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Acute Toxicity: oral

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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:
1986
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

Constituent 1
Chemical structure
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

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:
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 recovered at 4 days
males (2.0 ml/kg): sluggishness at 20 min to 3 hr; recovery at 1 day

females (4.0 ml/kg): sluggishness, unsteady gait at 8 min; marked sluggishness at 45 min to 2 hr; prostration, lacrimation at 1 day; survivor recovered at 4 days
females (2.0 ml/kg): sluggishness, unsteady gait at 10 min; prostration at 1 day; lacrimation at 1 to 2 days; marked sluggishness, intermittend tremors, kyphosis in 1 at 2 days; survivors recovered at 1 to 4 days
females (1.0 ml/kg): none noted
Body weight:
All surviving animals showed body weight gain over the 14 day observation period.
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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