Glycine, N, N' - (1,9-nonandeiyl) bis-, monopotasium salt

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

GLP compliance:

yes

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

470-270-6

EC Name:

-

Cas Number:

477773-67-4

Molecular formula:

C13H22N2O6K

IUPAC Name:

Glycine, N, N' - (1,9-nonandeiyl) bis-, monopotasium salt

Test material form:

solid

Test animals

Species:

rat

Strain:

Wistar

Remarks:

Han:RCC:WIST(SPF)

Sex:

female

Details on test animals or test system and environmental conditions:

Conditions
Standard Laboratory Conditions.
Air- conditioned with 10-15 air changes per hour, and continuously monitored enviironment with ranges for room tempertaure 22 +- 3°C and for relative humidity between 30-70% (values above 70% during cleaning process possible), automatically controlled light cycle of 12 hours light and 12 hours dark, music during the daytime light period.
Accomodation
In groups of three in Makrolon type-4 cages witj wire mesh tops and standard softwood bedding
Diet
Pelleted standard Provimi Kliba 3433 rat /mouse maintenance diet, batch no 80/86n ad libitum
Water
Community tap water from Fullinsdorf ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Doses:

The dose formulations were made shortly before each dosing occasion using a magnetic stirrer and a spatula as homogenizers.
The test item was first ground with a pestle and mortar and, thereafter, weighed into a tared glass beaker on a suitabe precision balance and tjhe vehicle added (weigjt-volume).
Homogeneity of the test item in the vehicle was maintained during administration using a magnetic stirrer.

The dosing voume was 10 mL/Kg body weight.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No deaths occured during the study.

Clinical signs:

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

Body weight:

The body weight of the animals was within the range commonly recorded for this strain and age.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The median lethal dose of the substance after single orl administration to female rats, observed over a period of 14 days is: LD50 (female rat): grater than 2000 mg/Kg body weight