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Acute Toxicity: dermal

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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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
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

Constituent 1
Chemical structure
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.

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