Registration Dossier
Registration Dossier
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EC number: 817-668-1 | CAS number: 667899-24-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From June 1994 to August 1994
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Limited documentation but relevant data given
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- limited documentation but relevant data given
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2,2-bis[[(2-ethyl-1-oxohexyl)oxy]methyl]propane-1,3-diyl bis(2-ethylhexanoate)
- EC Number:
- 230-743-8
- EC Name:
- 2,2-bis[[(2-ethyl-1-oxohexyl)oxy]methyl]propane-1,3-diyl bis(2-ethylhexanoate)
- Cas Number:
- 7299-99-2
- Molecular formula:
- C37H68O8
- IUPAC Name:
- 3-[(2-ethylhexanoyl)oxy]-2,2-bis{[(2-ethylhexanoyl)oxy]methyl}propyl 2-ethylhexanoate
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- not specified
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- yes
- Duration of treatment / exposure:
- 4 h
- Observation period:
- Time points: 30 - 60 min, 24, 48 and 72 h
- Number of animals:
- 3 females
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- The only sign of irritation was a slight transient erythema observed in all three rabbits 30-60 min after patch removal.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the study conditions, the test substance was non-irritating to rabbit skin.
- Executive summary:
A study was conducted to determine the skin irritation potential of the test substance in rabbits according to a method similar to OECD Guideline 404. The test substance was applied to the shaved skin of 3 female rabbits under a semi-occlusive patch for 4 h. Upon patch removal, the exposed skin was observed for signs of skin irritation at 30 -60 min, 24, 48 and 72 h. The only sign of irritation was a slight transient erythema observed in all three rabbits 30 -60 min after patch removal. Under the study conditions, the test substance was non-irritating to rabbit skin (Zeneca, 1994).
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