Registration Dossier
Registration Dossier
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EC number: 227-022-5 | CAS number: 5601-29-6
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:
- September 12, 1974
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
- Report date:
- 1974
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Similar Substance 01 - AY059
- IUPAC Name:
- Similar Substance 01 - AY059
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Tif RAI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: between 100 and 115g
- Fasting period before study:
- Housing: housed in groups of 5 in macrolon cages
- Diet: standard diet of Nafag ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
- fasting: overnight before tratment
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1 °C
- Humidity (%): 55 ± 5 %
- Photoperiod (hrs dark / hrs light): 14 hours light/day
IN-LIFE DATES: From: To:
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Doses:
- 1000, 3000, 4500, 8000, 10000, 15000 mg/kg
- No. of animals per sex per dose:
- 5 per sex per dose
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: no data
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 8 290 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 7 020 - < 9 790
- Mortality:
- see table below
- Clinical signs:
- other: see table below
- Gross pathology:
- see table below
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- LD50 = 8290 mg/kg bw
- Executive summary:
Method
The "Acute Oral Toxicity" for the test substance was determined by an Internal method similar to the OECD guideline 401.
Symptoms and mortality after administration were recorded during an observation period of 15 days. The LD was calculated by probit analysis method (maximum likelyhood, Goulden A., Methods of Statistical Analysis, John Wiley and Sons, 1960, 3rd printing, pages 404-408).
Result
LD50 = 8290 mg/kg bw
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