Sodium 5-oxo-1-palmitoyl-L-prolinate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

24.February.1998-10.March.1998

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

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:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sodium 5-oxo-1-palmitoyl-L-prolinate

EC Number:

261-406-3

EC Name:

Sodium 5-oxo-1-palmitoyl-L-prolinate

Cas Number:

58725-33-0

Molecular formula:

C21H38NNaO3.Na

IUPAC Name:

sodium (2S)-1-hexadecanoyl-5-oxopyrrolidine-2-carboxylate

Test material form:

other: white paste

Details on test material:

Test material:
Identification, reference: CS80602
Batch: 98034300
Appearance: white paste
Quantity received, packaging: 100 g, plastic jar
Date of receipt: february 11, 1998
Laboratory reference: 98-0437
Analytical sheet: not supplied
Homogeneity test: not required for less than 28 days studies
Storage: at room temperature, away from the light

Specific details on test material used for the study:

Test material:
Identification, reference: CS80602
Batch: 98034300
Appearance: white paste
Quantity received, packaging: 100 g, plastic jar
Date of receipt: february 11, 1998
Laboratory reference: 98-0437
Analytical sheet: not supplied
Homogeneity test: not required for less than 28 days studies
Storage: at room temperature, away from the light

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Reason for species selection : the Rat is the animal chosen by the regulatory authorities to evaluate the safety of drugs and chemicals.
Number and sex : 10 animals: 5 males and 5 females
Age, weight: about 6 weeks, weight between 183 g and 204 g (males) and 167 g and 178 g (females) at the beginning of the study.
Acclimatization: at least 5 days
Housing, diet: 5 animals by sex in polypropylene cages (310 x 465 x 190) in accordance with the requirements of the 86/609/EEC guideline. Complete pelleted rat maintenance diet UAR A04-10 (91360 - EPINAYSURORGE, FRANCE).

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

The day before the test, animals have been fasted prior to substance administration by withholding food and the product was placed at a temperature of 40°C in order to liquefy it. The next day, they received by gavage, according to the bodyweight, the product diluted with distilled water (Meram batch 62421) at the single dose of 2000 mg/kg under a constant volume of 5 ml/kg. The administered preparation was kept up under magnetic stirring during the treatments.
Reason for route of administration: Oral gavage is the route of choice for estimating potential adverse effects resulting from accidental oral ingestion.

Doses:

2000 mg/kg under a constant volume of 5 ml/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

The animals were observed daily for 14 days after the treatment.

Clinical examinations:
- a clinical observation was carried out at least once a day in order to evaluate the general appearance, the behaviour and vegetative functions of the animals. An individual clinical observation was realized one hour after treatment. The continuous observations during the five following hours were renewed each following day.
- body weights were taken just prior to the test material administration (D1) and again on days 4, 8 and 15.

Macroscopic examinations:
At termination of the 14 observation days, the rats were sacrificed after barbituric anaesthesia, then autopsied. All abnormalities were recorded.
No tissue was saved.

Results and discussion

Preliminary study:

no

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD0

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred

Clinical signs:

other: During the first hour following the treatment, a slight piloerection was observed in all the animals. During the 5 following hours, no modification in the aspect, behaviour or vegetative functions was observed. The daily examinations which were repeated t

Gross pathology:

The gross necropsy of the animals 14 days after the treatment did not show any visible organic or tissular lesions leading us to suspect a possible systemic toxicity of the product. Under the experimental conditions adopted, the oral LD0 of the test material CS80602 in male and female Rat is higher than 2000 mg/kg.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The single oral administration of the preparation CS80602 in the male and female Rat at the dose of 2000 mg/kg:
- did not cause any death, - had no significant toxic effect on the animals' behaviour or vegetative functions, - did not modify their weight growth, - did not cause any gross lesion visible at autopsy.
Under the experimental conditions adopted, oral LD0 of the test preparation is higher than 2000 mg/kg in the Rat.
According to the 67/548/EEC directive, the test preparation is unclassified ifswallowed.

Executive summary:

The single oral administration of the preparation CS80602 in the male and female Rat at the dose of 2000 mg/kg:

• did not cause any death,


• had no significant toxic effect on the animals' behaviour or vegetative functions,


• did not modify their weight growth,


• did not cause any gross lesion visible at autopsy.

Under the experimental conditions adopted, oral LD0 of the test preparation is higher than 2000 mg/kg in the Rat.

According to the 67/548/EEC directive, the test preparation is unclassified if swallowed.

 

In conclusion, the LD50 of the test item LCA08009 is higher than 2000 mg/kg body weight by dermal route in the rat.

According to the criteria for classification, packaging and labelling of dangerous substances and preparations in accordance with the E.E.C. Directives 67/548, 2001/59 and 99/45, the test item LCA08009 must not be classified. No symbol and risk phrase are required. In accordance with the Globally Harmonized System (COM(2007)355 final), the test item must not be classified in category 4.

No signal word and hazard statement are required.