Registration Dossier
Registration Dossier
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EC number: 213-551-9 | CAS number: 976-56-7
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:
- 1 978
- Report date:
- 1978
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:
- yes
Test material
- Reference substance name:
- Diethyl [[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl]phosphonate
- EC Number:
- 213-551-9
- EC Name:
- Diethyl [[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl]phosphonate
- Cas Number:
- 976-56-7
- Molecular formula:
- C19H33O4P
- IUPAC Name:
- diethyl (3,5-di-tert-butyl-4-hydroxybenzyl)phosphonate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Tif: RAIf (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CIBA-Geigy Ltd., Basle, Switzerland
- Weight at study initiation: 160-180 g
- Housing: in groups of 5 in Macrolon cages (type 3)
- Fasting period before study: overnight
- Diet: ad libitum rat food
- Water: ad libitum
- Acclimation period: at least 4 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/- 1 °C
- Humidity: 55 +/- 5 %
- Photoperiod (hrs dark / hrs light): 14/10
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 30 %
Before treatment the suspension was homogeneously dispersed with an Ultra-Turrax and during treatment it was kept stable with a magnetic stirrer. - Doses:
- 4640 mg/kg bw, 6000 mg/kg bw, 7750 mg/kg bw (highest dose possible)
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology - Statistics:
- not required
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 7 750 mg/kg bw
- Based on:
- test mat.
- Mortality:
- none
- Clinical signs:
- other: Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, exophthalmos, curved position and ruffled fur. The animals recovered within 8 to 13 days.
- Gross pathology:
- No substance related gross organ changes were seen.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral LD50 of the test item in rats of both sexes observed over a period of 14 days is greater than 7750 mg/kg.
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