Sodium lactate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2013-03-20 to 2013-05-06

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted 24th April 2002

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Sodium (S)-lactate

EC Number:

212-762-3

EC Name:

Sodium (S)-lactate

Cas Number:

867-56-1

Molecular formula:

C3H6O3.Na

IUPAC Name:

sodium 2-hydroxypropanoate

Specific details on test material used for the study:

- Name of test material (as cited in study report): PURASAL S
- Appearance: colourless liquid
- Lot/batch No.: 1208001453
- Expiry date: 13 August 2014
- Storage condition: at room temperature (15 - 25 °C)

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: S&K-LAP Kft., 2173 Kartal, Császár út 135, Hungary
- Weight at study initiation: 3406 to 3600 g
- Age of animals at treatment: approx. 12 weeks
- Housing: Animals were individually housed in AAALAC approved metal wire rabbit cages. Cages were of an open wire structure and cages. Cages were of an open wire structure and cages were placed together to allow some social interaction with rabbits in adjoining cages.
- Diet: ad libitum, UNI diet by AGRIBRANDS Europe Hungary PLC, H-5300 Karcag, Madarasi út, Hungary
- Water: ad libitum, municipal tap water
- Acclimation period: 18 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17.1–19.5 °C
- Humidity (%): 24–56%
- Air changes (per hr): 15–20
- Photoperiod (hrs dark/hrs light): 12/12

Test system

Type of coverage:

occlusive

Preparation of test site:

other: clipped and shaved

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

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

Duration of treatment / exposure:

4 h

Observation period:

72 h

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 6 cm²
- Coverage: one layer of medical gauze (open-weave with large holes, 5 × 5 cm) and three more layers of gauze over application area
- Type of wrap if used: occlusive (clear plastic with surrounding adhesive hypoallergenic plaster and medical elastic tubing to keep plastic in place)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsing with water (at body temperature) after patch removal
- Time after start of exposure: 4 h

OBSERVATION TIME POINTS (indicate if minutes, hours or days)
1, 24, 48, and 72 h after patch removal

SCORING SYSTEM
- Method of calculation: The irritation scores were evaluated according to the scoring system by Draize, 1959:

Erythema and eschar formation:
0 - No erythema
1 - Very slight erythema (barely perceptible)
2 - Well-defined erythema
3 - Moderate to severe erythema
4 - Severe erythema (beet redness) to slight eschar formation (injuries in depth)

Oedema formation:
0 - No oedema
1 - Very slight oedema (barely perceptible)
2 - Slight oedema (edges of area well-defined by definite raising)
3 - Moderate oedema (raised approximately 1 millimetre)
4 - Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure)

OTHER EXAMINATIONS
- Body weight: Body weights were recorded on the day of administration and at the end of the observation period
- Clinical observations and mortality: The animals were monitored for general clinical signs once daily

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

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

Max. score:

4

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 treated and also the control skin area did not show any irritations at any observation times: 24 h, 48 h and 72 h (see Table 1 and Table 2 in box "Any other information on results incl. tables"). After one hour, the administration area of one animal (01200) showed "very slight oedema - barely perceptible" and two animals (01130 & 01200) showed signs of "very slight erythema - barely perceptible".

Other effects:

- Other adverse local effects: none
- Other adverse systemic effects: no effects on body weight and no mortality and no adverse clinical signs of toxicity were noted.

Any other information on results incl. tables

Table 1: Scoring of edema formation and measured body weight

Animal no./sex	Body weight (g)		1 h	24 h	48 h	72 h
	At the beginning of the study	At the end of the study
01130/M	3600	3654	0	0	0	0
01126/M	3584	3629	0	0	0	0
01200/M	3406	3470	1	0	0	0
TOTAL			0.33	0	0	0

Table 2: Scoring of erythema formation

Animal No./Sex	Body weight (g)		1 h	24 h	48 h	72 h
	At the beginning of the study	At the end of the study
01130/M	3600	3654	1	0	0	0
01126/M	3584	3629	0	0	0	0
01200/M	3406	3470	1	0	0	0
TOTAL			0.66	0	0	0

M = male

Applicant's summary and conclusion

Interpretation of results:

other: CLP criteria not met

Conclusions:

In a primary dermal irritation study conducted according to OECD guideline 404, the test item did not induce skin irritation.

Executive summary:

In a primary dermal irritation study conducted according to OECD Guideline 404, male young adult New Zealand White albino rabbits (n= 3) were dermally exposed to 0.5 mL of Sodium (S)-lactate for 4 hours. Animals then were observed 1, 24, 48 and 72 hours after patch removal. Irritation was scored by the method of Draize.

In this study, Sodium (S)-lactate did cause at observation time point 1 hour after patch removal very slight erythema (score 1) to two animals and very slight edema (score 1) to one animal. At 24, 48 and 72 hours after patch removal, there were no observed clinical signs noted on the skin of the treated animals. Thus, under the conditions of this study, the test substance can be considered as non-irritating.