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Toxicological information

Acute Toxicity: inhalation

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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

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 levelsopen allclose all
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
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/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

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.