Distillates (coal tar), heavy oils

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

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: 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:

no

Test material

Test material information

Constituent 1

Reference substance name:

Creosote - US type P1/P13

IUPAC Name:

Creosote - US type P1/P13

Test material form:

aerosol dispenser: not specified

Remarks:

migrated information: aerosol

Details on test material:

Creosote [CAS No. 8001-58-9]: US Type P1/13 based on GC/MS
(Selection of Key Compounds)
(see RTI Study 6939 Project ID 70C-6939-001)

Name CAS-No. [%]
========================================
[US P1/13]
Naphthalene 91-20-3 9.0
1-Methylnaphthalene 90-12-0 2.3
2-Methylnaphthalene 91-57-6 5.1
Indene 95-13-6 0.9
Fluorene 86-73-7 4.2
Acenaphthylene 208-96-8 0.3
Acenaphthene 83-32-9 6.1
Phenanthrene 85-01-8 12.2
Anthracene 120-12-7 2.2
Fluoranthene 206-44-0 6.8
Pyrene 129-00-0 6.0
Benz[a]anthracene 56-55-3 0.5
Chrysene 218-01-9 1.5
Benzo(a)pyrene 50-32-8 0.5
Total of 5 remaining EPA-PAH: ca. 1.4

Test animals

Species:

rat

Strain:

other: Sprague-Dawley derived Crl:CD® BR VAF/Plus®

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source:
- 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

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/m^3 (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

Statistics:

--

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

discriminating conc.

Effect level:

5 000 mg/m³ air

Based on:

test mat.

Remarks:

analytical (gravimetric)

Exp. duration:

4 h

Mortality:

No deaths occurred at maximum dose.

Clinical signs:

other: 5000 mg/kg: 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. 60

Body weight:

5000 and 600 mg/kg: 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

Conclusions:

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