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EC number: 248-953-3 | CAS number: 28305-25-1
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
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- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
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- Flash point
- Auto flammability
- Flammability
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- Oxidising properties
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- Stability in organic solvents and identity of relevant degradation products
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- Additional physico-chemical properties of nanomaterials
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- Endpoint summary
- Stability
- Biodegradation
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- 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
Calcium (S)-lactate is not irritating to the skin. Calcium gluconolactate, containing calcium lactate is not irritating to the eyes, similar as shown for the structurally related Magnesium (S)-lactate, thus indicating that Calcium (S)-lactate is not irritating to the eyes.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2013-01-11 to 2013-03-19
- 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 2002
- Deviations:
- no
- GLP compliance:
- yes
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Puracal PP/USP
- Lot/batch No.: 1107003133
- Appearance: white crystalline powder
- Purity: 99.9%
- Expiry date: 29 July 2016
- Storage condition of test material: room temperature - 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, Csazar ut 135, Hungary
- Age at study initiation: ca. 13 weeks old
- Weight at study initiation: 3125-3459 g
- Housing: animals were individually housed in AAALAC approved metal wire rabbit cages.
- Diet (e.g. ad libitum): animals received UNI diet for rabbits ad libitum (produced by AGRIBRANDS Europe Hungary PLC, H-5300 Karcag, Madarasi ut, Hungary)
- Water (e.g. ad libitum): ad libitum, tap water
- Acclimation period: 19 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 25-54
- 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 g
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm²
- Type of wrap if used: plastic wrap
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
(indicate if minutes, hours or days): 60 minutes, 24, 48 and 72 hours after patch removal
SCORING SYSTEM:
- Method of calculation: according to Draize, 1959. - 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:
- At 1, 24, 48 and 72 hours after patch removal, there were no observed clinical signs noted on the skin of the treated animals. As no signs were recorded, the atudy was terminated after 72 hours.
- 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. - Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- In conclusion, in the acute dermal irritation/corrosion study conducted according to OECD 404, the test item calcium (S)-lactate is considered to be non-irritating.
- 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 g of calcium (S)-lactate (purity 99.9%) for 4 hours. Animals then were observed 1, 24, 48 and 72 hours after exposure. Irritation was scored by the method of Draize.
In this study, calcium (S)-lactate did not cause any skin effects. Thus, under the conditions of this study, the test substance can be considered as non-irritating.
- 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
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- 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
- 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.
- 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.
- 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:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- 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". As can be seen, calcium gluconolactate only resulted in slight conjunctival chemosis 1 hour after substance application, which was no longer observed 24 hours or later after substance application. In addition, slight conjunctival redness was observed in all three animals at 1 hour after substance administration, which was still present after 24 hours in 2/3 animals and even up to 72 hours in 1/3 animals. In none of the animals, effects on the iris or cornea were observed. Finally, treatment of the eyes with flluorescein did not reveal corneal damage.
- Other effects:
- No signs of systemic toxicity were observed.
- Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- In a primary eye irritation study conducted according to OECD 405, calcium gluconolactate was instilled into the conjunctival sac of the eye of three 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 calcium gluconolactate 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 and chemosis were observed, which were fully reversible within 7 days. 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.
Referenceopen allclose all
Table 1: Eye irritation scores
Scored item and animal number | Observation time | ||||||
Cornea | 1h | 24h | 48h | 72h | mean of 24, 48 and 72 h | ||
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 of 24, 48 and 72h | ||
Rabbit 511 | 1 | 0 | 0 | 0 | 0 | ||
Rabbit 534 | 0 | 0 | 0 | 0 | 0 | ||
Rabbit 535 | 1 | 0 | 0 | 0 | 0 | ||
Conjunctivae redness | 1h | 24h | 48h | 72h | mean of 24, 48 and 72h | ||
Rabbit 511 | 2 | 1 | 0 | 0 | 0,33 | ||
Rabbit 534 | 2 | 0 | 0 | 0 | 0 | ||
Rabbit 535 | 2 | 0 | 0 | 0 | 0 | ||
Conjunctivae chemosis | 1h | 24h | 48h | 72h | mean of 24, 48 and 72h | ||
Rabbit 511 | 2 | 0 | 0 | 0 | 0 | ||
Rabbit 534 | 1 | 0 | 0 | 0 | 0 | ||
Rabbit 535 | 1 | 0 | 0 | 0 | 0 |
Table 1: Eye irritation scores of calcium gluconolactate based on assessment and criteria of the OECD guideline protocol 405
Scored item and animal number | Observation time (h) | ||||||||
Cornea | 1 | 24 | 48 | 72 | 7 days | mean of 24/48/72 h | |||
Rabbit 2888 | 0 | 0 | 0 | 0 | 0 | 0 | |||
Rabbit 2989 | 0 | 0 | 0 | 0 | 0 | 0 | |||
Rabbit 3236 | 0 | 0 | 0 | 0 | 0 | 0 | |||
Iris | 1 | 24 | 48 | 72 | 7 days | mean of 24/48/72 h | |||
Rabbit 2888 | 0 | 0 | 0 | 0 | 0 | 0 | |||
Rabbit 2989 | 0 | 0 | 0 | 0 | 0 | 0 | |||
Rabbit 3236 | 0 | 0 | 0 | 0 | 0 | 0 | |||
Redness | 1 | 24 | 48 | 72 | 7 days | mean of 24/48/72 h | |||
Rabbit 2888 | 1 | 1 | 0 | 0 | 0 | 0.33 | |||
Rabbit 2989 | 1 | 1 | 1 | 1 | 0 | 1 | |||
Rabbit 3236 | 1 | 0 | 0 | 0 | 0 | 0 | |||
Chemosis | 1 | 24 | 48 | 72 | 7 days | mean of 24/48/72 h | |||
Rabbit 2888 | 1 | 0 | 0 | 0 | 0 | 0 | |||
Rabbit 2989 | 1 | 0 | 0 | 0 | 0 | 0 | |||
Rabbit 3236 | 1 | 0 | 0 | 0 | 0 | 0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Calcium (S)-lactate was tested negative for skin irritating properties in a study conducted according to OECD test guideline 404. The suitable read-across substances, Calcium gluconolacte and Magnesium (S)-lactate were tested negative for eye irritating properties in studies conducted in accordance with OECD test guideline 405. Thus, in accordance with CLP Regulation 1272/2008 no classification for eye or skin irritation is warranted for the target substance Calcium (S)-lactate.
Justification for classification or non-classification
Based on the available data, classification of Calcium (S)-lactate is not warranted according to CLP Regulation 1272/2008.
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