Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: - | 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 vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Between 27 December 2006 and 26 February 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- not specified
Test material
- Details on test material:
- - Name of test material (as cited in study report): ELDEW APS-307
- Chemical name: Phytosteryl/Decyltetradecyl Myristoyl Methyl Beta-Alaninate
- Substance type: Organic UVCB
- Physical state: Wax
- Analytical purity: 100 %
- Lot/batch No.: 609074
- Stability under test conditions: Stable
- Storage condition of test material: At room temperature, light shielding
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source:
SUKA FLAT, 1846 Saiba, Sugito-cho, Kitakatsushika-gun, Saitama Prefecture
- Age at study initiation:
Not stated
- Weight at study initiation:
2.26 kg to 2.58 kg
- Housing:
Animals were housed individually in Metal bracket cages.
- Diet (e.g. ad libitum):
Solid feed for test animals (RC-4). Animals were on a restricted diet of 100 g of feed a day, which was fed using an
automatic feeder. Food supplied by Oriental Yeast Co., Ltd., 3-6-10 Azusawa, Itabashi-ku, Tokyo, Japan.
- Water (e.g. ad libitum):
Tap water with chlorine added. Animals had free access to water through an automatic water supplying system.Tap water supplied by Kawasaki Waterworks Bureau.
- Acclimation period:
Thirteen days
ENVIRONMENTAL CONDITIONS
- Temperature (°C):
20 to 26°C
- Humidity (%):
30 to 70%
- Air changes (per hr):
All-fresh ventilation of 10 to 15 cycles per hour
- Photoperiod (hrs dark / hrs light):
Twelve hours continuous light (07:00 to 19:00) and twelve hours darkness
Test system
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- The test article was double-boiled in its original form to make it soft and then used in the experiment.
- Controls:
- other: The left eye remained untreated and was used for control purposes.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL of the test article was ocularly instilled.
Application Method: Observations were conducted on both eyes of the rabbits before instillation to visually confirm that were no abnormalities. The animals were fixed in place using retention devices. The lower eyelid of the right eye was pulled away from the eyeball in a saclike state. 0.1 mL of the test article was ocularly instilled. After instillation, the upper and lower eyelids were gently held together for 2 to 3 seconds. The left eye was left untreated.
- Concentration (if solution):
Undiluted. The test article was double-boiled in its original form to make it soft and then used in the experiment.
VEHICLE
- Amount(s) applied (volume or weight with unit):
Not applicable
- Concentration (if solution):
Not applicable
- Lot/batch no. (if required):
Not applicable
- Purity:
Not reported - Duration of treatment / exposure:
72 hours- Observation period (in vivo):
Approximately 1 hour and 24, 48 and 72 hours following treatment- Number of animals or in vitro replicates:
- 3 animals were tested in total. (After consideration of the ocular responses produced in the first treated animal, two additional animals were treated. )
- Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done):
Not applicable
- Time after start of exposure:
Not applicable
SCORING SYSTEM:
Observation of eye irritation:
Observations were conducted 1, 24, 48, and 72 hours after ocular instillation, and eye irritation was assessed in accordance with Grading criteria for ocular reactions below:
Grading criteria for ocular reactions
A. Cornea
Opacity: Degree of Density (readings was taken from most dense area)
0: No ulceration or opacity
1: Scattered or diffuse area of opacity (other than slight dulling of normal lustre); details of iris clearly visible
2: Easily discernible translucent area; details of iris slightly obscured
3: Nacrous area; no details of iris visible; size of pupil barely discernible
4. Opaque cornea; iris not discernible through the opacity
B. Iris
0: Normal
1: Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia; or injection; iris reactive to light( a sluggish reaction is considered to be an effect)
2: Hemorrhage, gross destruction, and/or no reaction to light (any or all of these conditions)
C. Conjunctivae
a. Redness (refers to palpebral and bulbar conjunctivae; excluding cornea and iris)
0: Normal
1: Some blood vessels hyperemic (injected)
2: Diffuse, crimson colour; individual vessels not easily discernible
3: Diffuse beefy red
b. Chemosis Swelling (refers to lids and/or nictating membranes)
0: Normal
1: Some swelling above normal
2: Obvious swelling, with partial eversion of lids
3: Swelling with lids about half closed
4: Swelling with lids more than half closed
As a reaction other than those described in Grading criteria for ocular reactions, secreta was also observed. Scoring was conducted based on the following grading criteria.
Secreta
0: No secreta observed
1: Somewhat large amount of secreta (more than the normal amount)
2: Large amount of secreta (secreta is evident, making the lids and nearby hairs moist)
3: Extremely large amount of secreta (secreta is evident, making the lids and much of the surrounding hairs moist)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 00101 Male
- Time point:
- other: Mean 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No effects observed
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 00102 Male
- Time point:
- other: Mean 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No effects observed
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 00103 Male
- Time point:
- other: Mean 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No effects observed
- Irritation parameter:
- iris score
- Basis:
- animal: 00101 Male
- Time point:
- other: Mean 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: No effects observed
- Irritation parameter:
- iris score
- Basis:
- animal: 00102 Male
- Time point:
- other: Mean 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: No effects observed
- Irritation parameter:
- iris score
- Basis:
- animal: 00103 Male
- Time point:
- other: Mean 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: No effects observed
- Irritation parameter:
- other: redness
- Basis:
- animal: 00101 Male
- Time point:
- other: Mean 24, 48 and 72 hours
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- other: redness
- Basis:
- animal: 00102 Male
- Time point:
- other: Mean 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- other: redness
- Basis:
- animal: 00103 Male
- Time point:
- other: Mean 24, 48 and 72 hours
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal: 00101 Male
- Time point:
- other: Mean 24, 48 and 72
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No effects observed
- Irritation parameter:
- chemosis score
- Basis:
- animal: 00102 Male
- Time point:
- other: Mean 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No effects observed
- Irritation parameter:
- chemosis score
- Basis:
- animal: 00103 Male
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No effects observed
- Irritation parameter:
- other: Secreta
- Basis:
- animal: 00101 Male
- Time point:
- other: Mean 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: No effects observed
- Irritation parameter:
- other: Secreta
- Basis:
- animal: 00102 Male
- Time point:
- other: Mean 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: No effects observed
- Irritation parameter:
- other: Secreta
- Basis:
- animal: 00103 Male
- Time point:
- other: Mean 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: No effects observed
- Irritant / corrosive response data:
- Ocular Reactions
The eye irritation reaction scores are shown in Table 1.
1 hour after ocular instillation of ELDEW APS-307, diffuse area of opacity was observed over approximately half to the entire area of the cornea, as well as hyperaemia of the conjunctivae, some swelling, and a large to extremely large amount of secreta. 24 hours after ocular instillation, only hyperaemia of the conjunctivae remained, and all symptoms had disappeared 72 hours after ocular instillation. - Other effects:
During the study period, there were no significant changes in body weight.
Any other information on results incl. tables
General observation of symptoms:
During the study period, there were no abnormalities in clinical signs observed.
Measurement of body weight:
.
During the study period, there were no significant changes in body weight.
Eye irritation:
1 hour after ocular instillation of ELDEW APS-307, diffuse area of opacity was observed over approximately half to the entire area of the cornea, as well as hyperaemia of the conjunctivae, some swelling, and a large to extremely large amount of secreta. 24 hours after ocular instillation, only hyperaemia of the conjunctivae remained, and all symptoms had disappeared 72 hours after ocular instillation.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- To investigate the eye irritation potential of ELDEW APS-307, a primary eye irritation study was implemented using rabbits and risk was assessed. Upon doing so, ELDEW APS-307 was categorized as “R-phrase is not required: Not irritating to eyes.”
- Executive summary:
In accordance with OECD 405 the registration substance is not considered to be an irritant to the eyes of rabbits.
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.
Although ECHA is providing a lot of online material in your language, part of this page is only in English. More about ECHA’s multilingual practice.
Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
the-echa-website-uses-cookies
find-out-more-on how-we-use-cookies