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Diss Factsheets

Administrative data

Description of key information

By way of read-across from the structurally equivalent substances S-lactic acid and potassium salts in general, it is concluded that potassium-S-lactate is not a skin sensitiser.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Justification for type of information:
For details and justification of read-across please refer to the read-across report attached to IUCLID section 13.
Reason / purpose for cross-reference:
read-across source
Positive control results:
Erythema and edema according to Draize (1979) and for other dermal reactions at 24 and 48 hours following each induction and challenge application. Results are presented for testing on 3 groups of 10 guinea pigs. In the first 24 hours of the challenge test, 8, 8 and 10 out of 10 animals showed positive sensitization reaction to the positive control (DNCB), and 48 hours after the beginning of the test, 8, 8 and 9 out of 10 animals still presented positive reaction to DNCB.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100% test material
No. with + reactions:
9
Total no. in group:
10
Clinical observations:
All effects observed were deemed irritation, not sensitization
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100% test material
No. with + reactions:
8
Total no. in group:
10
Clinical observations:
All effects observed were deemed irritation, not sensitization
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100% test material
No. with + reactions:
9
Total no. in group:
10
Clinical observations:
All effects observed were deemed irritation, not sensitization
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
100% test material
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
All effects observed were deemed irritation, not sensitization
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.5 mL of 0.1% DCNB
No. with + reactions:
28
Total no. in group:
30
Remarks on result:
positive indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
0.5 mL of 0.1% DCNB
No. with + reactions:
25
Total no. in group:
30
Remarks on result:
positive indication of skin sensitisation

Range finding trials:

Preliminary range-finding trials revealed very slight erythema and edema at the 100% concentration of the test article. No other dermal reactions were noted for the other concentrations (3, 10, and 30%). Therefore, the 100% concentration of the test article was utilised in the main study testing for contact dermal sensitisation potential.

Main study:

No mortalities occurred and all animals gained body weight. The test article (100%) produced very slight erythema at 3 sites and very slight edema at l site after the 1st induction. Erythema grades increased in severity after the 2nd induction application. One site was graded as severe erythema, however, this grade was given a 4 due to pinpoint pitting of the skin and scab formation, not for redness. Due to the increase of severity of the reactions, the concentration of the test article was reduced to 30 % and the induction site was changed to the left flank. Very slight erythema was noted after the 5th induction application. Grades ranging from very slight to severe erythema were noted from the 7th to the 9th induction applications. Again, the severe (grade 4) reactions were given this grade due to pinpoint pitting of the skin and the eschar formation, not for redness. After the challenge application, the test article (100 %) produced grade 4 erythema in up to 6 test animals. These gradings were very similar in character as those seen during the induction applications, that is, pinpoint pitting of the skin and eschar formation, very little redness. These reactions were considered to be irritation reactions, not sensitization reactions. Other reactions noted at challenge for the test animals were very slight to moderate erythema, and very slight to moderate edema. The test article (100%) produced grade 4 erythema in up to 8 naive control animals. These gradings were also pinpoint pitting of skin and eschar formation with very little redness. These reactions were considered to be irritation reactions, not sensitization reactions. Other reactions noted for the naive control animals were very slight to moderate erythema and very slight to moderate edema. The reactions seen in the naive control animals at challenge were similar to the reactions seen for the test group animals and the test article, SY-83, was not considered to be a contact dermal sensitizer.

Interpretation of results:
GHS criteria not met
Conclusions:
In a dermal sentitisation test (modification of the Buehler closed patch technique), lactic acid was tested negative for skin sensitisation.
Executive summary:

This study was conducted in guinea pigs of the Hartley strain to evaluate the contact dermal sensitisation potential of the test article, SY-83, using a method described in the EPA Guidelines, 1982 (modification of the Buehler Closed Patch Technique). No mortalities occurred and all animals gained body weight. The test article (100%) produced very slight erythema at three sites and very slight edema at one site after the first induction. Erythema grades increased in severity after the second induction application. One site was graded as severe erythema, however, this grade was given a 4 due to pinpoint pitting of the skin and scab formation, not for redness. Due to the increase of severity of the reactions, the concentration of the test article was reduced to 30% and the induction site was changed to the left flank. Very slight erythema was noted after the 5th induction application. Grades ranging from very slight to severe erythema were noted from the 7th to the 9th induction applications. Again, the severe (grade 4) reactions were given this grade due to pinpoint pitting of the skin and the eschar formation, not for redness.

After the challenge application, the test article (100%) produced grade 4 erythema in up to 6 test animals. These grades were very similar in character as those seen during the induction applications, that is, pinpoint pitting of the skin and eschar formation, very little redness. These reactions were considered to be irritation reactions, not sensitization reactions. Other reactions noted at challenge for the test animals were very slight to moderate erythema, and very slight to moderate edema. The test article (100%) produced grade 4 erythema in up to 8 naive control animals. These grades were also pinpoint pitting of skin and eschar formation with very little redness. These reactions were considered to be irritation reactions, not sensitization reactions. Other reactions noted for the naive control animals were very slight to moderate erythema and very slight to moderate edema. The reactions seen in the naive control animals at the challenge application were similar to the reactions seen for the test group animals and the test article, SY-83, was not considered to be a contact dermal sensitizer.

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 (see IUCLID section 13).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

By way of read-across from the structurally equivalent substances S-lactic acid and potassium salts in general, it is concluded that potassium-S-lactate is not a skin sensitiser:

In a dermal sensitisation study according to EPA guideline EPA OPP 81-6 with 2-hydroxypropionic acid in water, young adult Hartley guinea pigs (10 females) were tested using the method of modified Buehler Closed Patch Technique as described in American Biogenics Corporation (ABC) protocol A330. Historical data of dinitrochlorobenzene were used as a positive control.

No mortalities occurred and all animals gained body weight. The test article (83 % S-lactic acid in water) produced very slight erythema at 3 sites and very slight oedema at one site after the first induction. Erythema grades increased in severity after the 2nd induction application. One site was graded as severe erythema; however, this grade was given a 4 due to pinpoint pitting of the skin and scab formation, not for redness. Due to the increase of severity of the reactions, the concentration of the test article was reduced to 30% and the induction site was changed to the left flank. Very slight erythema was noted after the 5th induction application. Grades ranging from very slight to severe erythema were noted from the 7th to the 9th induction applications. Again, the severe (grade 4) reactions were given this grade due to pinpoint pitting of the skin and the eschar formation, not for redness.

After the challenge application, the test article produced grade 4 erythema in up to 6 test animals. These gradings were very similar in character as those seen during the induction applications, that is, pinpoint pitting of the skin and eschar formation, very little redness. These reactions were considered to be irritation reactions, not sensitization reactions. Other reactions noted at challenge for the test animals were very slight to moderate erythema, and very slight to moderate oedema. The test article (83 % S-lactic acid in water) produced grade 4 erythema in up to 8 naive control animals. These gradings were also pinpoint pitting of skin and eschar formation with very little redness. These reactions were considered to be irritation reactions, not sensitization reactions. Other reactions noted for the naive control animals were very slight to moderate erythema and very slight to moderate oedema.

The reactions seen in the naive control animals at the challenge application were similar to the reactions seen for the test group animals and the test item is not considered to be a contact dermal sensitiser.

The potassium moiety of potassium-S-lactate is considered to be devoid of any sensitising properties, based on the physiological role of potassium ions: Potassium is an essential bulk element for the human body.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on experimental evidence for a structurally equivalent substance, classification of potassium-S-lactate for skin sensitising properties is not warranted in accordance with CLP Regulation 1272/2008.