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Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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
Reason / purpose:
reference to same study
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals 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

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)
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:
Dose-related increase in apathy, discoordination, anormal posture, cyanosis, piloerection, and slightly reduced respiration
Body weight:
After 4 d, surviving animals appeared to have recovered to normal and showed normal weight gain.
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.

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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
4 030 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records
Reference
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
Qualifier:
according to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
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

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:
--
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.

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

Conclusions:
Based on the results of this study, the four-hour LC50 for Creosote P1/P13 was greater than 5000 mg/m³.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating conc.
Value:
5 000 mg/m³

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
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
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Iffa Crédo, 69210 L´Arbresle, France
- Age at study initiation: approx. 8 weeks
- Weight at study initiation: males: 258 ±11grams, females: 222 ±5 grams
- Fasting period before study: none
- Housing: polycarbonte cage, 1 animal per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: >= 5 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +-3
- Humidity (%): 50 +-20
- Air changes (per hr): approx. 13
- Photoperiod (hrs dark / hrs light): 12 / 12

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 30 - 35 cm2
- % coverage: about 10 % of the animals´ total surface.
- Type of wrap if used: gauze and bandage semiocclusive

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.91 ml/kg bw

Duration of exposure:
24 h
Doses:
2000 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 and weighing: day 0, 5, 8, and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
not applicable
Sex:
male/female
Dose descriptor:
LD0
Effect level:
2 000 mg/kg bw
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
none
Clinical signs:
No particular findings
Body weight:
No effects
Gross pathology:
No local reactions at the site of application / No abnormalities observed following macroscopic examination of organs
Other findings:
none
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw

Additional information

No data is available for anthracene oil itself. Data obtained for irritation originate from the closely related tar oil creosote. Due to the similar production process (fractionated distillation of coal tar using overlapping conditions), composition of both substances is similar. Major components are mid-range PAH for both substances (naphthalene to pyrene). Individual differences in distillation conditions and in starting material may cause gradual variation in qualitative and quantitative composition. But the nature of constituents and the individual components coincide and the percentage of single substances is of the same magnitude. Therefore, the irritating potential of both materials can be considered to be similar. Hence, creosote is used as supporting substance for irritating effects of anthracene oil.

Anthracene oil is expected to show little acute toxicity, based on results obtained from the closely related tar oil creosote: LD50(oral, rat) ~ 4000 mg/kg bw, LD50(dermal, rat) > 2000 mg/kg bw. No acute intoxication is expected from inhalation exposure, given the low vapour pressure and the observed low toxicity of structure-related substances (creosote, aerosol).

Justification for classification or non-classification

Based on experimental evidence, no classification required (LD/LC 50 values clearly above classification criteria).