Registration Dossier
Registration Dossier
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EC number: 230-786-2 | CAS number: 7320-37-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 02-09-1997
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Reliability assessed according to Klimisch scores.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Decyloxirane
- EC Number:
- 220-667-3
- EC Name:
- Decyloxirane
- Cas Number:
- 2855-19-8
- IUPAC Name:
- 2-decyloxirane
- Details on test material:
- The test material contains a slightly lower amount of C12 und C 14 epoxide than the registered substance.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Mol:Russian
- Details on test animals or test system and environmental conditions:
- according to guideline
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- undiluted
- Duration of treatment / exposure:
- according to guideline
- Observation period:
- 21 days
- Number of animals:
- 3
- Details on study design:
- according to guideline
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours mean
- Score:
- 1.9
- Max. score:
- 2
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours mean
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible within: 21 days
- Irritant / corrosive response data:
- The registered substance showed irritative properties which were fully reversible after 21 days.
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance has to be classified as "irritating to the skin".
- Executive summary:
The skin irritation potential of the test substance was evaluated in a study according to OECD Test Guideline 404 under GLP.
The undiluted test substance was applied unchanged under occlusive conditions for 4 hours to the shaved skin of three Mol:Russian rabbits, which were observed for 21 days post application. Over the first three days, clear erythema and oedema were observed in all rabbits, which reversed fully within 21 days.
Interpreting these results by applying the evaluation system of the EU regulation 1272/2008, the test substance is considered to be irritating to the skin. Since the composition of the registered substance is almost identical to the test substance, only the amount of C12 and C14 epoxide is slightly higher in the registered substance, this key study is taken as a valid read across for this endpoint and the registered substance is considered to be irritating to the skin accordingly.
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