Registration Dossier
Registration Dossier
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EC number: 416-140-4 | CAS number: 145650-60-8 IRGAFOS 38
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1992-07-07 to 1992-09-10
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study (OECD Guideline 401)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- adopted on 24-Feb-1987
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Bis(2,4-di-tert-butyl-6-methylphenyl)ethyl phosphate
- EC Number:
- 416-140-4
- EC Name:
- Bis(2,4-di-tert-butyl-6-methylphenyl)ethyl phosphate
- Cas Number:
- 145650-60-8
- Molecular formula:
- C32H51 O3 P
- IUPAC Name:
- bis(2,4-di-tert-butyl-6-methylphenyl) ethyl phosphite
- Details on test material:
- Physical properties: Solid, white
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Tif: RAI f (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY Ltd.
- Age at study initiation: Young adult
- Weight at study initiation: 176 to 220 g
- Fasting period before study: Prior to dosing, the animals were fasted overnight
- Housing: Segregated by sex, group-housed (5 animals per cage) in Macrolon cages type 4, with standardized soft wood bedding
- Diet: Rat chow (NAFAG 890 Tox, NAFAG, Gossau/SG, Switzerland), ad libitum
- Water: ad libitum
- Acclimation period: At least 5 days before administration
ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/- 2°C
- Humidity: 55 +/- 10%
- Air changes: 15 air changes/h
- Photoperiod: 12 hour/ day light cycle
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage): 10 ml/kg body weight - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 rats
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Observations:
Mortality: daily/ a.m. and p.m. on working days, a.m. on weekend days
Signs and symptoms: daily for 14 days
Body weight: immediately before administration and on days 7 and 14
Necropsies: The animals were submitted to a gross necropsy at the end of the observation period. - Statistics:
- From the body weights, the group means and their standard deviations were calculated.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: Piloerection, hunched posture, and dyspnea were seen, being common symptoms in acute tests. Additionally, reduced locomotor activity was observed in all animals. The animals recovered within 4 to 5 days.
- Gross pathology:
- No deviations from normal morphology were found.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information
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