Registration Dossier

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:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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

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.