Registration Dossier
Registration Dossier
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EC number: 610-601-5 | CAS number: 51032-53-2
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1984
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- not specified
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Triisooctyl 2,2',2''-[phosphoryltris(thio)]trisacetate
- EC Number:
- 274-011-6
- EC Name:
- Triisooctyl 2,2',2''-[phosphoryltris(thio)]trisacetate
- Cas Number:
- 69452-87-5
- Molecular formula:
- C30H57O7PS3
- Test material form:
- liquid
- Details on test material:
- Generic name: TGE - Phosphite
Constituent 1
- Specific details on test material used for the study:
- TEST MATERIAL NAME (as stated in study report): TK 12184/1 (Generic name: TGE - Phosphite)
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Sponsor / Batch No. 004-009
- Expiration date of the lot/batch: November 1984
- Purity: commercial grade
Test animals
- Species:
- rat
- Strain:
- other: Rat, Tif:RAIf (SPF)
- Remarks:
- Fl-crosses of RII 1/Tif x RII 2/Tif
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY LTD. Tierfarm, 4334 Sisseln, Switzerland
- Age at study initiation: 7-8 weeks
- Weight at study initiation: 173-203 g
- Fasting period before dosing: overnight
- Housing: in groups of 5 in Macrolon cages type 4 with standardized soft wood bedding
- Diet (e.g. ad libitum): Rat food, NAFAG No. 890, NAFAG AG, Gossau, SG CSwitzerland; ad libitum post dosing
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3° C
- Humidity (%): 55 ± 15%
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: distilled water
- Details on oral exposure:
- Dosage volume: 10 mL/kg
- Doses:
- 5000 mg/kg
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observation for mortality and signs and symptoms; body weights on days 1, 7, and 14.
- Necropsy of survivors performed: yes - Statistics:
- Group mean body weights and standard deviations were calculated
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No morality occurred
- Clinical signs:
- Dyspnoea, ruffled fur and curved body position. All animals returned to normal within 11 days.
- Body weight:
- Mean body weights increased during the study
- Gross pathology:
- No gross lesions were observed
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Not classified by CLP Criteria
- Conclusions:
- In a guideline (OECD 401) study, the acute oral lethal dose of TGE Phosphite in rats was greater than 5,000 mg/kg.
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