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

Acute Toxicity: dermal

Administrative data

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

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

Test material

Test material information

Constituent 1

Reference substance name:

Pitch, coal tar, high-temp.

EC Number:

266-028-2

EC Name:

Pitch, coal tar, high-temp.

Cas Number:

65996-93-2

Molecular formula:

not applicable

IUPAC Name:

Pitch, coal tar, high-temp.

Test material form:

solid

Details on test material:

pitch, coal tar, high-temp.; CCSG composite sample no. 8 (ATE 10444)
- State of aggregation: bulk solid
- Density: ca. 1.32 g/cm³ (composite sample)
1.15 - 1.4 g/cm³ (typical range for coal-tar pitch)

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

Test animals

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

Administration / exposure

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

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD0

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

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

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met