N,N,N',N'-tetrakis(2-hydroxypropyl)adipamide

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from June 22, 1988 to July 6, 1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

guideline test with GLP using N, N, N’, N’-Tetrakis (2-hydroxyethyl) hexanediamide which is used for read-across purpose, as structurally similar to N,N,N',N'-tetrakis(2-hydroxypropyl) adipamide. Thus, the study is used for read-across to avoid duplicate tests.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

not specified

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N,N,N',N'-tetrakis(2-hydroxypropyl)adipamide

EC Number:

260-982-3

EC Name:

N,N,N',N'-tetrakis(2-hydroxypropyl)adipamide

Cas Number:

57843-53-5

Molecular formula:

C18H36N2O6

IUPAC Name:

N,N,N',N'-tetrakis(2-hydroxypropyl)hexanediamide

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

Animals and Animal Husbandry:
Male and female New Zealand White rabbits were obtained from Hazleton Research Animals, Denver, PA. Upon arrival, all animals were examined for physical abnormalities, identified by uniquely numbered ear tags, and quarantined for approximately two weeks. The animals were individually housed in stainless steel cages suspended above absorbent-paper pan liners which were changed 3 times per week. All animal rooms were environmentally controlled with controls set to maintain a temperature of 65 F (18 °C) with a relative humidity range of 40 to 60%. Temperature and relative humidity were monitored 24 hr a day, and the light cycle was automatically controlled, 12 hr on and 12 hr off. All rabbits had free access to filtered tap water (via automatic watering) and were fed approximately 125 g/day of Purina Laboratory Rabbit Chow High Fiber Diet.
One day prior to being dosed, six male and six female rabbits were selected from a healthy stock population. At the time they were dosed, the animals were approximately 17 weeks old. The body weights ranged from 2231 to 2625 g for males and from 2270 to 2634 g for females.

Administration / exposure

Vehicle:

other: 0.85% saline

No. of animals per sex per dose:

6 per sex per dose

Control animals:

not specified

Details on study design:

Experimental Design
Test Substance Dose Number of
Administered (g/kq) Animals
Monomer QM-552 PMN 5.0 6M/6F

Observations and Determinations
All animals were observed for mortality, signs of ill health, or reaction to treatment at 1, 2 and 4 hr after dosing and once daily thereafter for 14 days. Body weights were recorded on Day 0 (prior to dosing) and on Days 7 and 14. Surviving rabbits were killed on Day 14 and a gross examination of organs was performed in situ.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no mortalities.

Clinical signs:

other: see remarks:

Gross pathology:

Necropsy revealed no gross changes.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The acute dermal LD50 (dermal, rabbits) in either sex is greater than 5000 mg/kg.bw.

Executive summary:

The dermal toxicity of test substance was assessed by applying the test article to the clipped intact skin of six male and six female New Zealand White rabbits at a dose of 5.0 g/kg body weight. The application sites were covered with impervious cuffs for a period of 24 hr, after which the cuffs were removed and the sites were wiped with water-soaked paper towels. There were no mortalities or treatment-related clinical signs over the 14 -day observation period. Erythema appeared on the application sites on Day 1, and test substance adhered to application sites throughout the observation period. There were no treatment-related body-weight effects. Necropsy revealed no gross changes. The acute dermal LD50 in male and female rabbits was greater than 5.0 g/kg. According to CLP (Regulation EC No. 1272/2008), the test substance is not to be classified for acute dermal toxicity.