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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
Eye irritation
Administrative data
- Endpoint:
- eye 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:
- 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 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- 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 material name: Santicizer Platinum P1400
- Supplied by: Ferro Corporation
- Data Received: 08/19/10
- Storage: Room Temperature and humidity
- Description: Clear yello liquid
- Sample preparation: The test article was used as received
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 / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- 1 female and 2 males
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Myrtle's Rabbitry, Inc. Thompsons, TN
- Date received: 10/21/10
- Date of birth: 07/20/10
- Weight at study initiation: 2.7 -2.8 kg
- Housing: 1/ cage in suspended cages
- Diet ( ad libitum): Fresh PMI Rabbit Chow - daily
- Water: ad libitum
- Acclimation period: five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): This parameter deviated from the standard protocol. This did not influence the study animals and the integrity of the study.
- Humidity (%): This parameter deviated from the standard protocol. This did not influence the study animals and the integrity of the study.
- Air changes (per hr): no info
- Photoperiod (hrs dark / hrs light): 12hr /12 hr
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- Single 0.1 mL dose into eye
- Observation period (in vivo):
- 1, 24, 48, 72 hours
- Duration of post- treatment incubation (in vitro):
- Not applicable
- Number of animals or in vitro replicates:
- Three rabbits: 2 males and 1 female
- Details on study design:
- SCORING SYSTEM: see attachment
TOOL USED TO ASSESS SCORE: sodium fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 1 Female and 2 Males
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 80
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 1 Female and 2 Males
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 10
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 1 Female and 2 Males
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- 1 Female and 2 Males
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Ocular finding
Treated eyes: There was no corneal opacity, iritis or conjunctival irritation at any observation period.
Control eyes: The control eyes appeared normal at all observation periods. - Other effects:
- Systemic observation
There were no abnormal physical signs noted during the observation period.
Any other information on results incl. tables
Table 1. Ocular Findings, Systemic Observations, and Body Weights |
|||||||
Animal No. / Sex |
Item |
Tissue |
Reading |
1 hour |
24 hours |
48 hours |
72 hours |
H3811 / Male |
A |
Cornea |
Opacity |
0 |
0 |
0 |
0 |
B |
Area |
0 |
0 |
0 |
0 |
||
|
1. Total = (A x B) x 5 |
0 |
0 |
0 |
0 |
||
C |
Iris |
|
0 |
0 |
0 |
0 |
|
|
2. Total = (C x 5) |
0 |
0 |
0 |
0 |
||
D |
Conjunctiva |
Redness |
0 |
0 |
0 |
0 |
|
E |
Chemosis |
0 |
0 |
0 |
0 |
||
F |
Discharge |
0 |
0 |
0 |
0 |
||
|
3. Total = (D+E+F) x 2 |
0 |
0 |
0 |
0 |
||
|
Total = 1+2+3 |
0 |
0 |
0 |
0 |
||
|
Systemic Observations |
A |
A |
A |
A |
||
|
Sodium Fluorescein |
|
0 |
N/A |
N/A |
||
|
Pretest Body Weight: 2.7 Kg |
|
|
|
|
||
|
|||||||
H3812 / Male |
A |
Cornea |
Opacity |
0 |
0 |
0 |
0 |
B |
Area |
0 |
0 |
0 |
0 |
||
|
1. Total = (A x B) x 5 |
0 |
0 |
0 |
0 |
||
C |
Iris |
|
0 |
0 |
0 |
0 |
|
|
2. Total = (C x 5) |
0 |
0 |
0 |
0 |
||
D |
Conjunctiva |
Redness |
0 |
0 |
0 |
0 |
|
E |
Chemosis |
1 |
0 |
0 |
0 |
||
F |
Discharge |
1 |
0 |
0 |
0 |
||
|
3. Total = (D+E+F) x 2 |
4 |
0 |
0 |
0 |
||
|
Total = 1+2+3 |
4 |
0 |
0 |
0 |
||
|
Systemic Observations |
A |
A |
A |
A |
||
|
Sodium Fluorescein |
|
0 |
N/A |
N/A |
||
|
Pretest Body Weight: 2.7 Kg |
|
|
|
|
||
|
|||||||
H3837 / Female |
A |
Cornea |
Opacity |
0 |
0 |
0 |
0 |
B |
Area |
0 |
0 |
0 |
0 |
||
|
1. Total = (A x B) x 5 |
0 |
0 |
0 |
0 |
||
C |
Iris |
|
0 |
0 |
0 |
0 |
|
|
2. Total = (C x 5) |
0 |
0 |
0 |
0 |
||
D |
Conjunctiva |
Redness |
0 |
0 |
0 |
0 |
|
E |
Chemosis |
0 |
0 |
0 |
0 |
||
F |
Discharge |
0 |
0 |
0 |
0 |
||
|
3. Total = (D+E+F) x 2 |
0 |
0 |
0 |
0 |
||
|
Total = 1+2+3 |
0 |
0 |
0 |
0 |
||
|
Systemic Observations |
A |
A |
A |
A |
||
|
Sodium Fluorescein |
|
0 |
N/A |
N/A |
||
|
Pretest Body Weight: 2.8 Kg |
|
|
|
|
A = Normal
The control eyes appeared normal at all observation points
Table 2. Mean scores (EU and GHS) |
||||
Time Points |
24 hours |
48 hours |
72 hours |
Mean |
Animal Number / Sex |
H3811 / Male |
|||
Corneal Opacity |
0 |
0 |
0 |
0.0 |
Iritis |
0 |
0 |
0 |
0.0 |
Conjunctival Redness |
0 |
0 |
0 |
0.0 |
Conjunctival Edema (chemosis) |
0 |
0 |
0 |
0.0 |
|
||||
Animal Number / Sex |
H3812 / Male |
|||
Corneal Opacity |
0 |
0 |
0 |
0.0 |
Iritis |
0 |
0 |
0 |
0.0 |
Conjunctival Redness |
0 |
0 |
0 |
0.0 |
Conjunctival Edema (chemosis) |
0 |
0 |
0 |
0.0 |
|
||||
Animal Number / Sex |
H3837 / Female |
|||
Corneal Opacity |
0 |
0 |
0 |
0.0 |
Iritis |
0 |
0 |
0 |
0.0 |
Conjunctival Redness |
0 |
0 |
0 |
0.0 |
Conjunctival Edema (chemosis) |
0 |
0 |
0 |
0.0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Not irritating
- Conclusions:
- Based on the lack of effects observed, It was determined that the test material Santicizer P1400 did not produce irritation to eyes and does not meet the criteria for classification as an ocular irritant under GHS or EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
- Executive summary:
In a key EPA OPPTS Guideline 870.2400 study, the potential of the test material (Santicizer P1400) to cause ocular irritation or corrosion was evaluated after instillation into the rabbit eye. 0.1 mL of the test material was placed into the conjunctival sac of one eye of three healthy New Zealand White rabbits (1 female and 2 males) with the contralateral eye serving as control. Treated and control eyes were examined pretest and scored by the Draize technique at 1, 24, 48, and 72 hours post-exposure. Sodium fluorescein dye procedures were used at the 24 hour observation interval and animals were evaluated for mortality, toxicity, and pharmacological effects at each ocular observation point. Body weights were recorded pretest.
No abnormal physical signs were observed during the study period and no corneal opacity, iritis, or conjunctival irritation was observed at any observation point. In 1 animal at the 1 hour timepoint, chemosis (1) and discharge (1), without redness (0) was observed. However, this was fully reversible by 24 hours and not considered indicative of irritation by the test material. All control eyes appeared normal through the study period.
Based on the lack of effects observed, It was determined that the test material Santicizer P1400 did not produce irritation to eyes and does not meet the criteria for classification as an ocular irritant under GHS or EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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