5-chloro-2-(2,4-dichlorophenoxy)aniline

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP- Guideline Study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

24.02.1987

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

5-chloro-2-(2,4-dichlorophenoxy)aniline

EC Number:

260-480-4

EC Name:

5-chloro-2-(2,4-dichlorophenoxy)aniline

Cas Number:

56966-52-0

Molecular formula:

C12H8Cl3NO

IUPAC Name:

5-chloro-2-(2,4-dichlorophenoxy)aniline

Details on test material:

- Name of test material (as cited in study report): Trichloraminodiphenylether
- Physical state: fluid, brown
- Analytical purity: no data were available to the testing facility at the time the study was conducted
- Impurities (identity and concentrations): no data were available to the testing facility at the time the study was conducted
- Lot/batch No.: 9207 997
- Storage condition of test material: room temperature

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Élevage Cunicole de Val de Selle, 80160 Prouzel
- Weight at study initiation: 2.8 +/- 0.4 kg (mean of 3 males)
- Housing: individually
- Diet (e.g. ad libitum): "Lapins entretien référence 112 C" granules, offered ad libitum
- Water (e.g. ad libitum): tap water filtered through a 0.22 µm filter membrane, offered ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3
- Humidity (%): 50 +/- 20
- Air changes (per hr): non recycled air was filtered
- Photoperiod (hrs dark / hrs light): 12 h / 12 h

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The untreated eye served for control

Amount / concentration applied:

A volume of 0.1 mL of test material was first melt at ca. 35 °C and was then instilled into the conjunctival sac of the left eye of each animal. The lids were maintained closed for a few seconds to avoid loss of test material.

Duration of treatment / exposure:

Following application of the test material, the eye was not rinsed.

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

3 male animals were used

Details on study design:

The eyes were examined after 1 hour following treatment, after 24, 48 and after 72 hours. The findings were scored as recommended by the OECD TG 405, thus, according to the Draize scoring system (for details, see table below).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Remarks:

(mean for each animal)

Basis:

animal: 1, 2 and 3, respectively

Time point:

other: 24 - 48- 72 h

Score:

0

Max. score:

3

Reversibility:

other: not applicable

Remarks on result:

other: No conjunctival redness was observed

Results 2

Irritation parameter:

cornea opacity score

Remarks:

(mean for each animal)

Basis:

animal: 1,2 and 3, respectively

Time point:

other: 24 - 48 - 72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other: No corneal opacity was observed

Results 3

Irritation parameter:

chemosis score

Remarks:

(mean for each animal)

Basis:

animal: 1, 2and 3, respectively

Time point:

other: 24 - 48 - 72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other: No chemosis was observed

Results 4

Irritation parameter:

iris score

Remarks:

(mean for each animal)

Basis:

animal: 1, 2 and 3, respectively

Time point:

other: 24 - 48 - 72h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Remarks on result:

other: No iritis was observed

Irritant / corrosive response data:

No signs of eye irritation were noticed.

Other effects:

Lacrimation was observed in all animals at reading time point 1 hour; eye reading at this time point was not feasible because of an excess of test material.