Pent-4-enoyl chloride

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)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

Pent-4-enoic acid

EC Number:

209-732-7

EC Name:

Pent-4-enoic acid

Cas Number:

591-80-0

Molecular formula:

C5H8O2

IUPAC Name:

pent-4-enoic acid

In vivo test system

Test animals

Species:

mouse

Strain:

other: CBA / JNCrj

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Age at study initiation: 40 days
- Weight at study initiation: 21-25 g
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +/- 3°C
- Humidity (%): 55% +/- 15%
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Induction

Concentration / amount:

25 µL/ear

Challenge

Challenge 1

Route:

epicutaneous, open

Vehicle:

other: acetone/olive oil (4:1, v/v)

Challenge 2

Concentration / amount:

25 µL/ear

No. of animals per dose:

5

Details on study design:

5 animals 25 µL vehicle (negative control)
5 animals 25 µL 4-Pentenoic acid (5%, w/w)
5 animals 25 µL 4-Pentenoic acid (10%, w/w)
5 animals 25 µL 4-Pentenoic acid (25%, w/w)
5 animals 25 µL of a 0.1% solution of alpha-hexyl cinnamic aldehyde in the vehicle (positive control)

Positive control substance(s):

yes

Remarks:

alpha-hexyl cinnamic aldehyde

Study design: in vivo (LLNA)

Vehicle:

acetone/olive oil (4:1 v/v)

Concentration:

0, 5, 10, 25 % (w/w)

No. of animals per dose:

5

Details on study design:

MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: no data
- Criteria used to consider a positive response: a chemical is classified as a sensitizer if a threefold or greater elevation in 3H-TdR incorporation relative to vehicle control could be recorded with at least one test concentration

TREATMENT PREPARATION AND ADMINISTRATION:
- day 1: the weight of each animal was individually identified and recorded. Open application of 25 µl of the appropriate dilution of the test item, the vehicle alone or the positive control were administrated to the dorsum of each ear
- day 2 and 3: the application procedure carried out on day 1 was repeated
- day 4 and 5: no treatment
- day 6: the weight of each animal was recorded. All test and control animals were injected with 250 µl of phophte-buffered saline (PBS) containing 20 µCi (7.4e + 5 Bq) of [3H]-methyl thymidine via the tail vein. Five ours later, the animals were killed. The draining auricular lymph nodes from each ear were excised and pooled in PBS for each animal. A single cell suspension of lymph node cells (LNC) bilaterally from individual animals was prepared by gentle mechanical disaggregation through 200 µm-mesh stainless steel gauze. Lymph node cells were washed twice with an excess of PBS and precipitated with 5 % trichloracetic acid (TCA) at 4 °C for 18 h. Pellets were resuspended in 1 ml TCA and transferred to scintillation vials containing 5 ml of scintillation fluid for 3H-counting. Incorporation of 3H-methyl thymidine was measured by ß-scintillation counting as disintegrations per minute (dpm)

Positive control substance(s):

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

Statistics:

no data

Results and discussion

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Remarks on result:

other: 5 % 4-Pentenoic acid: 2.05 10 % 4-Pentenoic acid: 1.78 25 % 4-Pentenoic acid: 1.98 positive control (HCA): 3.79

Results 2

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: negative control: 1279.3 dpm 5 % 4-Pentenoic acid: 2617.16 dpm 10 % 4-Pentenoic acid: 2277.98 dpm 25 % 4-Pentenoic acid: 2528.51 dpm positive control (HCA): 4843.78 dpm

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information

Conclusions:

Under the test conditions of the study, 4-Pentenoic acid revealed no sensitising properties in the local lymph node assay in mice and is therefore not sensitising.