1,2,3-Propanetriol, homopolymer, docosanoate

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: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Polyglycerintribehenat

IUPAC Name:

Polyglycerintribehenat

Details on test material:

- Name of test substance: Polyglycerintribehenat
- Batch number: Partie 29
- Degree of purity/content: 85.8% behenic acid bound as behenic ester, 13.0% polyglycerin
- Date of manufacture: 02-Feb-1996
- Physical state/appearance: solid (congealed melt), beige at room temperature; liquid, beige at about 85 °C; powder, white after grinding the cooled down test substance
- Storage conditions: room temperature
- Stability and homogeneity: The stability of the test substance over the study period has been proven by reanalysis. The stability and homogeneity of the test substance in olive oil DAB 10 has not been determined analytically. The homogeneity of the test substance preparations was provided by stirring.

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach, FRG
- Age at study initiation: young adult animals
- Weight at study initiation: animals of comarable weight (150 - 300 g; ± 20% of the mean weight)
- Fasting period before study: at least 16 hours before administration
- Housing: single housing in stainless steel wire mesh cages, type DK-III (Becker & Co., Castrop-Rauxel, FRG)
- Diet: Kliba-Labordiaet 343 (Klingentalmuehle AG, Kaiseraugst, Switzerland) ad libitum
- Water: tap water ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Remarks:

DAB 10

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/kg: 4 g/100 ml; 2000 mg/kg: 40 g/100 ml
- Justification for choice of vehicle: the test substance cannot be homogenized in water

DOSE VOLUME APPLIED: 5 ml/kg

Doses:

200; 2000 mg/kg

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: A check for any dead or moribund animals was made twice each workday and once on Saturdays, Sundays and on public holidays. Clinical signs and symptoms were recorded several times on the day of administration, at least once each workday for the individual animals. Individual body weights were determined shortly before application (day 0), weekly thereafter and at the end of the study (before fasting period).
- 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.

Remarks on result:

other: no mortality

Mortality:

No mortality.

Clinical signs:

other: Male animals: impaired general state, poor general state, dyspnoea, apathy, staggering, piloerection; Female animals: no abnormality.

Gross pathology:

No pathologic findings noted.

Any other information on results incl. tables

Symptoms of the male animals (cageside observations):

Dose (mg/kg)	200	No. of animals	2000	No. of animals
Impaired general state	H3-H5	3/3	H2-D1	3/3
Poor general state	H0-H2	3/3	H2-H3	1/3
Dyspnoea	H0-H5	3/3	H2-D1	3/3
Apathy	H0-H2	3/3	H2-H3	1/3
Staggering	H0-H2	3/3
Piloerection	H1-H5	3/3	H2-D1	3/3

H: Hour; D: Day

 

Individual body weights (g):

Dose	200 mg/kg	Weight day:	0	7	13
Males		01	186	265	309
		02	175	244	278
		03	179	260	297
Females		01	175	203	216
		02	175	208	224
		03	173	206	219
Dose	2000 mg/kg	Weight day:	0	7	13
Males		01	179	252	289
		02	175	242	280
		03	175	247	285
Females		01	186	223	230
		02	178	206	210
		03	177	214	231

 

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information

Conclusions:

Under the conditions of this study the median lethal dose of the test substance after oral application was found to be greater than 2000 mg/kg body weight for the male and female animals.

Executive summary:

The study was performed to assess the acute toxicity following oral administration of the test substance, applied as a suspension in olive oil DAB 10, in Wistar rats. The study procedure was based on the EEC gudeline and modified according to the acute toxic class method. To each group of six fasted animals (three males and three females) a single oral dose of the test material preparation in olive oil DAB 10 at dose levels of 200 and 2000 mg/kg body weight was given.

Signs of toxicity noted in male animals of the 200 and 2000 mg/kg dose groups comprised impaired or poor general state, dyspnoea, apathy and staggering. These symptoms are considered to be unspecific toxicity symptoms. The animals appeared normal within 2 days after application. The female rats of both dose groups did not show any signs of toxicity. The expected body weight gain was oberved in the course of the study. No mortality occured. No abnormalities were noted at necropsy of animals sacrificed at the end of the study.

Conclusion: Under the conditions of this study the median lethal dose of the test substance after oral application was found to be greater than 2000 mg/kg body weight for the male and female animals.