Registration Dossier
Registration Dossier
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EC number: 204-798-3 | CAS number: 126-71-6
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Report date:
- 1989
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-2 (Acute Dermal Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- other: TSCA
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Triisobutyl phosphate
- EC Number:
- 204-798-3
- EC Name:
- Triisobutyl phosphate
- Cas Number:
- 126-71-6
- Molecular formula:
- C12H27O4P
- IUPAC Name:
- triisobutyl phosphate
Constituent 1
- Specific details on test material used for the study:
- - Name of test material: Tri-siobutylphosphate
- Physical state: clear liquid
- Analytical purity: 99.7%
- Lot/batch No.: NBP 3983659
- Storage condition of test material: room temperature
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hazleton Research Animals, Inc. Denver, Pennsylvania
- Age at study initiation: at least 8 weeks old
- Weight at study initiation: Males: 2.4 - 2.9 kg. Females: 2.6 - 3.0 kg
- Fasting period before study: not specified
- Housing: individually housed. Suspended, stainless steel
- Diet (ad libitum): Lab Rabbit Chow HF (Purina #5326), (125 g/day while on test) .
- Water (ad libitum): Automatic watering system, Municipal water supply (Elizabethtown Water Co.).
- Acclimation period: 57 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15.6- 21.1°C
- Humidity (%):30-70%
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark
IN-LIFE DATES:
Not specified
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: the dorsal area of the trunk
- % coverage: not specified
- Type of wrap if used: impervious plastic sleeve. The sleeve was secured with tape.
REMOVAL OF TEST SUBSTANCE
- Washing: with gauze and water
- Time after start of exposure: 24 hrs
TEST MATERIAL
- Amount(s) applied: 5.2 mL/kg
VEHICLE
Not applicable - Duration of exposure:
- 24 hours
- Doses:
- 5000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Viability Check: twice Dail y
Observations of Phamacologic and Toxicologic Signs: Approximately 1, 2 and 4 hours after dosing and daily thereafter for fourteen days.
Body Weights: Pre-test (at the time of clipping). Pre-dose (weights used for calculation of doses). Day 7 and 14
- Necropsy of survivors performed: yes (day 14)
- Other examinations performed: clinical signs, body weight,organ weights, histopathology - Statistics:
- No data
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no mortality occurred
- Mortality:
- All animals survived throughout the study.
- Clinical signs:
- other: Most animals exhibited severe dermal effects (necrosis, followed by eschar formation, and exfoliation of the eschar tissue) at a small portion or less than half the dose site which persisted throughout the study. Single occurrences of nasal discharge, and
- Gross pathology:
- Except for one animal which exhibited clear fluid in the abdominal cavity, other gross postmortem observations were similar to those seen in control animals in this laboratory or were considered to represent normal physiological variation.
- Other findings:
- Most animals had decreased food consumption on Days 2 and 3; this continued in a few animals through Day 7 .
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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