Registration Dossier

Diss Factsheets

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other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment.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

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
438-530-3
EC Name:
-
Cas Number:
5343-44-2
Molecular formula:
C20H41NO
IUPAC Name:
N,N-di-tert-butyldodecanamide
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:
None
Body weight:
All animals gained weight
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.