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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 241-789-3 | CAS number: 17831-71-9
- 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:
- August 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- One old rabbit study report was available to evaluate the eye irritation/corrosion potential of tetraethyleneglycol diacrylate (TNO 1978). In this study, only one rabbit was exposed to the test substance and the observation period was of 7 days after exposure. The scores (mean 24-48-72hr) showed irritating effects. The cornea opacity score increased between 72h and 7th day after exposure (score 2 > 3) showing a corrosive effect. As the study was finished 7 days after exposure instead of 21 days as required by the test guideline OECD 405, it is not possible to conclude if the substance is eye irritating or eye corrosive. The other limitation of this study is the absence of information on substance purity.
An in vitro eye corrosion test was performed in order to determine the correct classification for human hazard assessment. The results of this OECD 437 (BCOP) test were negative with an IVIS score of 1.2%. With this result, no GHS classification is required.
The registrants are surprised of the non-classification for eye irritation and decided to perform a new in vivo study according to the OECD TG 405 in order to be sure that no classification of the substance is needed for eye irritation.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 2017
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Oxybis(2,1-ethanediyloxy-2,1-ethanediyl)diacrylate
- EC Number:
- 241-789-3
- EC Name:
- Oxybis(2,1-ethanediyloxy-2,1-ethanediyl)diacrylate
- Cas Number:
- 17831-71-9
- Molecular formula:
- C14H22O7
- IUPAC Name:
- 2-(2-{2-[2-(prop-2-enoyloxy)ethoxy]ethoxy}ethoxy)ethyl prop-2-enoate
- Test material form:
- liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River France, L’Arbresle, France
- Age at study initiation: approximately 16 weeks old
- Weight at study initiation: 3197 g
- Housing: individually in labeled cages with perforated floors
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 24°C
- Humidity (%): 70-98 %
- Air changes (per hr): Ten or greater air changes per hour with 100% fresh air (no air recirculation)
- Photoperiod (hrs dark / hrs light): A 12-hour light/12-hour dark cycle
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 ml
- Number of animals or in vitro replicates:
- 1 rabbit
- Details on study design:
- The animal was treated by instillation of 0.1 mL of the test item, in the conjunctival sac of one of the eyes after gently pulling the lower lid away from the eyeball. The lids were then
gently held together for about one second to prevent loss of the test item. The other eye remained untreated and served as the reference control.
Throughout the study, the animal was observed for general health/mortality and moribundity twice daily, in the morning and at the end of the working day. Animals were not removed
from the cage during observation, unless necessary for identification or confirmation of possible findings. The animal, showing pain, distress or discomfort, which was considered not
transient in nature or is likely to become more severe, was sacrificed for humane reasons based on OECD guidance document on the recognition, assessment, and use of clinical signs
as humane endpoints for experimental animals used in safety evaluation.
Observations for toxicity were performed once daily throughout the study.
The animal was weighed individually on Day 1 (pre-dose).
The eyes of the animal were examined approximately 1 after instillation of the test item. The irritation scores and a description of all other (local) effects were recorded.
The irritation was assessed according to the following numerical scoring system. At each observation, the highest scores given were recorded:
CORNEAL IRRITATION
Opacity: degree of density (area most dense taken for reading)
No ulceration or opacity (may include slight dulling of normal luster) .................................................................. .0
Scattered or diffuse areas of opacity, details of iris clearly visible ......................................................................... .1
Easily discernible translucent area, details of iris slightly obscured ....................................................................... .2
Nacreous area, no details of iris visible, size of pupil barely discernible ............................................................... .3
Opaque cornea, iris not discernible through the opacity ........................................................................................ .4
Area of cornea involved:
No ulceration or opacity ......................................................................................................................................... .0
One quarter or less but not zero ............................................................................................................................. .1
Greater than one quarter, but less than half ............................................................................................................ .2
Greater than half, but less than three quarters......................................................................................................... .3
Greater than three quarters, up to whole area ......................................................................................................... .4
IRIS
Normal ................................................................................................................................................................... .0
Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia, or injection, any of
these or combination thereof, iris still reacting to light (sluggish reaction is positive) .......................................... .1
No reaction to light, hemorrhage, gross destruction (any or all of these) ............................................................... .2
CONJUNCTIVAL IRRITATION
Redness (refers to palpebrae and sclera, excluding cornea and iris):
Blood vessels normal ............................................................................................................................................. .0
Some blood vessels definitely hyperaemic (injected) ............................................................................................. .1
Diffuse, crimson color, individual vessels not easily discernible ........................................................................... .2
Diffuse beefy red .................................................................................................................................................... .3
Chemosis (refers to lids and/or nictitating membranes):
No swelling ………………………………………… ........................................................................................... .0
Any swelling above normal (includes nictitating membranes) .............................................................................. .1
Obvious swelling with partial eversion of lids ....................................................................................................... .2
Swelling with lids about half closed ...................................................................................................................... .3
Swelling with lids more than half closed ................................................................................................................ .4
Discharge:
No discharge (may include small amounts observed in inner canthus of normal animals) ..................................... 0
Any amount different from normal and/or lacrimation ........................................................................................... 1
Discharge with moistening of the lids and hairs just adjacent to lids ...................................................................... 2
Discharge with moistening of the lids and hairs (considerable area around the eye) ............................................. 3
Where standard lighting was considered inadequate for observing minor effects, eye examinations were
performed using an ophthalmic examination lamp.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks on result:
- other:
- Remarks:
- observation time : 1h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other:
- Remarks:
- observation time : 1h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Irritant / corrosive response data:
- Instillation of a volume of 0.1 mL into one eye of the rabbit resulted in severe irritation of the conjunctivae, which consisted of redness, chemosis and discharge. Scoring of the cornea and iris was not possible due to the extreme swelling. The animal was sacrificed for humane reasons one hour after dosing. At necropsy, dissection of the eye did not reveal iridial
irritation or corneal epithelial damage.
Based on the severity of the effects, the two other animals assigned to the study were not dosed. - Other effects:
- No staining of (peri) ocular tissues by the test item was observed and no test item remnants were seen.
Head tilt was noted in the animal, which indicates severe pain.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Based on the initial rabbit dosed, SR268 should be classified as: having irreversible effects on the eyes (Category 1).
- Executive summary:
The objective of this acute eye irritation study was to assess the possible irritation or corrosion potential when a single dose of SR268 was placed in the conjunctival sac of the rabbit eye.
A single sample of 0.1 mL was instilled into one eye of the rabbit. Observations were made 1 hour after instillation.
Instillation of the test item resulted in severe irritation of the conjunctivae, which consisted of redness, chemosis and discharge. Scoring of the cornea and iris was not possible due to the extreme swelling. Furthermore, head tilt was noted in the animal indicating severe pain. The animal was sacrificed for humane reasons one hour after dosing. At necropsy, dissection of the eye did not reveal iridial irritation or corneal epithelial damage.
Based on the severity of the effects, the two other animals assigned to the study were not dosed.
Based on the initial rabbit dosed, SR268 should be classified as: having irreversible effects on the eyes (Category 1).
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.