Glycine, N-methyl-N-(1-oxododecyl)-, 1-methylethyl ester

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

22-03-1996

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Specific details on test material used for the study:

Identity: ISOPROPYL N-LAUROYLSARCOSINATE
Description: pale yellow liquid
Batch number: 002013
Purity: 92.9 %
Stability of test item: stable under storage conditions
Expiry date: 31-03-2003

Test animals

Species:

rat

Strain:

Wistar

Remarks:

HanBrl:WIST (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

Test system: Rat, HanBrl: Wist (SPF)
Rationale: Recognized by the international guidelines as a recommended test system
Source: RCC Ltd., Füllinsdorf / Switzerland
Number of animals: 3 m / 3 f
Age when treated: 8 - 10 weeks
Acclimatization: Under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.

Husbandry
Standard Laboratory Conditions. Air-conditioned with 10-15 air changes per hour, and continuously monitored environment with target ranges for temperature 22 +/- 3°C and for relative humidity between 30-70 %. 12 hours fluorescent light/12 hours dark, music during the light period.
Accommodation: Groups of three per sex in Makrolon type-4 cages with wire mesh tops and standardized softwood bedding.
Diet: Pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet ad libitum.
Water: Community tap-water, from Itingen ad libitum.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Remarks:

PEG 300

Details on oral exposure:

Dose levels were in terms of test item as supplied unless otherwise stated by the sponsor. The preparations were made shortly before each dosing. The test item was weighed into a tared glass beaker on a suitable precision balance and the vehicle added (weight:volume). The mixtures were prepared using a magnetic stirrer. Homogeneity of the test item in the vehicle was maintained during administration using a magnetic stirrer.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3 m / 3 f

Control animals:

no

Details on study design:

The animals received a single oral dose of the test item by gavage at 2000 mg/kg body weight after being fasted for 16 to 20 hours (access to water was permitted). Food was provided again approximately 3 hours after dosing. The application volume was 10 mL/kg body weight.

Statistics:

No statistical analysis was used.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

No death occurred during the study.

Clinical signs:

other: No clinical signs were noted during the course of the study.

Gross pathology:

No macroscopic findings were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The median lethal dose of the test item was > 2000 mg/kg bw.

Executive summary:

One group of three male or three female HanBrl: WIST (SPF) rats was treated by oral gavage with the test item at 2000 mg/kg bw. The test item was suspended in vehicle (PEG 300) at a concentration of 0.2 g/mL and administered at a volume of 10 mL/kg.

The animals were examined for clinical signs daily during the acclimatization period, four times during test day 1 and once daily during test days 2-15. Mortality/viability was recorded daily during the acclimatization period and together with clinical signs at the same time intervals on test day 1 and twice daily on test days 2-15. Body weights were recorded on day 1 (prior to administration) and on days 8 and 15. All animals were necropsied and examined macroscopically.

All animals survived until the end of the study period. No clinical signs were evident during the course of the study. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were observed at necropsy.

The median lethal dose of the test item was > 2000 mg/kg bw.