Pentyl valerate

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

18.Aug. 2016 to 13. Sept. 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

yes

Remarks:

not critical (no air condition for several hours in the room with the cages)

GLP compliance:

yes (incl. QA statement)

Remarks:

certified by Slovak National Acreditation Service, Karloeská 63, 840 00 Bratislava 4, Slovak Republic

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

Pentyl valerate

EC Number:

218-528-7

EC Name:

Pentyl valerate

Cas Number:

2173-56-0

Molecular formula:

C10H20O2

IUPAC Name:

pentyl valerate

Test material form:

liquid

In vivo test system

Test animals

Species:

mouse

Strain:

CBA/Ca

Sex:

male

Details on test animals and environmental conditions:

Source: AnLab Prague (Czech Republic), 29 females (non-pregnant, nulliparous), 6 days acclimated, 10 weeks old at first dose, healthy,
housing, diet, water, bedding according guideline, animal identification by marking with a permanent penn on the tail,
The study was approved by State Veterinary and Food Administration of SR according to national requrements for the protection of animals

Study design: in vivo (LLNA)

Vehicle:

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

Concentration:

pre-screen test: undiluted (100%)
main study: 100%, 50%, 25%

No. of animals per dose:

2 for pre-screen-test, application on both ears
5 for main study, application on both ears
5 negative control (vehicle), application on both ears
5 positive control, applicationon both ears

Details on study design:

Pre-screen test: undiluted test substance (100%) was applicated to both ears, no effects (clinical signs, local irritation) seen
Main study: conentrations of 100, 50 and 25% were applicated to both ears. Clinical signs and erythema at the ears were checked dayly, ear thickness every second day, body weight before and at the end of the study. At day 6 (last day of the study) radioactive I-iododeoxyuridine (2µCi in 250µl) was injected in the tail vein. Five hours later the animals were killed and the auricular lymph nodes were taken. All lymph nodes of one dose group were given together, weighed and prepared in a cell suspension. The cellular proliferation was determined by as incorporated radioactivity by an automatic gamma counter as counts per minute. A disintegration per minute (DPM) per dose group and a stimulation index (SI) were calculated.

Positive control substance(s):

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

Statistics:

pooled treatment group approach, no statistics for SI

Results and discussion

Positive control results:

SI = 5,42

In vivo (LLNA)

Results

Results 1

Key result

Parameter:

SI

Value:

1.58

Results 2

Key result

Parameter:

SI

Value:

1.83

Results 3

Key result

Parameter:

SI

Value:

1.89

Cellular proliferation data / Observations:

pre-screening test: no clinical signs
main study: no clinical signs observed, dose-dependant increase in pooled lymph node weights and DPM values, SI (except positive control group) under the threshold of 3, therefore not sensitizng in this test

Any other information on results incl. tables

Main study: 5 test groups: Negative control (vehicle), positive control, test substance: 25%, 50%, 100%, dose-dependent lymph node weights and DPM values

all SI < 3 => therefore not sensitizing in this test

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Conclusions:

Pentyl valerate is not a skin sensitizer in the LLNA