Pitch, coal tar, high-temp., < 1% 4- to 5-membered condensed ring aromatic hydrocarbons

Endpoint summary

Description of key information

No particular acute toxicity was noted in experimental studies in rats with the structure-related substance coal tar pitch. LD50 oral and dermal were > 15000 mg/kg bw and > 2000 mg/kg bw, respectively.

These values are adopted for Pitch, coal tar, high-temp., < 1% 4- to 5-membered condensed ring aromatic hydrocarbons [EC no. 701-305-8].

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: oral

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

REPORTING FORMAT FOR THE ANALOGUE APPROACH

- ANALOGUE APPROACH JUSTIFICATION
The source substance, Pitch, coal tar, high temp. [CAS no. 65996-93-2], as precursor of CTPhtht is used as structure-analogue: similar structure and phys-chem. properties like the target substance, Pitch, coal tar, high-temp., < 1% 4- to 5-membered condensed ring aromatic hydrocarbons [EC no. 701-305-8] (CTPhtht), but potentially higher bioavailability than CTPhtht.

Reason / purpose for cross-reference:

read-across source

Principles of method if other than guideline:

Read-across to preceding entry:
Source test material: pitch, coal tar (CTP)
Reference: Sterner et al. 1987, Acute toxicity, oral

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 15 000 mg/kg bw

Based on:

test mat.

Reference 2

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

03 June - 03 July 1987

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Specific details on test material used for the study:

Electrode binder [CAS No. 65996-93-2]
- Name of test material (as cited in study report): 101.110
- Physical state: solid, black powder

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
- Rationale for the selection of the limit 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

Statistics:

not applicable

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 15 000 mg/kg bw

Mortality:

none

Clinical signs:

other: none

Gross pathology:

no particular findings

Interpretation of results:

GHS criteria not met

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

Reference 1

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

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

Specific details on test material used for the study:

- Name of test material (as cited in study report): coal tar pitch
- Substance type: organic
- Lot/batch No.: A-10063A
- Expiration date of the lot/batch: 24 Sep. 2011
- Stability under test conditions: stable
- Storage condition of test material: room temperature in the dark

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 - 308 g; females: 191 - 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

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:

other: Black and yellow staining of fur and the treated skin area, 3 cases of bloody nasal, ocular discharge (chromodacryorrhoea, snout), the latter not treatment related (stress symptom).

Gross pathology:

no particular findings

Interpretation of results:

GHS criteria not met

Reference 2

Endpoint:

acute toxicity: dermal

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

REPORTING FORMAT FOR THE ANALOGUE APPROACH

- ANALOGUE APPROACH JUSTIFICATION
The source substance, Pitch, coal tar, high temp. [CAS no. 65996-93-2], as precursor of CTPhtht is used as structure-analogue: similar structure and phys-chem. properties like the target substance, Pitch, coal tar, high-temp., < 1% 4- to 5-membered condensed ring aromatic hydrocarbons [EC no. 701-305-8] (CTPhtht), but potentially higher bioavailability than CTPhtht.

Reason / purpose for cross-reference:

read-across source

Principles of method if other than guideline:

Read-across to preceding entry:
Source test material: pitch, coal tar (CTP)
Reference: Beerens-Heijnen 2010, Acute toxicity, dermal

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Additional information

Acute toxicity (oral and dermal application) was tested using pitch, coal tar, high temp. (coal tar pitch) [CAS No. 65996-93-2] as supporting substance. This substance is closely structure-related to the target substance Pitch, coal tar, high-temp., < 1% 4- to 5-membered condensed ring aromatic hydrocarbons [EC No. 701-305-8] (CTPhtht) with similar properties. The target substance CTPhtht is obtained from the precursor coal tar pitch by high temperature distillation, a process that removes volatiles still further and leaves a more condensed and inert residue.

In the acute oral and dermal toxicity studies, no mortality and no indicators of substance related other toxic effects were observed at limit concentrations of 15000 and 2000 mg/kg bw, respectively. These results are adopted to the target substance CTPhtht. Exposure by inhalation is considered not to be relevant, as CTPhtht is a solid with a high melting point and a very low vapour pressure.

Justification for selection of acute toxicity – oral endpoint
Valid GLP study according to OECD TG 401 with the supporting substance pitch, coal tar, high-temp., (precursor material); 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 with the supporting substance pitch, coal tar, high-temp., (precursor material); no mortality and no other signs of toxicity observed.

Justification for classification or non-classification

Based on experimental evidence from the supporting substance pitch, coal tar, high-temp. (precursor material), no classification required, as LD 50 values are clearly above classification criteria of Regulation (EC) No 1272/2008).