Registration Dossier
Registration Dossier
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EC number: 221-781-6 | CAS number: 3234-28-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1997-09-23
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Reliability has been 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 405 (Acute Eye 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
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Mol:Russian
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- according to guideline
- Observation period (in vivo):
- according to guideline
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- according to guideline
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72 hours mean
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72 hours mean
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72 hours mean
- Score:
- 0.9
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The registered substance is not irritating to the eyes
- Executive summary:
The eye irritation potential of the test substance was evaluated in a study according to OECD Test Guideline 405 under GLP conditions.
The amount of 0.1 ml of the undiluted substance was applied unchanged for 24 hours to the eyes of three Mol:russian rabbits, which were observed for 7 days post application. Over the first three days minimal effects on the conjunctiva were observed which did fully reverse within 3 days.
Interpreting these results by applying the evaluation system of the EU regulation 1272/2008, the test substance is not considered to be eye irritating.
Since the composition of the registered substance is almost identical to the test substance, only the amount of C12 and C14 epoxide is slightly lower in the registered substance, this key study is taken as a valid read across for this endpoint and the registered substance is also considered to be non irritating to the eye accordingly.
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