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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

Referenceopen allclose all

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
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

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.

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  
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.

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
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.

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.