Registration Dossier
Registration Dossier
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EC number: 243-283-8 | CAS number: 19766-89-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- Oct 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline conforme GLP Study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
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:
- 2-ethylhexanoic acid
- EC Number:
- 205-743-6
- EC Name:
- 2-ethylhexanoic acid
- Cas Number:
- 149-57-5
- IUPAC Name:
- 2-ethylhexanoic acid
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): 2-Ethylhexansäure (CAS 149-57-5)
- Physical state: clear liquid
- Analytical purity: 99 %
- Lot/batch No.: RM 13 2904
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG Kastengrund
- Age at study initiation: 3 - 5 month
- Weight at study initiation: 3.0 - 3.6 kg
- Housing: single housing
- Diet (e.g. ad libitum): Altromin 2123 Haltungsdiät - Kaninchen; Altromin GmbH Lage/Lippe
- Water (e.g. ad libitum): Tab water
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 °C
- Humidity (%): 50 +/- 20 %
- Photoperiod (hrs dark / hrs light): 12h/12h
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 100 µL
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
no
SCORING SYSTEM:
Draize
TOOL USED TO ASSESS SCORE:
fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 0.44
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- 0.56
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 -72 h
- Score:
- 1.2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- 0.89
- Max. score:
- 4
- 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:
- With reference the reported scores and the reversibility of the observed effects 2-ethylhexanoic acid does not have to be classified as irritant to the eyes according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC) and in the EU Dangerous Substances Directive (67/548/EEC).
Based on a read-across approach, sodium 2-ethylhexanoate is not considered to be a eye irritant and is therefore not subjected for labelling and classification requirements according to regulatory requirements. - Executive summary:
A read across was performed from the source substance 2 -ethylhexanoic acid to the target substance sodium 2 -ethylhexanoate (for read across justification please refer to attached document, IUCLID Chapter 13).
2 -Ethylhexanoic acid was tested for its eye irritant properties in 3 New Zealand White rabbits. The study was performed according to OECD Guideline 405.
Effects on conjunctivae (mean redness score: 1.2 and mean swelling score: 0.89), cornea (mean score: 0.44) and iris (mean score: 0.56) were observed 24 - 72 h after application. These signs were fully reversible within 72 h (corneal effects) and 7 days (all other observed effects).
With reference the reported scores and the reversibility of the observed effects 2-ethylhexanoic acid does not have to be classified as irritant to the eyes according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC) and in the EU Dangerous Substances Directive (67/548/EEC).
Based on a read-across approach, sodium 2-ethylhexanoate is not considered to be a eye irritant and is therefore not subjected for labelling and classification requirements according to regulatory requirements.
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