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Diss Factsheets

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

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.