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EC number: 601-595-5 | CAS number: 119302-20-4
- 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
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:
- 20 July to 5 November 1999
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- not specified
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Wistar Crl:(WI) BR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: Approximately 7 weeks old
- Weight at study initiation: Within 20% of sex mean
- Fasting period before study: Overnight prior to dosing until approximately 3-4 hours after administration of the test substance.
- Housing: Group housing of 3 animals per sex per cage in polycarbonate cages containing purified sawdust as bedding material.
- Diet (e.g. ad libitum): Free access to standard pelleted laboratory animal diet (Carfil Quality BVBA, OUd-Turnhour, Belgium).
- Water (e.g. ad libitum): Free access to tap water
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21˚C
- Humidity (%): 50%
- Air changes (per hr): 15 Air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours of artificial fluorescent light/12 hours dark. - Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage): 10mL/kg
- Justification for choice of vehicle: The vehicle was selected based on a pretest performed at NOTOX.
DOSAGE PREPARATION (if unusual): Formulations (w/w) were prepared within 4 hours prior to dosing. Homogeneity was accomplished to a visually acceptable level.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Toxicity of the test substance was assessed by stepwise treatment of groups of 3 animals. - Doses:
- 200 mg/kg
2000 mg/kg - No. of animals per sex per dose:
- 3 Animals
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations and weighing: Twice daily
- Necropsy of survivors performed: Yes, by asphyxiation using oxygen/carbon dioxide procedure.
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: Twice daily viability/mortality; body weights Days 1 (pre-admin), 8 and 15 and at death; clinical signs were taken on day 1 and once daily thereafter, until day 15. - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 200 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- The incidence of mortality is reported in Table No. 1 below.
Two females and two males were found dead on days 2 and 4 and on days 4 and 5, respectively. The two other animals (one female and one male) were sacrificed moribund on day 7 and day 5, respectively, as indicated by the combination of clinical signs and considerable body weight loss observed in these animals. - Clinical signs:
- other: Within the 200 mg/kg dose group, signs of alopecia and/or scabs (in the neck) became apparent in two females during week 2. Based on the time of occurrence, these findings were considered not related to treatment and of no toxicological significance. Wi
- Gross pathology:
- Reduced spleen and thymus size was found among the 2000 mg/kg treated animals, at macroscopic post mortem examination.
- Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the current test conditions the oral LD50 value for the test substance is within the following range 200-2000 mg/kg body weight.
Reference
Table 1:
Dose Level (mg/kg) | Mortality | Sex | Date of Treatment |
200 | 0/3 | females | 20-Jul-99 |
200 | 0/3 | males | 22-Jul-99 |
2000 | 3/3 | females | 27-Jul-99 |
2000 | 3/3 | males | 29-Jul-99 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 200 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:
- 12 August to 3 November 1999
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- not specified
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- other: Wistar Crl:(WI) BR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: Approx. 9 weeks old
- Weight at study initiation: Did not exceed +/- 20% of sex mean.
- Housing: Individually housed in polycarbonated cages containing purified saw dust as bedding material.
- Diet (e.g. ad libitum): Free access to standard pelleted laboratory animal diet (Carfil Quality BVBA, Oud-Turnout, Belgium).
- Water (e.g. ad libitum): Free access to tap-water.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21˚C
- Humidity (%): 50%
- Air changes (per hr): Approximately 15 air changes per hour.
- Photoperiod (hrs dark / hrs light): 12 hours of artificial light/12 hours dark
IN-LIFE DATES: From: 12 August 1999 To: 26 August 1999 - Type of coverage:
- semiocclusive
- Vehicle:
- polyethylene glycol
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Back of animals
- % coverage: 10%
- Type of wrap if used: Surgical gauze patch, successively covered with aluminium foil and Coban flexible bandage. A piece of Micropore tape was additionally used for fixation of the bandages to females only.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Water
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 mL/kg body weight - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5 Males and 5 Females
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations and weighing: Observations - twice daily, body weights - days 1 (pre-administration), 8 and 15.
- Necropsy of survivors performed: Yes, Sacrificed by asphyxiation using an oxygen/carbon dioxide procedure.
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: Clinical signs - On day 1 of dosing and once daily thereafter, until day 15. - Statistics:
- Not performed
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred
- Clinical signs:
- other: Scabs and scales were seen in the treated skin-area of one female between days 2 and 8. Red staining of the fur in the neck appeared in another female on day 9 and persisted until termination. Based on the incidence and time of occurrence, this finding
- Gross pathology:
- No abnormalities were found at macroscopic post mortem examination of the animals.
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under current test conditions the LD50 value for test substance exceeds 2000 mg/kg body weight.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
GLP study conducted according to OECD Guideline 423 and EU Method B.1. Under the current test conditions the oral LD50 value for Pymordiol is within the following range 200-2000 mg/kg body weight.
Justification for selection of acute toxicity – dermal endpoint
CLP study conducted according to OECD Guideline 402 and EU Method B.3. Under current test conditions the LD50 value for test substance exceeds 2000 mg/kg body weight.
Justification for classification or non-classification
Based on acute oral LD50 greater than 200 but less than 2000 mg/kg bw, this substance might either be classified as EU CLP Acute Oral Tox Cat 3 (if the LD50 is less than 300 mg/kg bw) or Acute Oral Tox Cat 4 (if LD50 is greater than 300 mg/kg bw).
Precautionarily, this substance is therefore classified as Acute Oral Tox Cat 3, H301.
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