N,N-dimethyldecylamine N-oxide

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

24 May - 01 August 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N,N-dimethyldecylamine N-oxide

EC Number:

220-020-5

EC Name:

N,N-dimethyldecylamine N-oxide

Cas Number:

2605-79-0

Molecular formula:

C12H27NO

IUPAC Name:

decyl(dimethyl)amine oxide

Test material form:

other: aqueous solution

Details on test material:

- Name of test material (as cited in study report): N,N-dimethyldecylamine-N-oxide (solution)
- Substance type: colourless to yellowish liquid
- Analytical purity: 40.5% active (aqueous solution)
- Impurities (identity and concentrations): peroxide: 0.01%, free amine: < 0.5%
- Purity test date: 2011-11-14
- Lot/batch No.: 1108042301
- Expiration date of the lot/batch:2 years in original closed packaging
- Storage condition of test material: 10 - 25°C

Test animals

Species:

rat

Strain:

other: CD/ Crl: CD(SD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at study initiation: Approximately 8 weeks old
- Weight at study initiation: males 250-262 g; females 208-223 g
- Fasting period before study: 16 h
- Housing: During the 14-day observation period the animals were kept singly in MAKROLON cages (type III plus).
- Diet: Commercial diet, ssniff® R/M-H V1534 (ssniff Spezialdiäten GmbH, 59494 Soest, Germany served as food ad libitum. Feeding was discontinued approx. 16 hours before administration
- Water: Drinking water in bottles was offered ad libitum.
- Acclimation period: At least 5 adaptation days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12h/12h

IN-LIFE DATES: From: To: 01 June 2012-26 June 2012

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 5cmx6cm
- % coverage: approximately 10%
- Type of wrap if used: 8 layers of gauze covered with a plastic sheet and secured with adhesive plaster

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not applicable
- Time after start of exposure: not applicable

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5.08 mL/kg bw
- Concentration (if solution): 40.5 % w/w
- Constant volume or concentration used: not applicable
- For solids, paste formed: not applicable

VEHICLE
- Amount(s) applied (volume or weight with unit): Test material supplied as aqueous solution
- Concentration (if solution): 40.5 %w/w
- Lot/batch no. (if required): not applicable
- Purity: not applicable

Duration of exposure:

24 hours

Doses:

2000 mg AO/kg bw

No. of animals per sex per dose:

5 animals/sex/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were performed before and immediately, 5, 15, 30 and 60 min, as well as 3, 6 and 24 hours after administration. All animals were observed daily for a period of 14 days. Individual body weights were recorded before administration of the test item and thereafter in weekly intervals up to the end of the study. Changes in weight were calculated and recorded.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, skin reactions

Statistics:

not applicable

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

act. ingr.

Mortality:

No deaths during the study

Clinical signs:

other: No clinicals signs of toxicity

Gross pathology:

No macroscopic findings were observed at necropsy

Other findings:

skin reactions - no skin reactions were seen in any of the animals

Any other information on results incl. tables

TABLE 1: Summarised results

 

Symptoms/ Criteria	N,N-dimethyldecylamine-N-oxide 2000 mg/kg b.w. (n=5)
	Males	Females
Clinical signs	None	None
Skin reactions	None	None
Mortality Within 6h Within 24 h Within 7d Within 14 d	0 0 0 0	0 0 0 0
Mean body weight (g) Start After 7 days After 14 days	255.4 317.4 (+24.3 %) 370 (+44.9 %)	216.4 235.4 (+8.8 %) 256.0 (+18.3 %)
Inhibition of body weight gain	None	None
Necropsy findings	None	None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute dermal LD50 is > 2000 mg AO/kg bw

Executive summary:

Test Guideline

OECD Guideline 402 and EC Method B3

Method and material

C10 AO was applied to the shaved backs of CD rats (5 male/5 female) at a dose of 2000 mg AO/kg bw. An occlusive bandage was applied and the rats exposed for a period of 24 hours. After exposure the bandage was removed and the rats observed for 14 days for mortality, clinical signs and skin reactions. At the end of the study all animals were necropsied and examined macroscopically.

Results

There were no deaths and no clinical signs of toxicity. No skin reactions were observed in any of the animals and there were no macroscopic findings at necropsy. Bodyweight gain was normal.

The acute dermal LD50 is > 2000 mg AO/kg bw.

Conclusion

In accordance with CLP Regulation (EC) No 1272/2008 the substance is not classified for acute dernal toxicity.