Tar, coal, high-temp.

Acute Toxicity: oral

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:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Test guideline 2

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

Test material information

Constituent 1

Reference substance name:

Tar, coal, high-temp.

EC Number:

266-024-0

EC Name:

Tar, coal, high-temp.

Cas Number:

65996-89-6

Molecular formula:

not applicable

IUPAC Name:

naphthalene

Details on test material:

- Name of test material (as cited in study report): Coal Tar
- Molecular formula (if other than submission substance): not applicable
- Molecular weight (if other than submission substance): not applicable
- Substance type: organic
- Physical state: liquid, viscous
- Stability under test conditions: no measured data; based on chemical structure assumed to be stable
- 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: 164 - 210 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 levels

Effect levels 1

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Effect levels 2

Key result

Sex:

female

Dose descriptor:

LD0

Effect level:

2 000 mg/kg bw

Mortality:

none

Clinical signs:

other: 300 mg/kg bw: on day 1 piloerection, apathy, decreased response to stimuli, hunched posture, ischaemic mucous membranes; day 2 - 14: no clinical signs of intoxication. 2000 mg/kg bw: on day 1 and 2 piloerection, apathy, decreased response to stimuli, hun

Gross pathology:

no particular findings

Other findings:

none

Applicant's summary and conclusion

Interpretation of results:

other: not classifiable

Remarks:

The oral LD50 is higher than 2000 mg/kg bw.