Amines, C12-14 (even numbered)-alkyldimethyl, N-oxides

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1977-11-18 - 1977-12-01

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

no

Remarks:

Pre-GLP

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Dodecyldimethylamine oxide

EC Number:

216-700-6

EC Name:

Dodecyldimethylamine oxide

Cas Number:

1643-20-5

Molecular formula:

C14H31NO

IUPAC Name:

dodecyl(dimethyl)amine oxide

Constituent 2

Reference substance name:

N,N-dimethyltetradecylamine N-oxide

EC Number:

222-059-3

EC Name:

N,N-dimethyltetradecylamine N-oxide

Cas Number:

3332-27-2

Molecular formula:

C16H35NO

IUPAC Name:

dimethyl(tetradecyl)amine oxide

Details on test material:

- Name of test material (as cited in study report): P7270 (dodecyl dimethyl amine oxide)
- Molecular formula (if other than submission substance): Unspecified
- Substance type: Pure active substance
- Physical state: Liquid
- Analytical purity: See confidential details on test substance
- Impurities (identity and concentrations): Not available
- Composition of test material, percentage of components: Not available
- Isomers composition: Not available
- Purity test date: Not available
- Lot/batch No.: Not available
- Expiration date of the lot/batch: Not available
- Stability under test conditions: Not available
- Storage condition of test material: Room temperature
- Other: None

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Ind.
- Age at study initiation: Not available
- Weight at study initiation: Male- 211 - 264 gm and Female- 190 - 232 gm
- Fasting period before study: 18-20 hours
- Housing: Individually housed in stainless steel cages with stainless steel grid flooring
- Diet (e.g. ad libitum): Purina Rat Chow manufactured by the Ralston Purina Co.
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: Minimum 4 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.7 - 22.8 °C
- Humidity (%): 46 - 63%
- Air changes (per hr): Not available
- Photoperiod (hrs dark / hrs light): 12 hours on/off fluorescent lighting


IN-LIFE DATES: From: 1977-11-18 To: 1977-12-01

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: Not applicable
- Amount of vehicle (if gavage): Not applicable
- Justification for choice of vehicle: Not applicable
- Lot/batch no. (if required): Not applicable
- Purity: Not applicable


MAXIMUM DOSE VOLUME APPLIED: 1.4 ml


DOSAGE PREPARATION (if unusual): None


CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: None

Doses:

1500, 2100, 3000, 4100, and 5800 mg P7270/kg bw which is equivalent to 420, 588, 840, 1148, and 1624 mg DDAO/kg BW

No. of animals per sex per dose:

5 males and 5 females per dose level

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observation was done at 1/4, 1/2, 1, 2 and 4 hours post-administration and daily thereafter for 14 days. Prefasted body weight was taken and on 14th day.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, mortality and gross pathology

Statistics:

LD50 was calculated using the computer program BLISS 17 (D. J. Finney)

Results and discussion

Preliminary study:

Not applicable

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

3 800 mg/kg bw

Based on:

test mat.

95% CL:

3 100 - 4 800

Remarks on result:

other: aqueous solution as manufactured and supplied containing 28 %w/w AO

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 064 mg/kg bw

Based on:

act. ingr.

95% CL:

868 - 1 344

Mortality:

0/5 males and 0/5 females at 1500 mg/kg
0/5 males and 2/5 females at 2100 mg/kg
1/5 males and 0/5 females at 3000 mg/kg
2/5 males and 4/5 females at 4100 mg/kg
5/5 males and 4/5 females at 5800 mg/kg

Clinical signs:

other: The gross toxic signs observed included decreased motor activity and salivation in all five test groups. Pilo erection was observed in the 4100 and 5800 mg/kg dose groups. Blanching and nasal hemorrhaging were observed in the 2100, 3000, 4100 and 5800 mg/

Gross pathology:

1500 mg/kg (male/female): Not remarkable observation
2100 mg/kg (male): Tan discoloration and pale lungs
(female): Gas and fluid in stomach and intestines
3000 mg/kg (males): Gas and fluid in stomach and intestines
(females): Petechiae on lungs
4100 mg/kg (males): Tan discoloration on lungs, fluid filled stomach and intestines, bright red lungs.
(females): Fluid in stomach, yellow fluid in small intestine, Gas and fluid in stomach and intestine, Fluid filled stomach and intestines and Tan discoloration on lungs.
5800 mg/kg (males): Liver- colored lungs, fluid filled stomach and small intestines, Tan discoloration and petechiae on lungs.
(females): Liver- colored lungs, fluid filled stomach and small intestines, Tan discoloration and petechiae on lungs, gas and fluid in
stomach.

Other findings:

- Organ weights: None
- Histopathology: None
- Potential target organs: None
- Other observations: None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Remarks:

Migrated information

Conclusions:

The LD50 of P7270 is 3800 mg/kg which is equivalent to 1064 mg AO/kg on an active DDAO level. Therefore this test material is classified under OECD GHS Toxicity Category IV.

Executive summary:

The LD50 of dodecyl dimethyl amine oxide is 1064 mg/kg bw based on an active substance level (3800 mg/kg nominal as P7270). Therefore it was concluded that this test substance belongs to OECD GHS Toxicity Category IV.