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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010/03/19 to 2010/04/09
- 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 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Commission Regulation (EC) No. 440/2008, B.5
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
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 / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 2 to 4 months old.
- Weight at study initiation: 3.2 to 3.4 kg.
- Housing: The animals were housed individually in Pajon cages (50 cm x 57 cm x 75 cm).
- Diet: 110 Pelleted diet, ad libitum.
- Water: tap water, ad libitum.
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 18 ± 3 °C
- Humidity: 30-70 %
- Photoperiod (hrs dark / hrs light): 12
IN-LIFE DATES: 26 March to April 10 2010.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- A single dose of 100 mg of the test item in its original form was introduced into the conjunctival sac of the left eye after gently pulling the lower lid away from the eyeball. The lower and upper eyelids were held together for about one second to avoid any loss of test item. The eyes were not rinsed after administration of the test item
- Observation period (in vivo):
- 1, 24, 48 and 72 hours, 5 days
- Number of animals or in vitro replicates:
- 3 animals
- Details on study design:
- Just before treatment, the eyes of each animal were examined in order to check the absence of any signs of ocular irritation, ocular defects or pre-existing corneal injury. The test item, propineb, was first administered to a single animal. Since the test item was not severely irritant on this first animal, it was then evaluated sequentially on two other animals. A single dose of 100 mg of the test item, propineb, in its original form was introduced into the conjunctival sac of the left eye after gently pulling the lower lid away from the eyeball. The lower and upper eyelids were held together for about one second to avoid any loss of test item. The right eye, which remained untreated, served as control.
The eyes were not rinsed after administration of the test item. The eyes were examined approximately 1 hour, 24, 48 and 72 hours after administration of the test item. Since there were persistent ocular reactions at 72 hours, the observation period was extended up to their complete reversibility (day 5). Conjunctival reactions, iritis and corneal opacification were evaluated daily for each animal.
For the evaluation of corneal opacification (presence or absence, affected area), the eyes were examined under a UV lamp after instillation of one or two drops of 0.5% sodium fluorescein solution (a clear fluorescence is visible in the areas of opacification). This evaluation was performed on day 2 and repeated thereafter whenever necessary. The degree of ocular lesions was recorded as specified by DRAIZE and any serious lesions or toxic effects other than ocular lesions were also recorded and fully described. Each animal was weighed at the beginning (before treatment) and at the end of the observation period.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 96 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 96 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0.3
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0.7
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
Any other information on results incl. tables
Table one
Eye irritation scores according to the Draize scheme
| Cornea | Iris | Conjunctiva-redness | Conjunctiva-chemosis | ||||||||
Animal number (body weight in kg) | 972 (3.2) | 970 (3.2) | 971 (3.4) | 972 (3.2) | 970 (3.2) | 971 (3.4) | 972 (3.2) | 970 (3.2) | 971 (3.4) | 972 (3.2) | 970 (3.2) | 971 (3.4) |
Time of observation |
|
|
|
|
|
|
|
|
|
|
|
|
1 hour | 0 | 0 | 0 | 1 | 0 | 0 | 3 | 2 | 3 | 2 | 2 | 2 |
24 hours | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 2 | 1 | 1 | 2 | 0 |
48 hours | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 1 | 0 | 0 |
72 hours | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 1 | 0 | 0 |
120 hours | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Mean scores 24-72 hours | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 2.0 | 0.7 | 0.3 | 1.0 | 0.7 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item was administered to induce ocular irritation was evaluated in rabbits according to OECD (No. 405, 24th April 2002) and Commission Regulation (EC) (No. 440/2008, B.5, 30 May 2008) guidelines. A single dose of 100 mg of the test item in its original form was introduced into the left conjunctival sac. The right eye was not treated and served as control. Under the experimental conditions of the study, the test item was slightly irritating when administered by ocular route to rabbits. According to the classification criteria laid down in Council Directive 67/548/EEC (and subsequent adaptations) on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labeling of dangerous substances, the test item propineb should not be classified as irritating to the eyes
- Executive summary:
The potential of the test item, Propineb, to induce ocular irritation was evaluated in rabbits according to OECD (No. 405, 24th April 2002) and Commission Regulation (EC) (No. 440/2008, B.5, 30 May 2008) guidelines. The study was conducted in compliance with the principles of Good Laboratory Practice Regulations.
The test item was first administered to a single male New Zealand White rabbit. Since the test item was not severely irritant on this first animal, it was then evaluated sequentially in two other animals. A single dose of 100 mg of the test item in its original form was introduced into the left conjunctival sac. The right eye was not treated and served as control. The eyes were not rinsed after administration of the test item.
Ocular reactions were observed approximately 1 hour, 24, 48 and 72 hours after the administration and then daily until reversibility of the ocular reactions (day 5). The mean values of the scores for chemosis, redness of the conjunctiva, iris lesions and corneal opacity were calculated for each animal. The interpretation of results was carried out according to the classification criteria laid down in Council Directive 67/548/EEC (and subsequent adaptations).
A slight or moderate chemosis was noted from day 1 in all animals, persisting until day 2 in one animal and until 4 in another one. A slight to severe redness of the conjunctiva was observed in all animals on days 1 and 2, persisting in one of them until day 4. A clear discharge was noted on day 1 in all animals, persisting in two of them on day 2. An iritis was noted in 1/3 animals on day 1.
Mean scores calculated for each animal over 24, 48 and 72 hours were 1.0, 0.7 and 0.0 for chemosis, 2.0, 0.7 and 0.3 for redness of the conjunctiva, 0.0, 0.0 and 0.0 for iris lesions and 0.0, 0.0 and 0.0 for corneal opacity. Under the experimental conditions of the study, the test item Propineb was slightly irritant when administered by ocular route to rabbits. However, according to the classification criteria laid down in Council Directive 67/548/EEC (and subsequent adaptations), the test item should not be classified as irritating to the eyes.
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