Reaction product of Saccharose, Glycerine, biodiesel propoxylated

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

22 Oct 2013 to 28 Nov 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted in compliance with OECD test guideline 423 and GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction product of Saccharose, Glycerine, biodiesel propoxylated

EC Number:

940-005-3

Molecular formula:

Unspecified

IUPAC Name:

Reaction product of Saccharose, Glycerine, biodiesel propoxylated

Test material form:

other: liquid

Details on test material:

Color of test item: red to brown, clear
Test item No.: 13/0453-1
Batch identification: T41/012/13
Purity: 100% UVCB
Homogeneity: The test item was homogeneous by visual inspection. Additionally, the homogeneity of the test item was ensured after shaking the test item container.
Storage conditions: room temperature

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

Strain: Crl:Wl (Han) SPF
Supplier: Charles River Wiga GmbH, Sulzfeld, Germany
Age on day 0: Young adult animals (female animals approx. 10 weeks)
Sex: Nulliparous and non-pregnant female animals were used for the test as suggested by the OECD guideline when there is no indication that male animals are likely to be more sensitive to the acute effects of the test item.
Arrival in the testing facility: Acclimatization period of at least 5 days before the beginning of the experimental phase; during the acclimatization period, the animals were accustomed to the environmental conditions of the study and to the diet.
Body weight on day 0: Animals of comparable weight (± 20% of the mean weight)
Room temperature/relative humidity: The animals were housed in fully air-conditioned rooms. Central air-conditioning guaranteed a range of 22°C ±
3°C for temperature and of 30 – 70% for relative humidity. There were no deviations from these ranges, which influenced the results of the study.
Air changes per hour: approx. 10
Day/night rhythm: 12 h/12 h
Housing: Makrolon cages (type III), single housing
Diet: The animals received a VRF1(P) diet (SDS Special Diets Services, Altrip, Germany) and tap water ad libitum.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Feed was withdrawn from the animals at least 16 hours before administration. The administration volume was 1.89 ml/kg bw.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

The test item was administered to 2 test groups of 3 fasted rats each.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortality occured.

Clinical signs:

other: No clinical signs were observed during clinical examination

Gross pathology:

There were no macroscopic pathological findings in the animals sacrificed at the end of the observation period (6 females).

Any other information on results incl. tables

Table 1. Effects on body weight.

Individual body weight changes
Dose (mg/kg bw):	2000					2000
Administration:	1					2
Animal No.:	R948	R949	R950	Mean weight	Standard-deviation	R960	R961	R962	Mean weight	Standard-deviation
Body weight at study day (g)
0	180	182	183	181.7	1.53	188	185	185	186.0	1.73
7	199	203	204	202.0	2.65	213	197	205	205.0	8.00
14	210	208	214	210.7	3.06	217	206	223	213.3	8.62

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this study the median lethal dose of Reaction product of Saccharose, Glycerine, biodiesel propoxylated after oral administration was found to be greater than 2000 mg/kg bw in rats.

Executive summary:

In an acute oral toxicity study performed according to the Acute Toxic Class method, 2000 mg/kg of the undiluted test item Reaction product of Saccharose, Glycerine, biodiesel propoxylated were administered by gavage to two test groups of three fasted Wistar rats each (2000 mg/kg bw in 6 females).

At 2000 mg/kg (first and second test group), no mortality occurred, and no clinical signs were observed. The mean body weight increased within the normal range throughout the study period with one exception in the second test group. One female showed

stagnation of body weight during the second week. There were no macroscopic pathological findings at the end of the observation

period.

The acute oral LD50 was calculated to be > 2000 mg/kg bw.