1-(6-FLUORO-3,4-DIHYDRO-2H-CHROMEN-2-YL)ETHANONE

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2005-01-18 to 2005-01-21

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

Study was conducted according to OECD Guideline 404 (Acute Dermal Irritation / Corrosion) and EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion); however, the test substance is not adequately characterized and insufficient information is provided on the test animals.

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 404 (Acute Dermal Irritation / Corrosion)

Deviations:

not specified

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

not specified

GLP compliance:

no

Remarks:

The study was conducted in a facility operating to Good Laboratory Practice within the UK national GLP monitoring programme, but the study report has not been audited by the QA unit. No formal claim of GLP compliance is made for this study.

Test material

Test material information

Constituent 1

Reference substance name:

1-(6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl)ethan-1-one

Cas Number:

620176-90-1

Molecular formula:

C11H11FO2

IUPAC Name:

1-(6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl)ethan-1-one

Test material form:

liquid

Details on test material:

- Name of test material (as cited in study reports): JNJ-7928531-AAA (T001481)
- Physical state: liquid
- Appearance: Colourless, light yellow to brown liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS: no data


ENVIRONMENTAL CONDITIONS: no data

Test system

Type of coverage:

semiocclusive

Preparation of test site:

not specified

Vehicle:

not specified

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): no data

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3

Details on study design:

TEST SITE: no data

REMOVAL OF TEST SUBSTANCE: no data

OBSERVATION TIME POINTS:
- Skin reactions were observed 1, 24, 48, and 72 hours after administration.

SCORING SYSTEM:
- According to Draize
- Primary Irritation Index
0 = Non-irritant
>0 - 2 = Mild irritant
>2 - 5 = Moderate irritant
>5 - 8 = Severe irritant

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 4

Irritation parameter:

edema score

Basis:

mean

Remarks:

3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

Very slight erythema was noted at two treated skin sites at the 24 and 48-hour observations. One treated skin site appeared normal throughout the study and the remaining treated skin sites appeared normal at the 72-hour observation.

Any other information on results incl. tables

Table 1. Individual Skin Reactions Following 4-Hour Exposure Period

Skin Reaction	Observation Time	Individual Scores – Rabbit Number and Sex			Total
		63 Male	64 Male	65 Male
Erythema/Eschar Formation	1 Hour	0	0	0	(0)
	24 Hour	1	1	0	2
	48 Hour	1	1	0	(2)
	72 Hour	0	0	0	0
Oedema Formation	1 Hour	0	0	0	(0)
	24 Hour	0	0	0	0
	48 Hour	0	0	0	(0)
	72 Hour	0	0	0	0
Sum of 24 and 72 Hour Readings					2
Primary Irritation Index (S/6) and Classification					2/6=0.3
					Mild Irritant

( ) = Total values not used for calculation of primary irritation index

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The Primary Irritation Index was 0.3 in the study, therefore, the test item was considered to be a mild irritant to rabbit skin. However, the test item should not be classified as the mean score for all animals is below the cut off value of 2.3.