Dodecanamide, N,N-dibutyl-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

438-530-3

EC Name:

-

Cas Number:

5343-44-2

Molecular formula:

C20H41NO

IUPAC Name:

N,N-dibutyldodecanamide

Details on test material:

- Name of test material (as cited in study report): N,N-dibutyldodecanamide (HAEL no. 94-0003, KAN 905762, CIN 10005762)
- Physical state: light yellow liquid
- Analytical purity: not reported
- Impurities (identity and concentrations): not reported
- Lot/batch No.: 1093-002
- Expiration date of the lot/batch: not reported

Test animals

Species:

rat

Strain:

other: CD®(SD)BR VAF/Plus™

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Kingston, NY, USA
- Age at study initiation: 6-7 weks (males), 7-8 weeks (females)
- Weight at study initiation: 148-167 g (males), 158-166 g (females)
- Fasting period before study: overnight
- Housing: individually in suspended, stainless steel, mesh cages
- Diet (e.g. ad libitum): Agway®Prolab™ diet, RMH 3000 (certified) pellets ad libitum (except for overnight fast prior to dosing)
- Water (e.g. ad libitum): mains water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 68-73°F
- Humidity (%): 47-59%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light

IN-LIFE DATES: From: 10 February 1994 To: 30 March 1994

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed 3 times on the day of dosing and once daily thereafter. Observations included, but were not limited to, changes in the skin and fur; faeces and urine; eyes and mucous membranes; respiratory, circulatory, autonomic, and central nervous systems; and somatomotor activity and behaviour pattern. Body weights were recorded on Days 0 (proir to treatment), 7 and 14
- Necropsy of survivors performed: yes

Statistics:

No (limit dose)

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

None

Clinical signs:

other: None

Gross pathology:

No treatment-related changes noted at necropsy

Any other information on results incl. tables

No abnormal clinical signs were noted at any time during the 14 -day observation period. No mortality was observed, and all animals gained weight. No treatment-related changes were observed at necropsy, and no tissues were collected for histological examination.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral LD50 of N,N-dibutyldodecanamide was greater than 2000 mg/kg for male and female rats.

Executive summary:

In an acute oral toxicity study, male and female rats were administered a single limit dose of 2000 mg N,N-dibutyldodecanamide/kg by gavage. The test material was administered as received. No abnormal clinical signs were noted at any time during the 14-day observation period. No mortality was observed, and all animals gained weight. No treatment-related changes were observed at necropsy.

The acute oral LD50 for N,N-dibutyldodecanamide was greater than 2000 mg/kg for male and female rats.