Glycerol, 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: 1a Guideline study. Study was conducted in accordance to GLP and OECD guideline 401.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Glycerol, propoxylated

EC Number:

500-044-5

EC Name:

Glycerol, propoxylated

Cas Number:

25791-96-2

Molecular formula:

(C3 H6 O)n (C3 H6 O)n (C3 H6 O)n C3 H8 O3 n=>1-<6.5 mol PO

IUPAC Name:

alpha, alpha’, alpha’’-1,2,3-propanetriyltris[w-hydroxypoly(oxy-methyl-1,2-ethanediyl)]

Details on test material:

Test substance: Propoxylated glycerol mw 300 (NLP) described as a colourless viscous liquid, purity not reported.
Batch Number: 0133759A
Purity: 99.98%, Contains 200 ppm antioxidant.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, Manston, Kent, UK
- Age at study initiation: 5-8 weeks
- Weight at study initiation: males 134-156g; females 132-150g

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: undiluted

Doses:

2000 mg/kg

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Bodyweights were recorded on the day of dosing and on days 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: At the end of the study all animals were subject to gross necropsy, macroscopic abnormalities were recorded, no tissues were retained.

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Effect levels 2

Sex:

male/female

Dose descriptor:

LD0

Effect level:

>= 2 000 mg/kg bw

Remarks on result:

other: No signs of systemic toxicity observed at 2000 mg/kg bw.

Mortality:

No animals died.

Clinical signs:

other: There were no signs of systemic toxicity. All rats gained in bodyweight over the observation period.

Gross pathology:

Unremarkable.

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

The rat oral LD50 for this glycerine/propylene oxide adduct mw 300 is >2000 mg/kg. No adverse effects were observed at this dose level.