Coke (coal), naphtha cracking ethylene manuf. by-product

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study is comparable to OECD 401 with acceptable restrictions mostly due to reduced reporting in times before GLP.

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Reference 2

Reference Type:

other company data

Title:

Unnamed

Year:

2002

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

Dose volumes extending the recommended amounts.

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Coke (coal), naphtha cracking ethylene manuf. by-product

EC Number:

305-500-5

EC Name:

Coke (coal), naphtha cracking ethylene manuf. by-product

Cas Number:

94581-02-9

Molecular formula:

C

IUPAC Name:

Coke (coal), naphtha cracking ethylene manuf. by-product

Constituent 2

Reference substance name:

Acetylene coke

IUPAC Name:

Acetylene coke

Constituent 3

Reference substance name:

XXVI/564

IUPAC Name:

XXVI/564

Details on test material:

- Name of test material (as cited in study report): Acetylenkoks
- Physical state: solid
- Purity: not reported
- Expiration date of the lot/batch: not reported
- Stability under test conditions: not reported
- Storage condition of test material: not reported

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Gassner
- Mean weight at study initiation: 210 g (male), 170 (female)

ENVIRONMENTAL CONDITIONS
not reported

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: aqueous emulsion containing 0.5% CMC (carboxy methylcellulose)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 50%

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg = maximum 4.2 mL per male and 3.4 mL per female animal, respectively

Doses:

10000 mg/kg

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: Weighing was performed at the beginning of the study and on days 5, 8 and 14. Observation of clinical signs was several times on the day of administration and once daily afterwards except on weekends and on holidays.
- Necropsy of survivors performed: yes

Statistics:

Not performed.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Mortality:

No mortality observed

Clinical signs:

No clinical signs observed

Body weight:

Mean body weight at d0, d5, d8 and d14
males: 210, 244, 263 and 291 g
females: 170, 189, 195 and 210 g

Gross pathology:

nothing abnormal observed

Applicant's summary and conclusion

Executive summary:

The study was comparably performed according to OECD 401 with acceptable restrictions mostly due to reduced reporting in times before GLP. Groups of 5 rats per sex and dose were administered with 10,000 mg/kg of the test substance. The dose volume was 20 mL/kg bw (= maximum 4.2 mL/ animal). The acute LD50 for male and female rats is > 10,000 mg/kg. No clinical signs or abnormal necropsy findings were observed.

Conclusion

Acetylene coke is practically nontoxic after swallowing.