Pentane-2,3-dione

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:

comparable to guideline study

Data source

Reference

Reference Type:

publication

Title:

Evaluation of the hypersensitivity potential of alternative butter flavorings

Author:

Anderson, S.E., Franko, J., Wells, J.R., Lukomska, E., and Meade, B.J.

Year:

2013

Bibliographic source:

Food Chem Toxicol., 62: 373–381.

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: Method described in the ICCVAM Peer Review Panel report

Principles of method if other than guideline:

Mice (5 per group) were exposed topically to the test chemical on the dorsal surface of each ear (25 ll per ear) for three consecutive days. On day 6, mice were injected intravenously 20 lCi 3H-thymidine and euthanized five hours later. The left and right auricular draining lymph nodes located at the bifurcation of the jugular vein were excised and pooled for each animal. Single cell suspensions were made and incubated overnight in 5% trichloroacetic acid and samples were counted using a Packard Tri-Carb 2500TR liquid scintillation analyzer.

Stimulation indices (SI) were calculated by dividing the mean disintegrations per minute (DPM) per test group by the mean DPM for the vehicle control group.

EC3 values (concentration of chemical required to induce a 3-fold increase over the vehicle control) were calculated based on the equation from Basketter et al. (1999).

Dosing concentrations (12.5–50%) were selected based on the results from the concentration range finding studies. The concentration of chemical required to induce a 3-fold increase over the vehicle control (EC3) was calculated based on the equations from Basketter et al. (1999).

GLP compliance:

not specified

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

Pentane-2,3-dione

EC Number:

209-984-8

EC Name:

Pentane-2,3-dione

Cas Number:

600-14-6

Molecular formula:

C5H8O2

IUPAC Name:

pentane-2,3-dione

Test material form:

liquid

Specific details on test material used for the study:

2,3-pentanedione, (97%, CAS# 600-14-6).
Sigma–Aldrich
Chemical Company, Inc. (Milwaukee, WI)

In vivo test system

Test animals

Species:

mouse

Strain:

Balb/c

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Taconic (Germantown, NY)
- Females (if applicable) nulliparous and non-pregnant: not specified]
- Age at study initiation: 6-8 weeks
- Housing: 5 animals per cage in ventilated plastic showbox cages with hardwood chip bedding.
- Diet (e.g. ad libitum): ad libitum NIH-31 modified 6% irradiated rodent diet
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 68-72
- Humidity (%): 36-57

Study design: in vivo (LLNA)

Vehicle:

other: Acetone

Concentration:

0, 12.5, 25, 50 % v/v

No. of animals per dose:

5 per group

Positive control substance(s):

other: DNCB 0.3 %

Statistics:

For analysis, data was first tested for homogeneity using the Bartlett’s Chi Square test. If homogeneous, a one-way analysis of variance (ANOVA) was conducted.
If the ANOVA showed significance at p < 0.05 or less, the Dunnett’s Multiple Range t test was used to compare treatment groups with the control group. Linear
trend analysis was performed to determine if the test articles had exposure concentration- related effects for the specified endpoints. Statistical analysis was performed using Graph Pad Prism version 5.0 (San Diego, CA). Statistical significance is designated by *(p 6 0.05) and **(p 6 0.01).

Results and discussion

In vivo (LLNA)

Results

Key result

Parameter:

EC3

Value:

17.9

Applicant's summary and conclusion

Interpretation of results:

Category 1 (skin sensitising) based on GHS criteria

Conclusions:

The test chemical tested positive in the LLNA with an EC3 value of 17.9%.

Executive summary:

Based on an LLNA study in female mice, the test chemical is considered to be a category 1 sensitizer according to GHS criteria.