2-amino-2',5-dichlorobenzophenone

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

03 Nov - 20 Dec 2005

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

2-amino-2',5-dichlorobenzophenone

EC Number:

220-985-2

EC Name:

2-amino-2',5-dichlorobenzophenone

Cas Number:

2958-36-3

Molecular formula:

C13H9Cl2NO

IUPAC Name:

4-chloro-2-(2-chlorobenzoyl)aniline

Test material form:

solid: particulate/powder

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

- Age at study initiation: no data
- Weight at study initiation: males 2659-3056 g
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5 - 20°C
- Humidity (%): 35 - 50%
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

other: 0.5 % (m/v) solution of Tylose MH 1000 in deionised water

Controls:

other: Approximately 24 hours before testing the fur on the backs of the animals was closely clipped over an area of approximately 4 x 5 cm on the left and right side of the spine. One area was used as control.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 g

VEHICLE
- Amount(s) applied: 0.5 ml of a 0.5 % (m/v) solution of Tylose MH 1000 in deionised water

Duration of treatment / exposure:

Animal 1: 3 min, 1 and 4 h
Animals 2 and 3: 4 h

Observation period:

1, 24 48 and 72 h after patch removal

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: ca. 6 cm2
- Type of wrap if used: gaze patch

REMOVAL OF TEST SUBSTANCE
- Washing: cleaned with deionised water without altering the integrity of the epidermis
- Time after start of exposure: 4h

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: #1, 2 and 3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

animal: #1 and 3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritant / corrosive response data:

Animal 1: very slight erythema and very slight edema were observed at 1 h grading following 3 min and 1 h treatment. Very slight edema was observed at 1 h grading after 4 h treatment.
Animal 2: very slight edema was observed at the 1 and 24 h gradings following 4 h treament. At the 48 h grading, the skin reaction had fully reversed.
Animal 3: very slight edema was observed at the 1 h grading following 4 h treament.

Other effects:

No further local or systemic effects were noted.

Any other information on results incl. tables

Animal No:	Exposureperiod	Observed grades of skin alterations at each observation time
		Erythema hours after administration				Oedema hours after administration
		1	24	48	72	1	24	48	72
1	3 min	1	0	0	0	1	0	0	0
	1h	1	0	0	0	1	0	0	0
	4h	0	0	0	0	1	0	0	0
	Control	0	0	0	0	0	0	0	0
2	4h	0	0	0	0	1	1	0	0
	Control	0	0	0	0	0	0	0	0
3	4h	0	0	0	0	1	0	0	0
	Control	0	0	0	0	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In accordance with the results of this study and in accordance with the criteria of Regulation /EC) 1272/2008, ADB may be classified as a substance that is non-irritant to the skin.