Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
21/5/15 to 25/6/15
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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Qualifier:
according to guideline
Guideline:
EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
GLP compliance:
yes (incl. QA statement)
Type of study:
mouse local lymph node assay (LLNA)

Test material

Constituent 1
Chemical structure
Reference substance name:
methyl 2-fluoroprop-2-enoate
EC Number:
607-233-2
Cas Number:
2343-89-7
Molecular formula:
C4H5FO2
IUPAC Name:
methyl 2-fluoroprop-2-enoate
Test material form:
other: Light brown liquid
Details on test material:
- Name of test material (as cited in study report): 2-Propenoic acid, 2-fluoro, methyl ester, EC Number: 607-233-2
- Physical state: Light brown liquid
- Analytical purity: 98.7%
- Lot/batch No.: 03026-20140801
- Expiration date of the lot/batch: 27 August 2015
- Storage condition of test material: Approximately 4°C in the dark

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories B.V., Horst, The Netherlands
- Age at study initiation: 8 to 12 weeks
- Weight at study initiation: 15 to 23 g
- Housing: Suspended solid floor polypropylene cage
- Diet (e.g. ad libitum): Free access to 2014C Teklad Global Rodent diet
- Water (e.g. ad libitum): Free access to mains tap water
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25 °C
- Humidity (%): 30 to 70 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hours dark, 12 hours light

Study design: in vivo (LLNA)

Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
10, 25, 50 and 100% v/v in vehicle
No. of animals per dose:
4

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Key result
Parameter:
SI
Value:
1.48
Test group / Remarks:
25%
Remarks on result:
other: negative
Key result
Parameter:
SI
Value:
1.35
Test group / Remarks:
50%
Remarks on result:
other: negative
Key result
Parameter:
SI
Value:
1.36
Test group / Remarks:
100%
Remarks on result:
other: negative

Any other information on results incl. tables

Individual Clinical Observations and Mortality Data

    Day 1 Day 2  Day 3     Day 4 Day 5  Day 6 
Concentration (% v/v) in acetone/olive oil 4:1 Animal Number  Pre-dose  Post-dose  Pre-dose  Post-dose  Pre-dose  Post-dose       
 Vehicle 1 -1  0  0  0  0  0  0  0  0  0 
 Vehicle 1 -2  0  0  0  0  0  0  0  0  0 
 Vehicle 1 -3  0  0  0  0  0  0  0  0  0 
 Vehicle 1 -4  0  0  0  0  0  0  0  0  0 
 25 2 -1  0  0  0  0  0  0  0  0  0 
 25 2 -2  0  0  0  0  0  0  0  0  0 
 25 2 -3  0  0  0  0  0  0  0  0  0 
 25 2 -4  0  0  0  0  0  0  0  0  0 
 50 3 -1  0  0  0  0  0  0  0  0  0 
 50 3 -2  0  0  0  0  0  0  0  0  0 
 50 3 -3  0  0  0  0  0  0  0  0  0 
 50 3 -4  0  0  0  0  0  0  0  0  0 
 100 4 -1  0  0  0  0  0  0  0  0  0 
 100 4 -2  0  0  0  0  0  0  0  0  0 
 100 4 -3  0 0  0  0  0  0  0  0  0 
 100 4 -4  0  0  0  0  0  0  0  0  0 

Individual Body Weights and Body Weight Change

    Body Weight (g)   
 Concentration (% v/v) in acetone/olive oil 4:1 Animal Number  Day 1  Day 6  Body Weight Change (g) 
 Vehicle 1 -1  20.3  20.5  0.2 
 Vehicle 1 -2  20.4  21.1  0.7 
 Vehicle 1 -3  19.5  20.7  1.2 
 Vehicle 1 -4  18.8  19.4  0.6 
 25 2 -1  20.7  20.8  0.2 
 25 2 -2  21.0  21.1  0.1 
 25 2 -3  18.4  18.7  0.3 
 25 2 -4  22.1  22.0  -0.1 
 50 3 -1  17.7  19.8  2.1 
 50 3 -2  22.3  21.2  -1.1 
 50 3 -3  19.1  19.9  0.8 
 50 3 -4  17.8  18.3  0.5 
 100 4 -1  19.1  19.6  0.5 
 100 4 -2  19.4  20.2  0.8 
 100 4 -3  22.4  21.4  -1.0 
100 4 -4  21.0 20.7  -0.3

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance is considered to be a non-sensitiser under the conditions of the test.
Executive summary:

Introduction

A study was performed to assess the skin sensitization potential of the test item in the CBA/Ca strain mouse following topical application to the dorsal surface of the ear.

Methods

Following a preliminary screening test in which no clinical signs of toxicity were noted at a concentration of 100%, this concentration was selected as the highest dose investigated in the main test of the Local Lymph Node Assay. Three groups, each of four animals, were treated with 50 μL (25 μL per ear) of the undiluted test item or the test item as a solution in acetone/olive oil 4:1 at concentrations of 50% or 25% v/v. A further group of four animals was treated with acetone/olive oil 4:1 alone.

Results

The Stimulation Index expressed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control group are as follows:

Concentration (% v/v) in acetone:olive oil 4:1  Stimulation Index  Result 
 25 1.48  Negative 
 50 1.35  Negative 
 100 1.36  Negative 

Conclusion

The test item was considered to be a non-sensitizer under the conditions of the test.