Registration Dossier
Registration Dossier
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EC number: 265-196-4 | CAS number: 64742-93-4 A complex black solid obtained by blowing air through a heated residuum, or raffinate from a deasphalting process with or without a catalyst. The process is principally one of oxidative condensation which increases the molecular weight.
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: This study is assigned a Klimisch score of 2. Although the study report does not provide sufficent data, the results of this study can be utilized. Not a GLP study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 973
- Report date:
- 1973
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Pre-guideline study according to the Draize methodology
- GLP compliance:
- no
Test material
- Reference substance name:
- Asphalt, oxidized
- EC Number:
- 265-196-4
- EC Name:
- Asphalt, oxidized
- Cas Number:
- 64742-93-4
- Molecular formula:
- Not applicable
- IUPAC Name:
- Asphalt, oxidized
- Reference substance name:
- Asphalt Sample 77220
- IUPAC Name:
- Asphalt Sample 77220
- Test material form:
- liquid: viscous
- Details on test material:
- Described as sample 77220.
The material is steep compounding (airblown).
CAS number 64742-93-4
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: albino
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- undiluted
Amount applied: 0.5 other: g - Duration of treatment / exposure:
- 24hrs
- Number of animals or in vitro replicates:
- 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 1.5
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: Study authors concluded that irritation was due to the physical nature of the test material
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- other: included within conjunctivae score
Any other information on results incl. tables
The only effect noted was conjunctival reddening (score 2)at the 1 hour observation period in 3 of 4 rabbits.
No other effects were observed.
It is assumed that the irritation that occurred was due to the physical nature of the test material.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- 24 -, 48 -, and 72 -hour mean scores for cornea, iris, and conjunctival irritation were observed to be 0. Based on these results, the test material is not considered to be an ocular irritant.
- Executive summary:
In an ocular irritation test in albino rabbits, 0.5 g of the test material (asphalt sample 77220) was applied to the conjunctival sac of 4 animals. Observations for eye irritation were made at 1, 24, 48 hours and 7 days after treatment.
For the one hour observation the test material was removed from the conjunctival sac and after evaluation a fresh sample of 0.5 g wasre-introduced into the conjunctival sac.
The test material was removed from the conjunctival sac 24 hours after the first treatment.The only effect noted was conjunctival reddening (score 2) at the 1 hour observation period in 3 of 4 rabbits. 24 -, 48 -, and 72 -hour mean scores
for cornea, iris, and conjunctival irritation were observed to be 0.
Based on these results, the test material is not considered to be an ocular irritant.
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