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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Remarks:
- In vivo study
- 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- Principles of method if other than guideline:
- Deviations of temperature and humidity (for several days during the study) were deemed to have had no adverse effects on the study animals or the integrity of the study, since all the animals gained weight normally, and were free from signs of stress based on daily observations.
- GLP compliance:
- 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:
- - Test article: Santicizer Platinum P 1400
- Batch No.: RP 620
- Supplied by: Ferro Corporation
- Date received: 08/09/10
- Storage: Roon temperature and humidity
- Description: Clear yellow liquid
- Sample preparation
Constituent 1
- Specific details on test material used for the study:
- Label Identity: Santicizer P-1400
Batch No: RP-620
Supplied by: Ferro Corporation
Data received: 08/19/2010
Storage: Room temperature and humidity
Description: Clear yellow liquid
Sample preparation: Te test article was used as received
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Myrtle Rabbitry Inc., Thompson Station, TN
- Received on: 10/21/10
- Date of birth: 07/20/10
{Age at study initiation 3 months 21 days - study initiation date mm/dd 11/09/2010}
- Weight at study initiation: 2.7 -3.0 kg
- Housing: suspended wire bottom cages
- Diet (e.g. ad libitum): Fresh PMI Rabbit Chow (Diet #5321) - daily
- Water (e.g. ad libitum): freeily available
- Acclimation period: (>5 days) - approx 3 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C):[ Room temperature]. Parameters deviated from the protocol for several days during the study;
- Humidity (%): Parameters deviated from the protocol for several days during the study - Deviations of temperature and humidity were deemed to have had no adverse effects on the study animals or the integrity of the study, since all the animals gained weight normally, and were free from signs of stress based on daily observations.
- Air changes (per hr): no info
- Photoperiod: 12 hr light/12 hr dark
Fresh PMI rabbit chow was priovided daily (diet #5321) and drinking water was available ad-lib. The animal room was kept clean and vermin-free.
IN-LIFE DATES:
Study initiation: 11/08/2010
Experimental start due: 11/09/2010
Experimental term data: 11/12/2010
Draft report signed: 01/07/2011
Final report signed: 03/03/2011
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml/site applied to a 2x3 cm gauze patch. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 60 minutes, 24, 48, 72 hours post patch removal
- Number of animals:
- 3 male rabbits
- Details on study design:
- TEST SITE
- Area of exposure: 10x10
- % coverage: 3x3 cm
- Type of wrap if used: porous, not irritating tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): ethanol (end of exposure time) prior scoring
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritant / corrosive response data:
- Dermal observations:
Well defined erythema and very slight edema was observed at 1 hour following the 4 hour exposure. At 24 and 48 hours, absent to very slight erythema and very slight edema was observed. No erythema or edema was observed at 72 hours.
Systemic Observations and Body Weights:
There were no abnormal physical signs noted during the observation period - Other effects:
- Systemic Observations and Body Weights:
There were no abnormal physical signs noted during the observation period. All body weight changes were normal.
Any other information on results incl. tables
Table1. Dermal Observations, Body Weights, and Systemic Observations |
|||
Rabbit Eartag |
Animal Number |
||
H3798 |
H3799 |
H3800 |
|
Sex |
Male |
Male |
Male |
Pre-test Body Weight (Kg) |
2.7 |
2.9 |
3.0 |
Terminal Body Weight (Kg) |
2.7 |
2.9 |
3.0 |
Erythema and Eschar Formation |
|||
Time after Patch Removal |
|
|
|
60 minutes |
2 |
2 |
2 |
24 hours |
0 |
1 |
1 |
48 hours |
0 |
0 |
1 |
72 hours |
0 |
0 |
0 |
Edema |
|||
60 minutes |
1 |
1 |
1 |
24 hours |
1 |
1 |
1 |
48 hours |
1 |
1 |
1 |
72 hours |
0 |
0 |
0 |
Systemic Observations |
|||
60 minutes |
A |
A |
A |
24 hours |
A |
A |
A |
48 hours |
A |
A |
A |
72 hours |
A |
A |
A |
A = Normal
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Not classified
- Conclusions:
- The test material Santiciser P1400 is a mild dermal irritant under the conditions of the study but does not meet the criteria for classification under EU CLP or GHS.
- Executive summary:
The test material Santicizer Platinum P1400 was investigated to determine the irritant and corrosive effects when applied dermally for 4 hours. Three New Zealand rabbits were dosed dermally with 0.5 ml of the test material, which was applied and kept in contact to one skin site for 4 hours, at which time the wrapping was removed. The skin was evaluated for edema, erythema and scored at 1, 24, 48 and 72 hr (numerical Draize technique) following the patch removal. Toxicological and pharmacological effects, body weight and mortality were also recorded.
The results of the study showed well defined erythema and very slight edema at 1hr after the 4 hour exposure. At 24 and 48 hours, slight erythema and very slight edema was observed. These effects were fully reversible in all 3 tested animals by 72 hours. No adverse clinical signs, abnormal body weight or mortality were observed during the study. In conclusion, the test material Santiciser P1400 is a mild dermal irritant but does not meet the criteria for classification under EU CLP or GHS.
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