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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1990 -11-08 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:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
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:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Females nulliparous and non-pregnant: yes
- Age at study initiation: Young adults, 6-8 weeks.
- Weight at study initiation: 149-171 g.
- Fasting period before study: 18 h before dosing
- Housing: The rats were housed by sex in polypropylene cages with mesh floors suspended over absorbent paper lined trays with a maximum of 5 animals per cage.
- Diet: Rat and Mouse No. 1 Diet.
- Water: ad libitum.
- Acclimation period: 7 days.
The diet and water are analysed on a regular basis.
ENVIRONMENTAL CONDITIONS
- Temperature: 19 - 21°C
- Humidity: 50%
- Photoperiod: 12 h light/dark (light hours 0700-1900 h)
The rats were uniquely identified within the study using an ear punch system.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 0.5% aqueous CMC
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
DOSAGE PREPARATION:
On the day of dosing, Desmedipham was freshly prepared in 0.5% CMC at a concentration of 200 mg/mL - Doses:
- Single dose of 2000 mg/kg bw
- No. of animals per sex per dose:
- 5/sex
- Control animals:
- no
- Remarks:
- Not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The rats were observed frequently on the day of dosing and once daily for 14 days following dosing. They were weighed immediately prior to dosing, 7 days after dosing and at sacrifice at the end of the 14 day observation period.
- Necropsy of survivors performed: yes, at the end of the observation period and sacrifice by carbon dioxide asphyxiation, each animal was subjected to necropsy.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No deaths at the limit dose
- Mortality:
- No mortality was observed
- Clinical signs:
- other: other:
- Body weight:
- other body weight observations
- Gross pathology:
- No abnormalities detected
Any other information on results incl. tables
Table 1: Desmedipham: Acute Oral Toxicity (Limit) Test in Rats Test Results 2000 mg/kg bw
Sex | Animal | Mortality | Clinical signs | Necropsy Findings |
Males | 1 2 3 4 5 | 0/5 | NAD NAD NAD NAD NAD | NAD NAD NAD NAD NAD |
Females | 6 7 8 9 10 | 0/5 | NAD NAD NAD NAD NAD | NAD NAD NAD NAD NAD |
NAD = No abnormalities detected
Table 2: Desmedipham: Acute Oral Toxicity (Limit) Test in Rats Body Weights 2000 mg/kg bw
Sex | Animal | Body weight (g) | |||
At Dosing | After 7 days | After 14 days | Gain (Loss) | ||
Males | 1 2 3 4 5 | 159 171 163 163 156 | 220 239 231 240 213 | 265 275 280 270 245 | 106 104 117 107 89 |
Mean ± S.D. | 162 6 | 229 12 | 267 14 | 105 10 | |
Females | 6 7 8 9 10 | 151 149 158 152 156 | 195 194 205 190 199 | 209 211 215 201 217 | 58 62 57 49 61 |
Mean ± S.D. | 153 4 | 197 6 | 211 6 | 57 5 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral LD50 of desmedipham was >2000 mg/kg/bw in male and female rats under the conditions of this study. Desmedipham does not require classification for oral acute toxicity in any category according to the CLP criteria.
- Executive summary:
The acute oral toxicity potential of Desmedipham, was investigated in rats. The vehicle for the dosing solution was 0.5% carboxymethylcellulose (CMC). There were no deaths following a single orally administered dose of Desmedipham at the limit dose level of 2000 mg/kg bw to a group of 5 male and 5 female rats. No clinical signs or necropsy findings were noted. The Median Oral Lethal Dose (LD50) of Desmedipham in male and female rats is greater than 2000 mg/kg bw. Desmedipham does not require classification for oral acute toxicity in any category according to the CLP criteria.
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