Fast Pyrolysis Bio-oil

Endpoint summary

Description of key information

 Only a 7-day dose range-finding study (BIOTOX-21) is available for repeated dose toxicity of Fast Pyrolysis Bio-oil. Testing is not proposed based on REACH annex VIII section 8.6.1 column 2: The short-term toxicity study (28 days) does not need to be conducted if relevant human exposure can be excluded in accordance with Annex XI Section 3: Testing in accordance with Sections 8.6 and 8.7 of Annex VIII and in accordance with Annex IX and Annex X may be omitted, based on the exposure scenario(s) developed in the Chemical Safety Report. Moreover, according to ECHA guidance (R.8 p. 117), if there are indications of corrosivity, a substance would not be tested for systemic toxicity by any route of exposure. Therefore, testing is not proposed according to Annex IX section 8.6.1 either. See CSR for further information. 

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records

Reference

Reference 1

Endpoint:

short-term repeated dose toxicity: oral

Remarks:

other: 7-day oral dose range-finding

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

01.01.2003 - 30.06.2005

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Remarks:

Guideline study, final study report not available. Results published in BIOTOX project (BIOTOX. 2005. An assessment of bio-oil toxicity for safe handling and transportation. Final Technical Report. Part I: Publishable Final Report. Report drafted by Blin, J. Project N°: S07.16365. Project co-ordinator: Centre de Coopération Internationale de Recherche Agronomique pour le Développement (Cirad). Partners: Aston University, Bundesforschungsanstalt für Forst- und Holzwirtschaft (BFH)).

Qualifier:

according to guideline

Guideline:

OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)

Deviations:

yes

Remarks:

range finding study for 28-day study

Qualifier:

according to guideline

Guideline:

other: EEC Directive No 96/54, B7

Deviations:

yes

Remarks:

range finding study

GLP compliance:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Route of administration:

oral: gavage

Vehicle:

propylene glycol

Duration of treatment / exposure:

7 days

Frequency of treatment:

Daily for 7 days

Remarks:

Doses / Concentrations:

Basis:
no data

No. of animals per sex per dose:

3

Control animals:

yes, concurrent vehicle

Observations and examinations performed and frequency:

Clinical signs and mortality were checked daily. Body weight was recorded three times and food consumption twice during the dosing period.

Sacrifice and pathology:

On completion of the treatment period, after at least 14 hours fasting, all animals were sacrified by carbon dioxide inhalation and exsanguination. The adrenals, brain, heart, testes and epididymes, kidneys, liver, lungs, ovaries, spleen and thymus were weighed wet.

Other examinations:

A complete macroscopic post-mortem examination (external surfaces, all orifices, the cranial cavity, the external surfaces of brain, the thoracic, abdominal and pelvic cavities with associated organs and tissues, neck with associated organs and tissues) was performed on all study animals.

Statistics:

The specific sequence was used for the statistical analyses of body weight, food consumption and organ weight data.

Details on results:

No macroscopic abnormalities were observed.

Key result

Dose descriptor:

NOAEL

Effect level:

>= 150 mg/kg bw/day (actual dose received)

Based on:

test mat.

Sex:

male/female

Basis for effect level:

other: At 150 mg/kg/day, there were no clinical signs of toxicity, a slight and temporary reduction in the body weight gain of the females and no effect on food consumption.

Key result

Dose descriptor:

dose level:

Effect level:

>= 500 mg/kg bw/day (actual dose received)

Based on:

test mat.

Sex:

male/female

Basis for effect level:

other: At 500 mg/kg/day, there were no clinical signs, but there was a reduction in body weight gain and for males, a reduction in food consumption. One male had dilatation of the duodenum.

Key result

Dose descriptor:

dose level:

Effect level:

>= 1 500 mg/kg bw/day (actual dose received)

Based on:

test mat.

Sex:

male/female

Basis for effect level:

other: see 'Remark'

Key result

Critical effects observed:

not specified

Conclusions:

Oral NOAEL was determined as 150 mg/kg/day.

Executive summary:

The potential toxicity of the test item was evaluated following daily oral administration (gavage) to rats for 7 days. The study was conducted according to OECD 407 guideline and was a dose range-finding study for 28 -day study. No hematological, clinical chemistry or histopathology examinations were carried out. According to study results, NOAEL is 150 mg/kg/day.

Reference 2

Endpoint:

short-term repeated dose toxicity: oral

Data waiving:

other justification

Justification for data waiving:

other:

Critical effects observed:

not specified

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

NOAEL

150 mg/kg bw/day

Study duration:

subchronic

Species:

rat

Quality of whole database:

The methodology and results from the study have been published in final technical report of BIOTOX project. (BIOTOX. 2005. An assessment of bio-oil toxicity for safe handling and transportation. Final Technical Report. Part I: Publishable Final Report. Report drafted by Blin, J. Project N°: S07.16365. Project co-ordinator: Centre de Coopération Internationale de Recherche Agronomique pour le Développement (Cirad). Partners: Aston University, Bundesforschungsanstalt für Forst- und Holzwirtschaft (BFH)). The study was a 7-day range finding study. The original final study report is not available.

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
The only available study for repeated dose toxicity is a 7-day dose range-finding study conducted for fast pyrolysis bio-oil in BIOTOX project.

Repeated dose toxicity: via oral route - systemic effects (target organ) digestive: other

Justification for classification or non-classification

Fast Pyrolysis Bio-oil is not classified for repeated dose toxicity. The data is inconclusive for classification. Fast Pyrolysis Bio-oil may cause toxicological effects following repeated exposure. Those effects are considered to reflect rather corrosivity of the substance than repeated exposure toxicity.