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EC number: 219-034-4 | CAS number: 2322-77-2
- 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
Endpoint summary
Administrative data
Description of key information
LD50 oral (rat): > 2000 mg/kg bw [Draft report, Kurth 1996]
LD50 dermal (rat): > 2000 mg/kg bw [Draft report, Kurth 1996]
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- June to July 1996
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 1996
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Han:WIST (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Schering AG
- Weight at study initiation: 103-114 g (males), 100-107 g (females)
- Fasting period before study: ca. 18 hours
- Housing: 1 animal/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22°C
- Humidity (%): 54-64%
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- other: 900 mg NaCI + 85 mg Myrj 53 ad 100 ml bidist. water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/ml (males), 100 mg/ml female
- Amount of vehicle (if gavage): 10 ml/kg (males); 20 ml/kg (females)
- Lot/batch no.: G/9324-1 (males); G/9358-1 (females)
- Rationale for the selection of the starting dose: A higher dosage than 2000 mg/kg was not tested in the present study since this dose level is established as the upper limit dose for classification and labelling requirements concerning dangerous substances. - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: day 1, 7 and 14
- Necropsy of survivors performed: yes - Statistics:
- none (limit test)
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No animal died in the course of the study.
- Clinical signs:
- other: No compound related clinical findings.
- Gross pathology:
- Autopsy revealed no compound related findings.
- Conclusions:
- A single oral administration of the test substance by gavage to male and female rats at the limit-dose 2000 mg/kg was tolerated without mortalities, clinical signs, effects on body weight gain and gross pathological findings. According to OECD TG 423 the oral LD50 of the test substance is therefore > 2000 mg/kg body weight.
- Executive summary:
In an acute oral toxicity study similar to OECD TG 423 (adopted 22 March 1996), groups of fasted, Wistar rats, female and male weighing 100-107 and 103-114g, respectively, (3/sex) were given a single oral dose of D-ET-Dienon in 900 mg NaCI + 85 mg Myrj 53 ad 100 ml bidist. water at a dose of 2000 mg/kg bw and observed for 14 days.
Oral LD50 Combined => 2000 mg/kg bw
Limit test
No mortality occurred during the test
There were no treatment related clinical signs, necropsy findings or changes in body weight.
The test item is of low Toxicity based on the LD50 in male and female Wistar rats.
Reference
No animal died in the course of the study. After application of 10 ml/kg of the formulation containing 200 mg test item/ml to the third animal it was established that this formulation was not homogeneous (although the vial was shaken between the applications a deposit of the substance was detected). Therefore the female animals were treated with a suspension containing 100 mg test item/ml with an application volume of 20 ml/kg. The applications to the male animals were not repeated because neither the female animals treated with a homogeneous formulation nor the male animals treated with the inhomogeneous suspension showed any compound-related findings. A single oral (gavage) application of 2000 mg/kg was tolerated without compound-related clinical findings. The body weight gain on days 7 and 14 was within the normal range for rats of this age and strain, which are routinely used in the laboratory. Autopsy revealed no compound-related findings.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- June to July 1996
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 24 February 1987
- Deviations:
- yes
- Remarks:
- - 3 instead of 5 animals/sex used
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Han: WIST (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Schering AG
- Weight at study initiation: 106-118 g (males) and 95-111 g (females)
- Fasting period before study: ca. 19 hours
- Housing: 1 animal/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22°C
- Humidity (%): 54-64%
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- occlusive
- Vehicle:
- other: 900 mg NaCl ad 100 ml bidist. water
- Details on dermal exposure:
- Amount of drug substance: 190-236 mg + 0.3 ml vehicle
- Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: day 1, 7 and 14
- Necropsy of survivors performed: yes - Statistics:
- none (limit dose)
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No animal died during the course of the study.
- Clinical signs:
- other: No compound related clinical findings.
- Gross pathology:
- Autopsy revealed no compound related findings.
- Conclusions:
- A single dermal administration of the test substance to male and female rats at the limit-dose 2000 mg/kg was tolerated without mortalities, compound-related clinical findings, effects on body weight gain and gross pathological findings. According to OECD TG 402 the dermal LD50 of the test substance is therefore > 2000 mg/kg body weight.
- Executive summary:
In an acute dermal toxicity study similar to OECD TG 402 (adopted 24 February 1987), groups of young adult Wistar rats (3/sex) were dermally exposed to D-ET-Dienon in physiological saline for 24 hours at a dose 2000 mg/kg bw. Animals then were observed for 14 days.
Dermal LD50 Combined = > 2000 mg/kg bw
No mortality occurred during the limit test.
The test item is of low Toxicity based on the combined LD50 value of > 2000 mg/kg bw.
There were no treatment related clinical signs, necropsy findings or changes in body weight.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
Additional information
In an acute oral toxicity study equivalent to OECD TG 423 (adopted 22 March 1996), groups of fasted, Wistar rats, female and male weighing 100-107 and 103-114g, respectively, (3/sex) were given a single oral dose of D-ET-Dienon in 900 mg NaCI + 85 mg Myrj 53 ad 100 ml bidist. water at a dose of 2000 mg/kg bw and observed for 14 days.
Oral LD50 Combined => 2000 mg/kg bw
Limit test
No mortality occurred during the test
There were no treatment related clinical signs, necropsy findings or changes in body weight. The test item is of low Toxicity based on the LD50 in male and female Wistar rats.
In an acute dermal toxicity study similar to OECD TG 402 (adopted 24 February 1987), groups of young adult Wistar rats (3/sex) were dermally exposed to D-ET-Dienon in physiological saline for 24 hours at a dose 2000 mg/kg bw. Animals then were observed for 14 days.
Dermal LD50 Combined = > 2000 mg/kg bw
No mortality occurred during the limit test.
The test item is of low Toxicity based on the combined LD50 value of > 2000 mg/kg bw. There were no treatment related clinical signs, necropsy findings or changes in body weight.
Justification for classification or non-classification
Based on the study results a classification according to Regulation (EC) No. 1272/2008 (CLP) is not required.
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