Amides, tall-oil fatty, N,N-di-Me

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1971

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Older proprietary study conducted prior to development of guidelines and GLP, limited information available on methods.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1971

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

Standard acute oral toxicity study in the rat, conducted prior to development of the guidelines

GLP compliance:

no

Remarks:

study conducted prior to development of GLP

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Amides, tall-oil fatty, N,N-di-Me

EC Number:

269-665-4

EC Name:

Amides, tall-oil fatty, N,N-di-Me

Cas Number:

68308-74-7

Molecular formula:

not applicable for UVCB

IUPAC Name:

Amides, tall-oil fatty, N,N-di-Me

Constituent 2

Reference substance name:

DMATO

IUPAC Name:

DMATO

Test material form:

other: liquid

Details on test material:

DMAD Lot 418 (DMAD = 90% DMATO)

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

The animals were male and female adult albino Sprague-Dawley rats, weighing 200-300 g. They were housed in individual screen-bottom cages and provided with water and laboratory chow ad libitum.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

The test substance was administered as a single dose by gavage.

Doses:

5, 10 or 20 g/kg bw

No. of animals per sex per dose:

6

Control animals:

no

Details on study design:

The animals were observed for two weeks after dosing.

Statistics:

Not applicable.

Results and discussion

Preliminary study:

Not applicable.

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

10 000 - 20 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 1 male dosed with 5 g/kg bw died on day 3, and 1 male dosed with 10 g/kg bw died on day 3. All males dosed with 20 g/kg bw died on days 4 and 5.

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

5 000 - 10 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 1 female dosed with 5 g/kg bw died on day 3, all females dosed with 10 g/kg died between days 3 and 5, and all females dosed with 20 g/kg bw died between days 2 and 4.

Mortality:

Males: 1 male dosed with 5 g/kg bw died on day 3, and 1 male dosed with 10 g/kg bw died on day 3. All males dosed with 20 g/kg bw died on days 4 and 5.

Females: 1 female dosed with 5 g/kg bw died on day 3, all females dosed with 10 g/kg died between days 3 and 5, and all females dosed with 20 g/kg bw died between days 2 and 4.

Clinical signs:

other: Not reported.

Gross pathology:

Not reported.

Other findings:

Not reported.

Any other information on results incl. tables

Table 1. Mortality in rats following oral administration

Dose level (g/kg)	Females		Males
	No. dead/no. dosed	Day of death	No. dead/no. dosed	Day of death
5	1/6	3	16	3
10	6/6	3,5	1/6	3
20	6/6	2,4	6/6	4,5

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The estimated oral LD50 for females was between 5 and 10 g/kg bw, and for males was between 10 and 20 g/kg bw.

Executive summary:

The acute oral toxicity of DMAD (90% DMATO) was evaluated in male and female Sprague-Dawley rats. The test material was administered by gavage at dose levels of 5, 10 or 20 g/kg bw. The rats were observed for 14 days after dosing. One female and one male died at the limit dose of 5 g/kg bw. All females administered 10 or 20 g/kg bw died within 1 week of dosing. One male administered 10 g/kg bw died on day 3, and all males administered 20 g/kg bw died within 1 week of dosing. The estimated oral LD50 for females was between 5 and 10 g/kg bw, and for males was between 10 and 20 g/kg bw.