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EC number: 237-198-5 | CAS number: 13684-56-5
- 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:
- 1990-11-24 to 1991-03-18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Desmedipham
- EC Number:
- 237-198-5
- EC Name:
- Desmedipham
- Cas Number:
- 13684-56-5
- Molecular formula:
- C16 H16 N2 O4
- IUPAC Name:
- ethyl 3´-phenylcarbamoyloxycarbanilate
- Test material form:
- solid: particulate/powder
- Details on test material:
- The test material is Desmedipham but the purity has not been specified.
Constituent 1
- Specific details on test material used for the study:
- The test material is in a white powder form.
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: Young adults.
- Weight at study initiation: Not provided.
- Housing: Individually in aluminium cages with grid floors beneath which were peat moss filled trays.
- Diet: Standard Rabbit Diet, ad libitum.
- Water: ad libitum
- Acclimation period: 12 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-19
- Mean Relative Humidity (%): 57
- Air changes (per hr): Not provided.
- Photoperiod: 12 h light/dark cycle (light hours 0700-1900 h).
The rabbits were uniquely identified within the study by an indelible number on the inner surface of the ear.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 100 mg
Instillation of the test material was by the following technique:
The rabbit was held firmly but gently and the test material placed into the right eye by gently pulling the lower eyelid away from the eyeball to form a sac into which the test material was dropped. The lids were then gently held together for 1-2 seconds. - Duration of treatment / exposure:
- Single instillation
- Observation period (in vivo):
- One rabbit was treated first and observed up to 24 h after instillation for signs of severe irritation. As none were noted, the remaining 2 rabbits were then treated. The eyes were examined for irritation and ocular reactions were recorded 1, 24, 48 and 72 h after instillation.
- Number of animals or in vitro replicates:
- 3 animals
- Details on study design:
- Approximately 24 h before test commencement, both eyes of the rabbits were examined and only animals with no ocular defects were used in the test.
SCORING SYSTEM:
TOOL USED TO ASSESS SCORE: The eyes were examined for irritation, using a hand held magnifier and pen torch.
OECD Recommended Scoring System:
CORNEA:
1- Opacity: degree of density (area most dense taken for reading)
No ulceration or opacity - 0
Scattered or diffuse areas of opacity (other than slight dulling of normal lustre), 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
2- Area of Opacity
A quarter (or less) but not more - 1
Between a quarter and a half - 2
Between half and three quarters - 3
Between three quarters and the whole surface - 4
IRIS:
Normal - 0
Markedly deepened folds, congestion, swelling, moderate circumcorneal hyperaemia or injection (any of these or combination of any thereof), iris still reacting to light (sluggish reaction is positive) - 1
No reaction to light, haemorrhage, gross destruction (any or al 1 of these) - 2
CONJUNCTIVAE:
1- Redness (refers to palpebral and bulbar conjunctivae):
Blood vessels normal - 0
Some blood vessels definitely hyperaemic (injected) - 1
Diffuse, crimson colour, individual vessels not easily discernible - 2
Diffuse beefy red - 3
2- Chemosis (lids and/or nictitating membranes):
No swelling - 0
Any swelling above normal (including 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
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.22
- Max. score:
- 3
- Reversibility:
- fully reversible within: persisting until 48 h in one treated eye. All treated eyes were normal by 72 h post instillation.
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Details of reaction scores are given in the table below.
No corneal or iridial responses were noted.
Slight conjunctival redness and a slight discharge were noted 1 h post instillation with slight redness persisting until 48 h in one treated eye. All treated eyes were normal by 72 h post instillation.
Any other information on results incl. tables
Table 1: Desmedipham: Acute Eye Irritation Test in Rabbits Reaction Scores
Area of Eye | Observation Time/ Animal /Sex/Score | |||||||||||
1 h | 24 h | 48 h | 72 h | |||||||||
4/male | 5/male | 6/male | 4/male | 5/male | 6/male | 4/male | 5/male | 6/male | 4/male | 5/male | 6/male | |
Cornea: degree/opacity area/opacity
Iris
Conjunctivae: redness chemosis
Discharge |
0 0
0
1 0
- |
0 0
0
1 0
SL |
0 0
0
0 0
- |
0 0
0
0 0
- |
0 0
0
1 0
- |
0 0
0
0 0
- |
0 0
0
0 0
- |
0 0
0
1 0
- |
0 0
0
0 0
- |
0 0
0
0 0
- |
0 0
0
0 0
- |
0 0
0
0 0
- |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Desmedipham is practically non-irritant to rabbit eyes and does not require classification for eye irritation in any category according to the CLP criteria.
- Executive summary:
The eye irritation potential of Desmedipham, was investigated in 3 New Zealand White rabbits. Slight conjunctival redness and a slight discharge were noted at 1 h post instillation with slight redness persisting until 48 h post instillation in one treated eye. Desmedipham is practically non-irritant to rabbit eyes and does not require classification for eye irritation in any category according to the CLP criteria.
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