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Diss Factsheets

Administrative data

Description of key information

No study is available on the skin sensitisation potential of ammonium-S-lactate itself. Therefore, available data from skin sensitisation studies conducted with suitable read-across partners were used in a weight-of-evidence approach to assess the sensitisation potential of the target substance. None of the available studies showed skin sensitising potential of the read-across substances. Based on these results, the target substance ammonium-S-lactate is not considered to be a skin sensitiser.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation, other
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:
Not specified
Reading:
other: see Remarks on results
Remarks on result:
no indication of skin sensitisation
Cellular proliferation data / Observations:
One animal was found dead on day 18 (reason not stated). No erythema was observed after induction or challenge applications, and 12% Ammonium Lactate lotion was not a sensitizer using guinea pigs.
Interpretation of results:
GHS criteria not met
Conclusions:
In conclusion, in a dermal skin sensitisation study with guinea pigs a 12% Ammonium lactate lotion was not skin sensitising.
Executive summary:

In a dermal skin sensitisation study 10 guinea pigs were treated with a 12% ammonium lactate lotion under occlusive conditions. One animal was found dead on day 18. No erythema was observed after induction or challenge applications. Based on the results, it can be stated that the test item was not a skin sensitiser.

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:
skin sensitisation: in vivo (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:
No data
Parameter:
SI
Value:
1
Test group / Remarks:
Dose group 5%
Parameter:
SI
Value:
1.4
Test group / Remarks:
Dose group 10%
Parameter:
SI
Value:
2.2
Test group / Remarks:
Dose group 25%
Interpretation of results:
GHS criteria not met
Conclusions:
In a local lymph node assay in mice, lactic acid was tested negative for skin sensitisation.
Executive summary:

In a dermal sensitisation test conducted according to OECD 429, female CBA mice were treated with concentrations of 5, 10 and 25 % lactic acid in DMSO. Stimulation indices of 1.0 (test group 5 %), 1.4 (test group 10 %) and 2.2 (test group 25 %) were measured. As the maximum stimulation index was < 3, lactic acid can be considered not to be skin sensitising.

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:
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 report attached in section 13 of IUCLID.
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.
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
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
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 skin sensitiser.

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:

No data is available for ammonium-S-lactate itself. As the target substance dissociates into ammonium and lactate ions in aqueous media, the assessment of the sensitisation potential can be based on available data of dissociable ammonium compounds and lactic acid. Further details on the read-across rationale are provided in IUCLID section 13. Thus, available data on the corresponding acid lactic acid (source substance) is considered to be suitable for read-across. The source substance lactic acid was tested negative for skin sensitisation in two studies (LLNA conducted according to OECD 429 and modified Buehler closed patch test using guinea pigs). Available data on (racemic) ammonium-DL-lactate showed also no skin sensitisation (a) in an in vivo study with guinea pigs and (b) in two modified Draize prophetic patch test on humans (please refer to IUCLID section 7.10.4).

Based on these results, the target substance ammonium-S-lactate is not considered to be a skin sensitizer.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the results from the read-across partners, classification of ammonium-S-lactate for skin sensitisation is not warranted according to CLP Regulation 1272/2008.