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EC number: 616-020-3 | CAS number: 7381-13-7
- 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:
- April 2007 - May 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1,1'-(1,3-Phenylenedicarbonyl)diazepan-2-one
- EC Number:
- 616-020-3
- Cas Number:
- 7381-13-7
- Molecular formula:
- C20H24N2O4
- IUPAC Name:
- 1,1'-(1,3-Phenylenedicarbonyl)diazepan-2-one
- Details on test material:
- none
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: New Zealand
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elevage de Gerome (Quartier Labaste - F40260 Linxe)
- Age at study initiation:
- Weight during the test: the animals weighed between 2.46 kg and 2.87 kg.
- Housing: in an individual box
- Acclimation period: 5-days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): between 18°C and 21 °C
- Humidity (%): between 40% and 68%
- Air changes (per hr): conventional air conditioned
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 g of the test item
- Observation period (in vivo):
- Ocular examinations were performedd on both right and left eyes 1 hour, 24, 48 and 72 hours following treatment.
If no reaction is observed 72 hours after instillation, the study is terminated. - Number of animals or in vitro replicates:
- 3 rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): test item remove with isotonic sodium chloride
SCORING SYSTEM:
CHEMOSIS (A)
• No swelling................................... ............ ....................................................................... .............. 0
• Slight swelling, including the nictitating membrane ...................................................................... 1
• Swelling with eversion ofthe eyelid............................................................................ .................. 2
• Swelling with eyelid half-closed...................................................................................... ........... ... 3
• Swelling with eyelid more than half-closed .................................................................... .... ........... 4
DISCHARGE (B)
• No discharge .................................................. ..................... .. ... ...................................................... 0
• Slight discharge (normal slight secrelions in the inner corner not to be
taken into account)....................................................................................................................... .. 1
• Discharge with moistening ofthe eyelids and neighbouring hairs ........ ............................ ............. 2
• Discharge with moistening of the eyelids and large areas around the eye ..................................... 3
REDNESS (C)
• Blood vessels normal. .................................................................................................................... 0
• Vessels significantly more prominent than normal........................................................................ 1
• Vessels individuaIly distinguishable with difficulty
Generalised red coloration........................................................................... ........ ..................... 2
Generalised deep red coloration .................................................. ................. ..... ................ .... ... 3
IRIS (D)
• Normal................... ................................................................................................................ ........ 0
• Iris significantly more wrinkled than normal, congeslion,
swelling ofthe iris which continues to react to light, even slowly................................................. 1
• No reaction to light, haemorrhage, significant damage
(any or all ofthese characteristics) ................................................................................................ 2
CORNEA: DEGREE OF OPACITY (E)
• No modification visible either directly or after
instillation of fluorescein (no 1055 of glint or polish) ...................... .......... ..................................... 0
• Translucent areas (diffuse or disseminated), iris details clearly visible .......... ............ .... ............... 1
• Easily identifiable translucent area, iris details slightly obscured.................................................. 2
• Opalescent area, no iris details visible, pupil outline scarcely distinguishable .............................. 3
• Total comeal opacity, completely obscuring the iris and pupil.............................................. ........ 4
CORNEA: EXTENT OF OPACITY (F)
• Opaque area present but covering one quarter or less .................................................................... 1
• Between one quarter and half.. ....................................................................................................... 2
• Between half and three quarters .. ......................................................... .......................................... 3
• Between three quarters and the entire surface.................................. .............................................. 4
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- CHEMOSIS
- Basis:
- animal: #1,#2,#3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- conjunctivae score
- Remarks:
- REDNESS
- Basis:
- animal: #1,#2,#3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: no effects
- Irritation parameter:
- iris score
- Remarks:
- LESION
- Basis:
- animal: #1,#2,#3
- Time point:
- other: 24.48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects
- Irritation parameter:
- cornea opacity score
- Remarks:
- OPACITY
- Basis:
- animal: #1,#2,#3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- conjunctivae score
- Remarks:
- DISCHARGE
- Basis:
- animal: #1,#2,#3
- Time point:
- other: 1 hour
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- REDNESS
- Basis:
- animal: #1,#2,#3
- Time point:
- other: 1 hour
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- CHEMOSIS
- Basis:
- animal: #2, #3
- Time point:
- other: 1 hour
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- - Raw data for each individual animal at each observation time up to removal of each animal from the test: data are given in above block of fields
'Irritation / corrosion results'. - Other effects:
- none
Any other information on results incl. tables
The ocular conjunctivae reactions observed during the study have been slight and rapidly reversible in the three animals: a slight redness was noted only 1 hour after the test item instillation associated a slight chemosis in two animals only 1 hour after the test item instillation
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- not to be classified
- Executive summary:
The test item was instilled as supplied, at the dose of 0.1 g, into the eye of one New Zealand rabbit (n=3).
The ocular conjunetivae reactions observed during the study have been slight and rapidly reversible in the three animals: a slight redness was noted only 1 hour after the test item instillation assoeiated a slight chemosis in !wo animals only 1 hour after the test item instillation.
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