Registration Dossier
Registration Dossier
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EC number: 422-630-9 | CAS number: 22208-25-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 422-630-9
- EC Name:
- -
- Cas Number:
- 22208-25-9
- Molecular formula:
- C18H26O9
- IUPAC Name:
- 2,2-bis({[(3-oxobutanoyl)oxy]methyl})butyl 3-oxobutanoate
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- Albino
Test system
- Type of coverage:
- semiocclusive
- Vehicle:
- other: No vehicle was used.
- Amount / concentration applied:
- 500 mg
- Duration of treatment / exposure:
- 4 h
- Number of animals:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- mean score 1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- mean score 2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- mean score 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- mean score 1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- mean score 2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- mean score 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritant / corrosive response data:
- Reversibility of any observed effect: Changes fully reversible within 1 days
- Other effects:
- Yellow staining of the treated skin by the test substance was observed on day 1.
Any other information on results incl. tables
Exposure to the test substance resulted in very slight erythema in the treated skin-areas of two rabbits, which had resolved within 24 hours after exposure.
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance was determined to be not a skin irritant in rabbits.
- Executive summary:
The study was conducted according to EU Method B.4 (GLP study). A total of 3 New Zealand White rabbits were exposed to the test substance. According to the scores obtained from erythema and edema, the substance was determined not to be a skin irritant.
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