Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
- Principles of method if other than guideline:
- Five male and five female rats received a single dose of 3.1 or 5 ml Disflamoll DPK/kg bw by gavage. The animals were observed for mortality, clinical signs, and body weight. A gross pathological examination of the surviving rats was conducted randomly.
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Not applicable
- Molecular formula:
- C19 H17 O4 P1
- IUPAC Name:
- Not applicable
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Animals were housed in groups of 5 animals conventional in Macrolon cages type III on dust free wood granules at a temperature of 22+/- 1.5°C. Light/dark rythmus was 12 hours. and air humidity 60 +/- 55
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 5.0 ml/kg; 3.1 ml/kg bw.
- No. of animals per sex per dose:
- 5/sex/dose
- Control animals:
- not specified
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mL/kg bw
- Mortality:
- 1 male animal died at a dose of 5 ml/kg bw.
- Clinical signs:
- other: Decreased general condition.
- Gross pathology:
- No findings.
Any other information on results incl. tables
| Dose (ml/kg bw) | Sex | Mortality | No of animals | Animals with symtoms | start of symtoms | decrease of general condition | |
| 5,0 | male | 1 | 5 | 5 | after 10 hours | yes | |
| 5,0 | female | 0 | 5 | 5 | after 10 hours | yes |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Executive summary:
In an acute oral toxicity test in 10 male and female Wistar rats the LD50 was >5000 ml/kg bw (5000 ml/kg bw = 6050 mg/kg bw; density = 1.21 mg/µg).
The decrease of general condition was the only symptom that was seen.
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