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EC number: 238-484-2 | CAS number: 14484-64-1
- 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
- Study period:
- 1987-11-19 - 1987-12-03
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-2 (Acute Dermal Toxicity)
- Version / remarks:
- revised Nov. 1984
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- US FDA (21 CFR 58) and US EPA (40 CFR 160 and 40 CFR 792)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Ferbam
- EC Number:
- 238-484-2
- EC Name:
- Ferbam
- Cas Number:
- 14484-64-1
- Molecular formula:
- C9H18FeN3S6
- IUPAC Name:
- iron(3+) tris(dimethyldithiocarbamate)
- Test material form:
- solid: particulate/powder
- Details on test material:
- Appearance: Black powder
Bulk density: 0.21 g/mL
Solubility: Water: approximately 1 ppm; acetone: 0.81 g/100mL (20 °C); chloroform: 2 g/100mL (20 °C)
Storage: At ambient temperature in the dark in closed container
Stability: At least 14 days at 55 °C; poor in organic solvents
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
Adult rabbits of the NZW strain (9-10 weeks old at study start, SPF-quality) were supplied by the Broekman Institute, Someren, The Netherlands. Upon receipt each animal was identified with an ear tag. At least five days prior to dosing (acclimatization period) the animals were individually housed in metal cages (RUCO, Valkenswaard, The Netherlands). The animals had free access to tap-water (via automatic nozzles) and were held on a restricted diet of a standard laboratory animal feed (LK-01) obtained from Hope Farms, Woerden, The Netherlands. Certificates of analysis for both diet and drinking water are retained in the NOTOX archives.
ENVIRONMENTAL CONDITIONS
The animal room was air-conditioned, with the temperature maintained within the range of 20-21°C and the relative humidity within the range of 55-65% during the study. The artificial light cycle was 12 hours light, 12 hours dark.
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- methylcellulose
- Details on dermal exposure:
- Dosing
On the day of dosing the test substance was suspended in 1% aqueous methyl cellulose (Boom B.V., Meppel , The Netherlands) and was evenly spread on a surgical gauze (6x10 cm) that was fixed to successively micropore and flexible bandage (Coban, 3M, St. Paul, Minn., USA). This patch was applied to the clipped area of each animal and fixed with adhesive tape (Sleek, Smith and Nephew, Hull, U.K.). The dose volume was 7.5 ml/kg body weight. The dose level was 4000 mg/kg body weight. The day of dosing was designated as day 0.
Observations
Cage-side observations were performed on the day of dosing (approximately once every two hours) and once daily thereafter for 14 days. Any signs of toxicity were recorded along with the time of onset and duration. Individual body weights were measured weekly. At the end of the study (day 14) all animals were killed with euthesate and subjected to necropsy. In addition, observations regarding changes of the treated skin surface were performed following bandage removal and on day 4, 7, and 14. - Duration of exposure:
- 24 hours
- Doses:
- 4000 mg/kg bw
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily (Observations regarding changes of the treated skin surface were performed following bandage removal and on day 4, 7, and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: - Statistics:
- not reported
Results and discussion
- Preliminary study:
- Upon request of the sponsor the test could be performed as a limit test. One group of animals, comprising 5 males and 5 females, was treated with a single dermal dose of test substance at 4000 mg/kg body weight.
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 4 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortalities occurred during the 14-day observation period.
- Clinical signs:
- other: Six animals showed a closed 3rd eyelid which was red or swollen in some animals (Table 1). The treated skin surface of the animals revealed slight erythema and oedema, which disappeared by the end of the first week (Table 2). In addition the treated surfa
- Gross pathology:
- Macroscopic abnormalities at necropsy at the end of the observation period included local dark red areas in the lungs, enlarged spleen, accessory spleen tissue in the pancreas, dilated ileum and some petechiae in the dorso-lateral muscles (Table 1).
- Other findings:
- not reported
Any other information on results incl. tables
Table 1: Individual Animal Observations Acute Dermal Toxicity study in the rabbit - Test item at 4000 mg/kg |
||||||||||||
Physical/Clinical Parameter | Animal Number/Sex | |||||||||||
3202 M |
3204 M |
3206 M |
3208 M |
3210 M |
3250 F |
3252 F |
3254 F |
3258 F |
3260 F |
|||
No effects of treatment | DPD | 14 | 14 | 14 | ||||||||
3rd eyelid | ||||||||||||
- closed | DPD | 2-4 | 2 | |||||||||
- closed and swollen | DPD | 1 | ||||||||||
- closed and red | DPD | 1 | 1 | |||||||||
Dead | KIL | X | X | X | X | X | X | X | X | X | X | |
Necropsy findings: | ||||||||||||
- no gross lesions | X | X | X | X | X | X | X | |||||
- Lungs local dark red areas | X | |||||||||||
- Enlarged spleen | X | |||||||||||
- Accessory spleen tissue in the pancreas | X | |||||||||||
- diated ileum | X | |||||||||||
- some small petechiae in dorso-lateral muscles | X | X | ||||||||||
Glossary of terms for lsit of individuel findings: DPD = Days post dosing KIL = Killed at necropsy KGL = no gross lesions X = positive |
Table 2: Group Incidences for irritation of the treated skin surface Acute dermal toxicity study in the rabbit - Test iteml at 4000 mg/kg body weight |
||||
Observation | Day of Evaluation | |||
1* | 4 | 7 | 14 | |
No abnomalities | 0 | 3 | 5 | 10 |
Sligth erythema | 9 | 0 | 0 | 0 |
Oedema | 9 | 2 | 0 | 0 |
Black discolouration | 9 | 6 | 5 | 0 |
* Following bandage removal |
Table 3: Indivudual body weights and dose volumes Acute dermal toxicity study in the rabbit - Test item at 4000 mg/kg body weight |
||||||
Dose Level (mg/kg) | Animal number | Body Weight (g) on: | Body weight Gain (g) Day 0-14 | Dose Volume (mL) | ||
Day 0* | Day 7 | Day 14 | ||||
4000 (Males) |
3202 | 2196 | 2343 | 2536 | 340 | 16.5 |
3204 | 2395 | 2402 | 2513 | 118 | 18.0 | |
3206 | 1804 | 1920 | 2174 | 370 | 13.5 | |
3208 | 2065 | 2237 | 2358 | 293 | 15.5 | |
3210 | 1991 | 2125 | 2290 | 299 | 14.9 | |
Mean | 2090 | 2205 | 2347 | 284 | ||
S.D. | 221.6 | 191.4 | 152.4 | 98.0 | ||
N | 5 | 5 | 5 | 5 | ||
4000 (Females) |
3250 | 2145 | 2279 | 2347 | 202 | 16.1 |
3252 | 2152 | 2283 | 2402 | 250 | 16.1 | |
3254 | 2277 | 2352 | 2470 | 193 | 17.1 | |
3258 | 2172 | 2215 | 2356 | 184 | 16.3 | |
3260 | 2349 | 2424 | 2502 | 153 | 17.6 | |
Mean | 2219 | 2313 | 2415 | 196 | ||
S.D. | 90.1 | 83.4 | 68.7 | 35.2 | ||
N | 5 | 5 | 5 | 5 | ||
* Day of dosing |
Applicant's summary and conclusion
- Interpretation of results:
- other: EU GHS criteria not met
- Conclusions:
- Under the conditions used in this study, the LD50 value for both males and females was noted as exceeding 4000 mg/kg.
- Executive summary:
The test material has been assessed in an acute dermal toxicity study in accordance with U.S. EPA FIFRA Guideline 81 -2 and in compliance with GLP. One group of NZW rabbits, comprising 5 males and 5 females, was treated with a single dermal dose of the test item at 4000 mg/kg body weight for 24 hours. No mortalities occurred during the 14-day observation period. A sign of toxicity was a closed and red or swollen 3rd eyelid. The treated skin surface of the animals revealed slight erythema and oedema, which disappeared by the end of the first week. In addition the treated surface was black discoloured due to staining by the test substance. All animals showed body weight gain during the study period. Macroscopic abnormalities noted in animals at necropsy included local dark red areas in the lungs, enlarged spleen, accessory spleen tissue in the pancreas, dilated ileum and petechiae in the dorso-lateral muscles. The LD50 value for both males and females was noted as exceeding 4000 mg/kg body weight.
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