Registration Dossier
Registration Dossier
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EC number: 212-338-8 | CAS number: 791-28-6
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:
- other: Comparable to guideline study with acceptable restrictions (mostly due to reduced reporting in times before GLP)
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
Test material
- Reference substance name:
- Triphenylphosphine oxide
- EC Number:
- 212-338-8
- EC Name:
- Triphenylphosphine oxide
- Cas Number:
- 791-28-6
- Molecular formula:
- C18H15OP
- IUPAC Name:
- triphenylphosphine oxide
- Details on test material:
- - Name of test material (as cited in study report): Triphenylphosphinoxid
- Purity: pure
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gassner
- Weight at study initiation: males: 222 (170 - 252) g; females: 176 (153 - 188) g
ENVIRONMENTAL CONDITIONS
not reported
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 2 - 30% aqueous suspension with carboxymethyl cellulose and 2 - 3 drops of Cremophor EL.
MAXIMUM DOSE VOLUME APPLIED: 21.4 mL/kg bw - Doses:
- 6400; 3200; 1600; 800; 400; 320; 200 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 7 days
- Frequency of observations and weighing: Body weight was measured on the application day, on day 3 and 4, respectively, and on day 7. Observation of clinical signs was several times on the day of administration and once daily afterwards with the exception of weekends and on holidays.
- Necropsy of survivors performed: yes - Statistics:
- Calculation of LD50 by method of Litchfield and Wilcoxon.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 685 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 486 - 966
- Remarks on result:
- other: mortality was observed in doses of 320 mg7kg bw and higher
- Mortality:
- see table "any other information"
- Clinical signs:
- Convulsions, dyspnea, apathy, tremors, salivation, eye discharge, partial exophthalmus, ventral or lateral body position, staggering, exsiccosis, paresis of hind limbs.
6400 and 3200 mg/kg bw:
15 minutes after application convulsions, dyspnea, cower position.
Hours later apathy, tremors, cower position, at 6400 mg/kg bw additionally gasping for breath, partial exophtalmus.
During observation period lateral position, dyspnea, apathy, partially secretion out of eyes and mouth, cower position.
1600 mg/kg bw:
Hours after application dyspnea, cower position, apathy, lateral body position, staggering, clonic convulsions.
Symptoms stable for the following days, additionally tremors and secretion out of mouth and eyes.
800 - 320 mg/kg bw:
Hours after application staggering, partially cower position and creeping, at 800 and 400 mg/kg bw additionally convulsions, latero-abdominal position, dyspnea, aggressiveness, partially weakness of hind limbs, biting convulsions, partially tremors, salivation.
Amelioration of symptoms during the following days, 800 mg/kg additionally exsiccosis.
Animals free of symptoms around day 4.
200 mg/kg bw:
Hours after application cower position, slight apathy.
Animals free of symptoms on day 2. - Body weight:
- Body weight gain stagnated during observation period in survivors of all dose groups.
- Gross pathology:
- Hyperemia, dilatation of heart and gastroesophageal vestibule, fine ulcerations, diarrhoeic intestinal content, discoloration of kidneys and liver in animals that died. Nothing abnormal found in sacrificed animals.
Any other information on results incl. tables
Mortality
mg/kg % # 1h 24h 48h 7d
------------------------------------------
6400 30 5M 0/5 5/5 5/5 5/5
5F 0/5 5/5 5/5 5/5
3200 30 5M 0/5 4/5 5/5 5/5
5F 0/5 3/5 4/5 5/5
1600 16 5M 0/5 2/5 2/5 5/5
5F 0/5 5/5 5/5 5/5
800 8 5M 0/5 1/5 1/5 2/5
5F 0/5 2/5 4/5 4/5
400 4 5M 0/5 0/5 0/5 0/5
5F 0/5 0/5 1/5 2/5
320 4 5M 0/5 0/5 0/5 0/5
5F 0/5 0/5 1/5 1/5
200 2 5M 0/5 0/5 0/5 0/5
5F 0/5 0/5 0/5 0/5
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Applicant's summary and conclusion
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