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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2001 - 2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

24-02-1987

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

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: 5 m / 5 f per group
Age when treated: 9 - 12 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: Makrolon type-4 or type-3 cages
Diet: Pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet ad libitum.
Water: Community tap-water, from Itingen ad libitum.

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

One day before treatment, the backs of the animals were clipped with an electric clipper, exposing an area of approximately 10 % of the total body surface. Only those animals without injury or irritation on the skin were used in the test.
On test day 1, the test item was applied at a dose of 1840 mg/kg body weight or 2000 mg/kg evenly on the intact skin with a syringe and covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and fixed with an elastic adhesive bandage.
Application volume/kg body weight: 2 or 2.2 mL/kg
Twenty-four hours after the application the dressing was removed and the skin was flushed with lukewarm tap water and dried with disposable paper towels. Thereafter, the reaction sites were assessed.

Duration of exposure:

24 h

Doses:

1840 or 2000 mg/kg bw

No. of animals per sex per dose:

5 m / 5 f

Control animals:

no

Details on study design:

Mortality: Daily during acclimatization and twice daily during days 1-15
Body weight: On test days 1 (pre-administration), 8 and 15
Clinical signs: Daily during acclimatization and at least four times on test day 1 after the test item administration. Once daily during days 2-15
Necropsy: All animals at the end of the observation period

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 deaths occurred during the study

Clinical signs:

other: Slight scales were observed in one female dosed with 1840 mg/kg on test day 8 until test day 12. All other animals were without clinical signs.

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:

A group of five male and five female HanBrl: WIST (SPF) rats was treated with the test item at 1840 mg/kg by dermal application. The test item was used undiluted and administered at a volume of 2 mL/kg.

A second group of five male and five female HanBrl: WIST (SPF) rats was treated with the test item at 2000 mg/kg by dermal application. The test item was used undiluted and administered at a volume of 2.2 mL/kg.

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

No deaths occurred during the study. Slight scales were observed in one female dosed with 1840 mg/kg on test day 8 until test day 12. All other animals were without clinical signs. 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.