4-bromo-2,2-diphenylbutyric acid

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2004-02-03 to 2004-02-06

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Study performed similar 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, testing methodology and results for a thorough assessment of reliability.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

Inadequate documentation of test material, test animals, environmental conditions, methodology and results.

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

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

Deviations:

yes

Remarks:

Inadequate documentation of test material, test animals, environmental conditions, methodology and results.

GLP compliance:

no

Remarks:

The study was conducted in a facility operating to Good Laboratory Practice within the UK national GLPmonitoring 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:

4-bromo-2,2-diphenylbutyric acid

EC Number:

253-648-3

EC Name:

4-bromo-2,2-diphenylbutyric acid

Cas Number:

37742-98-6

Molecular formula:

C16H15BrO2

IUPAC Name:

4-bromo-2,2-diphenylbutanoic acid

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material (as cited in study report): JNJ-1580774-AAA (T000835)
- Physical state: solid powder
- Appearance: slight beige

Specific details on test material used for the study:

no data

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:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

Duration of treatment / exposure:

a single, 4-hour semi-occluded application to the intact skin

Observation period:

at 1, 24, 48 and 72 h intervals after administration

Number of animals:

3 males

Details on study design:

TEST SITE: no data

REMOVAL OF TEST SUBSTANCE: no data

SCORING SYSTEM:
according to Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48 h

Score:

1

Reversibility:

fully reversible within: 72h

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48 h

Score:

1

Reversibility:

fully reversible within: 72h

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48 h

Score:

1

Reversibility:

fully reversible within: 72h

Results 4

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

72 h

Score:

0

Results 5

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

72 h

Score:

0

Results 6

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

72 h

Score:

0

Results 7

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24 h

Score:

1

Reversibility:

fully reversible within: 72h

Results 8

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Results 9

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Results 10

Irritation parameter:

edema score

Basis:

animal #1

Time point:

48 h

Score:

0

Results 11

Irritation parameter:

edema score

Basis:

animal #1

Time point:

72 h

Score:

0

Results 12

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 1 h

Score:

1

Reversibility:

fully reversible within: 72 h

Results 13

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 1 h

Score:

1

Reversibility:

fully reversible within: 72 h

Results 14

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 1 h

Score:

1

Reversibility:

fully reversible within: 72 h

Results 15

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 1 h

Score:

0

Results 16

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 1 h

Score:

0

Results 17

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: 1 h

Score:

0

Irritant / corrosive response data:

Very slight erythema was noted at all treated skin sites at the 1, 24 and 48-hour observations.Very slight oedema was noted at one treated skin site at 24-hour observation. All treated skin sites appeared normal at the 72-hour observation.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance was found to be mildly irritating to rabbit skin. However, based on the criteria of the CLP Regulation, the substance should not be classified for skin irritation as reversible effects are observed and the scores for erythema and edema of the three animals were below the cut-off value of 2.3.