2-amino-2',5-dichlorobenzophenone

Eye irritation

Administrative data

Endpoint:

eye 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.5 (Acute Toxicity: Eye 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 / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Age at study initiation: no data
- Weight at study initiation: males 2753 - 2905 g
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 21 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5-21.5 °C
- Humidity (%): 330 - 40 %
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye of the same animal served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

Duration of treatment / exposure:

Single exposure
The treated eyes were rinsed out with deionised water to remove the solid test item particles from the eyes of all animals one hour after instillation, carefully.

Observation period (in vivo):

1, 24, 48 and 72 h post-instillation

Number of animals or in vitro replicates:

3 animals

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: The treated eyes were rinsed out with deionised water to remove the solid test item particles from the eyes of all animals one hour after instillation, carefully.
- Time after start of exposure: immediately after exposure

TOOL USED TO ASSESS SCORE: hand-slit lamp (Reine OPTOTECHNIK) 1, 24, 48 and 72 hours after instillation

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity 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:

iris score

Basis:

animal: #1, 2 and 3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: reversibility not applicable

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal: #1, 2 and 3

Time point:

24/48/72 h

Score:

0.67

Max. score:

3

Reversibility:

fully reversible within: 72 h

Results 4

Irritation parameter:

chemosis score

Basis:

animal: #1 and 2

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 5

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 h

Irritant / corrosive response data:

A moderate redness and a moderate swelling of the conjunctivae were observed on the day of instillation. 24 h after the instillation, only a slight redness and a slight swelling of the conjunctivae were observed in all animals, the slight redness continued up to 48 h after instillation in all animals but the slight swelling continued up to 48 h after instillation only in one animal.
The cornea and the iris were not affected.
72 h after instillation signs of irritation were not longer observed.

Other effects:

No further local or systemic effectes were noted.

Any other information on results incl. tables

Alteration	Animal No.	Observed grades of ocular lesions at each observationtime
		Hours after instillation
		1		24		48		72
		Control	Test item	Control	Test item	Control	Test item	Control	Test item
Cornea	1	1	0	0	0	1	0	0	0
	2	1	0	0	0	1	0	0	0
	3	0	0	0	0	1	0	0	0
Iris	1	0	0	0	0	1	1	0	0
	2
	3	0	0	0	0	0	0	0	0
Conjunctivae Redness	1	0	0	0	0	1	0	0	0
	2
	3	0	0	0	0	0	0	0	0
Conjunctivae Chemosis	1	0	0	0	0	1	0	0	0
	2
	3	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 eye.