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.
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin 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 was assigned a Klimisch score of 2. The study report does not provide adequate detail on methodology but the results of the study can be useful information. The study was pre-guideline according to the Draize method.
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 Draize methodology. 24hr occluded patch test on abraded and non-abraded rabbit skin
- 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
- Species:
- rabbit
- Strain:
- other: albino
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 grams
- Duration of treatment / exposure:
- no data
- Number of animals:
- 4
- Details on study design:
- No Data
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1.8
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: intact skin
- Irritation parameter:
- primary dermal irritation index (PDII)
- Score:
- 1
Any other information on results incl. tables
No oedema seen at any time point at any test site.
The test material produced a very slight black stain over the test sites, but the authors stated that it was still possible to evaluate the erythema present.
Some erythema (score 2) was seen at 24 hours in both intact and abraded sites but this had resolved by 72 hours.
Primary irritation score was 1.0
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the observations of erythema and lack of oedema, the test material is not considered to be a skin irritant in the albino rabbit.
- Executive summary:
In a primary dermal irrtitation study, 0.5 g of the test material (aphalt sample 77220) was applied undiluted to the abraded and non abraded skin of 4 albino rabbits. Erythema and oedema were scored at 24 and 72 hours.
Erythema (mean = 1.9) was observed in all 4 animals at the 24 hour and 72 hour observations at the intact and abraded skin sites. No oedema was noted in at any site thorughout the study period. Based on these observations, the test material is not considered to be a skin irritant in the albino rabbit.
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