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EC number: 938-572-7 | 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 vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 03 February 2015 to 09 April 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-ethyl-2-(methoxymethyl)propane-1,3-diol
- EC Number:
- 231-621-7
- EC Name:
- 2-ethyl-2-(methoxymethyl)propane-1,3-diol
- Cas Number:
- 7658-03-9
- Molecular formula:
- C7H16O3
- IUPAC Name:
- 2-ethyl-2-(methoxymethyl)propane-1,3-diol
- Reference substance name:
- 2-ethylpropane-1,3-diol
- EC Number:
- 220-038-3
- EC Name:
- 2-ethylpropane-1,3-diol
- Cas Number:
- 2612-29-5
- Molecular formula:
- C5H12O2
- IUPAC Name:
- 2-ethylpropane-1,3-diol
- Test material form:
- liquid
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- chicken
- Strain:
- other: Ross 308
- Details on test animals or tissues and environmental conditions:
- Chicken heads were collected after slaughter in a commercial abattoir from chickens (approximately 7 weeks old) which are used for human consumption. Heads were collected by a slaughter house technician and heads transported to CiToxLAB Hungary Ltd. at ambient temperature at the earliest convenience.
After collection, the heads were inspected for appropriate quality and wrapped with tissue paper moistened with saline, then placed in a plastic box which was closed (4-5 heads per box). The heads were received at CiToxLAB Hungary Ltd. and processed within approximately 2 hours of collection.
After removing the head from the plastic box, it was put on soft paper. The eyelids were carefully cut away with scissors, avoiding damaging the cornea. One small drop of fluorescein solution 2 % (w/v) was applied onto the cornea surface for a few seconds and subsequently rinsed off with 20 mL physiological saline. Then the fluorescein-treated cornea was examined with a hand-held slit lamp, with the eye in the head, to ensure that the cornea was not damaged. If the cornea was in good condition, the eyeball was carefully removed from the orbit.
The eye ball was carefully removed from the orbit by holding the nictitating membrane with a surgical forceps, while cutting the eye muscles with bent scissors. Care was taken to remove the eyeball from the orbit without cutting off the optical nerve too short. The procedure avoided pressure on the eye while removing the eyeball from the orbit, in order to prevent distortion of the cornea and subsequent corneal opacity. Once removed from the orbit, the eye was placed onto damp paper and the nictitating membrane was cut away with other connective tissue. The prepared eyes were kept on the wet papers in a closed box so that the appropriate humidity was maintained.
The prepared eye was placed in a steel clamp with the cornea positioned vertically with the eye in the correct relative position (same position as in the chicken head). Again avoid too much pressure on the eye by the clamp. Because of the relatively firm sclera of the chicken eyeball, only slight pressure was needed to fix the eye properly. The clamp with the eyeball was transferred to a chamber of the superfusion apparatus. The clamp holding the eye was positioned in such a way that the entire cornea was supplied with isotonic saline dripping from a stainless steel tube, at a rate of approximately 3-4 drops/minute or 0.1 to 0.15 mL/minute. The door of the chamber was closed except for manipulations and examinations, to maintain temperature and humidity.
The appropriate number of eyes was selected and after being placed in the superfusion apparatus, were examined again with the slit lamp microscope to ensure that they were in good condition. The focus was adjusted to see clearly the isotonic saline which was flowing on the cornea surface. Eyes with a high baseline fluorescein staining (i.e., > 0.5) or corneal opacity score (i.e., > 0.5) were rejected. The cornea thickness was measured, any eye with cornea thickness deviating more than 10 % from the mean value for all eyes, or eyes that showed any other signs of damage, were rejected and replaced. If the selected eyes were appropriate for the test, acclimatization started and it was conducted for approximately 45 to 60 minutes. The chambers of the superfusion apparatus were at controlled temperature (32±1.5°C) during the acclimatization and treatment periods.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 30 µL/eye
- Duration of treatment / exposure:
- 10 seconds and then rinsed with physiological saline
- Duration of post- treatment incubation (in vitro):
- 30, 75, 120, 180 and 240 minutes after post-treatment rinse.
- Number of animals or in vitro replicates:
- 3 eyes for test material and positive control
1 eye for negative control - Details on study design:
- At the end of the acclimatization period, a zero reference measurement was recorded for cornea thickness and opacity to serve as a base line (t=0) for each individual eye. The cornea thickness of the eyes should not change by more than 5% within approximately 45 minutes before the start of application. Slight changes in thickness (-1.6% to 0.0%) were observed in the eyes, this is considered normal when maintaining enucleated eyes. Following the equilibration period, the fluorescein retention was measured. Base line values were required to evaluate any potential test item related effect after treatment. All eyes were considered to be suitable for the assay.
After the zero reference measurements, the eye in its retainer was taken out of the chamber and placed on a layer of tissue with the cornea facing upwards. The eye was held in horizontal position, while the test item was applied onto the centre of the cornea. The test item was applied in a volume of 30 μL onto the entire surface of the cornea attempting to cover the cornea surface uniformly with the test substance, taking care not to damage or touch the cornea.
The positive control eyes were treated in a similar way with 30 μL benzalkonium chloride solution 5 % (w/v). The negative control eye was treated with 30 μL of physiological saline (Salsol solution 0.9 %). One eye was treated with physiological saline, three eyes with the test item and another three with benzalkonium chloride solution 5 % (w/v).
The time of application was observed, then after an exposure period of 10 seconds from the end of the application, the cornea surface was rinsed thoroughly with 20 mL physiological saline at ambient temperature, taking care not to damage the cornea but attempting to remove all residual test item. The eye was returned to the chamber after rinsing. The time while the eye was out of the chamber was limited to the minimum.
The control eyes and test eyes were evaluated pre-treatment and at approximately 30, 75, 120, 180 and 240 minutes after the post-treatment rinse. Minor variations within approximately ±5 minutes were considered acceptable. Corneal thickness and corneal opacity were measured at all time points. Fluorescein retention was measured on two occasions, at base line (t=0) and approximately 30 minutes after the post-treatment rinse. Haag-Streit Bern 900 slit-lamp microscope was used for the measurements.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- percent corneal swelling
- Remarks:
- at up to 75 minutes
- Value:
- 0.5
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: Class I
- Irritation parameter:
- percent corneal swelling
- Remarks:
- at up to 240 minutes
- Value:
- 0.5
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: Class I
- Irritation parameter:
- cornea opacity score
- Value:
- 0.67
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: Class II
- Irritation parameter:
- fluorescein retention score
- Value:
- 2.17
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: Class III
Any other information on results incl. tables
Treatment |
Replicate |
Corneal thickness (instrumental units)/Corneal swelling (%) |
Corneal opacity score |
Fluorescein retention |
|||||||||||||
Observation time (min) |
Observation time (min) |
Maximum change in opacity |
Observation time (min) |
Change in fluorescein retention |
|||||||||||||
0 |
30 |
75 |
120 |
180 |
240 |
0 |
30 |
75 |
120 |
180 |
240 |
0 |
30 |
||||
Physiological saline |
A |
60 |
60/0.0 |
60/0.0 |
60/0.0 |
60/0.0 |
60/0.0 |
0 |
0.5 |
0.5 |
0.5 |
0.5 |
0.5 |
0.5 |
0.5 |
0.5 |
0.0 |
DMP tech |
A |
64 |
64/0.0 |
64/0.0 |
64/0.0 |
64/0.0 |
63/‑1.6 |
0 |
0.5 |
0.5 |
1.0 |
1.0 |
1.0 |
1.0 |
0 |
2 |
2.0 |
B |
61 |
62/1.6 |
62/1.6 |
62/1.6 |
62/1.6 |
62/1.6 |
0 |
0.5 |
0.5 |
0.5 |
0.5 |
0.5 |
0.5 |
0 |
2 |
2.0 |
|
C |
61 |
61/0.0 |
61/0.0 |
60/‑1.6 |
60/1.6 |
60/‑1.6 |
0 |
0.5 |
0 |
0.5 |
0.5 |
0.5 |
0.5 |
0.5 |
3 |
2.5 |
|
Mean |
|
-/0.5 |
-/0.5 |
-/0.0 |
-/0.0 |
-/0.5 |
|
0.67 |
|
2.17 |
|||||||
Benzalkonium chloride |
A |
64 |
67/4.7 |
69/7.8 |
72/12.5 |
76/18.8 |
78/21.9 |
0 |
4 |
4 |
4 |
4 |
4 |
4.0 |
0 |
3 |
3.0 |
B |
64 |
67/4.7 |
70/9.4 |
72/12.5 |
77/20.3 |
79/23.4 |
0 |
4 |
4 |
4 |
4 |
4 |
4.0 |
0.5 |
3 |
2.5 |
|
C |
62 |
64/3.2 |
66/6.5 |
68/9.7 |
72/16.1 |
76/22.6 |
0 |
3 |
4 |
4 |
4 |
4 |
4.0 |
0 |
3 |
3.0 |
|
Mean |
|
-/4.2 |
-7.9 |
-/11.6 |
-/18.4 |
-/22.6 |
|
4.0 |
|
2.83 |
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- The test material treated eyes showed no corneal swelling, a mean maximum change in opactiy score of 0.67 and a mean change in fluorescein of 2.17. The test item could not be classified as either a severe irritant or as a non-irritant on the basis of these data.
- Executive summary:
An ex vivo eye irritation study has been conducted in isolated chicken's eyes with the submission substance in accordance with OCED guideline 438. Zero reference values were taken for corneal thickness, corneal opacity and fluorescein retention for each eye before 10 µL of test material, physiological saline (negative control) or benzalkonium chloride (positive control) was added. The test material and positive control were tested in triplicate. The negative control was tested in a single eye. After a 10 second exposure, the eyes were rinsed with saline. Corneal swelling, corneal opacity change and fluorescein retention change was noted for all eyes. The test material treated eyes showed no corneal swelling, a mean maximum change in opactiy score of 0.67 and a mean change in fluorescein of 2.17. The test item could not be classified as either a severe irritant or as a non-irritant.
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