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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1990-10-28 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 404 (Acute Dermal 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, a white powder, was stored in the dark under ambient conditions.
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 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: 7 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 18
- Mean Relative Humidity (%): 67
- 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 means of an indelible number on the inner surface of the ear.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Remarks:
- Approximately 24 h before treatment. Care was taken to avoid abrading the skin.
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- 0.5 g, moistened with water
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48 and 72 h after patch removal
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: Dorsal area of the trunk of each rabbit.
- % coverage: Not provided.
- Type of wrap if used: The patch was then covered with Micropore tape and the trunk was loosely bound with Elastoplast Elastic Bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the patches were removed and the skin wiped with water dampened tissues to remove surplus test material without altering the existing response or the integrity of the epidermis.
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
1, 24, 48 and 72 h after patch removal
SCORING SYSTEM:
- Method of calculation: OECD Recommended Scoring System:
1- Erythema and Eschar Formation:
No erythema: 0
Very slight erythema (barely perceptible): 1
Well defined erythema: 2
Moderate to severe erythema: 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth): 4
2- Oedema Formation:
No oedema: 0
Very siight oedema (barely perceptible): 1
Slight oedema (edges of area well defined by definite raising): 2
Moderate oedema (area raised approximately 1 mm): 3
Severe oedema (raised by more than 1 mm and extending beyond area of exposure): 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema 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:
- edema 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
Any other information on results incl. tables
Table 1:
Desmedipham: Acute Dermal Irritation Test in Rabbits Reaction Scores
Animal/sex | Erythema | Oedema | ||||||
1 h | 12 h | 24 h | 72 h | 1 h | 12 h | 24 h | 72 h | |
1/male | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
2/male | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
3/male | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
h = Hours after patch removal
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Desmedipham is non-irritant to rabbit skin and does not require classification for skin irritation in any category according to the CLP criteria.
- Executive summary:
The acute dermal irritation potential of Desmedipham, was investigated in 3 New Zealand White rabbits. No skin reactions were noted following a 4 hour semi-occlusive application of Desmedipham to rabbit skin. Desmedipham is non-irritant to rabbit skin and does not require classification for skin irritation in any category according to the CLP criteria.
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