Amines, C14-16 (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:

1984-9-13 to 1984-10-18

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Consumer Product Safety Commission Protocol

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Amines, C14-16 (even numbered) -alkyldimethyl, N-oxides

IUPAC Name:

Amines, C14-16 (even numbered) -alkyldimethyl, N-oxides

Details on test material:

- Name of test material (as cited in study report): Ammonyx MCO (30% active)
- Lot/batch No.: 01-41

Test animals

Species:

rat

Strain:

other: CD

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River
- Age at study initiation: No data
- Weight at study initiation: 200-300 g
- Fasting period before study: 18 hours
- Housing: raised wire mesh cages
- Diet: Lab Blox ad libitum
- Water: ad libitum
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): Air conditioned quarters
- Photoperiod (hrs dark / hrs light): No data

Administration / exposure

Route of administration:

other: Rigid stomach tube

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Following administration of each dose level the animals were observed for fourteen days for signs of toxicity.

Doses:

0.4 mL per 100g bodyweight equating to 4.0 g/kg boidyweight
0.5 mL per 100 g bodeweight equating to 5.0 g/kg bodyweight
0.7 mL per 100 g bodyweight equating to 7.0 g/kg bodyweight

No. of animals per sex per dose:

5 males and 5 females per dose level

Control animals:

no

Details on study design:

The animals were examined daily and mortality recorded. An autopsy was performed if autolysis had not occurred.

Statistics:

The method of Litchfield and Wilcoxon was used to calculate the oral LD50 (see Table 1, attached)

Results and discussion

Preliminary study:

No data

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

5 600 mg/kg bw

Based on:

test mat.

Remarks on result:

other: aqueous solution as manufactured and supplied containing 30 %w/w AO

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 680 mg/kg bw

Based on:

act. ingr.

Mortality:

See Table 1 (attached)

Clinical signs:

other: See Table 1 (attached)

Gross pathology:

Autopsy were performed on rats that did not show any signs of autolysis. At autopsy, no macroscopic changes were noted in any of the internal organs.

Other findings:

No data

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The LD50 was calculated to be 5.6 g/kg bodyweight based on test material. This result equates to an LD50 of 1680 mg/kg bodweight based on active ingredient.