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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

February 19,1990 to March 15, 1990

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study was performed according to good laboratory practices, and according to a recognized guideline. However, the exact guideline designation was not given, and the test substance purity and batch were not disclosed.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: EPA Federal Insecticide, Fungicide, and Rodenticide Act (40 CFR), The Toxic Substances Control Act (40 CFR), and the OECD Guidelines.

Deviations:

no

Remarks:

Study report stated there were no deviations.

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:

The test material was designated as Stepan Agent X1401-91, which is an off white waxy solid of undesignated purity. The test substance was stored at room temperature throughout the study in a clear, colorless glass jar with a black plastic lid.

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

Young adult New Zealand White rabbits (five male and five female) weighing between 2984 and 3607 grams at the start of the study.
All animals were acclimated to the laboratory for at least four days before the study. Animals were housed singly in wire mesh suspension cages and fed Purina Laboratory Rabbit Chow or other comparable diet, and tap water ad libitum. The animals were obtained on a 12-hour light/12-hour dark cycle. Cage cards and individual ear marks or tags were used to identify each rabbit.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

physiological saline

Details on dermal exposure:

This study was designed to examine the potential lethality of a single pre-selected dermal dose of test material (2.0 ;/kg).

Shortly prior to dosing the hair of each rabbit was closely clipped from the ventral area of the trunk using an electric clipper, so as to expose at least 10% of the body surface area. Animals were weighed shortly before dosing, in order to calculate doses.

The sample (3.0 ml physiological saline water vehicle) was applied at the selected dose to five male and five female rabbits. The test material was applied directly to the intact skin of the animal or to a sleeve of rubber dental dam, which was wrapped around the animal and secured with staples. An outer layer of porous gauze dressing was wrapped around the trunk of the animal and secured with tape. The animal was then fitted with an appropriate restraining device to prevent removal of the wrapping. The time of application was recorded.

At the end of the approximate 24-hour exposure period, the wrapping was removed and any unabsorbed sample removed by gentle sponging using a towel moistened with water or other appropriate solvent. The presence or absence of sample residue on the wrapping and on the rabbits was documented.

Duration of exposure:

24 hours

Doses:

2g/kg bw

No. of animals per sex per dose:

Five males and five females per dose.

Control animals:

no

Details on study design:

Animals were observed for signs of toxicity and behavioral changes once on the day of treatment. Observations were more frequent if clinical signs were present. All surviving rabbits were maintained for at least 14 days following exposure. Examinations for gross signs of toxicity were carried out once daily with an additional check for viability during the day. Observations were made for erythema, edema, atonia, desquamation, necrosis, coriaceousness, fissuring and for other evidence of irritation or injury once daily. All appropriate observations and observation times were documented.

Body weight was measured for each animal on the day of dosing (just prior to dosing), at necropsy on animals which did not survive the observation period, on Day 7 and Day 14 at necropsy.

Gross necropsies were performed on each animal that dies. At the end of the 14-day observation period the surviving rabbits were weighted, sacrificed, and a gross necropsy was performed on each animal.

The study report included identification of animals, test procedure, protocol deviations if any, description of the test material, dose level, body weight data, tabulation of mortalities, clinical in-life observations, necropsy observations, and dermal observations.

Statistics:

No details provided.

Results and discussion

Preliminary study:

No preliminary study was conducted.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed.

Clinical signs:

other: Slight to moderate erythema was observed in some animals, as well as slight edema, atonia and desquamation. These effects were observed on Days 1-8 and up to Day 11 in some animals, but generally tapered off after about Day 5. Nasal discharge and fecal s

Gross pathology:

No significant effects observed.

Other findings:

No additional findings not provided above.

Any other information on results incl. tables

Table 1: Body Weight Data in Male and Female Rats Treated Dermally with Stepan Agent x1401-91

		Body Weight (g)
Animal No.	Sex	Day 0	Day 7	Day 14	Body weight Change Day 0-14 (g)
1-442	M	3088	3194	4306	118
2-443	M	3218	3383	3441	223
3-445	M	3157	3225	3380	223
4-446	M	3174	3297	3420	246
5 -454	M	2984	3067	3164	180
Mean (S.D.)		3124 (91)	3225 (114)	3322 (128)	198 (51)
6 -460	F	3219	3309	3602	383
7 -461	F	3291	3387	3573	282
8 -475	F	3349	3462	3730	381
9 -476	F	3381	3461	3365	-16
10-477	F	3607	3703	3923	216
Mean (S.D.)		3369 (146)	3464 (148)	3619 (174)	249 (164)

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

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

Conclusions:

Under the conditions of the study, the dermal LD50 value for Stepan Agent X1401-91 was determined to be >2 g/kg bw in the New Zealand White Rabbit.

Executive summary:

The acute dermal toxicity of Stepan Agent X1401 -91 was evaluated in a limit test in compliance with the protocols specified in the Federal Insecticide, Fungicide and Rodenticide Act (40 CFR), the Toxic Substances Control Act (40 CFR) and the OECD Guidelines.

No deaths occurred during the observation period. Any clinical changes and /or irritative effects or gross necropsy findings observed during the observation period or following sacrifice were documented in the study report. The acute dermal LD50 was determined to be > 2.0 g/kg body weight in the male and female New Zealand White rabbits tested.