Reaction mass of 3-[3-(2,3-dihydroxypropoxy)-2-hydroxypropoxy]propane-1,2-diol and 3-(2,3-dihydroxypropoxy)propane-1,2-diol and 3-[3-[3-(2,3-dihydroxypropoxy)-2-hydroxypropoxy]-2-hydroxypropoxy]propane-1,2-diol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

3 - 19 September 1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study was performed according to OECD guidelines and according to GLP principles.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Polyglycerol-3

IUPAC Name:

Polyglycerol-3

Details on test material:

- Name of test material (as cited in study report): Polyglycerol-3
- Substance type: yellowish, clear, viscous liquid
- Physical state: liquid
- Analytical purity: active component 100%
- Composition of test material, percentage of components: in addition to diglycerol containing the higher condensated oligomers of glycerol like triglycerol, tetraglycerol and pentaglycerol.
- Isomers composition:
- Purity test date:
- Lot/batch No.: 3603 1195
- Expiration date of the lot/batch: after 2 years (25°C, closed bottle)
- Stability under test conditions: stable
- Storage condition of test material: ambient
- Other: Density 1.29 g/ml

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Fa. Harlan Winkelmann GmbH, Borchen, Germany
- Strain: Hsd/Cpb: WU
- Weight at study initiation: males: 226-229 g, females: 162-195 g
- Fasting period before study: 16 hours
- Housing: collective housing up to maximum of 5 animals per cage (Makrolon type III).
- Diet (e.g. ad libitum): free access
- Water (e.g. ad libitum): free access
- Acclimation period: range finding: 34 days, main study 8 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 1.55 ml/kg b.w.

Doses:

2000mg/kg b.w.

No. of animals per sex per dose:

5

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: day 0 (before treatment), 7 and 14 (after treatment)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs at frequent intervals, necropsy

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortality occurred.

Clinical signs:

other: No abnormal clinical signs were observed apart from hematuria in one female animal.

Gross pathology:

Gross pathological examinations at day 14 after treatment revealed abnormal findings in only one female rat (the one with the decreased body weight). The mucosal membrane of the urinary bladder showed dark-red color and gravelly surface.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral toxicity of Polyglycerol-3 was investigated in 5 male and 5 female Wistar rats. A single oral dose of 2000 mg/kg b.w. was administrated to all rats. Clinical observations were conducted during 14 day observation, body weight was measured at days 0, 4 and 14, gross pathological examinations were performed on all animals on day 14. In result, no abnormal clinical signs were observed. Weight gains were normal in all animals apart from a decreased body weight in one female and a reduced weight gain in two females on day 14. Gross pathological examinations at day 14 (terminal necropsy) revealed abnormal findings in one female rat which may be test substance dependent. According to requirements of the limit test, the LD50 values 24h and 14 days were > 2000 mg/kg b.w. (males and females).