item. On completion of the observation period, the animals were sacrificed then subjected to a macroscopic post-mortem examination. The interpretation of results was based on the classification criteria laid down in Council Directive 67/548/EEC (and subsequent adaptations).
Neither mortality nor clinical signs observed during the study. Lower body weight gain was noted during the first week in 1/3 females of the first assay and in 2/3 females of the confirmatory assay. The body weight gain of the other animals was not considered to be affected by treatment with the test item. At necropsy, no apparent abnormalities were observed in any animal.Under the experimental conditions of this study, the oral LD50 of the test item, Propineb, was higher than 2000 mg/kg in rats. According to the classification criteria laid down in Council Directive 67/548/EEC (and subsequent adaptations), concerning the potential toxicity by oral route, the test item should not be classified.
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