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Diss Factsheets

Toxicological information

Repeated dose toxicity: oral

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Administrative data

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)).

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2005

Materials and methods

Test guidelineopen allclose all
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

Test material

Constituent 1
Reference substance name:
Fast Pyrolysis Bio-oil (BIOTOX-21)
IUPAC Name:
Fast Pyrolysis Bio-oil (BIOTOX-21)
Test material form:
liquid: viscous
Details on test material:
BIOTOX-21: Biomass: Spruce, produced with Fluidised bed at 500 °C

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
propylene glycol
Duration of treatment / exposure:
7 days
Frequency of treatment:
Daily for 7 days
Doses / concentrations
Remarks:
Doses / Concentrations:

Basis:
no data
No. of animals per sex per dose:
3
Control animals:
yes, concurrent vehicle

Examinations

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.

Results and discussion

Results of examinations

Details on results:
No macroscopic abnormalities were observed.

Effect levels

open allclose all
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'

Target system / organ toxicity

Key result
Critical effects observed:
not specified

Applicant's summary and conclusion

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.