1,2,3-Propanetriol, homopolymer

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1989

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study performed according to OECD guideline and according to GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

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:

1,2,3-Propanetriol, homopolymer

EC Number:

607-759-2

Cas Number:

25618-55-7

Molecular formula:

(C3 H8 O3)x

IUPAC Name:

1,2,3-Propanetriol, homopolymer

Test material form:

liquid: viscous

Details on test material:

- Name of test material (as cited in study report): Diglycerin
- Physical state: liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Strain: Hoe WISKf(SPF71)
- Source: Hoechst AG Kastengrund - SPF breed
- Weight at study initiation: 173-190 g (male); (mean = 182 g; s = ± 7; n = 5); 166-180 g (male); (mean = 176 g; s = ± 6; n = 5)
- Age at study initiation: 7 weeks (males); 8 weeks (females)
- Fasting period before study: 16 hours before and 3-4 hours after application
- Diet: Altromin 1324 (Altromin GmbH, Lage/Lippe), ad libitum
- Water: Tap water ad libitum
- Acclimatization period: minimum 5 days

ENVIRONMENTAL CONDITIONS
- Housing: in groups of 5 animals, in plastic cages, softwood pellets
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 50 +/- 20%
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

- concentration in vehicle: 20 % (w/w)

Doses:

2000 mg/kg bodyweight

No. of animals per sex per dose:

5 male rats, 5 female rats

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations after application / Weighing once weekly
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred during the study.

Clinical signs:

other: No clinical signs were observed during the course of the study.

Gross pathology:

Dissection of rats killed at the end of the observation period revealed no macroscopic findings.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The median lethal dose of the test item (LD50) after single oral administration to male and female rats is greater than 2000 mg/kg body weight.

Executive summary:

The acute oral toxicity of the test item was investigated in 5 female and 5 male rats using purified water as vehicle. The study was performed according to OECD test guideline 401 and followed the principles of GLP. All animals were administered the test compound by single-dose gavage at a dose-level of 2000 mg/kg body weight. The observation period was 14 days. No deaths occurred during the study. Clinical signs of intoxication were also not observed during the course of the study. Body weight development was normal and within the range commonly recorded for this strain and age. At necropsy no macroscopic findings were recorded. Based on the findings of this limit-test the median lethal dosage (LD50) of the test item in male/female rats is greater than 2000 mg/kg body weight.