Benzene, ethenyl-, ar-bromo derivs.

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

26 March to 9 April 1987

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted in compliance with agreed protocol, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OPP 81-5 (Acute Dermal Irritation)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Benzene, dibromoethyl Benzene, ethenyl-, ar-bromo derivs.

EC Number:

603-094-7

Cas Number:

125904-11-2

Molecular formula:

C8 H6 Br2

IUPAC Name:

Benzene, dibromoethyl Benzene, ethenyl-, ar-bromo derivs.

Test material form:

liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Mohican Valley Rabbitry, Loudonville, Ohio, USA
- Age at study initiation: young adult
- Weight at study initiation: 2087 to 2399 g
- Housing: individual suspended wire-mesh cages
- Diet: Purina Certified Rabbit Chow # 5322 ad libitum
- Water: tap water from on-site wells ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature: 70-73 Fahrenheit degrees
- Humidity: 40-66%
- Photoperiod: 12 hours light/12 hours dark

IN-LIFE DATES: from 26 March to 9 April 1987

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

14 days

Number of animals:

6 (3 males and 3 females)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: fissuring present on days 4 and 5 and desquamation observed from day 6 to 14

Results 2

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

>= 1 - <= 2

Max. score:

4

Reversibility:

fully reversible within: 5 days

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 9 days

Remarks on result:

other: fissuring present on days 4 and 5; desquamation observed on days 6 to 13

Results 4

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

>= 1 - <= 2

Max. score:

4

Reversibility:

fully reversible within: 6 days

Results 5

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: desquamation observed on days 5 to 13

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

>= 1 - <= 2

Max. score:

4

Reversibility:

fully reversible within: 4 days

Results 7

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

>= 2 - <= 3

Max. score:

4

Reversibility:

fully reversible within: 10 days

Results 8

Irritation parameter:

edema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

>= 1 - <= 2

Max. score:

4

Reversibility:

fully reversible within: 5 days

Results 9

Irritation parameter:

erythema score

Basis:

animal #5

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 8 days

Remarks on result:

other: desquamation observed from day 5 to 14

Results 10

Irritation parameter:

edema score

Basis:

animal #5

Time point:

24/48/72 h

Score:

>= 1 - <= 2

Max. score:

4

Reversibility:

fully reversible within: 5 days

Results 11

Irritation parameter:

erythema score

Basis:

animal #6

Time point:

24/48/72 h

Score:

>= 2 - <= 3

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 12

Irritation parameter:

edema score

Basis:

animal #6

Time point:

24/48/72 h

Score:

>= 2 - <= 3

Max. score:

4

Reversibility:

fully reversible within: 5 days

Irritant / corrosive response data:

The test substance was considered to be a moderately irritating substance based on a PII (primary irritation index calculated with 24 and 72 hours values) of 4.1.
According to the EU criteria, the test substance is classified as a skin irritant and labelled with R38

Other effects:

fissuring and desquamation were observed in most animals

Applicant's summary and conclusion

Interpretation of results:

moderately irritating

Remarks:

Migrated information Criteria used for interpretation of results: US EPA pesticides

Conclusions:

Irritating to the skin - R38

Executive summary:

In a primary skin irritation study, 0.5 mL of undiluted test substance were applied to the intact shaved skin of 6 rabbits. Significant inflammation of the skin was observed. The test substance was therefore considered to be a skin irritant and should be labelled with R38.