Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: oral

Currently viewing:

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:
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.