Chlorobenzene

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1983

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Chlorobenzene

EC Number:

203-628-5

EC Name:

Chlorobenzene

Cas Number:

108-90-7

Molecular formula:

C6H5Cl

IUPAC Name:

chlorobenzene

Details on test material:

- Name of test material (as cited in study report): chlorobenzene pure
- Physical state: liquid
- Analytical purity: pure (further data not reported)

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hacking & Churchill Ltd., Huntingdon, UK
- Weight at study initiation: approx. 3.0 Kg
- Diet (e.g. ad libitum): Standard diet ("Ssniff K" provided from Versuchstierdiäten GmbH, Soest/Westfalen) availabe ad libitum
- Water (e.g. ad libitum): tap water available ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25 °C
- Humidity (%): 40-60%
- Photoperiod (hrs dark / hrs light): 12 hours dark/12 h light cycle


IN-LIFE DATES: From: October To: November 1982

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin areas of the test animal serve as control

Amount / concentration applied:

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

Duration of treatment / exposure:

4 hours

Observation period:

14 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 6.25 cm²
- Type of wrap if used: gauze patch of approximaltely 2.5 * 2.5 cm²=6.25 cm²


REMOVAL OF TEST SUBSTANCE
- Washing (if done): water was used to wash the area treated
- Time after start of exposure: 4 hours from the end of the treatment


SCORING SYSTEM: according to Draize method.

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: 6 days

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 6 days

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 6 days

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 6 days

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 6 days

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 6 days

Irritant / corrosive response data:

All 3 animals showed marked erythema and edema on the application sites. The intensity of the skin reaction pertained the margins of the application sites. Until 3 days after the treatment skin desquamation was observed. No significant differences in skin reaction appeared among each animal.

Any other information on results incl. tables

Readings	Animal	Erythema	Edema
24 h	64	3	1
24 h	95	3	1
24 h	100	2	1
48 h	64	3	1
48 h	95	3	1
48 h	100	2	1
72 h	64	3	1
72 h	95	3	1
72h	100	2	1
Mean 24 -72h	64	3	1
Mean 24 -72h	95	3	1
Mean 24 -72h	100	2	1
Total mean		2.7	1

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant)

Remarks:

Migrated information Criteria used for interpretation of results: other: EU-GHS

Executive summary:

Suber H, 1983.

The primary irritant/corrosive effect of pure chlorobenzene, has been tested on rabbit skin according to "OECD Guideline for Testing of Chemicals No. 404" without deviations. 3 New Zealand White rabbits have been tested with 0.5 mL of pure chlorobenzene for 4 hour-exposure followed by a post expsoure period of 14 days. The evaluation was performed according to Draize.

All 3 animals showed marked erythema and edema on the application sites. The intensity of the skin reaction pertained the margins of the application sites. Until 3 days after the treatment skin desquamation was observed. No significant differences in skin reaction appeared among each animals.

Mean scores over 24, 48, and 72 hours for each animal were 2.7 of max 4 for erythema and 1 of max4 for edema.

According to EU-GHS regulations chlorobenzene shall be classified as "Skin irritation cat 2, H315". The definition of this category is: causes skin irritation.