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EC number: 941-532-1 | 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
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- Explosiveness
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- 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
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- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
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- Endpoint summary
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- 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
Endpoint summary
Administrative data
Description of key information
The aim of the first study was to determine the corrosivity potential of the test item Tall Oil Pitch, reaction product with triethylene glycol using the EpiDerm™ Human Skin Model after treatment periods of 3 and 60 minutes. The study was conducted according to the OECD 431 Guideline and under GLP conditions.
Duplicate tissues were treated with the test item for exposure periods of 3 and 60 minutes. Negative and positive control groups were treated for each exposure period. The test item was found to have the potential to cause color interference with the MTT end-point therefore additional tissues were incorporated into the testing to correct for this. At the end of the exposure period the test item was rinsed from each tissue before each tissue was taken for MTT‑loading. After MTT loading each tissue was placed in 2 mL Isopropanol for MTT extraction.
At the end of the formazan extraction period each well was mixed thoroughly and triplicate 200 mL samples were transferred to the appropriate wells of a pre-labeled 96‑well plate. The optical density (OD) was measured at 570 nm (OD570).
A second study was done to evaluate theskin irritation potential of the test item Tall Oil Pitch, reaction product with triethyleneGlycol using the EPISKINTM reconstructed human epidermis model after a treatment period of 15 minutes followed by a post-exposure incubation period of 42 hours.The study was conducted according to the OECD 439 Guideline and under GLP conditions.
The quality criteria required for acceptance of results in the test were satisfied.
The results of the study showed thatthe relative mean viability of the test item treated tissues was 85.2% after the 15-Minute exposure period and 42-Hours post-exposure incubation period.
In conclusion, the test item was not classified as irritant according to the results of this study.
Finally, a study was conducted to to evaluate the potential of the test item Tall Oil Pitch, reaction product with triethylene glycol to induce serious eye damage using a Bovine Corneal Opacity and Permeability (BCOP) test method (OECD 437). The test was done under GLP conditions.
The undiluted test item was applied for 10 minutes followed by an incubation period of120 minutes. Negative and positive control items were tested concurrently. The twoendpoints, decreased light transmission through the cornea (opacity) and increased passage ofsodium fluorescein dye through the cornea (permeability) were combined in an empirically
derived formula to generate anIn Vitro Irritancy Score (IVIS).
The positive control In Vitro Irritancy Score was within the range of 31.6 to 58.7. The positive control acceptance criterion was therefore satisfied.
The negative control gave opacity of =3.0 and permeability =0.077. The acceptance criteria were therefore satisfied. The In Vitro Irritancy Score of the test item was 1.0.
In conclusion, according to the criteria for classification (No category), the test item Tall Oil Pitch, reaction product with triethylene glycol (CAS: 2135769-54-7) does not require classification to UN GHS or EU CLP.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25 October 2017 - 03 November 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Deviations:
- yes
- Remarks:
- Deviations were considered to have not affected the integrity or validity of the study.
- Qualifier:
- according to guideline
- Guideline:
- other: Method B.40bis of Commission Regulation (EC) No 440/2008
- Version / remarks:
- Method B.40bis of Commission Regulation (EC) No 440/2008, of 30 May 2008, laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
- Deviations:
- yes
- Remarks:
- Deviations were considered to have not affected the integrity or validity of the study.
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Identification: Tall Oil Pitch, reaction product with triethylene glycol
Batch: LABO 16-02
Purity: 100%
Physical state/Appearance: brown viscous liquid
Expiry Date: 14 November 2018
Storage Conditions: room temperature in the dark - Test system:
- human skin model
- Source species:
- other: Reconstructed Human Epidermis Model Kit
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: MatTek
- Source strain:
- not specified
- Justification for test system used:
- This test is able to reliably discriminate chemicals that are corrosive to skin from non-corrosive chemicals, and can therefore be used for the classification of skin corrosion hazard according to the GHS System adopted by the OECD
- Vehicle:
- not specified
- Details on test system:
- Pre-Incubation
The assay medium was pre warmed before use. 0.9 mL of this assay medium was pipetted into the appropriate wells of two pre-labeled 6-well plates for both the 3 Minute and 60 Minute exposure periods. EpiDerm™ tissues were transferred into the 6 well plates containing the assay medium. The 6 well plates containing the EpiDerm™ samples were pre-incubated (37 °C, 5% CO2) for approximately 1 hour before dosing.
Application of Test Item and Rinsing
Before pre-incubation was complete, a 24 well plate was prepared for use as a “holding plate” for both the 3 Minute and 60 Minute exposure periods. This plate was used to maintain the viability of the tissue inserts between rinsing following chemical exposure and MTT loading. Another 24 well plate was prepared for the MTT loading. 300 µL of either pre warmed assay medium (holding plate) or MTT medium (MTT loading plate) was dispensed into each well. The two plates were placed into the incubator until required.
After pre incubation of the EpiDerm™ tissues, the medium was aspirated and replaced with 0.9 mL of fresh assay medium. The 6-well plate for the 3 Minute exposure period was returned to the incubator, while the other was being dosed for the 60 Minute exposure. For the 60 Minute exposure period, 50 µL of sterile distilled water (negative control) was added to the first two tissues. The tissues were dosed at regular intervals to allow for the time taken to rinse each tissue following exposure and to ensure that each tissue gets an equal exposure time. 50 µL of the test item and 50 µL of 8.0 N Potassium Hydroxide (positive control) were also applied to the corresponding tissues in turn. The plate was returned to the incubator (37 °C, 5% CO2) for the 60 Minute exposure period.
When dosing for the 60 Minute exposure period was complete, the same procedure was repeated for the 3 Minute exposure period. Because the exposure time was so short, the tissues were dosed at regular intervals to ensure that each tissue received an equal exposure time and to allow for the time taken to rinse each tissue following exposure. Rinsing was achieved by filling and emptying each tissue under a constant soft stream of Dulbecco’s Phosphate Buffered Saline (DPBS) to gently remove any residual test item. Excess DPBS was removed by blotting the bottom of the tissue insert with tissue paper. Each tissue was placed into the prepared holding plate until all tissues were rinsed. They were then blotted and transferred to the 24 well plate prepared for MTT loading. The plate was incubated (37 °C, 5% CO2) for 3 hours. Once the 60 Minute exposure period was complete, the same rinsing and MTT loading procedure was repeated.
After the 3 Hour MTT incubation was complete, the inserts were blotted and transferred to labeled 24 well plates for MTT extraction. 2 mL of MTT extractant (isopropanol) was used to completely immerse each insert and the plate was covered with plate sealer to prevent Isopropanol evaporation. The plates stood overnight at room temperature, to allow extraction to proceed.
Absorbance/Optical Density Measurements
After extraction, each tissue was pierced with a pipette fitted with a 1000 µL tip and the extraction solution was forced vigorously up and down to form a homogenous solution. 3 x 200 µL aliquots of the extract were transferred to the appropriate wells of a pre labeled 96 well plate. 200 µL of isopropanol alone was added to the three wells designated as blanks. Absorbency at 570 nm (OD570) of each well was measured using the Labtech LT 4500 microplate reader. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount and concentration (s) applied (volume or weight with unit): 50 µL of the test item was applied to the corresponding tissues
POSITIVE CONTROL
- Amount(s) applied (volume or weight) and concentrations: 8.0 N Potassium Hydroxide (positive control) were applied to the corresponding tissues
Batch: SLBM9898V
Purity: 7.92M
Expiry Date: 7 April 2020
Storage Conditions: room temperature
Supplier: Sigma-Aldrich
NEGATIVE CONTROL
- Amount(s) applied (volume or weight) and concentrations: 50 µL
Identification: Sterile distilled water
Batch:3012436
Purity: not applicable
Expiry Date: 01 October 2018
Storage Conditions: room temperature
Supplier: Aguettant Ltd - Duration of treatment / exposure:
- 3 Hour incubation
- Number of replicates:
- two tissue replicates of each treatment group
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 minutes
- Value:
- 99.3
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60 minutes
- Value:
- 100.2
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item Tall Oil Pitch, reaction product with triethylene glycol was considered to be non-corrosive to the skin, according to the result of this study.
- Executive summary:
The aim of this study was to determin the corrosivity potential of the test item Tall Oil Pitch, reaction product with triethylene glycol using the EpiDerm™ Human Skin Model after treatment periods of 3 and 60 minutes. The study was conducted according to the OECD 471 Guideline and under GLP conditions.
Duplicate tissues were treated with the test item for exposure periods of 3 and 60 minutes. Negative and positive control groups were treated for each exposure period. The test item was found to have the potential to cause color interference with the MTT end-point therefore additional tissues were incorporated into the testing to correct for this. At the end of the exposure period the test item was rinsed from each tissue before each tissue was taken for MTT‑loading. After MTT loading each tissue was placed in 2 mL Isopropanol for MTT extraction.
At the end of the formazan extraction period each well was mixed thoroughly and triplicate 200 mL samples were transferred to the appropriate wells of a pre-labeled 96‑well plate. The optical density (OD) was measured at 570 nm (OD570).
The quality criteria required for acceptance of results in the test were satisfied.
The results of the study showed that the test itemTall Oil Pitch, reaction product with triethylene glycol is not corrosive.
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 09 November 2017 - 04 December 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- yes
- Remarks:
- Deviations were considered to have not affected the integrity or validity of the study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- yes
- Remarks:
- Deviations were considered to have not affected the integrity or validity of the study
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Identification: Tall Oil Pitch, reaction product with triethylene glycol
CAS RN: 2135769-54-7
CAS name: Tall-oil pitch, ester with triethylene glycol
Batch: LABO 16-02
Purit y: 100%
Physical state/Appearance: Brown viscous liquid
Expiry Date: 14 November 2018
Storage Conditions: Room temperature in the dark, under nitrogen - Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other:
- Source strain:
- not specified
- Justification for test system used:
- This test is able to reliably discriminate chemicals that are corrosive to skin from non-corrosive chemicals, and can therefore be used for the classification of skin corrosion hazard according to the GHS System adopted by the OECD
- Vehicle:
- not specified
- Details on test system:
- Application of Test Item and Rinsing (Day 1)
2 mL of maintenance medium, warmed to approximately 37 C, was pipetted into the second
column of 3 wells of the 12-well plate.
Triplicate tissues were treated with the test item for an exposure period of 15 minutes. The
test item was applied topically to the corresponding tissues ensuring uniform covering.
10 µL (26.3 µL/cm 2) of the test item was applied to the epidermis surface. Triplicate tissues
treated with 10 µL of DPBS served as the negative controls and triplicate tissues treated with
10 µL of SDS 5% w/v served as the positive controls. To ensure satisfactory contact with the
positive control item the SDS solution was spread over the entire surface of the epidermis
using a pipette tip (taking particular care to cover the center). After a 7-Minute contact time
the SDS solution was re-spread with a pipette tip to maintain the distribution of the SDS for
the remainder of the contact period (re-spreading is not required for the negative control or
test item). The plates were kept in the biological safety cabinet at room temperature for
15 minutes.
At the end of the exposure period, each tissue was removed from the well using forceps and
rinsed using a wash bottle containing DPBS with Ca++ and Mg++. Rinsing was achieved by
filling and emptying each tissue insert for approximately 40 seconds using a constant soft
stream of DPBS to gently remove any residual test item. The rinsed tissues were transferred
to the second column of 3 wells containing 2 mL of maintenance medium in each well. The
rinsed tissues were incubated at 37 C, 5% CO2 in air for 42 hours.
MTT Loading/Formazan Extraction
Following the 42-Hour post-exposure incubation period each 12-well plate was placed onto a
plate shaker for 15 minutes to homogenize the released mediators in the maintenance
medium. 1.6 mL of the maintenance medium from beneath each tissue was transferred to
pre-labeled micro tubes and stored in a freezer at -14 to -30 ºC for possible inflammatory
mediator determination.
2 mL of a 0.3 mg/mL MTT solution, freshly prepared in assay medium, was pipetted into the
third column of 3 wells of the 12-well plates. The tissues were transferred to the MTT filled
wells, being careful to remove any excess maintenance medium from the bottom of the tissue
insert by blotting on absorbent paper. The tissues were incubated for 3 hours at 37 °C,
5% CO2 in air. At the end of the 3-Hour incubation period each tissue was placed onto
absorbent paper to dry. A total biopsy of the epidermis was made using the EPISKIN
biopsy punch. The epidermis was carefully separated from the collagen matrix using forceps
and both parts (epidermis and collagen matrix) placed into labeled 1.5 mL micro tubes
containing 500 µL of acidified isopropanol, ensuring that both the epidermis and collagen
matrix were fully immersed. Each tube was plugged to prevent evaporation and mixed
thoroughly on a vortex mixer. The tubes were refrigerated at 1 to 10 °C until Day 6 of the
experiment, allowing the extraction of formazan crystals out of the MTT-loaded tissues.
Absorbance/Optical Density Measurements
At the end of the formazan extraction period each tube was mixed thoroughly on a vortex
mixer to produce a homogenous colored solution.
For each tissue, duplicate 200 µL samples were transferred to the appropriate wells of a
pre-labeled 96-well plate. 200 µL of acidified isopropanol alone was added to the two wells
designated as ‘blanks’. The optical density was measured (quantitative viability analysis) at
570 nm (without a reference filter) using the Labtech LT-4500 microplate reader. - Control samples:
- yes, concurrent negative control
- yes, concurrent no treatment
- yes, concurrent positive control
- Amount/concentration applied:
- 10 µL (26.3 µL/cm2) of the test item was applied to the epidermis surface
- Duration of treatment / exposure:
- 15 minutes
- Duration of post-treatment incubation (if applicable):
- 42-Hour post-exposure
- Number of replicates:
- riplicate tissues
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1
- Value:
- 95.4
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 2
- Value:
- 74.7
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3
- Value:
- 85.2
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- Relative Mean Viability %
- Run / experiment:
- Mean
- Value:
- 85.2
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- QUALITY CRITERIA
The results of the assay are considered acceptable if the following assay acceptance criteria are achieved:
Positive Control:
The assay establishes the acceptance criterion for an acceptable test if the relative mean tissue viability for the positive control treated tissues is ≤40% relative to the negative control treated tissues, and the standard deviation (SD) value of the percentage viability is ≤18%.
Negative Control:
The assay establishes the acceptance criterion for an acceptable test if the mean OD 570 for the negative control treated tissues is ≥0.6 and ≤1.5, and the SD value of the percentage viability is ≤18%.
Test Item:
The assay establishes the acceptance criterion for an acceptable test if the standard deviation calculated from individual percentage tissue viabilities of the three identically treated tissues is ≤18%. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to the results of this study, the test material Tall Oil Pitch, reaction product with triethylene glycol was classified as non-irritant.
- Executive summary:
The aim of this study was to evaluate the skin irritation potential of the test item Tall Oil Pitch, reaction product with triethylene Glycol using the EPISKINTM reconstructed human epidermis model after a treatment period of 15 minutes followed by a post-exposure incubation period of 42 hours. The study was conducted according to the OECD 439 Guideline and under GLP conditions.
The quality criteria required for acceptance of results in the test were satisfied.
The results of the study showed thatthe relative mean viability of the test item treated tissues was 85.2% after the 15-Minute exposure period and 42-Hours post-exposure incubation period.
In conclusion, the test item was not classified as irritant according to the results of this study.
Referenceopen allclose all
For the test item the relative mean tissue viabilities obtained after the 15-Minute exposure period followed by the 42-Hour post-exposure incubation period were compared to the mean
of the negative control treated tissues (n=3). The relative mean viabilities were calculated in the following way:
Relative mean viability (%) = (mean OD 570 of the test item / mean OD 570 of negatove control) x100
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 04 December 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- 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)
- 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)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Identification: Tall Oil Pitch, reaction product with triethylene gl ycol
CAS RN: 2135769-54-7
CAS name: Tall oil pitch, ester with triethylene glycol
Batch: LABO 16-02
Purit y: 100%
Physical state/Appearance: brown viscous liquid
Expiry Date: 14 November 2018
Storage Conditions: room temperature in the dark, under nitrogen - Species:
- other: bovine
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Eyes from adult cattle (typically 12 to 60 months old) were obtained from a local abattoir as a by-product from freshly slaughtered animals. The eyes were excised by an abattoir employee after slaughter, and were placed in Hanks’ Balanced Salt Solution (HBSS) supplemented with antibiotics (penicillin at 100 IU/mL and streptomycin at 100 µg/mL). They were transported to the test facility over ice packs on the same day of slaughter. The corneas were prepared immediately on arrival
- Vehicle:
- not specified
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.75 mL
- Duration of treatment / exposure:
- 32 ± 1 ºC for 120 minutes
- Duration of post- treatment incubation (in vitro):
- incubation: 32 ± 1 ºC for 90 minutes
- Number of animals or in vitro replicates:
- Three corneas were randomly allocated to the negative control. Three corneas were also allocated to the test item and three corneas to the positive control item.
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
The medium from both chambers of each holder was replaced with fresh complete EMEM. A pre-treatment opacity reading was taken for each cornea using a calibrated opacitometer. The average opacity for all corneas was calculated. Three corneas were randomly allocated to the negative control. Three corneas were also allocated to the test item and three corneas to the positive control item.
QUALITY CHECK OF THE ISOLATED CORNEAS
All eyes were macroscopically examined before and after dissection. Only corneas free of damage were used.
TREATMENT METHOD: The EMEM was removed from the anterior chamber of the BCOP holder and 0.75 mL of the test item or control items were applied to the appropriate corneas. The holders were gently tilted back and forth to ensure a uniform application of the item over the entire cornea. Each holder was incubated, anterior chamber uppermost, at 32 ± 1 ºC for 10 minutes. At the end of the exposure period the test item and control items were removed from the
anterior chamber and the cornea was rinsed 3 times with fresh complete EMEM containing phenol red before a final rinse with complete EMEM without phenol red. The anterior chamber was refilled with fresh complete EMEM without phenol red. A post-treatment opacity reading was taken and each cornea was visually observed. The holders were incubated, anterior chamber facing forward, at 32 ± 1 ºC for 120 minutes. After incubation the holders were removed from the incubator, the medium from both chambers was replaced with fresh complete EMEM and a final opacity reading was taken. Each cornea was visually observed.
Following the final opacity measurement the permeability of the corneas to sodium fluorescein was evaluated. The medium from the anterior chamber was removed and replaced with 1 mL of sodium fluorescein solution (4 mg/mL). The dosing holes were plugged and the holders incubated, anterior chamber uppermost, at 32 ± 1 ºC for 90 minutes.
After incubation the medium in the posterior chamber of each holder was decanted and retained. 360 µL of media representing each cornea was dispensed into the appropriate wells of a pre-labeled 96-well plate. The optical density was measured (quantitative viability analysis) at 492 nm (without a reference filter) using the Labtech LT-4500 microplate reader.
NEGATIVE CONTROL USED
dentification: Sodium chloride 0.9% w/v
Lot: 3012488
Purit y: 0.9%
Supplier: Aguettant Ltd
Expiry Date: 01 November 2018
Storage Conditions: room temperature
POSITIVE CONTROL USED
Identification: Ethanol
Batch: STBD7546V
Purit y: >99.8%
Supplier: Sigma Aldrich
Expiry Date: 01 April 2018
Storage Conditions: room temperature in the dark
REFERENCE
he negative control item, sodium chloride 0.9% w/v, was used as supplied. The positive control item, ethanol, was used as supplied.
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Test Item
- Value:
- 1
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- The positive control In Vitro Irritancy Score was within the range of 31.6 to 58.7. The
positive control acceptance criterion was therefore satisfied.
The negative control gave opacity of ≤3.0 and permeability ≤0.077. The negative control
acceptance criteria were therefore satisfied. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to the criteria for classification (No category), the test item Tall Oil Pitch, reaction product with triethylene glycol (CAS: 2135769-54-7) does not require classification to UN GHS or EU CLP.
- Executive summary:
The aim of this study was to evaluate the potential of the test item Tall Oil Pitch, reaction product with triethylene glycol to induce serious eye damage. The study was performed according to OECD 437 Guideline (Bovine Corneal Opacity and Permeability (BCOP) test method) and under GLP conditions.
The undiluted test item was applied for 10 minutes followed by an incubation period of 120 minutes. Negative and positive control items were tested concurrently. The two endpoints, decreased light transmission through the cornea (opacity) and increased passage of sodium fluorescein dye through the cornea (permeability) were combined in an empirically
derived formula to generate anIn Vitro Irritancy Score (IVIS).
The positive controlIn VitroIrritancy Score was within the range of 31.6 to 58.7. The positive control acceptance criterion was therefore satisfied.
The negative control gave opacity of =3.0 and permeability =0.077. The negative control
acceptance criteria were therefore satisfied.
The In Vitro Irritancy Score of the test item was 1.0.
In conclusion, according to the criteria for classification (No category), the test item Tall Oil Pitch, reaction product with triethylene glycol (CAS: 2135769-54-7) does not require classification to UN GHS or EU CLP.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Justification for classification or non-classification
EU CLP Not classified for Irritation and corrosion to skin
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.