Fast Pyrolysis Bio-oil

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

10 March 2005 - 29 March 2005

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study with acceptable restrictions (final report not dated nor signed by study director)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

yes

Remarks:

the relative humidity recorded in the animal room was sometimes outside of the target ranges specified in the study plan

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: EC Directive 2004/73/EC B.1 tris, 27th April 2004

GLP compliance:

yes (incl. QA statement)

Remarks:

Agence Francaise de Securite Sanitaire des Produits de Sante

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Fast Pyrolysis Bio-oil (BIOTOX-21)

IUPAC Name:

Fast Pyrolysis Bio-oil (BIOTOX-21)

Test material form:

gas under pressure: refrigerated liquefied gas

Details on test material:

Supplier: ASTON
name: BIOTOX-21
batch number: on the analytical certificate: 110205
description: brown liquid
storage conditions: at + 4 °C and protected from light
purity: 100 %
stability: February 2006.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

propylene glycol

Details on oral exposure:

Oral gavage with a metal cannula

Doses:

2000 mg/kg; 10 mL/kg

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

The animals were fasted overnight (about 18 h) before dosing, but had free access to water. Food was given back approximately 4 h after administration of the test item. The animals were observed frequently for few hours after administration of the test item and daily thereafter. The observation period was 14 days. The animals were weighed individually just before administration of the test item on day 1 and thereafter on days 8 and 15.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was noted during the study

Clinical signs:

other: Hypoactivity or sedation, piloerection and dyspnea (all animals); unsteady gait (3/6 animals), were observed within 6 hours of treatment, but they were subsided by day 2 until the end of the study.

Gross pathology:

Macroscopic examination of the main organs of the animals revealed no apparent abnormalities.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

LD50 of the test item is higher than 2000 mg/kg in rats.

Executive summary:

The acute oral toxicity of the test item BIOTOX-21 was evaluated in rats according to OECD 423 and EC 2004/73/EC, B.1, tris guidelines and in compliance with GLP. Hypoactivity, piloerection, dyspnea and unsteady gait were observed during the day of administration only. LD50 of the test item was found to be higher than 2000 mg/kg in rats.