1-propoxypropan-2-ol

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:

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

Test material information

Constituent 1

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 levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

4.92 mL/kg bw

95% CL:

3.58 - 6.78

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

2.83 mL/kg bw

95% CL:

1.61 - 4.98

Effect levels 3

Sex:

male

Dose descriptor:

LD50

Effect level:

4 330 mg/kg bw

95% CL:

3 150 - 5 976

Effect levels 4

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.