Registration Dossier

Diss Factsheets

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

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978
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

Constituent 1
Chemical structure
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.