Ammonium N-methyl-N-(1-oxododecyl)glycinate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

17 Feb - 29 Mar 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Version / remarks:

2008

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Ammonium N-methyl-N-(1-oxododecyl)glycinate

EC Number:

268-130-2

EC Name:

Ammonium N-methyl-N-(1-oxododecyl)glycinate

Cas Number:

68003-46-3

Molecular formula:

C15H29NO3.H3N

IUPAC Name:

ammonium 2-(N-methyldodecanamido)acetate

Test animals

Species:

rat

Strain:

other: Crl:WI

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland GmbH, Sulzfeld, Germany
- Weight at study initiation: 220 - 282 g
- Housing: The rats were caged in macrolone cages (type 3) individually during the 24 h application and separately according to sex in groups of 2 or 3 during the remaining time. The animals were provided with specific environment material such as hay bricks (Provimi Kliba AG, Kaiseraugust, Switzerland) as well as hiding tunnels of polycarbonate (Plexx, Netherlands). Lignocel-Granulat (Altromin, Lage, Lippe, Germany) served as bedding material.
- Diet: pelleted diet Altromin 1324 (Altromin, Lage, Lippe, Germany), ad libitum
- Water: tap water acidified with hydrochloric acid, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: back/flanks (6 x 8 cm)
- Type of wrap if used: The test material was applied onto the shaved skin and covered with 4-layered gauze which was fixed with adhesive tape (Gothaplast) by wrapping the trunk of the animals.

REMOVAL OF TEST SUBSTANCE
- Washing: The bandage and gauze were removed after the exposure time and residual test material was removed using mild soap and lukewarm water.
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied: 1 mL/kg bw

Duration of exposure:

24 h

Doses:

2000 mg/kg bw (range finding study)
2000 mg/kg bw (main study)

No. of animals per sex per dose:

1 female (range finding study)
5 males and 5 females (main study)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Each rat was observed for mortality and clinical signs 1, 3 and 6 h after test material application and thereafter daily for a period of 14 consecutive days. Body weights were recorded on days 0, 7 and 14.
- Necropsy of survivors performed: yes

Results and discussion

Preliminary study:

The animal showed piloerection one and three hours after test material application of a dose of 2000 mg/kg bw. Six hours after test material application as well as from day 1 to the end of the observation period on day 14, the animal was free of any abnormalities. After termination of the 24 h application on day 1, a slight to well defined erythema (grade 2) was displayed on the treated skin areas, but no edema was observed. On day 2, a very slight erythema (grade 1) was still observed, whereas no skin reactions were recorded on day 3 until the remaining study period.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: very slight to slight erythema and very slight edema were observed up to day 3 after test material application but fully reversible within 4 days

Mortality:

No mortality occurred during the study period.

Clinical signs:

other: Both, all female and male animals did not show any abnormalities after the dermal application of a dose of 2000 mg/kg bw during the entire 14-day observation period.

Gross pathology:

All animals did not display any pathological alterations during macroscopically examination.

Other findings:

On day one, a very slight erythema (grade 1) was observed in 2/10 animals, whereas a slight to well defined erythema (grade 2) was observed in 7/10 animals. Additionally, a very slight edema (grade 1) was observed in 2/10 animals. On day 2, very slight erythema (grade 1) were observed in 5/10 animals and a slight to well defined erythema (grade 2) was recorded in 4/10 animals. Very slight erythema (grade 1) were also observed in 3/10 animals on day 3 after test material application. Furthermore, the treated skin areas of 6/10 animals displayed isolated scales (day 3). However, all skin reactions were fully reversible within 4 days after application of the test material until the end of the study period.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.