Sodium lactate

Endpoint summary

Description of key information

Sodium lactate is neither irritating to skin nor to eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

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

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)

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)

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

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

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

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

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

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

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

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.

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

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.

Reference 2

Endpoint:

skin corrosion: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Reference 1

Endpoint:

eye irritation: in vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Justification for type of information:

For justification of read-across please refer to the read-across report attached to IUCLID section 13.

Reason / purpose for cross-reference:

read-across source

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis 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 scores for eye irritation/corrosion are given in Table 1 in box " Any other information on results incl. tables". Instillation of 49.2 mg of the test substance (a volume of approximately 0.1 mL) into one eye of each of three rabbits resulted in effects on the iris and conjunctivae. Iridial irritation (grade 1) was observed in two animals and had resolved within 24 hours. Irritation of the conjunctivae was seen as redness and chemosis, which had completely resolved within 24 hours in two animals and within 48 hours in one animal. Finally, there was no evidence of ocular corrosion and also no staining of (peri) ocular tissues by the test substance.

Other effects:

No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Table 1: Results

Scored item and animal No.			Observation time
Cornea			1h	24h	48h	72h	Mean 24/48/72h
Rabbit 511			0	0	0	0	0
Rabbit 534			0	0	0	0	0
Rabbit 535			0	0	0	0	0
Iris			1h	24h	48h	72h	Mean 24/48/72h
Rabbit 511			1	0	0	0	0
Rabbit 534			0	0	0	0	0
Rabbit 535			1	0	0	0	0
Redness			1h	24h	48h	72h	Mean 24/48/72h
Rabbit 511			2	1	0	0	0.33
Rabbit 534			2	0	0	0	0
Rabbit 535			2	0	0	0	0
Chemosis			1h	24h	48h	72h	Mean 24/48/72h
Rabbit 511			2	0	0	0	0
Rabbit 534			1	0	0	0	0
Rabbit 535			1	0	0	0	0

Interpretation of results:

other: CLP criteria not met

Conclusions:

In a primary eye irritation study conducted according to OECD 405, Magnesium (S)-lactate was instilled into the conjunctival sac of the eye of three young adult New Zealand White rabbits. Based on the results, the test substance can be considered as non-irritating to the eye.

Executive summary:

In a primary eye irritation study (OECD 405), 0.1 mL of Magnesium (S)-lactate was instilled into the conjunctival sac of one eye of each of three adult New Zealand White rabbits. Animals were observed for 7 days. Irritation was scored by the method of Draize. Only very mild conjunctival redness was observed in one rabbit, which were fully reversible within 48 hours. No signs of systemic intoxication was observed in any of the rabbits. Based on the results, the test item can be considered as not irritating.

This information is used in a read-across approach in the assessment of the target substance. For justification of read-across please refer to the read-across report attached to IUCLID section 13.

Reference 2

Endpoint:

eye irritation: in vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Justification for type of information:

For justification of read-across please refer to the read-across report attached to IUCLID section 13.

Reason / purpose for cross-reference:

read-across source

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.6

Max. score:

3

Reversibility:

fully reversible within: 72 h

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72 h

Remarks on result:

positive indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.6

Max. score:

3

Reversibility:

fully reversible within: 14 days

Remarks on result:

positive indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 h

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 h

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

One and 24 hours after the application, some blood vessels hyperaemic (injected) (grade 1) and some swelling above normal (grade 1) was recorded, accompanied by slight lacrimation in the case of the observation carried out 24 hours after the administration. 48 hours after the administration, some hyperaemic blood vessels (injected) (grade 1) were still observed in this animal, but the oedema had remitted completely.
No ocular lesions were recorded in this animal 72 hours, 7 or 14 days after the administration.
One hour after the administration, one of the animals (2011) was seen to have redness diffuse, crimson colour, individual vessels not easily discernible (grade 2). 24 h afterwards, diffuse redness, crimson colour, and individual vessels not easily discernible (grade 2), were still observed, but the edema had diminished to some swelling above normal (grade 1). One hour and 24 hours after the application, slight lacrimation was also observed in this animal. 48 hours after the administration, some hyperaemic blood vessels (injected) (grade 1) were observed.
No ocular lesions were observed 72 hours, 7 or 14 days after the administration.
One, 24 and 48 hours after the administration, diffuse redness, crimson colour, and individual vessels not easily discernible (grade 2) were observed in the remaining animal (2012). One hour after the administration, swelling, with the lids about half closed (grade 3), was also recorded in this animal. This lesion diminished progressively to obvious swelling, with partial eversion of lids (grade 2) during the observation carried out 24 hours after the application, and to some swelling above normal (grade 1) during the observation carried out 48 hours after the application. Slight (lacrimation (grade 1) was also recorded in this animal one hour and 24 hours after the treatment. 72 hours and 7 days after the application, some hyperaemic blood vessels (injected) (grade 1) were observed, which had remitted completely 14 days after the administration.
For details on the individual results please see Table 1 in box "Any other information on results".

Other effects:

None of the animals died or showed clinical signs during the course of testing.

Table 1: Primary Eye Irritation Test

Animal #	Region of eye		Observation period
			1h	24h	48h	72h	7d	14d
1997	Cornea	Density	0	0	0	0	0	0
	Iris		0	0	0	0	0	0
	Conjunctivae	Hyperaemia	1	1	1	0	0	0
		Edema	1	1	0	0	0	0
2011	Cornea	Density	0	0	0	0	0	0
	Iris		0	0	0	0	0	0
	Conjunctivae	Hyperaemia	2	2	1	0	0	0
		Edema	2	1	0	0	0	0
2012	Cornea	Density	0	0	0	0	0	0
	Iris		0	0	0	0	0	0
	Conjunctivae	Hyperaemia	2	2	2	1	1	0
		Edema	3	2	1	0	0	0

 

Interpretation of results:

other: CLP criteria not met

Conclusions:

In a primary eye irritation study conducted according to OECD 405, Ammonium (S)-lactate was instilled into the conjunctival sac of the eye of three young adult New Zealand White rabbits for 24 hours. Based on the results, the test item can be considered as not eye-irritating.

Executive summary:

In a primary eye irritation study (OECD 405), 0.1 mL of Ammonium (S)-lactate was instilled into the conjunctival sac of one eye of each of three young adult New Zealand White rabbits. Animals were observed for 14 days. Irritation was scored by the method of Draize. The behaviour and physical state of the rabbits, and the body-weight evolution were normal throughout the study. Only very mild conjunctival reactions were observed, which were fully reversible within 72 hours (two animals), and for the third animal within 14 days. Based on these results, the test item can be considered as not irritating in accordance with CLP Regulation 1272/2008.

This information is used in a read-across approach in the assessment of the target substance. For justification of read-across please refer to the read-across report attached to IUCLID section 13.

Reference 3

Endpoint:

eye irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available

Reference 4

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

The study was conducted according to the AFNOR (Association Française de Normalisation) guidelines (as valid in 1982, the year in which this study was published). Although the used protocol is similar to the current OECD protocol OECD TG 405, it differed in some respects. For instance, the scoring of the eye irritation test was done on a different (but related) scale than the current OECD TG 405 protocol and the applied scoring included a wider range of categories of severity of eye irritation (6 instead of 3 as nowadays applied in OECD TG 405; EC1272/2008). In addition, in this published study, no individual scores for the animals are given, but values based on averages of all animals.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

Version of 1979 (deviates from current)

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: AFNOR

Version / remarks:

Association Français de Normalisation (1982)

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: Official method approved by the French authorities for the testing of cosmetics and toiletries (Journal Officiel de la République Français, 1971 & 1973)

Deviations:

no

Principles of method if other than guideline:

Application of 0.1 mL of a 60 % aqueous solution of Sodium lactate into the lower conjunctival sac of one eye per rabbit (the other eye serving as control) to in total 6 New Zealand male albino rabbits and (with no rinsing of the eyes) subsequent observation of the eyes at 1, 24, 48, 72, 96 and 168 hours post substance application. Scoring was done on the AFNOR scale for interpretation of ocular irritation evaluations. The scores represent a total summed score (maximum 110) of the conjunctiva (maximum 20) + iris (maximum 10) + cornea (maximum 80) scores. In addition, reversibility is taking into account in this scoring method (completeness of recovery at 96 hours).

GLP compliance:

not specified

Specific details on test material used for the study:

- Physical state: colourless liquid

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: substance was applied undiluted

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Roucher SA, Couhé
- Age at study initiation: Not specified
- Weight at study initiation: 2.5 kg
- Housing: Not specified
- Diet (e.g. ad libitum): Not specified
- Water (e.g. ad libitum): not specified
- Acclimation period: Not specified

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not specified
- Humidity (%): Not specified
- Air changes (per hr): Not specified
- Photoperiod (hrs dark/rs light): Not specified

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL of a 60 % aqueous solution

Duration of treatment / exposure:

single treatment

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

6

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: A scoring system based on the AFNOR recommendations was used with modifications where appropriate. At each observation time, lesions of the conjunctiva, iris and cornea were scored separately using a numerical system based on that of Kay & Calandra (1962), the sum of these scores being the individual irritation index (IOI) for each animal. Calculation of the mean (and the standard deviation) of the IOI values obtained at any one time gave the mean ocular irritation index (MOI). The greatest MOI obtained over the range of observation times was identified as the acute ocular irritation index (AOI). See Table 1 in box “Any other information on materials & methods incl. tables”.

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Remarks on result:

probability of weak irritation

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Irritant / corrosive response data:

The observed maximum acute (at 1 or 24 hours) irritation index for sodium lactate was 12 (out of a maximum of 110) . This score would imply a classification "slightly irritant" when using the 1982 AFNOR criteria and categories., ie sodium lactate would end up in category 2 of 6 ranging from non irritant (Cat. 1) to extremely irritant (Cat. 6). After 48 hours, the mean irritation index (i.e. mean of 1, 24 and 48 hours) was 2.5, implying extensive recovery after 48 hours. Taking into account the more elaborate categorization (next to non irritant substances and additional 5 categories of eye irritant substances in the 1982 AFNOR versus only 2 categories on eye irritation severity according to CLP Regulation 1272/2008) and the rapid reversibility of the observed eye effects of Sodium lactate, the substance would not be classified as eye irritant applying CLP classifcation criteria.

Other effects:

None of the animals died or showed clinical signs during the course of testing.

Table 2: Ocular irritation indices determined in the rabbit in accordance with the principles of the proposed AFNOR protocol

Test material	Appearance	Approx. pH	Rinsing procedure	AOI	MOI	IOI	Classification AFNOR
Sodium lactate (purified, 60 % aqueous solution)	Colourless liquid	8.0	None	12.00	2.5 [2]	-	SII

AOI: Acute ocular irritation index, which was the 1-hr MOI in the case of the irritant and very irritant substances and was the 24-hr MOI for the severely and extremely irritant substances

MOI: Mean ocular irritation index after the number of days indicated in square brackets.

IOI: Individual ocular irritation index on day 7 in the number of rabbits indicated in brackets.

SI: Slightly irritant

Interpretation of results:

other: CLP criteria not met

Conclusions:

In a primary eye irritation study conducted according to AFNOR, Sodium lactate can be considered as not irritating to the eye by applying CLP criteria.

Executive summary:

In an eye irritation study conducted according to AFNOR, 0.1 mL of the test item was instilled into the conjunctival sac of one eye of each of six New Zealand White rabbits. Animals were observed for 7 days. At each observation time, lesions of the conjunctive, iris and cornea were scored separately using a numerical system based on that of Kay & Calandra (1962), the sum of these scores being the individual ocular irritation index (IOI) for each animal. Based on the results, the test item can be considered as not irritating to the eye by applying CLP criteria.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

By way of read-across from the structurally equivalent substances Sodium (S)-lactate, Ammonium (S)-lactate and Magnesium (S)-lactate, it is concluded that Sodium lactate is not irritating – neither to skin nor to eyes.

A concentrated aqueous solution of Sodium (S)-lactate was applied to the skin of rabbits. No symptoms of skin irritation were observed upon administration. Based on the results, it can be concluded by way of read-across, that the target substance is not irritating to skin.

In a primary eye irritation study (OECD 405), Ammonium (S)-lactate was instilled into the conjunctival sac of one eye of each of three young adult New Zealand White rabbits. Only very mild conjunctival reactions were observed, which were fully reversible within the prescribed study period, thus the test item can be considered as not irritating.

In an eye irritation study (conducted according to AFNOR), Sodium lactate was instilled into the conjunctival sac of one eye of each of six New Zealand White rabbits. Slight symptoms of irritation were observed, which were fully reversible within 7 days. Based on the results, the test item can be considered as not irritating to the eye.

In a primary eye irritation study (OECD 405), Magnesium (S)-lactate was instilled into the conjunctival sac of one eye of each of three young adult New Zealand White rabbits. Only very mild conjunctival reactions were observed, which were fully reversible within the prescribed study period, thus the test item can be considered as not irritating.

Thus, in accordance with CLP Regulation 1272/2008 no classification for eye or skin irritation is warranted for the target substance Sodium lactate.

Justification for classification or non-classification

Based on the available data, classification of Sodium lactate is not warranted according to CLP Regulation 1272/2008.