α-acetyl-γ-butyrolactone

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

GLP compliance:

yes

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

α-acetyl-γ-butyrolactone

EC Number:

208-235-2

EC Name:

α-acetyl-γ-butyrolactone

Cas Number:

517-23-7

Molecular formula:

C6H8O3

IUPAC Name:

3-acetyloxolan-2-one

Test material form:

other: liquid

Specific details on test material used for the study:

No data

In vivo test system

Test animals

Species:

mouse

Strain:

CBA

Sex:

female

Details on test animals and environmental conditions:

Individual caging / mice were provided with glass tunnel-tubes.
Cage type: Type II pp/pc.
Bedding: Bedding was available to animals during study
Light: 12 hours daily, from 6 am to 6 pm
Temperature: 22*/- C
Relative humidity: 30-70%
Ventilation: 15-20 air exchanges/hour
-The temparature and relative humidity were recorded twice every day during the acclimatisation and experimental phases.

Study design: in vivo (LLNA)

Vehicle:

dimethylformamide

Concentration:

Preliminary irritation/toxicity test: 100% and 50% w/v in DMF
Main study Experiment 1 : 100% undiluted, 50% and 25% w/v
Main study Experiment 2 : 50% and 10% and 2% w/v

No. of animals per dose:

5 animals/group
3 groups/experiment

Details on study design:

Preliminary irritation/toxicity test using two doses (undiluted 100%& and 50% w/v in DMF
Main study Experiment 1 : 5 animals/group; 100% undiluted, 50% and 25% w/v
Main study Experiment 2 : 5 animals/group; 50% and 10% and 2 w/v

Positive control substance(s):

hexyl cinnamic aldehyde (CAS No 101-86-0)

Results and discussion

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Value:

0.3

Test group / Remarks:

Based on 5 animals in 100% w/v group

Results 2

Parameter:

SI

Value:

0.5

Test group / Remarks:

Based on 5 animals in 50% w/v in DMF group

Results 3

Parameter:

SI

Value:

0.7

Test group / Remarks:

Based on 5 animals in 25% w/v in DMF group

Cellular proliferation data / Observations:

CELLULAR PROLIFERATION DATA
Mean DPM/node
100% undiluted = 74.7
50% w/v = 117.4
25% w/v = 167.3

Any other information on results incl. tables

The test item was a liquid, which was used undiluted or formulated in DMF. Since there were no confounding effects of irritation or systemic toxicity at the applied concentrations, the proliferation values obtained are considered to reflect the real potential of the test item to cause lymphoproliferation in the Local Lymph Node Assay. The resulted stimulation index values were under the threshold limit of 3 observed at the examined concentrations indicating that JAU 6476-ß-lacton (BCS-AA16476) is not a skin sensitizer.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In conclusion, under the conditions of the present assay JAU 6476-ß-lacton (BCS-AA16476) was shown to have no sensitization potential (non-sensitizer) in the Local Lymph Node Assay