A mixture of: N,N-di(hydrogenated alkyl C14-C18)phthalamic acid; dihydrogenated alkyl (C14-C18)amine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

February 19, `990 to March 6, 1990

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study was run by a method similar to a guideline study, but specific guideline number was not designated. Sample purity was note noted. GLP was followed.

Data source

Reference

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: EPA FIFRA and TSCA guidelines specified in 40 CFR 158, 162 , and OECD Guidelines. Specific guidelines not specified.

Deviations:

no

Remarks:

Report stated that no deviations occurred.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

87787-81-3

EC Number:

618-070-1

Cas Number:

87787-81-3

IUPAC Name:

87787-81-3

Constituent 2

Reference substance name:

A mixture of: N,N-di(hydrogenated alkyl C14-C18)phthalamic acid; dihydrogenated alkyl (C14-C18)amine

EC Number:

413-800-3

EC Name:

A mixture of: N,N-di(hydrogenated alkyl C14-C18)phthalamic acid; dihydrogenated alkyl (C14-C18)amine

Cas Number:

87787-81-3

Molecular formula:

C44H79NO3

IUPAC Name:

2-(dioctadecylcarbamoyl)benzoic acid; 2-(ditetradecylcarbamoyl)benzoic acid; 2-[(propan-2-yloxy)carbonyl]benzoic acid; 2-[octadecyl(tetradecyl)carbamoyl]benzoic acid; 2-octadecyl-2,3-dihydro-1H-isoindole-1,3-dione; 2-tetradecyl-2,3-dihydro-1H-isoindole-1,3-dione; benzene-1,2-dicarboxylic acid; dioctadecylamine; ditetradecylamine; octadecyl(tetradecyl)amine

Constituent 3

Reference substance name:

reaction mass of: N,N-di(hydrogenated alkyl C14-C18)phthalamic acid dihydrogenated alkyl (C14-C18)amine

IUPAC Name:

reaction mass of: N,N-di(hydrogenated alkyl C14-C18)phthalamic acid dihydrogenated alkyl (C14-C18)amine

Constituent 4

Reference substance name:

Stepan TAB-2

IUPAC Name:

Stepan TAB-2

Details on test material:

No data on test substance purity or composition. It is assumed to be typical commercial material. Test material designation is as Stepan Agent X1401-91. Test substance was stored at room temperature in a clear colorless glass jar with a black plastic lid..

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Young adult albino Sprague-Dawley rats, weighing between 227 and 332 grams at the start of the study. All animals were acclimated to the laboratory for at least four days before the study. Animals are usually housed five per cage in wire mesh suspension cages and fed Purina Laboratory Chow or other complete diet, and tap water ad libitum except overnight prior to dosing. The animals were obtained on a 12-hour light/12-hour dark cycle. Each rat were individually numbered via ear tags and ink marks on the tail. Overnight prior to dosing, food (but not water) was withheld from the rats. The time of fast initiation and the time of dosing was documented.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

The test material was administered as a 25% w/v formulation in corn oil to five male and five female rats at a dose level of 5.0 g/kg/bw. Test material was administered by esophageal intubation..

Doses:

5.0 mg/kg/bw as 25% in corn oil.

No. of animals per sex per dose:

five per sex per dose

Control animals:

no

Details on study design:

A group of ten rats (five per sex) were dosed by gavage with 5 g/kg dose level (25% in corn oil) by gavage. All animals were observed for gross signs of systemic toxicity and mortality several times during the day of dosing, and at least twice daily for a total of 14 days. Observations were documented. Animals were observed more often if animals exhibited definite signs of toxicity. Animals were weighed on the day of dosing and at death. Survivors were weighed 7 and 14 days after treatment. Gross necropsy was performed on any animal which died, and observations were documented. At the end of the 14-day observation period after dosing, each surviving rat was sacrificed, and a gross necropsy was performed. The terminal weight and appropriate observations were documented for each rat.

Statistics:

No data.

Results and discussion

Preliminary study:

No preliminary study performed.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

No mortality was observed in any of the ten animals tested.

Clinical signs:

other: Aside from a red stain on an unspecified number of female rats, and scruffy or oily hair noted for several male rats, no signs of stress or pain were noted. Behavior of animals was normal.

Gross pathology:

Gross necropsy was performed on all animals upon sacrifice.

Other findings:

No other findings.

Any other information on results incl. tables

Table 1: Body Weight Data in Male and Female Rats Treated Orally with a 25% w/v Formulation of Stepan Agent x1401-91 in Corn Oil

		Body Weight (g)
Animal No.	Sex	Day 0	Day 7	Day 14	Body weight Change Day 0-14 (g)
1-0863	M	309	369	387	78
2-*	M	325	378	401	76
3-0865	M	314	363	394	80
4-0866	M	332	396	429	97
5 - *	M	283	339	361	78
Mean (S.D.)		313 (19)	369 (21)	394 (25)	82 (9)
6 - *	F	237	259	275	38
7 - *	F	244	281	291	47
8 - *	F	271	294	288	17
9 - *	F	227	252	259	32
10-0872	F	241	269	281	40
Mean (S.D.)		244 (16)	271 (17)	279 (13)	35 (11)

·         = Lost ear tag prior to dosing.

 

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: US EPA pesticides

Conclusions:

The acute oral LD50 for Stepan TAB-2 was found to be >5.0 g/kg in male and female sprague-Dawley rats.

Executive summary:

A standard acute oral toxicity study was conducted for Stepan TAB-2 (designated as Stepan Agent x1401 -91) by the oral gavage route. The test material was administered as a limit dose of 5 g/kg body weight (25% in corn oil). Five male and five female rats constituted the dosed group. Body weights and clinical observations were recorded.. No mortality was observed over the 14 day post dosing observation period and all ten animals survived. Aside from a red stain on muzzle of one rat, and scruffy or oily hair noted, no signs of stress or pain were noted. Behavior of animals was normal. The acute oral LD50 for Stepan TAB-2 was found to be >5.0 g/kg in male and female rats, sprague-Dawley rats.