Registration Dossier

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:
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 lymphnode assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent

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