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EC number: 260-257-1 | CAS number: 56554-53-1
- 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
Endpoint summary
Administrative data
Description of key information
Skin irritation: not irritating
Eye irritation: not irritating (based on in vitro data from the target
substance and read-across from propane-1,2,3-triyl trisheptanoate [CAS
620-67-7])
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28 Aug - 03 Sep 2012
- 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:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The Department of Health of the Government of the United Kingdom, UK
- Species:
- human
- Strain:
- other: EPISKIN™ reconstructed human epidermis model
- Details on test animals or test system and environmental conditions:
- TEST SKIN MODEL
- Source: SkinEthic Laboratories, Nice, France
- Description: The EPISKIN™ model is a three-dimensional reconstructed human epidermis model consisting of adult human-derived epidermal keratinocytes seeded on a dermal substitute consisting of a collagen type I matrix coated with type IV collagen. A highly differentiated and stratified epidermis model is obtained after a 13-day culture period comprising of the main basal, supra basal, spinous and granular layers and a functional stratum corneum.
ADAPTATION TO CELL CULTURE CONDITIONS
2 mL of maintenance medium, warmed to appr. 37 °C was pipetted into the first column of 3 wells of a pre-labelled 12-well plate. Each epidermis unit was transferred into the maintenance medium filled wells (3 units per plate). A different 12-well plate was used for the test item and each control item. The tissues were incubated at 37 °C, 5% CO2 in air overnight.
INCUBATION CONDITIONS (Incubator)
- Temperature (°C): 37
- CO2 gas concentration (%): 5 - Type of coverage:
- other: open in vitro system
- Preparation of test site:
- other: intact reconstructed human epidermis
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: concurrent control tissues treated with Dulbecco’s Phosphate Buffered Saline (DPBS) with Ca2+ and Mg2+ served as negative controls, positive controls were exposed to 5% SDS
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 10 µL
NEGATIVE CONTROL
- Negative control: Dulbecco’s Phosphate Buffered Saline (DPBS) with Ca2+
and Mg2+
- Amount(s) applied: 10 µL
POSITIVE CONTROL
- Positive control substance: Sodium Dodecyl Sulphate (SDS), 5% w/v - Duration of treatment / exposure:
- 15 min
- Observation period:
- Not applicable. Post-treatment incubation period: 42 h
- Number of animals:
- Not applicable. The test was performed in triplicates for each treatment and control group.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: 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 Ca2+ and Mg2+. 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.
- Time after start of exposure: 15 min
CELL VIABILITY MEASUREMENTS
- Method: colourimetric MTT reduction assay
- Principles of method: Cell viability is measured by enzymatic reduction of the yellow tetrazolium salt (3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyl-tetrazolium bromide) to a blue formazan dye by mitochondrial succinate dehydrogenase in viable cells. The formazan product is extracted from the tissue with acidified isopropanol and the optical density of the extracts is measured at 540 nm using acidified isopropanol as blank.
- Time after exposure: 42 h (MTT loading/Formazan extractin) and on Day 6 (Absorbance/Optical density measurements)
INTERPRETATION OF RESULTS
For the test item, the relative mean tissue viabilities obtained after the 15 min exposure period followed by the 42 h post-exposure incubation period were compared to the mean of the negative control tissues (n = 3). The relative mean viabilities were calculated as follows:
Relative mean viability (%) = (mean OD540 of test item / mean OD540 of negative control) x 100
Classification of irritation potential was based upon relative mean tissue viability following the 15 min exposure period followed by the 42 h post-exposure incubation period according to the following criteria:
Relative mean tissue viability ≤ 50%: Irritant (I) R38
Relative mean tissue viability ≥ 50%: Non-irritant (NI)
The results were evaluated according to EU Commission Directive 2001/59/EC.
QUALITY CRITERIA
The results of the assay were 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 was ≤ 40% relative to the negative control treated tissues, and the standard deviation value of the percentage viability is ≤ 18%.
- Negative control: The assay establishes the acceptance criterion for an acceptable test if the mean OD540 for the negative control treated tissues was ≥ 0.6, and the standard deviation 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 tisues is ≤ 18%. - Irritation / corrosion parameter:
- % tissue viability
- Value:
- 101.6
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
Reference
QUALITY CRITERIA
The relative mean tissue viability for the positive control treated tissues was 12.2% relative to the negative control treated tissues and the standard deviation value of the percentage viability was 2.6%. The positive control acceptance criterion was therefore satisfied.
The mean OD540 for the negative control treated tissues was 0.784 and the standard deviation value of the percentage viability was 6.7%. The negative control acceptance criterion was therefore satisfied.
The standard deviation calculated from individual percentage tissue viabilities of the three identically treated tissues was 7.9%. The test item acceptance criterion was therefore satisfied.
The individual and mean OD540 values, standard deviations and tissue viabilities for the test item, negative control item and positive control item are given in Table 1. The mean viability values and standard deviations of the test item and positive control, relative to the negative control are also given in Table 1.
The relative mean viability of the test item treated tissues was 101.6% after a 15-minute exposure period.
The MTT solution containing the test item did not turn blue which indicated that the test item did not directly reduce MTT.
Table 1. Mean OD540 values and percentage viabilities for the negative control item, positive control item and test item
Item |
OD540 of tissues |
Mean OD540 of triplicate tissues |
± SD of OD540 |
Relative individual tissue viability (%) |
Relative mean viability (%) |
± SD of relative mean viability |
Negative control |
0.754 |
0.784 |
0.053 |
96.2 |
100* |
6.7 |
0.845 |
107.8 |
|||||
0.754 |
96.2 |
|||||
Positive control |
0.115 |
0.096 |
0.020 |
14.7 |
12.2 |
2.6 |
0.097 |
12.4 |
|||||
0.075 |
9.6 |
|||||
Test item |
0.801 |
0.796 |
0.062 |
102.2 |
101.6 |
7.9 |
0.856 |
109.2 |
|||||
0.732 |
93.4 |
SD: standard deviation
*: The mean viability of the negative control tissue is set at 100%
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:
- weight of evidence
- Study period:
- Oct 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Principles of method if other than guideline:
- In vitro eye irritation test using the SkinEthic reconstructed Human Corneal Epithelium (HCE) model
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The Department of Health of the Government of the United Kingdom, UK
- Species:
- human
- Strain:
- other: not applicable
- Details on test animals or tissues and environmental conditions:
- TEST TISSUE
- Test model: SkinEthic reconstructed Human Corneal Epithetial model (SkinEthic HCE)
- Source: HCE, SkinEthic Laboratories, Nice, France
- Description: Transformed human corneal epithelial cells of the cell line HCE (LSU EYE Center, New Orleans, USA) that form a corneal epithelial tissue (mucosa), devoid of stratum corneum, resembling, histologically, the mucosa of the human eye. The test item is applied directly to the culture surface, at the air interface, so that undiluted and/or end use dilutions can be tested directly. The model consists of an airlifted, living, corneal tissue construct, produced in polycarbonate inserts in serum-free and chemically defined medium.
- Age of tissue at study initiation: 6 days
- Tissue storage/maintenance: Upon arrival, tissues were stored at room temperature prior to transferring into 24-well plates designated “arrival plates” containing 300 µl of maintenance medium. It was ensured that there were no air bubbles present under the tissue inserts.
INCUBATION CONDITIONS
- Temperature (°C): 37
- CO2 (%): 5
PREPARATION OF TISSUE
Prior to treatment, 7-day old tissues were transferred from the “arrival plates” to 6-well plates designated “treatment plates” (for test item, negative and positive controls) containing 1 mL maintenance medium at room temperature. - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: yes, negative control solution (Solution A)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied in the test: 30 µL
NEGATIVE CONTROL
- Identity: Solution A (0.142 g/L Na2HPO4; 1.802 g/L Glucose; 7.149 g/L HEPES; 0.224 g/L KCl; 7.597 g/L NaCl)
- Concentration: as such
- Amount(s) applied in the test: 30 µL
POSITIVE CONTROL SUBSTANCE
- Identity: Sodium Dodecyl Sulphate (SDS)
- Concentration: 2% (w/v)
- Amount(s) applied in the test: 30 µL - Duration of treatment / exposure:
- 10 min at 37°C
- Observation period (in vivo):
- not applicable
- Number of animals or in vitro replicates:
- 3 tissues
- Details on study design:
- PRE-TEST
ASSESSMENT OF DIRECT TEST ITEM REDUCTION OF MTT
The MTT Assay, a colourimetric method of determining cell viability, is based on reduction of the yellow tetrazolium salt (3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyl-tetrazolium bromide) to a blue formazan dye by mitochondrial succinate dehydrogenase in viable cells.
The possible interference of the test item with the MTT assay by its potential ability to directly reduce MTT was tested prior to the main test. 30 µL of the test item was added to 1 mL of a 0.5 mg/mL MTT solution and incubated at 37 °C, 5% CO2 in air for 3 h. Untreated MTT solution was used as a control. If the MTT solution turned blue, the test item was presumed to have reduced MTT.
MAIN TEST
POST-EXPOSURE TREATMENT
- Removal of the test item: At the end of the exposure period, tissue inserts were removed from the wells and rinsed with Dulbecco’s Phosphate Buffered Saline without Ca++ and Mg++.
- Post-exposure incubation conditions: Tissues were placed into 24-well plates designated “holding plates” containing 300 µL of maintenance medium (at room temperature) until all tissues had been rinsed.
MTT ASSAY
- Loading: Following rinsing, tissues were transferred to 24-well plates (“MTT Loading plates”), each well containing 300 µL of a 0.5 mg/mL MTT solution freshly prepared in maintenance medium.
- Incubation conditions: 3 h at 37 °C, 5% CO2 in air
- Extraction: At the end of the incubation period, tissues were rinsed twice with phosphate buffered saline, blotted on absorbent paper to remove residual MTT and transferred to 24-well plates (“MTT extraction plates”) containing 750 µL isopropanol per well. Further 750 µL isopropanol were added to each well and plates were sealed to prevent evaporation.
- Extraction conditions: formazan crystals were extracted from the tissues overnight at room temperature protected from light.
- Optical density measurement: At the end of the extraction period, triplicate 200 µL aliquots of the extraction solutions were transferred to a 96-well plate. The optical density was measured at 540 nm (OD540) using the Anthos 2001 microplate reader for determination of tissue viability. Isopropanol served as blank.
TISSUE HISTOLOGY
One tissue per treatment group (test item, negative and positive controls) was retained for possible tissue histopathology.
The tissues were carefully cut out of the polycarbonate inserts with a sharp scalpel. The tissues were carefully cut in half. Both halves were placed into a 1.5 mL Eppendorf tube containing 1 mL of 10% formalin and stored at room temperature.
INTERPRETATION OF RESULTS
- Tissue viability: The mean OD540 values of the duplicate tissues were calculated. Each of these values had already been corrected for blanks by the microplate reader. The relative mean tissue viability (percentage of the negative control) was calculated as follows:
Relative mean tissue viability (%) = [(mean OD540 of test item)/(mean OD540 of negative control)] x 100
SCORING SYSTEM
The mean tissue viability for the test item was compared to the negative control and classified according to the following criteria:
Irritant (I): If the relative mean tissue viability (percentage of negative control) was < 60.
Non-Irritant (NI): If the relative mean tissue viability (percentage of negative control) was ≥ 60.
ASSAY ACCEPTANCE CRITERION
The results of the assay were considered acceptable if the following assay acceptance criterion was achieved:
- Assay acceptance criterion: Positive control
The assay meets the acceptance criterion for an acceptable test if the relative mean tissue viability for the positive control treated tissues is < 60% relative to the negative control treated tissues. - Irritation parameter:
- other: Relative Mean Viability (%)
- Value:
- 92.6
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- Refer to analogue justification provided in IUCLID section 13
- Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- other: Source: CAS 620-67-7, Hüls, 1993
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- other: Source: CAS 620-67-7, Hüls, 1993
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- other: Source: CAS 620-67-7, Hüls, 1993
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- other: Source: CAS 620-67-7, Hüls, 1993
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
- Executive summary:
The eye irritation potential of the target substance is determined based on an in vitro study with the target substance and on an adequate and reliable in vivo study of the structural analogue source substance propane-1,2,3-triyl trisheptanoate. In both studies (in vitro and in vivo) no eye irritation potential was detected. As explained in the analogue justification, the differences in molecular structure between the target and the source substances are unlikely to lead to differences in the eye irritation potential. Therefore, no significant eye irritation potential is identified for the target substance.
Referenceopen allclose all
The individual and mean OD540 values and mean viabilities for each treatment group are given in Table 1.
The relative mean viability of the test item treated tissues after a 10 min exposure period was 92.6%
It was considered unnecessary to proceed with tissue histopathology.
The MTT solution containing the test item remained yellow which indicated that the test item did not directly reduce MTT.
Table 1. Assessment of eye irritation potential – Viability of HCE tissues
Item |
OD540 of individual tissue |
Mean OD540 |
Relative Mean Viability (%) |
Negative control |
0.812 |
0.838 |
100* |
0.863 |
|||
Positive control |
0.152 |
0.111 |
13.2 |
0.069 |
|||
Test item |
0.779 |
0.776 |
92.6 |
0,773 |
* The mean viability of the negative control tissues was set at 100%
Assay Acceptance Criterion
The relative mean viability of the positive control treated tissues after a 10 min exposure period was 13.2%. Thus, the quality criterion required for the acceptance of results in the test was satisfied.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
In a GLP-compliant study according to OECD guideline 439, the skin irritation potential of propane-1,2,3-triyl 3,5,5-trimethylhexanoate was evaluated using the EPISKIN™ reconstructed human epidermis model after a treatment period of 15 min followed by a post-exposure incubation period of 42 h (Harlan, 2012a). The principle of the assay was based on the measurement of cytotoxicity in reconstructed human epidermal cultures following topical exposure to the test item (10 µL/tissue) by means of the colourimetric MTT reduction assay. Cell viability was measured by enzymatic reduction of the yellow MTT tetrazolium salt to a blue formazan salt (within the mitochondria of viable cells) in the test item treated tissues relative to the negative controls (treated with Dulbecco’s Phosphate Buffered Saline (DPBS) with Ca2+and Mg2+). Positive control tissues were treated with Sodium Dodecyl Sulphate (SDS), 5% w/v. After the 15 min exposure period, the relative mean tissue viability for the test item and positive control treated tissues compared to the control was 101.6% (± SD = 7.9%) and 12.2% (± SD = 2.6%), respectively. The quality criteria required for acceptance of results in the test were satisfied. Based on the study results, the test item was considered to be non-irritant in vitro.
Eye irritation / corrosion
Justification for grouping of substances and read-across
There are no data available on the in vivo eye irritation potential of propane-1,2,3-triyl 3,5,5-trimethylhexanoate (CAS 56554-53-1). In order to fulfil the standard information requirements set out in Annex VIII, Item 8.2, in accordance with Annex XI, Item 1.5, of Regulation (EC) No. 1907/2006, read-across from a structurally related substance is conducted. In accordance with Article 13(1) of Regulation (EC) No. 1907/2006, "information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met.” In particular for human toxicity, information shall be generated whenever possible by means other than vertebrate animal tests, which includes the use of information from structurally related substances (grouping or read-across).
Having regard to the general rules for grouping of substances and read-across approach laid down in Annex XI, Item 1.5, of Regulation (EC) No. 1907/2006, whereby physicochemical, toxicological and ecotoxicological properties may be predicted from data for reference substance(s) by interpolation to other substances on the basis of structural similarity, propane-1,2,3-triyl trisheptanoate (CAS 620-67-7) is selected as reference substance for assessment of the in vivo eye irritation potential of propane-1,2,3-triyl 3,5,5-trimethylhexanoate. The read-across is based on structural similarity between the source and target substances, which are triesters of glycerol and fatty acids with carbon chain lengths from C7-isoC9. A detailed analogue approach justification is provided in the technical dossier (see IUCLID Section 13).
Overview of eye irritation
CAS# |
56554-53-1 |
620-67-7 |
Chemical name |
Propane-1,2,3-triyl 3,5,5-trimethylhexanoate |
Propane-1,2,3-triyl trisheptanoate |
Molecular weight |
512.78 |
428.61 |
Eye irritation in vitro |
Experimental result |
-- |
Eye irritation in vivo |
RA: CAS 620-67-7 |
Experimental result: Not irritating |
--: Data lacking
Eye irritation in vitro
The eye irritation potential of propane-1,2,3-triyl 3,5,5-trimethylhexanoate was tested in vitro in a GLP-compliant study using the SkinEthic reconstructed Human Corneal Epithelium model (HCE) (Harlan, 2012b). The test is based on the hypothesis that irritant chemicals are able to penetrate the corneal epithelial tissue and are sufficiently toxic to cause cell death. Tissue viability after exposure is determined by means of the colourimetric MTT reduction assay and serves as parameter for the eye irritation potential. Triplicate SkinEthic tissues were treated with 30 µL of the test item, negative control (Solution A: 0.142 g/L Na2HPO4; 1.802 g/L Glucose; 7.149 g/L HEPES; 0.224 g/L KCl; 7.597 g/L NaCl) or positive control (2% w/v Sodium Dodecyl Sulphate) for 10 min. Cytotoxicity was determined by the reduction of MTT to formazan by viable cells in the test item treated tissues (quantitative measurement of tissue viability) relative to the negative control. For each treatment group, two tissues were used for viability measurement, while one tissue per group was retained for possible histopathology. The test item was considered to be an irritant if the relative mean tissue was < 60%; otherwise it was considered to be a non-irritant. The results of the assay were considered acceptable if the relative mean tissue viability of the positive control was < 60%. After a 10 min exposure, the relative mean viability of the test item and positive control treated tissues was 92.6%. It was considered unnecessary to proceed with tissue histopathology. The test item was considered to be a non-irritant. The relative mean tissue viability of the positive control treated tissue was 13.2%, thus satisfying the acceptance criterion.
Eye irritation in vivo
CAS No. 620-67-7
The eye irritation potential of propane-1,2,3-triyl trisheptanoate was investigated according to OECD guideline 405 and in compliance with GLP (Hüls, 1993). The undiluted test material (0.1 mL) was placed into the conjunctival sac of one eye of 3 male Small White Russian (Chbb:HM) rabbits each. The other eye remained untreated and served as control. The eyes were examined and scored 1, 24, 48 and 72 h after application. Within one hour, the administration of the test substance resulted in marked hyperaemia of some blood vessels in all 3 animals. After 24-72 h, no further symptoms of irritation to the eye mucosa and cornea were observed in any of the animals. Only the skin of the outer eyelids showed slight erythema after 24 h in all animals, which subsided after 48 h. Test substance instillation into the rabbit eye induced no iridial effects at any observation time point. No further local or systemic toxic effects were observed. The mean cornea, iris, conjunctivae and chemosis scores after 24, 48, and 72 h were 0 for all 3 animals, respectively. Thus, the test substance was not considered as eye irritant.
Justification for selection of eye irritation endpoint:
Hazard assessment is conducted based on the WoE from substance
specific in vitro data and read-across from a structural analogue
substances. The study is adequate and reliable based on the identified
similarities in structure and intrinsic properties between source and
target substances and overall quality assessment (refer to the endpoint
discussion for further details).
Justification for classification or non-classification
Based on substance specific studies and read-across following an analogue approach, the available data on the skin and eye irritation potential of propane-1,2,3-triyl 3,5,5-trimethylhexanoate do not meet the classification criteria according to Regulation (EC) No. 1272/2008 and are therefore conclusive but not sufficient for classification. There are no data available on respiratory irritation.
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.
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