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EC number: 907-489-8 | 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:
- From 21 September to 2 November 2017
- 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:
- Dimethyl adipate
- EC Number:
- 211-020-6
- EC Name:
- Dimethyl adipate
- Cas Number:
- 627-93-0
- Molecular formula:
- C8H14O4
- IUPAC Name:
- Dimethyl adipate
- Reference substance name:
- Dimethyl glutarate
- EC Number:
- 214-277-2
- EC Name:
- Dimethyl glutarate
- Cas Number:
- 1119-40-0
- Molecular formula:
- C7H12O4
- IUPAC Name:
- dimethyl glutarate
- Reference substance name:
- Dimethyl succinate
- EC Number:
- 203-419-9
- EC Name:
- Dimethyl succinate
- Cas Number:
- 106-65-0
- Molecular formula:
- C6H10O4
- IUPAC Name:
- dimethyl succinate
- Test material form:
- liquid
- Remarks:
- Colourless to brown liquid
Constituent 1
Constituent 2
Constituent 3
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- batch No.of test material:CY71353002
- Expiration date of the lot/batch: 01 June 2019
- Purity test date: 01 June 2017
- Analytical purity: 98.2%
- Commercial name of the registered substnace: Innroad Protect
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Refrigerated (2-8 °C)
- Stability under test conditions: Not assessed
- Solubility and stability of the test substance in the solvent/vehicle: Not applicable (The test item was applied as supplied, no formulation was required)
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: Not applicable (The test item was applied as supplied)
TREATMENT OF TEST MATERIAL PRIOR TO TESTING: None
Test animals / tissue source
- Species:
- other: Bovine cattle (Bos Taurus)
- Strain:
- other: Not appplicable
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: Bovine eyes were obtained from freshly slaughtered cattle at the abattoir EVA, Saint-Pierre-sur-Dives, France.
- Number of animals: not specified
- Characteristics of donor animals (e.g. age, sex, weight): bovine cattle were up to 12 months old (typically, 5 to 8 months old).
- Storage, temperature and transport conditions of ocular tissue (e.g. transport time, transport media and temperature, and other conditions): The eyes were transported to CiToxLAB France at ambient temperature, immerged in buffered Hanks medium containing an antibiotic [Hank’s Balanced Salts Solution (HBSS) plus penicillin/streptomycin (100 units/100 μg/mL final)]. A container with smooth internal surfaces was used for the transport to avoid damage to the corneas.
- Time interval prior to initiating testing: Upon arrival at CiToxLAB France, the selection and preparation of corneas was performed as soon as possible.
- indication of any existing defects or lesions in ocular tissue samples: careful macroscopic examination was performed on all eyes to detect the presence of any defects (opacity, scratches, pigmentation, etc). Any eyes with defects were discarded.
- Indication of any antibiotics used: As the corneas were not used immediately, they were stored after washing. Each cornea was stored individually in 12 mL of M199 medium containing 5% dextran, plus penicillin/streptomycin, at +4°C, for a maximum of 24 hours before use.
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 (± 8 μL)
- Concentration (if solution): Not applicable (the test item was tested undiluted).
VEHICLE: Not Applicable (As the test item was a non-surfactant liquid, it was tested undiluted (i.e. in its original form)). - Duration of treatment / exposure:
- 10 minutes (± 30 seconds)
- Duration of post- treatment incubation (in vitro):
- 2 hours (± 10 minutes) in a water bath at +32°C (± 1°C).
- Number of animals or in vitro replicates:
- The test item, the negative and positive control were tested on three corneas each.
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
Selection: a careful macroscopic examination was performed on all eyes to detect the presence of any defects (opacity, scratches, pigmentation, etc). Any eyes with defects were discarded. The examination was performed under a lamp, using HBSS in order to keep the eyes moistened and shiny. Particular attention was paid to the corneas and the eyes were swiveled in order to observe the fringe areas and any scratches directly under the light.
Preparation of the selected corneas: the tissues surrounding the eyeball were carefully pulled away and the cornea, surrounded by approximately 2 to 3 mm of sclera, was dissected out. The isolated corneas were stored in HBSS until all corneas had been prepared.
QUALITY CHECK OF THE ISOLATED CORNEAS
The corneas were carefully examined macroscopically before their assembly in the holders, in order to
detect the presence of any defects. Any corneas with defects were discarded.
NUMBER OF REPLICATES:The test item, the negative and positive control were tested on three corneas each.
NEGATIVE CONTROL USED: 0.9% Sodium Chloride
POSITIVE CONTROL USED: Absolute Ethanol
APPLICATION DOSE AND EXPOSURE TIME: 750 μL (± 8 μL) applied for 10 minutes (± 30 seconds)
TREATMENT METHOD: closed chamber
POST-INCUBATION PERIOD: yes. If YES please specify duration: 2 hours (± 10 minutes) in a water bath at +32°C (± 1°C).
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: On completion of the treatment period, the test item was removed from the front opening of the anterior chamber (open-chamber method) and the epithelium was rinsed as follows:
- the anterior chamber was emptied using a metal gavage tube attached to a vacuum pump,
- the corneas were rinsed four times with pre-warmed cMEM containing phenol red (i.e. until the test item had been completely removed from the chamber or until the phenol red was not discoloured).
Then, the corneas were finally rinsed with pre-warmed cMEM without phenol red.
- POST-EXPOSURE INCUBATION: no
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: An opacitometer was used to measure light transmission (i.e. the level of opacity) through the center of each mounted cornea. A numerical opacity measurement (arbitrary unit) was displayed and recorded.
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of UV/VIS spectrophotometry / OD490)
- Others (e.g, pertinent visual observations, histopathology): After permeability determination, the corneas were removed from the holders and observed for opaque
spots, other irregularities and any separation of the epithelium.
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA: please specify if the decision criteria as indicated in the TG was used.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Value:
- 32
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system:
No notable opaque spots or irregularities were observed on the negative control-treated corneas.
Opacity and fluorescein fixation were observed on the three corneas treated with the test item.
Opacity, fluorescein fixation and thickening of the corneas were observed on those treated with the positive control.
DEMONSTRATION OF TECHNICAL PROFICIENCY:
The individual and mean opacity and permeability values for the test item, positive control and negative control fulfilled all acceptance criteria.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes
Applicant's summary and conclusion
- Interpretation of results:
- other:
- Remarks:
- As the mean IVIS was > 3 and < 55, the eye hazard potential of the test item could not be predicted. The test item could not be identified as inducing serious eye damage (UN GHS Category 1) or as a test chemical not requiring classification for eye irritation or serious eye damage (UN GHS No Category).
- Conclusions:
- Under the experimental conditions of this study, the ocular corrosive or severe irritant potential of the test item, INNROAD PROTECT, could not be predicted. Theregistered substance Reaction mass of diethyl adipate and diethyl glutarate and diethyl succinate could not be identified as inducing serious eye damage (UN GHS Category 1) or as not requiring classification for eye irritation or serious eye damage (UN GHS No Category). According to the OECD Guideline 437, further testing should be conducted for classification and labeling purposes.
- Executive summary:
The objective of this study was to evaluate the potential irritant and corrosive properties of the test item, INNROAD PROTECT, to the eye. The Bovine Corneal Opacity and Permeability (BCOP) test method can identify chemicals inducing serious eye damage and chemicals not requiring classification for eye irritation or serious eye damage.
The design of this study was based on the OECD Guideline 437 and the study was performed in compliance with CiToxLAB France standard operating procedures and with the OECD Principles of Good Laboratory Practice.
Corneas obtained from freshly slaughtered calves were mounted in corneal holders. Both chambers of the corneal holder were filled with complemented MEM culture media (cMEM) and pre-incubated for 1 hour and 5 minutes (± 5 minutes) at +32°C.
A single experiment was performed using three corneas for each treated series (test item, positive control and negative control).
Before the treatment, a first opacity measurement was performed on each cornea using an opacitometer.
The test item, applied undiluted, and both negative and positive controls were applied in a single experiment, using a treatment time of 10 minutes and the closed-chamber treatment method. At the completion of the treatment period, all items were removed from the front opening of the anterior chamber and the epithelia were rinsed.
The corneas were then incubated for 2 hours (± 10 minutes) at +32°C before a second opacity measurement was performed.
After the second opacity measurement, the medium of the anterior chamber was removed and filled with a fluorescein solution. The holders were then incubated vertically for 90 minutes (± 5 minutes) at +32°C. At the end of the incubation period, the Optical Density of the solution from the posterior chamber of each holder was measured in order to determine the permeability of the cornea. Each cornea was then observed
for opaque spots and other irregularities.
Macroscopic examination:
Opacity and fluorescein fixation were observed on the three corneas treated with the test item.
In Vitro Irritancy Score:
All acceptance criteria were fulfilled. The study was therefore considered as valid. The mean In Vitro Irritancy Score (IVIS) of the test item-treated corneas was: 32.
As the mean IVIS was > 3 and < 55, the eye hazard potential of the test item could not be predicted. The test item could not be identified as inducing serious eye damage (UN GHS Category 1) or as a test chemical not requiring classification for eye irritation or serious eye damage (UN GHS No Category).
Under the experimental conditions of this study, the ocular corrosive or severe irritant potential of the test item, INNROAD PROTECT, could not be predicted.The registered substance Reaction mass of diethyl adipate and diethyl glutarate and diethyl succinate
could not be identified as inducing serious eye damage (UN GHS Category 1) or as not requiring classification for eye irritation or serious eye damage (UN GHS No Category). According to the OECD Guideline 437, further testing should be
conducted for classification and labeling purposes.
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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