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Diss Factsheets
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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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- 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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class 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:
- - Name of test material (as cited in study report): Santicizer Platinum P1400
- Supplied by Ferro Corporation
- Data received: 08/09/10
- Storage: Room temperature and humidity
- Description: Clear yellow liquid
- Specific Gravity: 1.05
- Sample preparation: Used as received
Constituent 1
- Specific details on test material used for the study:
- Identity: Santicizer Platinum P-1400
Batch:: RP-620
Supplier: Ferro Corporation
Date Received: 19 August 2010
Storage: Room temperature and humidity
Description: Clear yellow liquid
Specific gravity: 1.05
Sample Preparation: Used as received
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ace Animals, Boyertown, PA on 11/09/10
- Age at study initiation: Born on 09/14/10
- Weight at study initiation: 179-184 grams for males and 291-324 for females
- Fasting period before study: 16-20 hours prior dosing
- Housing: suspended wire cages
- Diet (e.g. ad libitum): Fresh PMI Rat Chow (Diet#5012) was freely available except for 16-20 hours prior dosing
- Water (e.g. ad libitum): freely available
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): parameters deviated from protocol - not adverse effect on the study animals or the integrity of the study
- Humidity (%): parameters deviated from protocol - not 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 light/12 hr dark
TEST DATES:
Study initiation: 08 November 2010
Experimental Start Date: 17 November 2010
Experiment Term date: 06 December 2010
Draft Report Signed: 06 January 2011
Final Report Signed: 03 March 2011
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 2000 mg/kg
- The test article was used as received and the dose was based on the sample weight as calculated from the specific gravity. - Doses:
- 1 single dose: 2000 mg/kg
- No. of animals per sex per dose:
- 3 males and 3 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: half hr, 1, 2, 3 hr post dose and once daily for 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: mortality, toxicity and pharmacological effects - Statistics:
- Not available
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 the 2000 mg/kg oral dose
- Clinical signs:
- other: No abnormal physical signs were observed during the treatment
- Gross pathology:
- No effects
- Other findings:
- No additional observations
Any other information on results incl. tables
Table 1. Body Weights and Dose Volume |
||||||
Animal No. |
Sex |
Dose Volume (mL) |
Body Weight (g) |
|||
Day 0 |
Day 7 |
Day 14 |
||||
1 |
Female |
0.34 |
179 |
246 |
262 |
|
2 |
Female |
0.34 |
180 |
238 |
265 |
|
3 |
Female |
0.35 |
184 |
243 |
277 |
|
Mean |
181 |
242 |
268 |
|||
S.D. |
2.6 |
4.0 |
7.9 |
|||
# |
3 |
3 |
3 |
|||
|
||||||
4 |
Male |
0.61 |
320 |
384 |
418 |
|
5 |
Male |
0.62 |
324 |
399 |
437 |
|
6 |
Male |
0.55 |
291 |
363 |
398 |
|
Mean |
312 |
382 |
418 |
|||
S.D. |
18.0 |
18.1 |
19.5 |
|||
# |
3 |
3 |
3 |
Table 2. Necropsy Observations |
||||||
Animal Number |
1 |
2 |
3 |
4 |
5 |
6 |
Sex |
Female |
Female |
Female |
Male |
Male |
Male |
Death (D) / Sacrifice (S) |
S |
S |
S |
S |
S |
|
Observation |
|
|
||||
Appeared normal / No findings |
X |
X |
X |
X |
X |
X |
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- Based on the results observed, the LD50 of the test material Santicizer Platinum P1400 was determined to be greater than 2000 mg/Kg body weight in rats.
- Executive summary:
The potential for oral acute toxicity of the test material Santicizer Platinum P1400 was determined according the OECD 423 and OPPTS 870.1000 Testing Guidelines. Three males and three females Sprague Dawley were dosed orally with 2000 mg/Kg of Santicizer Platinum P1400. The single dose was based on the sample weight as calculated from the specific gravity. A single dose was administered orally by syringe and dosing needle.
The animals were observed for mortality, body weight changes, general toxicity and pharmacological effects. All animals survived until the end of the treatment. No abnormal physical signs nor changes in body weights related to the treatment were observed. The gross pathology were normal. Based on the results of this study, the LD50 was considered to be greater than 2000 mg/Kg bw.
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