Amides, C16-C18 (even) , N,N'-ethylenebis

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

analytical purity of the test substance, humidity and temperature are not specified in the study report

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Amides, C16-C18 (even) , N,N'-ethylenebis

EC Number:

931-299-4

Cas Number:

68390-94-3

Molecular formula:

not available UVCB

IUPAC Name:

Amides, C16-C18 (even) , N,N'-ethylenebis

Constituent 2

Reference substance name:

Amides, C16-C18 (even), N,N’-ethylenebis

IUPAC Name:

Amides, C16-C18 (even), N,N’-ethylenebis

Test material form:

not specified

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Gota-Frisco Farms
- Age at study initiation: young adult, not further specified
- Weight at study initiation: 2.0 - 3.0 kg, weight variation did not exceed ± 20% of the group mean of each sex
- Housing: Individually housing in suspended stainless steel wire mesh bottom cages, conform to AAALAC standards and those published in the "Guide for the care and use of laboratory animals" NIH publication No. 85-23
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: Minimum of 5 days

ENVIRONMENTAL CONDITIONS

- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: 12 x 20 cm
- % coverage: 10%
- Type of wrap if used: A tubular stockinette sleeve and an adjustable harness were placed around the animal’s trunk. Nonirritating tape was used to secure both the gauze dressing and stockinette sleeve.

REMOVAL OF TEST SUBSTANCE
- Washing: yes, with distilled water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- For solids, paste formed: yes, the dressing was moistened with distilled water at a rate of 1 mL/g of test article to ensure good contact of the test article with the skin.

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for pharmacotoxic signs three times on the day of dosing and once daily thereafter for the duration of the study (15 days). Mortality checks were performed twice daily, a minimum of 5 h apart. Individual body weights were determined and recorded on Days 1, 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: Histopathology: At study termination (day 15), the heart, kidneys, liver, lungs and stomach were excised from each animal and preserved. After complete fixation, the liver and kidneys from each rabbit were embedded in paraffin, sectioned at 3-5 mm in thickness, stained with hematoxylin and eosin, and then examined microscopically by an SIB Pathologist.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

All animals survived until scheduled sacrifice.

Clinical signs:

other: No clinical signs of toxicity were noted during the study.

Gross pathology:

Necropsy examinations revealed the kidneys of two males to have a pitted capsular surface. No other gross abnormalities were noted.

Other findings:

- Histopathology: Microscopic examination of the liver revealed minimal chronic multifocal inflammation in three animals (one male and two females) and minimal acute exudative multifocal inflammation in one animal (male). In three of the ten test animals, chronic multifocal inflammation of the liver and kidneys occurred together.

- Other observations: The occurrence of the above pathological findings cannot be definitely attributed to treatment with the test article as similar lesions are commonly seen at this incidence level in the liver and kidneys of untreated stock laboratory rabbits.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.

Executive summary:

The registered substance is judged to be nonlethal and nontoxic when administered by the dermal route at 2000 mg/kg bw to New Zealand albino rabbits. The registered substance does not have to be classified for acute toxicity via the dermal route according to the criteria laid down in Regulation (EC) No. 1272/2008.