Distillates (coal tar), heavy oils

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Creosote

EC Number:

232-287-5

EC Name:

Creosote

Cas Number:

8001-58-9

IUPAC Name:

8001-58-9

Details on test material:

- Name of test material (as cited in study report): Product number 103.206
- Creosote Type WEI B
- Molecular formula (if other than submission substance): not applicable
- Molecular weight (if other than submission substance): not applicable
- Substance type: organic
- Physical state: liquid
- Analytical purity: not applicable (UVCB, distilled coal tar, complex hydrocarbon mixture.)
- Impurities (identity and concentrations): not applicable
- Composition of test material, percentage of components: no data
- Storage condition of test material: Stable at room temperature under exclusion of UV light

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga, Sulzfeld, Germany
- Age at study initiation: no data
- Weight at study initiation: males: 160 – 201 grams, females: 160 – 231 grams
- Housing: 5 rats per cage (Macrolon)
- Fasting period before study: 16 h
- Diet: ad libitum until 16 h pre-application and continued from 4 h post-application
- Water: ad libitum
- Acclimation period: =< 7 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +-2
- Humidity (%): 50 - 85
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg

Doses:

3138; 3668; 4184; 5230 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: 15 and 45 min, 1, 2 and 3 h, 6 h, 24 and 48 h, 3 and 5 d p.a
Frequency of weighing: day 0 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

Probit analysis according to Finney DY (1971)

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

4 030 mg/kg bw

95% CL:

3 642 - 4 505

Mortality:

see below "Remarks on results..."

Clinical signs:

other: Dose-related increase in apathy, discoordination, anormal posture, cyanosis, piloerection, and slightly reduced respiration

Gross pathology:

No particular organ effects reported in deceased and sacrificed animals. No significant macroscopic abnormalities were found at necropsy.
Residues of test material were found in the gastro-intestinal tract of moribund and deceased animals.

Any other information on results incl. tables

MORTALITY

Dose[mg/kg]	24 h		48 h		3-14 days		Mortality (%)
	Male	female	Male	female	Male	female	Male	female
3138	0/5	0/5	0/5	1/5	0/5	1/5	0	20
3668	0/5	1/5	1/5	2/5	1/5	2/5	20	40
4184	0/5	2/5	2/5	4/5	2/5	4/5	40	80
5230	1/5	4/5	3/5	5/5	4/5	5/5	80	100

The oral LD₅₀ for creosote in rats was 3500 – 4000 mg/kg bw for males and females.