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EC number: 265-477-1 | CAS number: 65122-06-7
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- from January to May, 1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- Source study has reliability 2; details on the read-across approach are attached in section 13.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
- Principles of method if other than guideline:
- Not specified.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Similar Substance 01
- IUPAC Name:
- Similar Substance 01
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 9 - 14 weeks of age.
- Weight at study initiation: 155 - 191 g (males), 152 - 189 m (females).
- Housing: 5 per cage.
- Diet: pellet suspended from 16 h before to 4 h post exposure.
- Water: ad libitum.
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 0.5 °C.
- Humidity: 60 ± 5 %.
- Photoperiod: 12 hrs dark / 12 hrs light.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Doses:
- 1000, 2000, 2500, 3100, 5000 mg/kg bw.
- No. of animals per sex per dose:
- 5 animal/sex/dose.
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days.
- Frequency of observations: twice daily.
- Other examinations performed: clinical signs (position, sedation, diarrhoea); histopathological examination of dead animals. - Statistics:
- LD50 value with p lower than 0.05 computed based on Rosiello et al., J. Tox. Environ. Health 3, 1977, 797.
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 2 400 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 1 600 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- Mortality occurred within 2 hours from administration.
- Clinical signs:
- Symptoms, as reduction of general conditions, sedation and diarrhoea, were evident starting from 10 minutes up to 3 days after administration.
- Gross pathology:
- Stomach and intestines of dead animals dosed from 2000 to 5000 mg/kg bw could not be evaluated due to discoloration.
The other organs at dosages 1000-3100 mg / kg showed no compound-related changes.
Any other information on results incl. tables
Results in female rats
| doses mg/kg | no. animals | no. dead animals | no. animals with symptoms | time of death | duration of symptoms |
| 1000 | 5 | 0 | 0 | ||
| 2000 | 5 | 1 | 5 | 2 h | 10 min to 3 d |
| 2500 | 5 | 3 | 5 | 2 h | 10 min to 3 d |
| 3100 | 5 | 5 | 5 | 2 h | 10 min to 3 d |
| 5000 | 5 | 5 | 5 | 1h 1/2 | 10 min to 3 d |
Results in male rats
| doses mg/kg | no. animals | no. dead animals | no. animals with symptoms | time of death | duration of symptoms |
| 1000 | 5 | 0 | 0 | ||
| 2000 | 5 | 0 | 5 | 10 min to 3 d | |
| 2500 | 5 | 2 | 5 | 2 h | 10 min to 3 d |
| 3100 | 5 | 4 | 5 | 1 h 1/2 | 10 min to 3 d |
| 5000 | 5 | 5 | 5 | 1h 1/2 | 10 min to 3 d |
Overall mortality
| doses mg/kg | no. animals | mortality % |
| 1000 | 10 | 0 |
| 2000 | 10 | 10 |
| 2500 | 10 | 50 |
| 3100 | 10 | 90 |
| 5000 | 10 | 100 |
Applicant's summary and conclusion
- Interpretation of results:
- other: Category 4 based on CLP criteria (EC 1272/2008)
- Conclusions:
- Acute oral exposure of rats to the substance lead to LD50 = 2400 mg/kg bw, equivalent to ca. 1600 mg/kg bw as active ingredient. Higher toxicity in female than in male rats was noted.
- Executive summary:
Method
Acute oral toxicity by gavage in both male and female rats with a 14-day observation period.
Results
LD50 of 2400 mg/kg for both male and female rats, equivalent to ca. 1600 mg/kg bw of active ingredient for the given purity of test material. Female rats showed higher sensitivity than males to the substance. Mortality occurred within 2 hours from administration. At necropsy, stomach and intestines of dead animals dosed from 2000 to 5000 mg/kg bw could not be evaluated due to discoloration; the other organs at dosages 1000 - 3100 mg / kg bw showed no compound-related effects.
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