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

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

February 20 to February 23, 1990

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was conducted following good laboratory practices, and following recognized protocols. However, the exact protocol was not cited, and no data were provided concerning test sample purity and batch number.

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 and Toxic Substances Control Act protocol provided in 40 CFR

Deviations:

no

Remarks:

study report states no deviations occurred.

GLP compliance:

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:

Test material was identified as Stepan Agent X1401-91, an off-white waxy solid. The test sample was stored at room temperature throughout the study in a clear, colorless glass jar with a black plastic lid. The test substance batch number and purity was not noted in the report.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Young, healthy adult New Zealand White rabbits or either sex with healthy, intact skin were used.
All animals were acclimated to the laboratory for one day 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.

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

physiological saline

Controls:

no

Amount / concentration applied:

0.5 grams

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

Six animals

Details on study design:

On the day prior to the test the application sites were prepared by clipping the hair from the dorsal area of the rabbits. Test substance (0.5 g) moistened with of physiological saline water was applied to or under a small surgical gauze patch, approximately 1 inch x 1 inch, two layers thick to one intact skin area on each of the test rabbits. The application sites were rotated to minimize bias due to site-to-site variation. Each was held in place with tape. After application of the parches the trunk of each rabbit was loosely wrapped with rubber dental dam which was secured with staples. An outer layer of gauze and tape was placed around the trunk of each animal. Each animal was fitted with an appropriate restraining device to prevent patch and wrapping removal. Following approximately 4 hours of exposure, the rabbits were released from restraint and the wrapping and patches were removed. The test sites may be wiped free of residual test material by a gentle sponging using a towel moistened with water.

The application sites were scored for each rabbit approximately 1/2 to 1 hour, 24 hours, 48 hours, and 72 hours after removal of the patches according to the Draize Scale. Additional observations were made on a per animal basis to establish reversibility of irritation. The skin was also observed for evidence of tissue destruction or deep injury (e.g., narcosis).

The times of dose application, patch removal and 1/2 to 1, 24-, 48-, and 72-hour readings were recorded as well as the corresponding irritation scores.

The values for each rabbit were totaled and averaged for each of the following categories:
1: Erythema and eschar formation, intact skin, ½-1 hour; 2) Erythema and eschar formation, intact skin, 24 hours; 3) Erythema and eschar formation, intact skin, 48 hours; 4) Erythema and eschar formation, intact skin, 72 hours; 5) Edema, intact skin 1/2 to 1 hour 6) Edema, intact skin, 24 hours; 7) Edema, intact skin, 48 hours; 8) Edema, intact skin, 72 hours.
The eight average scores from above were added together and the results divided by four to obtain the Primary Irritation Index (PII).
When applicable, the following classification for rating of hazard potential (40 CFR 156, Proposed) was used:
1. Category I – Corrosive (tissue destruction dermis and/or scarring).
2. Category II – Severe irritation at 72 hours (severe erythema or edema).
3. Category III –Moderate irritation at 72 hours (moderate erythema.
4. Category IV - Mild or slight or no irritation at 72 hours (no irritation or slight erythema)

Results and discussion

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Score:

0.3

Reversibility:

fully reversible

Irritant / corrosive response data:

See Table.

Any other information on results incl. tables

Primary Skin Irritation in Rabbits Following a 4 -Hour Dermal Application of Stepan Agent X14901 -91      

Skin Condition	Reading	Score for each Rabbit^a						Total Score	Average Score
		No. 1	No. 2	No 3	No.4	No.5	No.6
		Erythma   Formation
Intact	Site	A	B	C	D	A	B
	1.2 – 1 hour	1	0	1H	1	1H	1H	5	0.83
	24 hours	0	0	0H	0	0H	0H	0	0.00
	48 hours	0	0	0H	0	0H	0H	0	0.00
	72 hours	0	0	0H	0	0H	0H	0	0.00
		Edema Formation
	Site	A	B	C	D	A	B
Intact	1.2 – 1 hour	1	0	0	0	0	0	1	0.17
	24 hours	0	0	0	0	0	0	0	0.00
	48 hours	0	0	0	0	0	0	0	0.00
	72 hours	0	0	0	0	0	0	0	0.00

Primary Irritation Index (PII) = 0.3

H = Hair on site

Applicant's summary and conclusion

Interpretation of results:

slightly irritating

Remarks:

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

Executive summary:

The primary skin irritancy of Stepan Agent X1401 -91 was evaluated following test guidelines under the Federal Insecticide, Fungicide and Rodenticide Act (40 CFR), and the OECD Guidelines (Exact guideline not specified). No irritation persisted 72 hours following application. The Primary Irritation Index (PII) was found to be 0.3 based on erythema and edema. No changes in the coloration or texture of the skin were noted.. No evidence of corrosion (necrosis) was found.