Registration Dossier

Diss Factsheets

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:
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 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

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 / 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.

Categories Display