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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 695-930-2 | CAS number: 13676-53-4
- 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:
- 2017-04-03 to 2017-05-29
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
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)
- Version / remarks:
- adopted 26 July, 2013
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1-({3-[(2,5-dioxo-2,5-dihydro-1H-pyrrol-1-yl)methyl]phenyl}methyl)-2,5-dihydro-1H-pyrrole-2,5-dione
- EC Number:
- 695-930-2
- Cas Number:
- 13676-53-4
- Molecular formula:
- C16H12N2O4
- IUPAC Name:
- 1-({3-[(2,5-dioxo-2,5-dihydro-1H-pyrrol-1-yl)methyl]phenyl}methyl)-2,5-dihydro-1H-pyrrole-2,5-dione
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Storage, temperature and transport conditions of ocular tissue (e.g. transport time, transport media and temperature, and other conditions):
On the test day, fresh eyes were collected from the slaughterhouse and were transported in HBSS containing 1% Pen/Strep on ice to the laboratories. Immediately after arrival of the eyes, cornea preparation was initiated.
- Time interval prior to initiating testing:
At least 1 hour
- indication of any existing defects or lesions in ocular tissue samples:
Before the corneae were mounted in corneal holders with the endothelial side against the O-ring of the posterior chamber, they had been visually examined for defects and any defective cornea had been discarded.
- Indication of any antibiotics used:
1% Penicilin/Streptomycin
Test system
- Vehicle:
- physiological saline
- Controls:
- yes, concurrent vehicle
- yes, concurrent positive control
- Amount / concentration applied:
- TEST MATERIAL
- Concentration (if solution): 20% solution in physiological saline
VEHICLE
- Concentration (if solution): 0.9% NaCl physiological saline - Duration of treatment / exposure:
- 4 h at 32°C
- Duration of post- treatment incubation (in vitro):
- 90 min at 32°C
- Number of animals or in vitro replicates:
- each 3 corneae were used for the test item, the positive control and the negative control
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAE
Isolated corneae were obtained as a by-product from animals freshly slaughtered at an abattoir. Fresh eyes were collected from the slaughterhouse and transported in HBSS containing Pen/Strep on ice to the laboratories. Immediately after arrival of the eyes, cornea preparation was initiated.
The tissue surrounding the eyeball was carefully pulled away and the cornea will be excised leaving a 2 to 3 mm rim of sclera. The isolated corneae will be stored in a petri dish containing HBSS. Before mounting the corneae in corneal holders with the endothelial side against the O-ring ofthe posterior chamber, they were visually examined for defects and any defective cornea were discarded.
QUALITY CHECK OF THE ISOLATED CORNEAS
The eyes were visually checked for any defects of the cornea.
NUMBER OF REPLICATES
3
SOLVENT CONTROL USED (if applicable)
yes, pyhsiological saline
POSITIVE CONTROL USED
20% imidazole
APPLICATION DOSE AND EXPOSURE TIME
20% solution of the test item was applied and the corneae incubated for 4 h at 32°C
TREATMENT METHOD:
The eyes were incubated applying the closed chamber method.
POST-INCUBATION PERIOD:
No.
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period:
The eyes were washed at least three times
- POST-EXPOSURE INCUBATION:
Yes. 90 min at 32°C.
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity:
Corneal opacity was measured using an opacitometer (BASF-OP3.0, Duratec)
- Corneal permeability:
passage of sodium fluorescein dye measured with the aid of UV/VIS spectrophotometry (OD490)
- Others (e.g, pertinent visual observations, histopathology):
Beside illuminance measurement the corneae were observed visually and pertinent observations were recorded
SCORING SYSTEM:
In Vitro Irritancy Score (IVIS)
DECISION CRITERIA:
The following IVIS cut-off values for identifying test substances as inducing serious eye damage (UN GHS Category 1) and test substances not requiring classification for eye irritation or serious eye damage (UN GHS No Category) were used:
IVIS UN GHS
≤ 3 No Category
>3; ≤ 55 No prediction can be made
> 55 Category 1
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- mean IVIS of three experiments
- Value:
- 7.28
- Vehicle controls validity:
- valid
- Remarks:
- IVIS 0.59
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks:
- IVIS 121.72
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system:
No
DEMONSTRATION OF TECHNICAL PROFICIENCY:
The BCOP assay is considered to be valid if the in vitro irritation score obtained with the positive control falls within the two standard deviations of the current historical mean.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: The negative control responses should result in opacity and permeability values that are less than the established upper limits (Mean VaIue + 2 x Standard Deviation = 2.89) for background bovine corneae treated with the respective negative control. Mean in vitro score = 0.59.
- Acceptance criteria met for positive control:
The in vitro irritation score obtained with the positive control fell within the two standard deviations of the current historical mean and therefore this assay is considered to be valid. Mean in vitro score = 121.72.
Historical mean IVIS of the positive control:
Mean value (MV): 125.72
Standard deviation (SD): 18.54
MV-2 x SD: 88.65
MV+2 x SD: 162.80
Number of Replicates providing Historical Mean: 21
Historical mean IVIS of the negative control:
Mean value (MV): 1.27
Standard deviation (SD): 0.81
MV-2 x SD: -0.34
MV+2 x SD: 2.89
Number of Replicates providing Historical Mean: 21
Any other information on results incl. tables
Table 1: Opacity
Cornea No. |
Test Item |
Initial Opacity |
Final Opacity |
Change of Opacity Value |
Corrected Opacity Value |
1 2 3 MV |
Negative Control |
2.20 2.01 2.08 2.10 |
3.09 2.05 2.12 2.42 |
0.89 0.04 0.04 0.32 |
|
4 5 6 MV |
Positive Control |
3.20 3.16 3.05 3.14 |
94.43 96.42 92.88 94.58 |
91.23 93.25 89.84 91.44 |
90.91 92.93 89.52 91.12 |
7 8 9 MV |
Test Item |
0.98 2.85 0.88 1 .57 |
7.10 8.37 10.45 8.64 |
6.12 5.52 9.57 7.07 |
5.80 5.19 9.25 6.75 |
MV: mean value
Table 2: Permeability
Cornea No. |
Test Item |
OD490 |
Corrected OD490 Value |
1 2 3 MV |
Negative Control |
0.009 0.009 0.036 0.018 |
|
4 5 6 MV |
Positive Control |
1 .435 2.415 2.325 2.058 |
1.417 2.397 2.307 2.040 |
7 8 9 MV |
Test Item |
0.022 0.037 0.101 0.053 |
0.004 0.019 0.083 0.035 |
MV: mean value
Table 3: In Vitro Irritation Score
Cornea No. |
Test Item |
Corrected Opacity |
Corrected OD490 Value |
|
1 2 3 MV |
Negative Control |
0.89 0.04 0.04 0.32 |
0.009 0.009 0.036 0.018 |
0.59 |
4 5 6 MV |
Pos itive Control |
90.91 92.93 89.52 91.12 |
1 .417 2.397 2.307 2.040 |
121.72 |
7 8 9 MV |
Test Item |
5.80 5.19 9.25 6.75 |
0.004 0.019 0.083 0.035 |
7.28 |
MV: mean value
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- In the present study the treatment of bovine corneae with m-Xylylenebismaleimide for 4h at 32°C resulted in a mean IVIS of 7.28. There were signs of opacity in of the treated corneae after 4 h exposure and the corneae showed a yellowish colouration. However, in accordance with OECD Testguideline 437 (adopted July 26, 2013) the following cut-off values for classification according to GHS criteria the IVIS must be < 3 for no classification and > 55 to idenify a substance as inducing serious eye damage (UN GHS Category 1). All values between the afore mentioned values do not provide conclusive results, thus, no prediction can be made for the test item.
Due to the lack of further information, m-Xylylenebismaleimide is classified in Category 2 'causes serious eye irritation' according to Regulation EC No 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labelling of Chemicals (GHS) for precautionary reasons.
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.