Registration Dossier
Registration Dossier
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EC number: 204-596-5 | CAS number: 123-05-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-ethylhexanal
- EC Number:
- 204-596-5
- EC Name:
- 2-ethylhexanal
- Cas Number:
- 123-05-7
- Molecular formula:
- C8H16O
- IUPAC Name:
- 2-ethylhexanal
- Details on test material:
- - Name of test material (as cited in study report): 2-Ethylhexanal
- Analytical purity: 99 %
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 1, 24, 48, 72 hours
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24h-48h-72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24h-48h-72h
- Score:
- 0.4
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24h-48h-72h
- Score:
- 0.6
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24h-48h-72h
- Score:
- 0.2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Based on the results of this study 2 -Ethylhexanal is considered to be non irritating to the eye.
- Executive summary:
Three white New Zealand rabbits received instillations of 0.1 mL of the unchanged test substance to the eye and left unwashed. Scoring was performed 1, 24, 48 and 72h after instillation. The scores for cornea, iris, conjunctivae and chemosis were 0.0, 0.4, 0.6 and 0.2, respectively (mean of the 24, 48 and 72 h readings). All findings were reversible within 72h after instillation. Therefore, classification according to EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 is not warranted.
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