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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
June-July 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Propanoic acid, 2-hydroxy-, 2-ethylhexyl ester, (2S)-
EC Number:
606-097-1
Cas Number:
186817-80-1
Molecular formula:
C11H22O3
IUPAC Name:
Propanoic acid, 2-hydroxy-, 2-ethylhexyl ester, (2S)-
Constituent 2
Reference substance name:
2-ethylhexyl-S-lactate
IUPAC Name:
2-ethylhexyl-S-lactate
Details on test material:
Name of test material (as cited in study report): 2-ethylhexyl-lactate
Trade name: Purasolv EHL
Purity: min. 97 %

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Broekman Institute, Someren, the Netherlands
- Age at study initiation: males and females, young adults
- Weight at study initiation: 2330-2520 g
- Housing: individually in stainless steel cages, fitted with perforated floor
- Diet (e.g. ad libitum): standard laboratory diet, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 12 or 13 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):

IN-LIFE DATES: From: June 1, 1994 To: at least June 28, 1994 (end of study)

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: hair was removed using electric clippers
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml of test substance
Duration of treatment / exposure:
4-hour exposure
Observation period:
14 days
Number of animals:
3
Details on study design:
At the start of the study, a skin site suitable for application of the test substance was selected on the clipped back and flanks of the animal. Next, an amount of 0.5 ml of the substance was distributed over a patch measuring ca 2.5 × 2.5 cm (Melolin, Smith & Nephew). The loaded patch was fixed to the selected application site by means of adhesive tape (Leukopor, BDF, Germany) and the entire trunk of the rabbit was wrapped with a self-adhesive gauze (Fixomull, BDF, Germany) to maintain the test patch and test material in its position and to retard evaporation of volatile substances. The gauze was additionally fastened with two stripes of tape (Leukoflex, BDF, Germany).
After a 4-hour exposure period, the test material and patch were removed and the application site was cleaned with a paper tissue and water. Circa 1 hour later, the resulting skin reactions were evaluated by the method of Draize et al. (J. Pharmacol. Exp. Ther. 82 (1944) 377-390).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
>= 1 - <= 2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
>= 0 - <= 2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Other effects:
Slight scaliness was observed in all test animals at 48 hr, 72 hr and 7 d. At 14 days after treatment the scaliness had cleared.

Applicant's summary and conclusion

Interpretation of results:
irritating
Conclusions:
2-Ethylhexyl-lactate is irritating, but not corrosive to skin.
Executive summary:

In a primary dermal irritation study three young adult SPF bred New Zealand White albino rabbits (Broekman Institue, Someren, the Netherlands), weighing 2330–2520 g were dermally exposed to 0.5 ml of 2-ethylhexyl-lactate to a body surface area of 2.5 × 2.5 cm on the back or flank of the animals. Test sites were covered with a semi-occlusive dressing for 4 hours. Animals were observed for 14 days. Irritation was scored by the method of Draize.

The mean erythma or oedema score over the 24–72 hour observation period was 2, but the effects appeared fully reversible within 14 days. In this study, 2-ethylhexyl-lactate is a dermal irritant based on EU standards.