Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
May 1985
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Guideline 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 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG Kastengrund
- Age at study initiation: 3 -5 month
- Weight at study initiation: 2.8 - 2.9 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

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
Duration of treatment / exposure:
4 h, test substance was removed by washing with warm tab water at the end of the exposure period
Observation period:
14 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, lukewarm tap water
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24-72
Score:
0.66
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: eshar formation was still visible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24-72
Score:
0.33
Max. score:
4
Reversibility:
fully reversible
Remarks:
7 days
Irritant / corrosive response data:
Edema score was 0 at day 7 but raised to a grade 1 in one animal and grade 2 in another animal at day 14. Erythema and eshar formaton was still visible after 14 days. Because edema was gone at day 7 and returned afterwards it may concluded that scratching occurred. The over all assumption is that ethylhexanoic acid is only slightly irritating.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
With reference to the reported edema score (0) on day 7 after application and the conclusion that scratching may have caused its return on day 14 and with reference to the overall mean scores 24 to 72 h after application 2-ethylhexanoic acid was judged to be slightly irritant to the skin and does not have to be classified as irritant to the skin according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).
Based on a read-across approach, sodium 2-ethylhexanoate is not considered to be a skin 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 skin irritant properties in 3 New Zealand White rabbits. The study was performed according to OECD Guideline 404. Effects skin (mean erythema grade 0.66 and mean edema scores 0.33) were observed 24 - 72 hours after application. Edema score was 0 at day 7 but raised to a grade 1 in one animal and grade 2 in another animal at day 14. Erythema and eshar formaton was still visible after 14 days. Because edema was gone at day 7 and returned afterwards it may concluded that scratching occurred.

With reference to the reported edema score (0) on day 7 after application and the conclusion that scratching may have caused its return on day 14 and with reference to the overall mean scores 24 to 72 h after application 2-ethylhexanoic acid was judged to be slightly irritant to the skin and does not have to be classified as irritant to the skin according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).

Based on a read-across approach, sodium 2-ethylhexanoate is not considered to be a skin irritant and is therefore not subjected for labelling and classification requirements according to regulatory requirements.