Registration Dossier
Registration Dossier
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EC number: 305-500-5 | CAS number: 94581-02-9 Coke formed by cooling, to approximately 1500°C, hot acetylene containing split gases from aromatic residual oil produced from ethylene production by naphtha cracking at 800°C to 900°C (427°F to 482°F) (coal derived).
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- 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 Guideline 405 with acceptable restrictions (partly limited documentation; 50 μl instead of 100 μl test substance instilled. Study sufficient for evaluation of this endpoint.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 2 002
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- application volume
- Principles of method if other than guideline:
- Before OECD Guideline 405 was established, eye irritation was tested using an internal method (BASF test). White Vienna rabbits were used. Usually 50µl or mg of the test substance were applied to the conjunctival sac of one eye of 2 animals. The talcum-treated adjacent eye served as a control.
- GLP compliance:
- no
Test material
- 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
- Reference substance name:
- Acetylene coke
- IUPAC Name:
- Acetylene coke
- 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
Constituent 1
Constituent 2
Constituent 3
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: 2.51 - 2.54 kg
ENVIRONMENTAL CONDITIONS
not reported
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: approx. 50 µL of talcum into the other eye
- Amount / concentration applied:
- 50 µL
- Duration of treatment / exposure:
- Treatment was once. The eye was left unwashed.
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 2
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effect
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: no effect
- Remarks on result:
- other: Substance residues were observed on the day of application. Effects observed were equivalent to the effects of the negative control (talcum)
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect
- Remarks on result:
- other: Effects observed were equivalent to the effects of the negative control (talcum)
Any other information on results incl. tables
Descriptive scores of the raw data have been converted to Draize numerical scores.
Applicant's summary and conclusion
- Executive summary:
The study is comparable to OECD Guideline 405 with acceptable restrictions (limited documentation, reduced application volume). The study is however sufficient for evaluation of this endpoint. Corneal opacity and iritis were not observed; slight chemosis was observed only at the day of application. Conjunctivae redness was observed in both animals as reversible effect within one and eight days, respectively. Effects observed were equivalent to the effects of the negative control (talcum).
Conclusions
Acetylene coke is non-irritating to the eye.
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