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EC number: 686-816-3 | CAS number: 151840-68-5
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- February 13, 1996 to February 27, 1996
- Reliability:
- 1 (reliable without restriction)
- Justification for type of information:
- In vivo experimental study on the registered substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not applicable
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Bis(1-butyl-3-methyl cyclopentadienyl)Zirconium dichloride
- EC Number:
- 686-816-3
- Cas Number:
- 151840-68-5
- Molecular formula:
- C20 H30 CL2 Zr1
- IUPAC Name:
- Bis(1-butyl-3-methyl cyclopentadienyl)Zirconium dichloride
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- 1 male rabbit was acclimated for 15 days, examined for viability at least once a day. Animal was approximately 16 weeks at initiation of dosing and weighed 2.37 kg. Rabbit was housed singled caged in a stainless steel and wire mesh with absorbent paper below cages. Water was provided ad libitum, while feed (Agway certified RCA diet) was provided on a limited daily basis.
Environmental conditions
Temperature: 65 to 70 degrees Fahrenheit
Humidity: 40 to 60 percent relative humidity
Lighting: Approximately 12 hours light (0700 to 1900) and 12 hours dark (1900 to 0700) by automatic timer.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- Three 0.5 g doses
- Duration of treatment / exposure:
- 1st patch treatment - 3 minutes
2nd patch treatment - 1 hour
3rd patch treatment - 4 hours - Observation period:
- 14 days
- Number of animals:
- 1 - In an attempt to minimize animal pain and distress, one animal was initially dosed and observed through the 4 hour observation. Since this animal showed potential signs of corrosivity (blanching) no other animals were dosed.
- Details on study design:
- Preparation of Animals
Approximately 24 hours prior to topical administration of the test material, the hair of each rabbit in the area of the dorsal surface from the shoulder region to the lumbar region was closely clipped with an electric clipper. The skin was left intact. Elizabethan-type collars were placed around the neck of each rabbit at this time to acclimate them to wearing collars. Animals were reclipped as necessary. Collars remained on the animals a minimum of 26 hours and a maximum of 30 hours.
Preparation of Test Material
The undiluted test material was administered as received.
Administration of Test Material
The test material was administered as three 0.5 gram doses, each introduced under a 1 inch x 1 inch 2 ply gauze patch moistened with reverse osmosis water, then secured with non-irritating tape. The patch was loosely held in contact with the skin by means of a semi-occlusive dressing for the duration of the exposure period. After at least 3 minutes of exposure, the dressing and gauze patch were removed from the first site and the site was evaluated for dermal responses. After at least one hour, the dressing and gauze patch were removed from the second site and the site was evaluated for dermal responses. After at least 4 hours of exposure, the dressing and gauze patch were removed from the remaining site and the site was evaluated for dermal responses. Residual test material was removed, where possible, using peanut oil and paper towels without altering the existing response or integrity of the epidermis after the initial dermal evaluation for each dose site was performed. Collars were removed after the 4 Hour exposure period.
Experimental Evaluation
The animals were examined for viability twice daily Monday through Friday, and once daily on weekends and holidays (if applicable). Body weight was recorded on the day of dosing (Day 0) and at terminal sacrifice (Day 14). Dermal responses were evaluated at patch removal and at 60 minutes, 24 hours, 48 hours, and 72 hours following patch removal, and on Days 7, 10, and 14. After the Day 14 observations, all rabbits were sacrificed by intravenous injection of sodium pentobarbital solution and discarded without further examination.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks:
- Blanching of the skin was reported immediately after patch removal, 1 hour and 24 hours after exposure. Necrosis of the skin was reported on days 2, 3, 7 and 10. Slight erythema (core of 1) and desquamation was observed at 14 days.
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritant / corrosive response data:
- Skin Responses - 3 Minute Exposure
Topical application of EX-370 did not elicit dermal irritation at patch removal or the 60 minute observation. Well-defined erythema was noted at the 24 Hour observation. At the 48 Hour and 72 Hour observations very slight erythema was noted. The animal was free of erythema from Day 7 to 14. Very slight edema was noted at the 24 Hour and 72 Hour observations. In addition, desquamation was noted on Day 10.
Skin Responses - 1 Hour Exposure
Dermal irritation was not noted at patch removal. Severe erythema was noted at the 60 Minute observation through study termination. Moderate edema was noted at the 60 Minute observation and slight edema was observed from the 24 Hour observation through Day 14. Blanching was noted at the 60 minute observation and at the 24 Hour observation. Necrosis was noted from the 48 Hour observations through Day 7 and eschar was noted on Days 10 and 14. Desquamation was also noted on Day 14.
Skin Responses - 4 Hour Exposure
Severe erythema was noted upon patch removal through Day 10. Very slight erythema was observed on Day 14. Slight edema was noted throughout the study. Blanching was observed upon patch removal and at the 24 Hour observation. Necrosis was observed from the 48 Hour observation through Day 7. Eschar was noted on Days 7 and 10, and desquamation was noted on Day 14.
Any other information on results incl. tables
See individual animal data table attached.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (corrosive) based on GHS criteria
- Conclusions:
- Based on the results of this study, the test substance was determined to be corrosive.
- Executive summary:
The corrosivity of EX-370 was evaluated following its application to the clipped back of one New Zealand White rabbit. (In an attempt to minimize animal pain and distress, one animal was initially dosed and observed through the 4 hour observation. Since this animal showed potential signs of corrosivity, (blanching) no other animals were dosed.) The test material was administered as three 0.5 gram doses each introduced under a 2 ply gauze patch moistened with 0.2 ml of reverse osmosis water. The patch was then secured with non-irritating tape. The gauze was loosely held in contact with the skin by means of a semi-occlusive dressing for the duration of the exposure period. The dressings remained in place for three minutes, one hour and four hours, respectively. After exposure was completed, the dressing and gauze were removed. Each test site was graded for erythema, edema and other signs of dermal irritation at patch removal (prior to test material removal) and at 60 minutes, 24, 48, and 72 hours after test material administration and on Day 7, 10, and 14 after patch removal. All dermal scoring was made according to the Draize method of scoring (Draize, 1959). The contact of the test material with the dose sites caused heat to be released from the test material.
Skin Responses - 3 Minute Exposure
Topical application of EX-370 did not elicit dermal irritation at patch removal or the 60 minute observation. Well-defined erythema was noted at the 24 Hour observation. At the 48 Hour and 72 Hour observations very slight erythema was noted. The animal was free of erythema from Day 7 to 14. Very slight edema was noted at the 24 Hour and 72 Hour observations. In addition, desquamation was noted on Day 10.
Skin Responses - 1 Hour Exposure
Dermal irritation was not noted at patch removal. Severe erythema was noted at the 60 Minute observation through study termination. Moderate edema was noted at the 60 Minute observation and slight edema was observed from the 24 Hour observation through Day 14, Blanching was noted at the 60 minute observation and at the 24 Hour observation. Necrosis was noted from the 48 Hour observations through Day 7 and eschar was noted on Days 10 and 14. Desquamation was also noted on Day 14.
Skin Responses - 4 Hour Exposure
Severe erythema was noted upon patch removal through Day 10. Very slight erythema was observed on Day 14. Slight edema was noted throughout the study. Blanching was observed upon patch removal and at the 24 Hour observation. Necrosis was observed from the 48 Hour observation through Day 7. Eschar was noted on Days 7 and 10, and desquamation was noted on Day 14. In conclusion, EX-370 was determined to be corrosive based on the results of this study.
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