2-Propenoic acid, 2-fluoro-, methyl ester

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

18/5/15 to 4/6/15

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

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

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories UK Ltd.
- Age at study initiation: 12 to 20 weeks
- Weight at study initiation: 2.6 to 2.8 kg
- Housing: Individual suspended cages
- Diet (e.g. ad libitum): ad libitum, 2930C Teklad Global Rabbit diet
- Water (e.g. ad libitum): ad libitum, mains drinking water
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23 °C
- Humidity (%): 30 to 70%
- Air changes (per hr): 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours darkness, 12 hours light

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: Tested animals were also used as control - test item was adminstered to only one eye, with the other left untreated for control purposes.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml

Duration of treatment / exposure:

Eight hours

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

Three

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.7

Max. score:

1

Reversibility:

fully reversible within: 72 hours

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0.17

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Irritant / corrosive response data:

No corneal or iridial effects were noted in any animal during the study. Moderate conjunctival irritation was seen in two animals at one hour and minimal conjunctival irritation was seen in one animal at one hour. Minimal conjuctival irritation was seen at 24 hours and 48 hours. No effects were seen at 72 hours in the surviving animals.

Other effects:

The first treated animal was found dead three days after test substance application and the third animal was found dead two days after application.

Any other information on results incl. tables

Individual scores for Ocular Irritation

Rabbit name and sex	75066 Male				75073 Male				75083 Male
IPR	0				0				0
Time after treatment	1 hour	24 hours	48 hours	72 hours	1 hour	24 hours	48 hours	72 hours	1 hour	24 hours	48 hours
Cornea
Degree of Opacity	0	0	0	0	0	0	0	0	0	0	-
Area of Cornea Involved	0	0	0	0	0	0	0	0	0	0	-
Iris	0	0	0	0	0	0	0	0	0	0	-
Conjunctivae
Redness	1	1	1	0	1	1	1	0	2	1	-
Chemosis	1	1	0	0	1	0	0	0	1	1	-
Discharge	2	0	0	0	1	0	0	0	1	0	-

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The substance is not classified as corrosive or irritant based on the results of this study. It is not clear whether the mortalities noted on the study were test substance related.

Executive summary:

A study has been undertaken according to OECD method 405 and EU method B5 to determine the eye irritancy of 2 -Propenoic acid, 2 -fluoro-, methyl ester. The study shows that the test item does not meet the criteria for classification according to Regulation (EC) No. 1272/2008. It is not clear whether the observed mortalities within the study are test substance related.