Tar bases, coal, lutidine fraction

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

- Principle of test: Groups of five male and five female rats received a single oral dose of the test substance. The animals were then observed daily for a period of 14 days.
- Short description of test conditions: Animals received a single oral dose of the test substance of 200, 600, 1000 or 2000 mg/kg, administered by gavage in corn oil at a standard volume of 10 mL/kg.
- Parameters analysed / observed: Animals were checked regularly for mortality and any sign of toxicity. At the end of the study, surviving animals were humanely killed and were examined by necropsy for any macroscopic abnormalities.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Tar bases, coal, lutidine fraction

EC Number:

293-766-2

EC Name:

Tar bases, coal, lutidine fraction

Cas Number:

91082-52-9

IUPAC Name:

Tar bases, coal, lutidine fraction

Test material form:

liquid

Test animals

Species:

rat

Strain:

other: Alderley Park SPF albino

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: colony maintained in the laboratory at Alderley Park, Cheshire, UK
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: not reported
- Weight at study initiation: bodyweight range 221-390 g for males and 198-253 for females
- Fasting period before study: 26 to 24 hours before dosing
- Housing: not reported
- Diet (e.g. ad libitum): not reported
- Water (e.g. ad libitum): not reported
- Acclimation period: not reported

ENVIRONMENTAL CONDITIONS
- Temperature (°C): not reported
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): not reported

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20-200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: not reported
- Lot/batch no. (if required): not reported
- Purity: not reported

Doses:

200, 600, 1000 and 2000 mg/kg

No. of animals per sex per dose:

Five

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights

Statistics:

The acute oral median lethal dose was calculated from the mortality data using logistic regression. Confidence limits were calculated using a likelihood ratio interval (Williams 1986).

Results and discussion

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

971 mg/kg bw

Based on:

test mat.

95% CL:

758 - 1 245

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

1 239 mg/kg bw

Based on:

test mat.

95% CL:

943 - 1 629

Mortality:

Three female and one male animal dosed at 1000 mg/kg died or were killed in extremis on Day 1. All animals dosed 2000 mg/kg died or were killed in extremis on Day 1, and nine out of ten deaths were within the first two hours after dosing.

Clinical signs:

other: Significant signs of toxicity were seen in animals dosed at 200 or 600 mg/kg, but all animals had recovered four or five days after dosing. Extreme signs of toxicity (e.g. exophthalmus, piloerection, upward curviture of spine, urinary incontinence, dehydr

Gross pathology:

No macroscopic observations were detected at necropsy.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The substance was found to be acutely toxic to rats after administration by gavage of a single oral dose.

Executive summary:

The acute oral toxicity of the test substance was investigated under non-GLP in a study similar to an OECD guideline study. The experiment is considered relevant, adequate and conclusive.

Groups of five female and five male Alderley Park SPF albino rats, in the bodyweight range from 198-253 g for females and 221-390 g for males, were fasted for a period of 16 to 24 hours before exposure. Preparations of the test substance, in corn oil, were then dosed at a standard volume of 10 mL/kg. Single doses of 200, 600, 1000 and 2000 mg/kg were administered by gavage to separate groups of animals on Day 1. The animals were observed daily up to Day 15. None of the animals receiving a single dose of 200 or 600 mg/kg died. Three female animals and 1 male animal dosed at 1000 mg/kg died on Day 1. All animals dosed at 2000 mg/kg died on Day 1. Significant signs of toxicity were seen in animals receiving 200 and 600 mg/kg, and extreme signs of toxicity were seen in animals dosed at 1000 or 2000 mg/kg. Surviving animals recovered after four to five days. All animals lost weight initially (due to fasting prior to dosing), but all surviving animals had gained weight at the end of the study. No macroscopic observations were made at necropsy.