Registration Dossier
Registration Dossier
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EC number: 220-168-0 | CAS number: 2650-18-2
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:
- 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: well-documented, scientifically acceptable study report. Non GLP
- Remarks:
- The study is conducted on a read across test material. The complete read across justification is attached in section 13. The reliability of the original study is 2.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- Tested dose 1900 mg/kg bw instead of 2000 mg/kg bw
- GLP compliance:
- no
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Similar Substance 1
- IUPAC Name:
- Similar Substance 1
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Acclimatization period: at least 1 week before study start
Age at study start: about 12 weeks
Five animals per cage (type stainless steel DK-III); animal identification using cage cards.
The animals were housed in fully air-conditioned rooms with a room temperature of 20 - 24°C and a relative humidity of 30 - 70%. The day/night rhythm was 12 h light and 12 h dark.
A standardized animal laboratory diet as well as drinking (tap) water were available ad libitum.
Animals of a comparable weight were used.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- Aqueous preparation corresponds to the physiollogical medium.
Application volume: 10 ml/kg
Concentration (%): 50 (G/V) - Doses:
- 1900 mg/kg bw (38% of 5000 mg/kg bw formulation)
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: at least once each working day
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- >= 1 900 mg/kg bw
- Based on:
- act. ingr.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 1 900 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- none
- Clinical signs:
- other: urine turquoise-coloured
- Gross pathology:
- nothing abnormal detected
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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