3-amino-4-chlorobenzamide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study OECD404, GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

3-amino-4-chlorobenzamide

EC Number:

243-231-4

EC Name:

3-amino-4-chlorobenzamide

Cas Number:

19694-10-1

Molecular formula:

C7H7ClN2O

IUPAC Name:

3-amino-4-chlorobenzamide

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst Kastengrund, Germany
- Strain: Albino New Zealand rabbit, normal breeding
- Age at study initiation: ca. 3 - 5 months
- Weight at study initiation: 2.0 - 2.5 kg
- Housing: single cages arranged in a battery
- Diet: Altromin 2123 ad libitum + straw
- Water : de-ionized and chlorinated water ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/- 3
- Humidity (%): 50 +/- 20
- Lighting time: 12 h daily

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

other: aqueous sodium chloride solution 0.9%

Controls:

not required

Amount / concentration applied:

500 mg / 0,4 ml vehicle per animal

Duration of treatment / exposure:

4h

Observation period:

72 h after patch removal

Number of animals:

3

Details on study design:

About 24 hours before the start of the study the hair in the dorsal region of the body of 3 rabbits was removed with an electric clipper over an area of about 25 cm2. Only animals with intact skin were used.
Each animal was treated with 0.5 g aminochlorobenzamide pasted with 0.4 mL 0.9% aqeuous sodium chloride solution. The substance was applied over the whole surface of a 2.5 x 2.5 cm cellulose layer on a piece of surgical plaster (specially produced by Beiersdorf Aktiengesellschaft). The plaster was fixed to the prepared skin area and then covered with a semi-occlusive bandage.
The exposure period was 4 hours. After the exposure period all remnants of the test substance were carefully removed from the skin with warm tap water.
Examinations of the skin took place after 30 - 60 minutes as well as 24, 48 and 72 hours after removal of the patches.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of all tested animals

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Reversibility:

other: not relevant since no effect occured

Remarks on result:

other: no effect on any single animal

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

of all tested animals

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Reversibility:

other: not relevant since no effect occured

Remarks on result:

other: no effect on any single animal

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Classification acc. to (EC) 1272/2008: not irritating

Executive summary:

Test material was subject to a test of skin irritancy according to OECD Guideline 404. 500 mg of substance were applied to the skin of three rabbits under semi-occlusive conditions for 4 h. The scoring of skin reactions was performed after 24, 48 and 72h h after end of exposure.Mean values of the 24, 48 and 72 h readings were calculated for each animal. No effects (erythema mean score: 0, edema mean score: 0) were determined for the intact skin. Based on these findings the test material was judged not to be irritating to skin.