Anthracene oil

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

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:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Creosote

EC Number:

232-287-5

EC Name:

Creosote

Cas Number:

8001-58-9

Molecular formula:

not applicable

IUPAC Name:

Creosote

Test material form:

liquid

Details on test material:

- Substance type: organic

Specific details on test material used for the study:

- Name of test material (as cited in study report): Creosote; North American P1/P13 Creosote; North American Creosote Composite Test Material P1/P13
- Composition of test material, percentage of components: see under Test material information

Test animals

Species:

rat

Strain:

Sprague-Dawley

Remarks:

Crl:CD® BR VAF/Plus®

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Portage, Michigan, USA
- Age at study initiation: 53 – 75 days
- Weight at study initiation: males: 234 – 283 g, females: 192 – 216 g

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

whole body

Vehicle:

air

Mass median aerodynamic diameter (MMAD):

>= 1.3 - <= 3.4 µm

Geometric standard deviation (GSD):

>= 1.65 - <= 1.98

Details on inhalation exposure:

MMAD ± GSD [µm]:
5000 mg/m³: 3.4 ± 1.89 (2.5 % of particles ≤ 1 µm diameter)
600 mg/m³: 1.3 ± 1.64 (29 % of particles ≤ 1 µm diameter)

Analytical verification of test atmosphere concentrations:

yes

Remarks:

GC-FID after sampling (9 key aromatics quantified (approx. 50 % of creosote), then result extrapolated to total creosote by using a factor of 1.64)

Duration of exposure:

4 h

Concentrations:

600, 5000 mg/m³ (analytical)

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LC0

Effect level:

5 000 mg/m³ air (analytical)

Based on:

test mat.

Exp. duration:

4 h

Remarks on result:

other: concentration in air was determined gravimetrically

Effect levels 2

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 5 000 mg/m³ air (analytical)

Based on:

test mat.

Exp. duration:

4 h

Remarks on result:

other: highest concentration tested

Mortality:

No deaths occurred at maximum dose.

Clinical signs:

other: 5000 mg/m³: Directly after exposure, 9/10 animals with reduced activity. Three males and one female showed increased salivation. During the 14-day post-exposure period, five males and four females exhibited decreased activity. 600

Body weight:

5000 and 600 mg/m³: bw gain depressed, persisted for 14 days post exposure.

Gross pathology:

No significant macroscopic abnormalities were found at necropsy.

Any other information on results incl. tables

Table A6_1-1.               Table for Acute Toxicity (inhalation)
Dose[mg/m^3air]	Toxicological results*	Duration of clinical signs	Time of death	Mortality (%)	Particles£5mm (%)
males
600	0/2/5	4h – 14d	-	-	99
5000	0/5/5	4h – 14d	-	-	53
LC50value > 5000 mg/m^3air (aerosol)
females
600	0/0/5	4h – 14d	-	-	99
5000	0/4/5	4h – 14d	-	-	53
LC50value > 5000 mg/m^3air (aerosol)

*number of dead animals / number of animals with clinical signs of toxicity / total number of animals

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

as well as EU criteria according to CLP regulation

Conclusions:

Based on the results of this study, the four-hour inhalation LC50 for Creosote P1/P13 was greater than 5000 mg/m³.