Propane-1,2-diol, propoxylated

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Test procedure in accordance with national standard methods.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

Guideline not mentioned in report.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Propane-1,2-diol, propoxylated

EC Number:

500-039-8

EC Name:

Propane-1,2-diol, propoxylated

Cas Number:

25322-69-4

Molecular formula:

(C3 H6 O)n H2 O n= >1 - <4.5

IUPAC Name:

propane-1,2-diol, propoxylated

Details on test material:

Name: Propane-1,2-diol propoxylated
Molecular weight: Mn = 260 g/mole

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ORGANISMS: Rat, Sprague-Dawley
- Source: Charles RiverLabs Inc., Wilmington, MASS. USA
- Age: 6-10 weeks
- Weight at study initiation: females 164-180g; males 234-246 g
- Group size: 5M+5F rats/dose level (for limit test), 1M+1F in the range finding test.
- Controls: No

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

ADMINISTRATION: Oral gavage
- Doses: 5000 mg/kg (based on a range finding test)
- Doses per time period: Single
- Volume administered or concentration: undiluted
- Post dose observation period: 14 days

Doses:

5000 mg/kg

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

EXAMINATIONS: Clinical observations were made at 1, 4 and 24 hours after dosing and daily throughout the observation period. Bodyweights were recorded on days 0, 7 and 14. Gross pathological examination was carried out.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

In the limit test 1M+1F died within 24 hours of dosing, 1F died on the day after dosing.

Clinical signs:

other: Clinical signs included decreased avtivity, abnormal gait and stance, diarrhoea, dyspnoea, prostration and tremors.

Gross pathology:

In premature decedents mottled lungs, distended and/or fluid filled stomachs and intestines were observed. Necrospy findings in survivors at termination were unremarkable.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral LD50 for this propoxylated 1,2-propanediol (Molecular weight 230) is >5000 mg/kg. Clinical signs of intoxication were observed up to 48 hours after dosing.