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EC number: 246-788-1 | CAS number: 25279-09-8
- 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:
- 02 January 2018 - 20 January 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- 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
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2,6-dimethyloct-7-en-2-yl formate
- EC Number:
- 246-788-1
- EC Name:
- 2,6-dimethyloct-7-en-2-yl formate
- Cas Number:
- 25279-09-8
- Molecular formula:
- C11H20O2
- IUPAC Name:
- 2,6-dimethyloct-7-en-2-ol
- Test material form:
- liquid
Constituent 1
Test animals / tissue source
- Species:
- other: Cow
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: Deonar Abattoir slaughter house, Mumbai, Maharashtra
- Characteristics of donor animals (e.g. age, sex, weight): Between 1 to 5 years
- Storage, temperature and transport conditions of ocular tissue (e.g. transport time, transport media and temperature, and other conditions): Transported (in a sealed plastic container) under cold condition in Hanks’ Balanced Salt Solution containing antibiotics [e.g., penicillin at 100 IU/mL and streptomycin at 100 μg/mL]
- Time interval prior to initiating testing: The eyes were used within 24 hours from slaughter
- indication of any existing defects or lesions in ocular tissue samples: Corneas from eyes free of visible defects were used.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750 µL
- Duration of treatment / exposure:
- 10 minutes
- Duration of post- treatment incubation (in vitro):
- 2 h
- Number of animals or in vitro replicates:
- 3 replicates
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
Eyes were examined prior to use. Corneas from eyes free of visible defects were used. Corneas that have opacity lesser than seven opacity units or equivalent for the opacitometer were used in the study.
QUALITY CHECK OF THE ISOLATED CORNEAS
NUMBER OF REPLICATES : 3
NEGATIVE CONTROL USED : Yes (nomral saline)
POSITIVE CONTROL USED : Yes (dimethylformamide)
APPLICATION DOSE AND EXPOSURE TIME : 750 µL of test item; corneas were exposed for approx. 10 min.
TREATMENT METHOD: Open chamber
A volume of 750 μL was introduced into the anterior chamber through the dosing holes on the top surface of the chamber. The anterior compartment was then plugged. Post application of the test item the holders were turned to a horizontal position and slightly rotated to ensure uniform covering of the test item over the cornea.
POST-INCUBATION PERIOD: yes (2 h)
Once the medium was free of test item, the corneas were given a final rinse with EMEM (without phenol red). Media in the anterior and the posterior chamber was removed and fresh EMEM (without phenol red) was filled. The compartments were plugged and post treatment opacity of each cornea was recorded. Once the medium was free of test item, the corneas were given a final rinse with EMEM (without phenol red). Anterior chamber was then refilled with fresh EMEM without phenol red. After rinsing, the corneas were incubated for an additional period of approximately 2 hours ± 10 minutes at 32 ± 1ºC. At the end of post-exposure incubation period the media in the anterior and the posterior chamber were removed and fresh EMEM (without phenol red) was filled. The compartments were plugged and post treatment opacity of each cornea recorded.
After opacity measurement, the medium was removed from the anterior chamber and was filled with 1 mL of 4 mg/mL fluorescein solution whilst the posterior chamber was filled with fresh EMEM (without phenol red). The holders were then incubated in a horizontal position for approximately 90 ± 5 min at 32 ± 1 ºC. After the incubation the medium in the posterior chamber was transferred into labelled tubes. An aliquot of the medium from the posterior chamber was transferred to a 96-well plate. The plate reader was set to read at OD490. A reading of EMEM (without phenol red) was also recorded which served as blank.
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: Once, until no visual evidence of test item.
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: Opacitometer
- Corneal permeability: passage of sodium fluorescein dye (OD490)
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA:
≤ 3 No Category
> 3; ≤ 55 No prediction can be made
> 55 Category 1
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 1
- Value:
- 0.34
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 2
- Value:
- 1.31
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 3
- Value:
- 0.96
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- The mean IVIS score for the corneas treated with test item was found to be 0.87.
OTHER EFFECTS:
- Visible damage on test system: No.
DEMONSTRATION OF TECHNICAL PROFICIENCY: JRF Study nº 530-01-01-10123 (2015)
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes (mean IVIS = -0.49)
- Acceptance criteria met for positive control: Yes (mean IVIS = 160.97)
- Range of historical values if different from the ones specified in the test guideline:
Dimethylformide (positive control): Mean ± SD = 120.37 ± 30.51 (min 58.94, max 165.18)
Any other information on results incl. tables
Corneal Opacity
The mean final opacity values for dihydromyrcenyl formate treated eyes (0.68) did not show any observable increase in comparison to the control group (-0.78). An observable marked increase in final mean opacity was observed in the corneas treated with N,N-dimethylformamide (124.96).
Corneal Permeability
The mean final corneal permeability values for dihydromyrcenyl formate treated eyes (0.012) did not show any observable increase in comparison to the control group (0.019). An observable marked increase in mean final corneal permeability was observed in the corneas treated with N,N- dimethylformamide (2.400).
In vitro Irritancy Score (IVIS)
The mean In-Vitro Irritancy Score (IVIS) of normal saline (control) and N,N-dimethylformamide (positive control) treated corneas were found to be -0.49 and 160.97 which confirmed the reliability of the test procedure.
The mean IVIS score for the corneas treated with dihydromyrcenyl formate was found to be 0.87.
Dihydromyrcenyl Formate (0.75 mL) |
|||||||||||
Cornea holder N° |
Io (LUX) |
I (Initial) (LUX) |
Initial Opacity Value |
I (Post Treatment) (LUX) |
Post Treatment Opacity Value |
Corr. Opacity Value |
Final Opacity Value |
OD490 Value |
Corr. OD490Value |
Final OD490 Value |
IVIS |
20 |
1083 |
1019 |
2.92 |
1029 |
2.51 |
-0.41 |
0.37 |
0.065 |
0.017 |
-0.002 |
0.34 |
21 |
1103 |
1011 |
4.05 |
1011 |
4.05 |
0.00 |
0.78 |
0.102 |
0.054 |
0.035 |
1.31 |
22 |
1112 |
1061 |
2.34 |
1058 |
2.46 |
0.12 |
0.90 |
0.071 |
0.023 |
0.004 |
0.96 |
Mean |
0.68 |
- |
0.031 |
0.012 |
0.87 |
||||||
SD |
0.28 |
- |
0.020 |
0.020 |
0.49 |
Normal Saline (0.75 mL) |
|||||||||
Cornea Holder N° |
Io (LUX) |
I (Initial) (LUX) |
Initial Opacity Value |
I (Post Treatment) (LUX) |
Post Treatment Opacity Value |
Corr. Opacity Value |
OD490 Value |
Corr. OD490 Value |
IVIS |
13 |
1112 |
1054 |
2.61 |
1053 |
2.65 |
0.04 |
0.060 |
0.012 |
0.22 |
14 |
1067 |
961 |
4.82 |
1021 |
2.22 |
-2.60 |
0.091 |
0.043 |
-1.96 |
15 |
1052 |
990 |
2.92 |
985 |
3.13 |
0.21 |
0.051 |
0.003 |
0.26 |
Mean |
-0.78 |
- |
0.019 |
-0.49 |
|||||
SD |
1.58 |
- |
0.021 |
1.27 |
N,N-Dimethylformamide (0.75 mL) |
|||||||||||
Cornea holder N° |
Io (LUX) |
I (Initial) (LUX) |
Initial Opacity Value |
I (Post Treatment) (LUX) |
Post Treatment Opacity Value |
Corr. Opacity Value |
Final Opacity Value |
OD490 Value |
Corr. OD490 Value |
Final OD490 Value |
IVIS |
17 |
1088 |
1016 |
3.25 |
233 |
146.62 |
143.37 |
144.15 |
1.908 |
1.860 |
1.841 |
171.77 |
18 |
1094 |
969 |
5.56 |
287 |
112.45 |
106.89 |
107.67 |
3.385 |
3.337 |
3.318 |
157.44 |
19 |
1103 |
1024 |
3.50 |
266 |
125.79 |
122.29 |
123.07 |
2.108 |
2.060 |
2.041 |
153.69 |
Mean |
124.96 |
- |
2.419 |
2.400 |
160.97 |
||||||
SD |
18.31 |
- |
0.801 |
0.801 |
9.54 |
Keys: IVIS = In Vitro Irritation Score, Io =Baseline Reading (With medium but without cornea), I = LUX Reading with Medium and Cornea, OD490= Optical Density at 490 Wave Length, - = Not Applicable, Corr. = Corrected. Blank OD490value = 0.048.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item was determined to be not irritating to the eye.
- Executive summary:
An in-vitro eye irritation bovine corneal opacity and permeability test was performed according to OECD Guideline 437 (GLP study). Three sets, each consisting of three corneas were tested. The first set served as control and was treated with 750 μL normal saline. The second set served as positive control and was treated with 750 μL dimethylformamide with the third set treated with 750 μL test item. Post application the corneas were incubated for approximately 10 minutes after which the test item was washed-off the cornea and the corneas kept in incubation for approximately 2 h at 32 ± 1 ºC. At the end of the incubation period opacity readings were taken. Post opacity permeability reading was measured by applying 1 mL of fluorescein sodium solution (4 mg/mL) on to the anterior surface of the cornea and was incubated for approximately 90 min at 32 ºC. At the end of the incubation period the Optical Density (OD) was measured at 490 nm for the fluid collected from the posterior chamber. The mean In-Vitro Irritancy Score (IVIS) of normal saline (control) and dimethylformamide (positive control) treated corneas were found to be -0.49 and 160.97 which confirmed the reliability of the test procedure. The IVIS score for the corneas treated with test item was found to be 0.87 (No category according to OECD 437). Thus, the test item was determined to be not irritating to the eye.
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