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Administrative data

Description of key information

No particular acute toxicity was observed in experimental studies after single oral administration of coal tar pitch, high temp., a closely structure related pitch and after dermal administration of petro pitch itself. LD50 values were > 15000 mg/kg bw/day (oral, coal tar pitch) and > 2000 mg/kg bw/day  (dermal, petro pitch). No mortality and no other signs of toxicity were observed in both studies.

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
Study period:
03 June - 03 July 1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga, Sulzfeld/Germany
- Age at study initiation: no data
- Weight at study initiation: 180.0 - 200.0 g (m); 151.9 - 181.9 g (f)
- Fasting period before study: 16 h
- Housing: max. 5/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: >= 7 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +-2 °C
- Humidity (%): 50 - 85
- Photoperiod (hrs dark / hrs light): 12 / 12

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 50 % (w/v)
- Amount of vehicle (if gavage): The TS was applied in a constant volume of 5-% carboxymethylcellulose. 
- Justification for choice of vehicle: inert carrier material for suspending insoluble solids


MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg bw



CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:
The  dose was derived from a range-finding test and corresponded to the  maximally applicable volume.

Doses:
15000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: day 0 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopic organpathology
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 15 000 mg/kg bw
Mortality:
none
Clinical signs:
none
Body weight:
normal
Gross pathology:
no particular findings
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
15 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River, Germany
- Age at study initiation: 10 - 12 weeks
- Weight at study initiation: males: 281 - 296 g; females: 190 - 203 g
- Fasting period before study:
- Housing: Makrolon cages, individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +-3
- Humidity (%): 40 - 70 %
- Air changes (per hr): approx. 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: approx. 10 % of total body surface (males: ~25 cm2; females: ~18 cm2)
- Type of wrap if used: surgical gauze (Surgy 1D), covered with aluminum foil and Coban elastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw

VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:
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: 2x daily for clinical observation, day 1, 8 and 15 for body weight
- 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
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
no
Clinical signs:
black and yellow staining of fur and the treated skin area
Body weight:
normal
Gross pathology:
no particular findings
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Acute toxicity was determined using petro pitch (dermal application) and coal tar pitch, high temp. (oral application), a closely related substance with similar structure and properties. Exposure by inhalation is considered not to be relevant as petro pitch is a solid with a high melting point and a very low vapour pressure. Exposure to vapour, aerosols or particles containing petro pitch is of no concern.

The highest doses tested (oral route: 15000 mg/kg bw/day; dermal route: 2000 mg/kg bw/day) did not produce any mortality. In addition, indicators of other toxic effects could also not be observed.


Justification for selection of acute toxicity – oral endpoint
Valid GLP study according to OECD TG 401, no mortality and no other signs of toxicity observed.

Justification for selection of acute toxicity – dermal endpoint
Valid GLP study according to OECD TG 402, no mortality and no other signs of toxicity observed.

Justification for classification or non-classification

Based on experimental evidence, no classification required (LD50 values clearly above classification criteria of Regulation (EC) No 1272/2008).