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EC number: - | CAS number: -
- 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:
- 2010-08-11 to 2011-03-03
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- benzyl butyl cis-cyclohexane-1,2-dicarboxylate
- Cas Number:
- 1931129-39-3
- Molecular formula:
- C19H26O4
- IUPAC Name:
- benzyl butyl cis-cyclohexane-1,2-dicarboxylate
- Test material form:
- other: Clear Yellow Liquid
- Details on test material:
- - Identity: Santicizer Platinum 1400
- Batch No.: RP-620
- Supplier: Ferro Corporation
- Description: Clear Yellow Liquid
- Specific Gravity: 1.05
- Sample Preparation: The test article was used as received
Constituent 1
- Specific details on test material used for the study:
- Identity: Santicizer P-1400
Batch No: RP-620
Supplied by: Ferro Corporation
Data received: 09/19/2010
Storage: Room temperature and humidity
Description: Clear yellow liquid
Specific gravity: 1.05
Sample Preparation: The test article was used as received
TEST DATES:
Study Initiation: 08 November 2010
Experimental Start Date: 10 November 2010
Experimental Term Date: 24 November 2010
Draft Report Signed: 07 January 2011
FInal Report Signed: 03 March 2011
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Myrtle's Rabbitry Incorporated, Thompson Statio, TN
- Received on: 10/21/10
- Date of birdh: 07/20/10
- Weight at study initiation: 2.4-2.9 for males and 2.8-3.0 for females
- Housing: 1/cage in suspended cages
- Diet (e.g. ad libitum): PMI Rabbit Chow - daily
- Water (e.g. ad libitum): freely available
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): parameters deviated from protocol - no adverse effect on the study animals or the integrity of the study
- Humidity (%): parameters deviated from protocol - no adverse effect on the study animals or the integrity of the study
- Air changes (per hr): no info
- Photoperiod (hrs dark / hrs light): 12 hr dark/12 hr light
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- not specified
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 10x15 cm
- % coverage: 10%
- Type of wrap if used: piece of porous dressing (semi occlusive)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): water distillated
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg
- Constant volume or concentration used: yes - Duration of exposure:
- 24 hours
- Doses:
- Single Dose of 2000 mg/kg
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 1, 4 hours post dosing and once daily until Day 14
- Necropsy of survivors performed: yes
- Other examinations performed: mortality, toxicity, pharmacological effects, gross pathology - Statistics:
- An estimate of the LD50 was made based on the mortality occurring during the study.
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:
- All animals survived until the end of the study.
- Clinical signs:
- other: Few faces were observed in two males and one female was observed with soiling of the anogenital area on day 14. No other observation.
- Gross pathology:
- Necropsy did not reveal any treatment- related changes.
- Other findings:
- No further observations
Any other information on results incl. tables
Erythema was slight to well defined with very slight to slight edema at 24 hours and by day 14 there was no erythema or edema observed.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified
- Conclusions:
- The acute dermal toxicity LD50 of the test material Santicizer Platinum P 1400 is greater than 2000 mg/kg bw.
- Executive summary:
The test article Santicizer Platinum P1400 was applied dermally to five male and female rabbits. The test material was kept in contact with the scin for 24 hours (semi- occlusive patch). The test sites were scored for dermal irritation at 24 hours post dose and on day 14 using numerical Draize scoring code below. The skin was evaluated for ulceration, necrosis and tissue destruction. Mortality, body weights, toxicit, pharmacologic effects were recorded. The results of the study showed incidence of few faces in two males and one female with soiling of the angemital area on day 14. Erythema was slight to well denined with very slight to sligh edema at 24 hours and by day 14 no erytthema was observed. The body weights were normal as well as the necropsy results.
Based on the result of this study, the acute dermal toxicity LD50 of the test material Santicizer Platinum P 1400 is greater than 2000 mg/kg bw.
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