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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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010/03 to 2010/06
- 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 1987
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute 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:
- TEST ANIMALS
- Acclimatization period: at least 5 days.
- Age: 8 weeks Approximately.
- Water: tap water, ad libitum
- Weight at dosing: 372-387 g males and 217-242 g females.
- Housing: During the acclimation period, one to seven animals of the same sex were housed in polycarbonate cages with stainless steel lid (48 cm x 27 cm x 20 cm). During the treatment period, the animals were housed individually in polycarbonate cages with stainless steel lid (35.5 cm x 23.5 cm x 19.3 cm). Each cage contained autoclaved sawdust.
ENVIRONMENTAL CONDITIONS
- Temperature (22 ± 2°C):
- Humidity (30 to 70%):
- Air changes (per hr): Approximately 12
- Photoperiod (hrs dark / hrs light): 12
IN-LIFE DATES: 9 to 24 March 2010
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Details on dermal exposure:
- A single dose of 2000 mg/kg of the propineb in its original form was placed on a hydrophilic gauze pad (pre-moistened with 2 mL of purified water) and then applied to an area of the skin representing approximately 10% of the total body surface of the animals, calculated according to Meeh's formula (i.e. approximately 5 cm x 7 cm for the males and 5 cm x 6 cm for the females).
- Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5/sex/group
- Control animals:
- no
- Details on study design:
- previous non GLP study, in which the cutaneous LD50 of the test item was higher than 2000 mg/kg. Therefore, a limit test was carried out by administering 2000 mg/kg to one group of ten animals (five males and five females).
On the day before treatment, the dorsal area of each animal was clipped (i.e. approximately 5 cm x 7 cm for males and 5 cm x 6 cm for females) using an electric clipper. Only animals with healthy intact skin were used for the study. - Statistics:
- The data did not warrant statistical analysis
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortalities occurred at 2000 mg/kg bw, the only dose level tested.
The dermal LD50 for males was > 2000 mg/kg bw
for females was > 2000 mg/kg bw
for the combined sexes was > 2000 mg/kg bw. - Clinical signs:
- other: other: No systemic clinical signs were noted in any animal. A yellow coloration of the skin was noted in all animals between day 2 and day 15. This coloration masked the evaluation of cutaneous reactions in all animals on day 2, in 2/5 males and 1/5 femal
- Gross pathology:
- No abnormalities were observed at gross necropsy.
Any other information on results incl. tables
Table 1
Doses, toxicological results* / animals treated
Dose (mg/kg bw) | Male | Female | Combined |
2000 | 0/0/5 | 0/0/5 | 0/0/10 |
* : number of animals which died spontaneously and/or were sacrificed in moribund state/number of animals with signs of toxicity/total number of animals used per group
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 dermal application to rats according to OECD (No. 402, 24th February 1987)
and Commission Regulation (EC) (No. 440/2008, Part B.3, 30 May 2008) guidelines.
The study was conducted in compliance with the principles of Good Laboratory Practice. The test item, in its original form, was applied for 24 hours to the skin of one group of
ten Sprague-Dawley rats (five males and five females) treated at the dose-level of 2000 mg/kg.
The test site was then covered by a semi-occlusive dressing. The dermal LD50 of the test item, Propineb, was higher than 2000 mg/kg bw in male and female rats. - Executive summary:
The objective of this study was to evaluate the toxicity of the test item, Propineb (AE F074263), following a single dermal application to rats according to OECD (No. 402, 24th February 1987) and Commission Regulation (EC) (No. 440/2008, Part B.3, 30 May 2008) guidelines. The study was conducted in compliance with the principles of Good Laboratory Practice.
The test item, in its original form, was applied for 24 hours to the skin of one group of ten Sprague-Dawley rats (five males and five females) treated at the dose-level of 2000 mg/kg bw. The test site was then covered by a semi-occlusive dressing.
Mortality, clinical signs and body weight gain were checked for a period of 14 days following the single application 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 carried out according to the classification criteria laid down in Council Directive 67/548/EEC (and subsequent adaptations).
No deaths and no systemic clinical signs were observed during the study. A yellow coloration of the skin was noted in all animals between day 2 and day 15. This coloration masked the evaluation of cutaneous reactions in all animals on day 2, in 2/5 males and 1/5 females from day 3 until day 5 and in one male until day 9. An erythema was observed in 1/5 males on day 3 and 1/5 females from day 3 until day 5.
When compared to CIT historical control data, a lower body weight gain was noted in 1/5 females between day 1 and day 8 (9 g vs. 25 ± 11 g, in control data base) and in 4/5 males between day 1 and day 8 (17 to 37 g vs. 47 ± 7 g, in control data base) and between day 8 and day 15 (36 to 42 g vs. 51 ± 8 g, in control data base). The body weight gain of the other animals was not affected by treatment with the test item. No apparent abnormalities were observed at necropsy in any animal.
Under the experimental conditions of this study, the dermal 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 dermal route, the test item should not be classified.
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