(3S-cis)-3,6-dimethyl-1,4-dioxane-2,5-dione

Skin sensitisation

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

Test material information

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)

Results

Results 1

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%.

Results 2

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