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EC number: 268-594-6 | CAS number: 68130-51-8
- 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 vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 31. Aug. 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Version / remarks:
- OECD Guideline for the Testing of Chemicals, Method No. 437, edition adopted 26. Jul. 2013: “Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage”
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- Version / remarks:
- Commission Regulation (EU) 2017/735 amending Regulation (EC) No. 440/2008, EU Method B.47 Bovine Corneal Opacity and Permeability Test Method for Identifying (i) Chemicals Inducing Serious Eye Damage and (ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage, adopted 14. Feb. 2017
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Decanoic acid, mixed esters with heptanoic acid, isovaleric acid, octanoic acid and pentaerythritol
- EC Number:
- 268-594-6
- EC Name:
- Decanoic acid, mixed esters with heptanoic acid, isovaleric acid, octanoic acid and pentaerythritol
- Cas Number:
- 68130-51-8
- Molecular formula:
- C25H44O8 to C45H84O8 (in CH2 unit increments)
- IUPAC Name:
- 3-(heptanoyloxy)-2-[(octanoyloxy)methyl]-2-[(pentanoyloxy)methyl]propyl decanoate; 3-(heptanoyloxy)-2-{[(2-methylbutanoyl)oxy]methyl}-2-[(octanoyloxy)methyl]propyl decanoate
- Test material form:
- liquid
- Details on test material:
- Name Hatcol 1570
Batch no. B29855
Appearance slight yellow, clear liquid
CAS No. 68130-51-8
EINECS-No. 268-594-6
Molecular formula C10-H20-O2.C8-H16-O2.C7-H14-O2.C5-H12-O4.C5-H10-O2
Molecular weight not stated
Purity 99.7 %
Homogeneity homogeneous
Vapour pressure not stated
Stability H2O: not stated; EtOH: not stated; acetone: not stated; CH3CN: not stated; DMSO: not stated
Solubility H2O: not stated; EtOH: not stated; acetone: not stated; CH3CN: not stated; DMSO: not stated
Production date 14. Jun. 2017
Expiry date 14. Jun. 2019
Storage Room Temperature (20 ± 5°C)
Constituent 1
- Specific details on test material used for the study:
- No further details specified in the study report.
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Specification
Species Bos primigenius Taurus (fresh bovine corneas)
Origin
Fresh bovine eyes were obtained from the slaughterhouse Müller Fleisch GmbH, Enzstr. 2-4, 75217 Birkenfeld, Germany, on the day of the test. The cattle were between 12 and 60 months old. The eyes were transported to the test facility in Hanks’ Balanced Salt Solution with 1% Penicillin-Streptomycin solution (Penicillin 100 U/mL, Streptomycin 100 μg/mL) in a suitable cooled container.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 750 μL
- Duration of treatment / exposure:
- 10 minutes
- Duration of post- treatment incubation (in vitro):
- 2 hours
- Number of animals or in vitro replicates:
- For each treatment group (negative control solution, test item and positive control), three replicates were used.
- Details on study design:
- Preparations
After having carefully cleaned and sterilised the cornea holders, they were kept in the incubation chamber at 32 ± 1 °C.
On the day of the assay, the MEM without phenol red was supplemented with sodium bicarbonate, L-glutamine and 1% fetal calf serum (= complete MEM) and stored in a water bath at 32 ± 1 °C.
The same was performed with the MEM with phenol red, but without addition of sodium bicarbonate.
After the arrival of the corneas, they were examined and only corneas which were free from damages were used. The corneas were excised with a scalpel and cut from the globe with a 2-3 mm ring of sclera around the outside. Each cornea was transferred to a cornea holder in which pre-warmed cMEM (32 ± 1 °C) without phenol red was filled. The holders were then incubated for 1 hour in the incubation chamber at 32 ± 1 °C.
Experimental Parameters
Date of treatment: 31. Aug. 2017
Incubation time: 10 min.
Negative control: HBSS
Positive control: Dimethylformamide (undiluted)
Method Description
After the initial incubation, the medium was changed and the baseline opacity for each cornea was recorded. None of the corneas showed tissue damage; therefore, all corneas were used. For each treatment group (negative control solution, test item and positive control), three replicates were used. After removal of the pre-incubation medium (cMEM without phenol red), 750 μL negative control solution, test item and positive control were applied to each replicate.
According to the characteristics of the test item, the following treatment procedure was performed:
Closed Chamber Method
The respective substance (negative control solution, test item or positive control) was applied by pipetting 750 μL of the appropriate liquid through the refill hole in the holder on the cornea. The test item was given on the epithelium in such a manner that as much as possible of the cornea was covered with the test item.
Exposure time of the test item on the corneas was 10 minutes at 32 ± 1 °C. After thorough rinsing with cMEM with phenol red and final rinsing with cMEM without phenol red, the anterior chamber was filled with cMEM without phenol red, and the corneas were stored for additional 2 hours at 32 ± 1 °C (post-incubation).
After post-incubation time, the cMEM without phenol red was renewed in both chambers.
Then, the final opacity value of each cornea was recorded. The cMEM without phenol red was removed from the front chamber, and 1 mL sodium fluorescein solution (concentration: 4 mg/mL) was added to the front chamber.
The chambers were then closed again and incubated for 90 minutes at 32 ± 1 °C. After incubation, the content of the posterior chamber was thoroughly mixed. Then, the permeability of the cornea was measured as optical density of the liquid with a microtiter plate photometer at 492 nm.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Test Item
- Value:
- 0.41
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- The in vitro study was performed to assess corneal damage potential of Hatcol 1570 by quantitative measurements of changes in opacity and permeability in a bovine cornea.
The test item Hatcol 1570 was brought onto the cornea of a bovine eye which previously had been incubated with cMEM without phenol red at 32 ± 1 °C for 1 hour and whose opacity had been determined. The test item was incubated on the cornea for 10 minutes at 32 ± 1 °C. After removal of the test item and 2 hours post-incubation, opacity and permeability values were measured.
The test item was tested pure.
Under the conditions of the test, the test item Hatcol 1570 showed no effects on the cornea of the bovine eye. The calculated IVIS (in vitro irritancy score) is 0.41.
According to OECD Guideline no. 437 (Jul. 2013), a substance with an IVIS ≤ 3 requires no classification for eye irritation or serious eye damage.
The negative control (HBSS) and the positive control (undiluted dimethylformamide) have met the validity criteria.
No observations were made which might cause doubts concerning the validity of the study outcome. The test is considered valid.
Any other information on results incl. tables
Opacity and Permeability Values
The illuminance (unit: LUX) values which were measured before and after exposure are given in the following table:
Illuminance Values
Parameter |
Negative Control |
Test Item |
Positive Control |
||||||
1. Rep. |
2. Rep. |
3. Rep. |
1. Rep. |
2. Rep. |
3. Rep. |
1. Rep. |
2. Rep. |
3. Rep. |
|
(I) Measured values before exposure |
997 |
989 |
1043 |
1003 |
1017 |
976 |
1009 |
990 |
983 |
(I) Measured values after exposure |
1006 |
971 |
1020 |
981 |
1001 |
961 |
422 |
431 |
403 |
Rep. = Replicate
The values in the following tables present the calculated opacity values, according to evaluation:
Opacity Values Negative Control
Parameter |
Negative Control |
||
1. Rep. |
2. Rep. |
3. Rep. |
|
Opacity before exposure |
4.30 |
4.65 |
2.37 |
Opacity after exposure |
3.91 |
5.47 |
3.31 |
Opacity Difference |
-0.39 |
0.82 |
0.94 |
Mean Opacity Difference |
0.46 |
Rep. = Replicate
Opacity Values Test Item and Positive Control
Parameter |
Test item |
Positive Control |
||||
1. Rep. |
2. Rep. |
3. Rep. |
1. Rep. |
2. Rep. |
3. Rep. |
|
Opacity before exposure |
4.04 |
3.44 |
5.24 |
3.78 |
4.61 |
4.92 |
Opacity after exposure |
5.01 |
4.12 |
5.93 |
63.86 |
61.70 |
68.73 |
Opacity Difference |
0.97 |
0.69 |
0.70 |
60.08 |
57.10 |
63.81 |
Opacity Difference corrected |
0.52 |
0.23 |
0.24 |
59.63 |
56.64 |
63.36 |
Mean Opacity Difference corrected |
0.33 |
59.88 |
Rep. = Replicate
For the permeability measurement, three replicates for each treatment group were measured three time. cMEM without phenol red was measured as blank value as well. The optical density values at 492 nm are given in the following tables:
Optical density at 420 nm of Blank
Parameter |
cMEM without phenol red |
1. Measurement |
0.038 |
2. Measurement |
0.041 |
3. Measurement |
0.041 |
Mean |
0.040 |
Optical density at 420 nm of Negative Control, Test Item and Positive Control
Parameter |
Negative Control |
Test item |
Positive Control |
||||||
1. Rep. |
2. Rep. |
3. Rep. |
1. Rep. |
2. Rep. |
3. Rep. |
1. Rep. |
2. Rep. |
3. Rep. |
|
1. Measurement |
0.036 |
0..039 |
0.041 |
0.039 |
0..048 |
0.044 |
0.505 |
0.605 |
0.450 |
2. Measurement |
0.034 |
0.041 |
0.038 |
0.044 |
0.046 |
0.044 |
0.509 |
0.614 |
0.453 |
3. Measurement |
0.040 |
0.037 |
0.040 |
0.039 |
0.050 |
0.043 |
0.515 |
0.605 |
0.450 |
|
|||||||||
1. Measurement – blank |
-0.0040 |
-0.0010 |
0.0010 |
-0.0010 |
0.0080 |
0.0040 |
0.4650 |
0.5650 |
0.4100 |
2. Measurement – blank |
-0.0060 |
0.0010 |
-0.0020 |
0.0040 |
0.0060 |
0.0040 |
0.4690 |
0.5740 |
0.4130 |
3. Measurement – blank |
0.0000 |
-0.0030 |
0.0000 |
-0.0010 |
0.0100 |
0.0030 |
0.4750 |
0.5650 |
0.4100 |
Mean of each replicate |
-0.0033 |
-0.0010 |
-0.0003 |
0.0007 |
0.0080 |
0.0037 |
0.4697 |
0.5680 |
0.4110 |
Mean of the 3 replicate |
-0.0016 |
-- |
-- |
||||||
Corrected |
-- |
-- |
-- |
0.0022 |
0.0096 |
0.0052 |
0.4712 |
0.5696 |
0.4126 |
Corrected mean of the 3 replicates |
-- |
0.0057 |
0.4844 |
Rep. = Replicate
IVIS Values
The calculated IVIS for each replicate and the corresponding means are presented in the following table:
IVIS
Test Group |
IVIS |
Mean IVIS |
Relative Standard Deviation IVIS |
Negative Control HBSS |
-0.44 |
0.43 |
175.58% |
0.80 |
|||
0.94 |
|||
Test Item Hatcol 1570 |
0.55 |
0.41 |
23.39% |
0.37 |
|||
0.32 |
|||
Positive Control DMF undiluted |
66.70 |
67.14 |
3.30% |
65.19 |
|||
69.54 |
Note: the high relative standard deviations of the IVIS of test item and negative control are due to mathematical reasons, as the respective means are very small.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the study, the test item Hatcol 1570 showed no effects on the cornea of the bovine eye. The calculated IVIS (in vitro irritancy score) is 0.41.
According to OECD Guideline no. 437 (Jul. 2013), a substance with an IVIS ≤ 3 requires no classification for eye irritation or serious eye damage. - Executive summary:
Evaluation of Hatcol 1570 in the Bovine Corneal Opacity and Permeability (BCOP) Test Method following OECD Guideline 437 and EU Method B.47
Findings and Results:
One valid experiment was performed.
Bovine corneas were used. They were collected from slaughtered cattle which were between 12 and 60 months old.
The test item Hatcol 1570 was brought onto the cornea of a bovine eye which had been incubated with cMEM without phenol red at 32 ± 1 °C for 1 hour and whose opacity had been measured.
The test item was incubated on the cornea for 10 minutes at 32 ± 1 °C. After removal of the test item and 2 hours post-incubation, opacity and permeability values were measured.
HBSS was used as negative control. The negative control showed no irritating effect on the cornea and the calculated IVIS (in vitro irritancy score) is 0.43.
Dimethylformamide (DMF) undiluted was used as positive control. The positive control induced serious eye damage on the cornea and was within two standard deviations of the current historical mean. The calculated IVIS (in vitro irritancy score) is 67.14.
Under the conditions of the study, the test item Hatcol 1570 showed no effects on the cornea of the bovine eye. The calculated IVIS (in vitro irritancy score) is 0.41.
According to OECD Guideline no. 437 (Jul. 2013), a substance with an IVIS ≤ 3 requires no classification for eye irritation or serious eye damage.
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