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Diss Factsheets

Administrative data

Description of key information

No study is available elucidating the skin sensitization potential of the target substance Butyl-S-lactate. Thus, available data from suitable read-across partners were used in a weight-of-evidence approach to assess the skin sensitizing potential of Butyl-S-lactate. The source substance L-lactic acid was tested negative for skin sensitization in a modified Buehler test. In a dermal sensitization study conducted according to OECD 429, female CBA mice were treated with concentrations of 5, 10 and 20% n-butanol in distilled water. Based on this study, the source substance n-butanol can be considered as not skin sensitizing. Supporting information is derived from a dermal sensitization study conducted equivalent to OECD 406 with the source substance propanol. In this study, 15 guinea pigs of the Hartley strain were tested using the method of Magnusson and Kligman. Based on this results from this study, the source substance propanol can be considered as not skin sensitizing. Furthermore, in a human maximization test performed the test item ethyl lactate showed no skin sensitizing potential (see IUCLID section 7.10.4)

Based on the available data from suitable read-across partners, the target substance can be considered as not skin sensitizing.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

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
Key result
Parameter:
SI
Value:
1.6
Test group / Remarks:
5 %
Key result
Parameter:
SI
Value:
1.2
Test group / Remarks:
10 %
Key result
Parameter:
SI
Value:
1.4
Test group / Remarks:
20 %
Cellular proliferation data / Observations:
DETAILS ON STIMULATION INDEX CALCULATION : The incorporation of tritiated thymidine measured by beta scintillation counting was reported in disintegrations per minute. An SI was calculated for each chemical-treated group as the ratio of the disintegrations per minute in the treated group (or mean disintregrations per minute when individual animals were assesed) to the disintegrations per minute or mean disintegrations per minute of the concurrent vehicle control group.

EC3 CALCULATION : When the LLNA dose-response curve included concentrations that induced at least one SI greater than 3 and one SI less than 3, EC3 values were calculated by linear interpolation.For 1-butanol, no EC3 value was calculated since all SI values are < 3
CLINICAL OBSERVATIONS:

BODY WEIGHTS: no data
Interpretation of results:
GHS criteria not met
Conclusions:
In a local lymph node assay in mice, 1-butanol was tested negative for skin sensitisation.
Executive summary:

In a dermal sensitisation study conducted according to OECD 429, female CBA mice were treated with concentrations of 5, 10 and 20% 1-butanol in distilled water. Stimulation indices of 1.6 (test group 5%), 1.2 (test group 10%) and 1.4 (test group 20%) were measured. As the maximum stimulation index was < 3, 1-butanol can be considered as not 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 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:

Due to the rapid, enzymatically catalyzed hydrolysis of Butyl-S-lactate into n-butanol and L-lactic acid, the toxicology of Butyl-S-lactate can be understood in terms of the toxicology of n-butanol and L-lactic acid. Lactic acid is a ubiquitous and integral element of mammalian metabolism and therefore of minor toxicological relevance in comparison to n-butanol which is, as an alcohol, more important for the toxicological assessment. No study is available elucidating the skin sensitization potential of the target substance. Thus, available data from suitable read-across partners were used in a weight-of-evidence approach to assess the skin sensitizing potential of Butyl-S-lactate. The source substance L-lactic acid was tested negative for skin sensitization in a modified Buehler test. In a dermal sensitization study conducted according to OECD 429, female CBA mice were treated with concentrations of 5, 10 and 20 % n-butanol in distilled water. Based on this study, the source substance n-butanol can be considered as not skin sensitizing. Supporting data is available from the source substances propanol and ethyl lactate. In a dermal sensitization study (equivalent to OECD 406) with the source substance propanol, 15 guinea pigs of the Hartley strain were tested using the method of Magnusson and Kligman. Based on this study, the source substance propanol can be considered as not skin sensitizing. Furthermore, in a human maximization test performed the test item ethyl lactate showed no skin sensitizing potential (see IUCLID section 7.10.4)

Based on the available data from suitable read-across partners, the target substance can be considered as not skin sensitizing.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the negative results from suitable read-across partners, classification for Butyl-S-lactate for skin sensitization is not warranted.