Reaction product of Aminoguanidine bicarbonate and Tall Oil fatty acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

03-06-2001-19-06-2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study performed according with OECD guideline 420.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Deviations:

no

GLP compliance:

yes

Remarks:

Includes statement of compliance

Test type:

fixed dose procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

442-600-9

EC Name:

-

Molecular formula:

The substance is a UVCB for which it is not possible to provide a molecular formula

IUPAC Name:

(9E)-N-[(N'-hexadecanoyloctadecanehydrazido)methanimidoyl]octadec-9-enamide

Details on test material:

Name: HiTEC 7134
Source: Afton Chemicals
Colour: Brown
Physical state: Viscous liquid
Storage conditions: Ambient temperature in the dark

Test animals

Species:

rat

Strain:

other: Alpk: APfSD (Wistar derived)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Rodent Breeding Unit, Alderley Prk, Macclesfield, Cheshire, UK
- Age at study initiation: app. 8-12 weeks old
- Weight at study initiation: 381-413 g (males) and 241-266 g (females)
- Fasting period before study: yes
- Housing: maximum of 5 rats were housed per each cage, sexes separately, in cages suitable for animals of this strain and the weight range expected during the course of the study.
- Diet: ad libitum
- Water : ad libitum
- Acclimation period: animals were housed under the experimental conditions at least 5 days prior the initiation of the study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3º C
- Humidity (%): 30-70 %
- Air changes (per hr): a minimum of 15 changes per hour
- Photoperiod (hrs dark / hrs light): artificial, giving 12 hours light, 12 hours dark

IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle:
- Amount of vehicle (if gavage): 10 ml/kg bw
- Justification for choice of vehicle: the substance is miscible and stable in corn oil
- Lot/batch no. (if required): Y00790/007


MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg

DOSAGE PREPARATION: a measured amount of the test substance was formulated in corn oiland was then warmed and stirred thoroughly to ensure homogeneity.

Doses:

2000 mg/kg

No. of animals per sex per dose:

5 females and 5 males per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, careful examinations of all thoracic and abdominal viscera

Statistics:

NA

Results and discussion

Preliminary study:

Following a dose of 500 mg/kg, the animal survived and showed no signs of systemic toxicity. Following a dose of 2000 mg/kg, the animal survived and showed signs of slight, but not evident toxicity, with comlete recovery by day 3.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

None of the animals died.

Clinical signs:

other: No evident toxicity signs observed. Only one female presented signed of slight toxicity on days 3 to 5.

Gross pathology:

There were no compound-related abnormalities at post mortem examination. One male as a speckled thymus which is considered to be a spontaneous finding. One female killed in extremis on day 2 had oesophageal damage, lung abnormalities and fluid in the thorax, all of which were considered mis-dosing.

Other findings:

None.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The highest fixed dose of HiTEC 7134 administered in this test without causing any lethality (i.e.) the discriminating dose-level), was 2000 mg/kg to male and female rats.

Executive summary:

In a sighting phase, single animals received a single oral dose of 500 or 2000 mg/kg of HiTEC 7134 and were assessed daily for the following 6 days for signs of toxicity.

From the results of the sighting phase a single fixed dose level of 2000 mg/kg was selected for the main phase of the study.

In the main phase, a group of five male and five female Alpk: APfSD (Wistar derived) rats was dosed and assessed daily for the following 14 days for any signs of systemic toxicity. Their body weights were recorded at intervals during the study. At the end of the study all the animals were killed and examined post mortem.

No animals died in the sighting phase or in the main study. There were no signs of evident toxicity, and most of the animals showed an overral weight gain during the study. There were no compound related abnormalities at examination post mortem.

The highest fixed dose of HiTEC 7134 administered in this test without causing any lethality (i.e. the discriminating dose-level), was 2000 mg/kg to male and female rats.