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

Endpoint summary

Description of key information

Acute oral toxicity:

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.

Acute dermal toxicity:

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.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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

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

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

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.

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.

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

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

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

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

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.

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

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

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Justification for classification or non-classification

In both studies with oral and dermal dosing, LD50 values of > 2000 mg/kg were obtained. Therefore, there is no need for classification and labelling of the test item according to CLP Regulation 1272/2008/EG.