Dodecanamide, N,N-dibutyl-

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment.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 402 (Acute Dermal 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 weeks (males), 7 weeks (females)
- Weight at study initiation: 136-166 g (males), 150-172 g (females)
- Fasting period before study: no
- Housing: individually in suspended, stanless steel, mesh cages
- Diet (e.g. ad libitum): Agway®Prolab™ diet, RMH 3000 (certified) pellets ad libitum
- Water (e.g. ad libitum): mains water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 67-73°F
- Humidity (%): 49-59%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light

IN-LIFE DATES: From: 15 February 1994 To: 19 April 1994

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: not reported
- % coverage: not reported
- Type of wrap if used: fibre pad covered with an occlusive wrap

REMOVAL OF TEST SUBSTANCE
- Washing (if done): any residual test material was removed with running water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg

Duration of exposure:

24 hours

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 during the exposure period (day 0) and then 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 collected on Days 0 (prior 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

Other findings:

Incidental findings in the urinary tract of a single female rat included bilateral hydronephrosis, a thickened urinary bladder wall, and distension of the urinary bladder and both ureters with urine. Gross examination of the urethra failed to detect evidence of an obstruction. The urinary tract changes were considered not to be exposure-related.

Any other information on results incl. tables

No abnormal clinical signs were evident at any time during the 14 -day observation period. All animals survived to scheduled necropsy, and all gained weight normally. No treatment-related changes were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

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

Executive summary:

In an acute dermal toxicity study, male and female rats were administered a single limit dose of 2000 mg N,N-dibutyldodecanamide/kg. 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-dibutyldodecenamide was greater than 2000 mg/kg for male and female rats.