Potassium (S)-lactate

Endpoint summary

Description of key information

Potassium-S-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:

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

Adequacy of study:

supporting study

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:

other: overall irritation

Basis:

mean

Time point:

other: no data

Score:

0

Reversibility:

other: not adequate

Remarks on result:

no indication of irritation

Interpretation of results:

study cannot be used for classification

Conclusions:

In this study, potassium chloride is not a dermal irritant.

Executive summary:

In a dermal irritation study, rabbits were dermally exposed to potassium chloride. No irritation was observed in the animals (grade 0/6).

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:

skin irritation: in vivo

Type of information:

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

Adequacy of study:

key study

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:

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:

None of the animals died during the course of investigation and no clinical signs were observed.

Table 1: Scoring of oedema 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	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:

GHS 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 (OECD 404), young adult male New Zealand White rabbits (3/sex) were dermally exposed to 0.5 g of Sodium-L-Lactate (≥ 97% purity), for 4 hours to a body surface area of 6 cm². Animals then were observed for 1, 24, 48 and 72 hours. Irritation was scored by the method of Draize.

Neither mortality nor any adverse clinical signs of toxicity were observed during the study. The treated and also the control skin areas did not show any irritations at observations after 24, 48 and 72 hours. In this study, Sodium-L-Lactate is not a dermal irritant.

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 attaced to IUCLID section 13.

Reference 3

Endpoint:

skin irritation: in vivo

Type of information:

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

Adequacy of study:

key study

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:

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 time (see Table 1 and Table 2 in box "Any other information on results incl. tables").

Other effects:

None of the animals died during the course of investigation and no clinical signs were observed.

Table 1: Scoring of erythema formation

Animal no./ sex	Body weight (g)		1 h	24 h	48 h	72 h
	At the beginning of the experiment	At the end of the experiment
01915/M	3459	3539	0	0	0	0
01912/M	3125	3199	0	0	0	0
01914/M	3337	3416	0	0	0	0
TOTAL	-	-	0	0	0	0

Table 2: Scoring of oedema formation

Animal no./ sex	Body weight (g)		1 h	24 h	48 h	72 h
	At the beginning of the experiment	At the end of the experiment
01915/M	3459	3539	0	0	0	0
01912/M	3125	3199	0	0	0	0
01914/M	3337	3416	0	0	0	0
TOTAL	-	-	0	0	0	0

M = male

Interpretation of results:

GHS 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 (OECD 404), young adult male New Zealand White rabbits (3/sex) were dermally exposed to 0.5 g of Calcium-L-lactate (≥ 97 % purity), for 4 hours to a body surface area of 6 cm². Animals then were observed for 1, 24, 48 and 72 hours. Irritation was scored by the method of Draize.

Neither mortality nor any adverse clinical signs of toxicity were observed during the study. The treated and also the control skin areas did not show any irritations at any observation time. In this study, Calcium-L-lactate is not a dermal irritant.

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.

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:

key study

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:

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 hours) irritation index for Potassium-DL-lactate was 15 (out of a maximum of 110). This score would imply a classification “slightly irritant" when using the 1982 AFNOR criteria and categories. After 4 days, the mean ocular irritation index (i.e. mean of 1, 24, 48, 72 and 96 hours) was 0, implying extensive recovery after 4 days. See also Table 2 in box "Any other information on results incl. tables".

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
Potassium-DL-Lactate (purified, 60 % aqueous solution	Colourless liquid	8.1	None	15.00	0[4]	-	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:

GHS criteria not met

Conclusions:

In a primary eye irritation study according to AFNOR, Potassium-DL-lactate can be considered as not irritating to the eye.

Executive summary:

In an eye irritation study (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 these results, the test item can be considered as not irritating to the eye.

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:

GHS criteria not met

Conclusions:

In a primary eye irritation study according to OECD 405, ammonium 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, ammonium lactate can be considered as not eye-irritating.

Executive summary:

In a primary eye irritation study (OECD 405) 0.1 mL of ammonium 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.

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.

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, calcium-S-lactate, ammonium-S-lactate, and potassium chloride, it is concluded that potassium-S-lactate is not irritating – neither to skin nor to eyes.

A concentrated aqueous solution of sodium-S-lactate, solid (crystalline) calcium-S-lactate moistened with water, and potassium chloride, were applied to the skin of rabbits. No symptoms of skin irritation were observed upon administration of any of the substances. Since the test substances contain either S-lactate or potassium ions, i.e. the ionic constituents of potassium-S-lactate, it can be concluded with sufficient certainty 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 (according to AFNOR), potassium-DL-lactate (i.e. a racemate consisting of the target substance and its optical antipode) 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.

Justification for classification or non-classification

By way of read-across from structurally equivalent substances, potassium-S-lactate is identified as non-irritating to the skin or to the eyes. Therefore, classification for skin or eye irritation is not warranted.