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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Distillates (coal tar), benzole fraction
EC Number:
283-482-7
EC Name:
Distillates (coal tar), benzole fraction
Cas Number:
84650-02-2
Molecular formula:
not applicable
IUPAC Name:
Distillates (coal tar), benzole fraction
Details on test material:
- Name of test material (as cited in study report): light oil
- Molecular formula (if other than submission substance): not applicable
- Molecular weight (if other than submission substance): not applicable
- Substance type: organic
- Physical state: liquid
- Stability under test conditions: WAF (water accommodated fraction) limited
- Storage condition of test material: room temperature, exclusion of light

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Breeding farm s.r.o., Kolec u Kladna, CZ
- Age at study initiation: 8 - 10 weeks
- Weight at study initiation: 188 - 228 g
- Fasting period before study: approx. 20 h before treatment
- Housing: 3 animals/cage
- Diet: ad libitum until approx. 20 h before treatment, and again from 3 h post-treatment
- Water: ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +- 3
- Humidity (%): 30 – 70
- Photoperiod (hrs dark / hrs light): 12 /

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: approx. 20 % (w/v) at maximum (at 2000 mg/kg bw)
- Amount of vehicle (if gavage):
- Justification for choice of vehicle: tolerable solvent and expander forming a suspension

MAXIMUM DOSE VOLUME APPLIED: 1 mL/100 g bw

DOSAGE PREPARATION: mixing directly before application to produce a suspension

Doses:
300 mg/kg bw ; 2000 mg/kg bw
No. of animals per sex per dose:
3 (first dose) and 2x 3 (second dose)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: 2x/d (day 1 and 2); 1x/d (day 3 - 14)
Weighing: before treatment, day 8 and 15 post-treatment
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
not applicable

Results and discussion

Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Sex:
female
Dose descriptor:
LD0
Effect level:
2 000 mg/kg bw
Mortality:
none
Clinical signs:
other: 300 mg/kg bw: No clinical signs of intoxication 2000 mg/kg bw: on day 1 decreased response to stimuli, ischaemic mucous membranes; day 2 - 14: no clinical signs of intoxication
Gross pathology:
no particular findings
Other findings:
none

Any other information on results incl. tables

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Applicant's summary and conclusion