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EC number: 216-372-4 | CAS number: 1569-01-3
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: non-GLP study equivalent to OECD guideline 401
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 1-propoxypropan-2-ol
- EC Number:
- 216-372-4
- EC Name:
- 1-propoxypropan-2-ol
- Cas Number:
- 1569-01-3
- Molecular formula:
- C6H14O2
- IUPAC Name:
- 1-propoxypropan-2-ol
- Details on test material:
- - Name of test material (as cited in study report): PROPASOL Solvent P
- Physical state: clear, non-viscous liquid
- Lot/batch No.: #3251; S-066890
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 200 - 300 g
- Fasting period before study: overnight
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 8.0 ml/kg
- Doses:
- males: 2.0, 4.0, 8.0 ml/kg
females: 1.0, 2.0, 4.0 ml/kg
The relative density of Propasol Solvent P is 0.88 g/ml. - 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: weights were recorded at days 0 (before dose), 7, 14 (just prior to sacrifice)
- Necropsy of survivors performed: at death or sacrifice each animal is subjected to gross pathologic evaluation - Statistics:
- LD50's and the estimated LD50 slopes are calculated by the moving average method and are based on a 14-day observation period.
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 4.92 mL/kg bw
- 95% CL:
- 3.58 - 6.78
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 2.83 mL/kg bw
- 95% CL:
- 1.61 - 4.98
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 4 330 mg/kg bw
- 95% CL:
- 3 150 - 5 976
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 2 490 mg/kg bw
- 95% CL:
- 1 417 - 4 382
- Mortality:
- males (8.0 ml/kg): 5/5
males (4.0 ml/kg): 1/5
males (2.0 ml/kg): 0/5
females (4.0 ml/kg): 4/5
females (2.0 ml/kg): 1/5
females (1.0 ml/kg): 0/5 - Clinical signs:
- other: males (8.0 ml/kg): sluggishness, unsteady gait at 3 min; marked sluggishness at 5 min; prostration at 10 min; death of 1 at 1.5 h males (4.0 ml/kg): sluggishness, unsteady gait at 3 min; marked sluggishness at 10 min; lacrimation in 1 at 1 day; survirvors
- Gross pathology:
- males (8.0 ml/kg): lungs of 2 red; stomachs liquid-filled; glandular portion of 1 stomach red
males (4.0 ml/kg): in victim: lungs red; stomach liquid-filled; in survivors: nothing remarkable
males (2.0 ml/kg): nothing remarkable
females (4.0 ml/kg): in victims: lungs darks red; stomachs of 2 liquid-filled; in survivor: nothing remarkable
females (2.0 ml/kg): in victim: lungs red; stomach liquid-filled; in survivors: nothing remarkable
females (1.0 ml/kg): kidney of 1 small - Other findings:
- none
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the the LD50 value for male and female reported to be > 2000 mg/kg this material is not classified as acutely toxic according to EU criteria via oral ingestion.
- Executive summary:
Three groups of 5 male and 5 female Sprague-Dawley albino rats received by stomach intubation with a ball-end stainless steel needle dose levels of 8, 4, 2 ml/kg bw and 4, 2, 1 ml/kg bw, respectively. The LD50 for male rats receiving peroral doses of PROPASOL Solvent P was 4.92 ml/kg bw; that for females was 2.83 ml/kg bw. Signs of toxicity included sluggishness, unsteady gait, lacrimation, tremors (in one) and prostration. Most death occured at 1.5 hours to 3 days. One female succumbed at 6 days. Survivors recovered at 1 to 4 days. At necropsy, there were red lungs, liquid-filled stomachs, one red stomach (glandular section) and one small kidney.
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