Registration Dossier

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:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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/m3air]

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/m3air (aerosol)

 

females

600

0/0/5

4h – 14d

-

-

99

5000

0/4/5

4h – 14d

-

-

53

LC50value > 5000 mg/m3air (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.