Propanoic acid, 2-hydroxy-, propyl ester, (2S)-

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1994-06-13 to 2000-02-23

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted 17th July 1992

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

propyl (2S)-2-hydroxypropanoate

EC Number:

611-025-7

Cas Number:

53651-69-7

Molecular formula:

C6H12O3

IUPAC Name:

propyl (2S)-2-hydroxypropanoate

Specific details on test material used for the study:

- Name of test material (as cited in study report): n-propyl lactate
- Analytical purity: 99.5%
- Lot/batch No.:3
- Appearance: clear, colourless liquid
- Storage condition of test material: ambient

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- undiluted

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: young adult
- Weight at study initiation: 2260-2470 g
- Housing: individually in stainless steel cages, fitted with perforated floor
- Diet: standard laboratory rabbit diet, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 12 or 13 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 46-77.5 (upper limit higher than the intended 70%, because of meteorological circumstances or because of wet cleaning of the animal room; the 77.5% peak occurred for ca one hour at most)
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

VEHICLE
no vehicle used

Duration of treatment / exposure:

4 h

Observation period:

14 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: 100%
- Type of wrap if used: self-adhesive-gauze (Fixomull, BDF, Germany)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, application site was cleaned with a paper tissue and water
- Time after start of exposure: 4 h

OBSERVATION TIME POINTS
(indicate if minutes, hours or days): 1, 24, 48 and 72 hours and at 7 and 14 days after end of treatment.

SCORING SYSTEM: according to Draize et al., 1944 (see Table 1 in box "Any other information on materials and methods incl. tables")

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

The test substance showed slightly skin irritating properties, which had resolved within 48 hours to 7 days. Individual results are shown in Table 2 (please refer to box "Any other information on results incl. tables).

Any other information on results incl. tables

Table 2: Results after a 4 hours dermal exposure propyl (S)-lactate

Rabbit No	1 h A B	24 h A B	48 h A B	72 h A B	7 d A B	14 d A B
31	1-0^1	1-0^2	0-0^1	0-0^1	0-0^1	0-0
32	1-0^1	2-1^1	1-0^3	1-0^1	0-0^1	0-0
33	1-0^1	1-0^1	0-0^1	0-0^1	0-0^1	0-0

A: erythrema

B: oedema

¹= slight scaliness

²= moderate scaliness

³= very slight scaliness

 

Applicant's summary and conclusion

Interpretation of results:

other: CLP criteria not met

Conclusions:

In an acute dermal irritation/corrosion study conducted according to OECD 404, the test item was found to be non-irritating.

Executive summary:

In a primary dermal irritation study conducted according to OECD TG 404, three male New Zealand white rabbits were dermally exposed to 0.5 mL of the test item (99.5% purity) for 4 hours to a body surface area of 2.5 x 2.5 cm under semi-occlusive conditions. Animals then were observed for 1, 24, 48 and 72 hours and 7 and 14 days after removal of the dressings and test substance. Irritation was scored by the method of Draize.

The test item did not cause any skin effects, except a very slight erythema and edema in the treated skin-area, which had completely resolved within 24 hours to 7 days. Based on the results and in accordance with the criteria identified in the CLP Regulation 1272/2008, the test item is non-irritating.