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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Review

Data source

Reference
Reference Type:
review article or handbook
Title:
Safety assessment of glycolic acid, ammonium, calcium, potassium, and sodium glycolate, methyl, ethyl, ptopyl, and butyl glycolate, and lactic acid, ammonium calcium, potassium, sodium, and TEA-lactate, methyl, ethyl, isopropyl, and butyl lactate, and
Author:
Andersen, F.A.
Year:
1997
Bibliographic source:
International Journal of Toxicology, Vol.17, Suppl.1.

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
Version / remarks:
Skin Sensitisation: Local Lymph Node Assay)
GLP compliance:
not specified
Type of study:
mouse local lymph node assay (LLNA)

Test material

Constituent 1
Reference substance name:
L-(+)-lactic acid
EC Number:
201-196-2
EC Name:
L-(+)-lactic acid
Cas Number:
79-33-4
IUPAC Name:
2-hydroxypropanoic acid

In vivo test system

Test animals

Species:
guinea pig

Results and discussion

Positive control results:
The six-month reliability check with Alpha-hexylcinnamicaldehyde indicates that the Local Lymph Node Assay as performed at NOTOX is an appropriate model for testing for contact hypersensitivity.
The SI values calculated for Alpha-hexylcinnamicaldehyde concentrations 5, 10 and 25% were 1.7, 2.7 and 8.8 respectively. An EC3 value of 10.7% was calculated using linear interpolation.The calculated EC3 value was found to be in the acceptable range of 2 and 20%.

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: see Remark
Remarks:
The SI values calculated for the substance concentrations 10, 25 and 50% were 2.1, 1.5 and 0.9, respectively. Since there was no indication that the test substance elicit an SI ≥ 3 when tested up to 50%, L-lactide was considered not to be a skin sensitizer. It was established that the EC3 value (the estimated test substance concentration that will give a SI=3) (if any) exceeds 50%.
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: Mean DPM/animal values for the experimental groups treated with test substance concentrations 10, 25 and 50% were 787, 569 and 334 DPM respectively. See Table 1 and 2 below. The mean DPM/animal value for the vehicle control group was 380 DPM.

Any other information on results incl. tables

The SI values calculated for the substance concentrations 10, 25 and 50% were 2.1, 1.5 and 0.9, respectively.
Since there was no indication that the test substance elicit an SI ≥ 3 when tested up to 50%, L-lactide was considered not to be a skin sensitizer. It was established that the EC3 value (the estimated test substance concentration that will give a SI=3) (if any) exceeds 50%.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Classification: not sensitizing