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EC number: 288-752-8 | CAS number: 85895-78-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
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
- 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.
- 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.
- 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.
- 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.
- 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.
Referenceopen allclose all
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
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
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- 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.
- 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.
- 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.
- 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.
Referenceopen allclose all
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
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 |
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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