Fatty acids, tall-oil, reaction products with triethylenetetramine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

March 16, 2015 to March 31, 2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to OECD Guideline 423, in compliance with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: Guidance Document on Acute Oral Toxicity Testing, OECD Series on Testing and Assessment No 24, 2001

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: Guidance Document on the Recognition, Assessment and Use of Clinical Signs as Humane Endpoints for Experimental Animals Used in Safety Evaluation. Environmental Health and Safety Publications Series on Testing and Assessment No 19, 2000

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, tall-oil, reaction products with triethylenetetramine

EC Number:

272-905-0

EC Name:

Fatty acids, tall-oil, reaction products with triethylenetetramine

Cas Number:

68919-79-9

Molecular formula:

Not applicable for this UVCB.

IUPAC Name:

Fatty acids, tall-oil, reaction products with triethylenetetramine

Test material form:

semi-solid (amorphous): gel

Remarks:

migrated information: paste

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Velaz Prague, Czech Republic
- Age at First Dose: At least 6-7 weeks; female animals were non-pregnant and nulliparous
- Animal Health: The health condition of animals was examined by a veterinarian before initiation of the study.
- Housing Condition: The animals were housed in plastic cages suspended on stainless steel racks, up to 3 animals per cage, males and females separately in a room equipped with central air-conditioning
- Bedding: Lignocel S3/4
- Animals Identification: Each animal was marked with an ID number. Each cage was affixed with a cage card containing pertinent animal and study information. The animals in cages were marked by a line on the tail with an ink marker.
- Acclimation period: 5 d
- Diet: A laboratory food Altromin was offered in recommended doses each day approximately at the same time after dosing
- Water: Tap water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature: 22±2°C
- Humidity: 55%±10%
- Photoperiod: 12 h light/dark cycle (deviation ± 30 minute).

IN-LIFE DATES: From: March 16, 2015 To: March 31, 2015

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

VEHICLE
Lot Number: 04280314
Expiration: 03/2015
Manufacturer: Vulm.sk
Storage: Room temperature (20±5°C)

DOSE PREPARATION
The required amount of the test substance was mixed with vehicle shortly before administration.

DOSE ADMINISTRATION
The test substance was administered in a single dose by gavage using a stomach tube. Animals were fasted prior to dosing (food but not water were withheld over-night). Following the period of fasting, the

Doses:

2,000 mg/kg bw

No. of animals per sex per dose:

3 males and 6 females

Details on study design:

Number of Animals and Dose Level
Available information indicated that test substance is likely to be nontoxic considering to acute toxicity. Therefore, a limit dose of 2,000 mg/kg bw was used as starting dose. Group of 3 female rats were used. Test substance related mortality was not produced during 24 h; group of 3 females and 3 males were tested at the same dose.

Clinical Observation
Animals were observed individually immediately after the administration of the test substance and then 30 min, 1, 2, and 4 h later. Then each animal was inspected for the next 14 d.
Observations included changes in skin and fur, eyes and mucous membranes as well as respiratory, circulatory, autonomic and central nervous systems, somatomotor activity and behaviour pattern. Attention was directed to observations of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.

Body Weight
Individual weights of animals were determined shortly before the test substance was administered and weekly thereafter. Weight differences after first and second weeks post-application were calculated and recorded.

Necropsy
All test animals were subjected to gross necropsy. Detailed gross necropsy included careful examination of external surface of the body, all orifices, and cranial, thoracic and abdominal cavities. All gross pathological changes were recorded for each animal.

Results and discussion

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:

Animals lived through observation period without important visible signs of intoxication. Neither change of health nor negative reactions were registered.

Body weight:

The body weights of all animals were increasing during the study. No body weight losses were observed one and two weeks after application.

Gross pathology:

All animals (6 females and 3 males) were necropsied. During necropsy, no macroscopically changes were noticed.

Applicant's summary and conclusion

Conclusions:

The oral LD50 was found to be > 2,000 mg/kg bw in rats.

Executive summary:

A study was conducted to assess the acute oral toxicity of the test substance in Wistar rats according to OECD Guideline 423, in compliance with GLP. Groups of six female and three male rats received a single dose of 2,000 mg/kg bw by gavage. No mortality occurred and no symptoms of toxicity or body weight loss were seen during the observation period. Under the study conditions, the oral LD50 was > 2,000 mg/kg bw in rats (Hozova R, 2015).