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

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

GLP - Guideline study conducted according to the OECD TG 404 (1981) with following minor deviation: the duration of the observation period depended on the achievement of the reversibility of the skin findings and thus was individual for each animal; the guideline recommends a 14 day period of observation.

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 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

12.05.1981

Deviations:

yes

Remarks:

but minor

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

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Élevage Cunicole de Val de Selle, 80160 Prouzel
- Weight at study initiation: 2.7 +/- 0.1 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): 12h / 12h

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: The left flank of each animal remained untreated and served for control.

Amount / concentration applied:

An amount of 0.5 mL of test material was first melt at ca. 35 °C and was then applied onto a dry hydrophilic gauze (ca. 6 cm²) for application on the skin.

Duration of treatment / exposure:

4 hours

Observation period:

The animals were observed during 6, 7 and 14 days, for the first, the second and the third animal respectively.

Number of animals:

3 male animals were used

Details on study design:

The gauze with test material was placed onto the shaved skin of the right flank of each animal. The gauze was covered and maintained in place by means of a semiocclusive dressing for 4 hours.
At the end of the treatment period, the dressing was removed and residues of test material were gently wiped away from the application site.
The skin reaction at the application site was evaluated after 1 hour following removal of the dressing, and again after 24, 48 and 72 hours, and then daily until reversibility of the findings was achieved.
The findings were scored as recommended by the OECD TG 404, thus, according to the Draize scoring system (for details, see table below).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

(mean value)

Time point:

other: 24 - 48 - 72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 5 days

Remarks on result:

other: no skin dryness was observed

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

(mean value)

Time point:

other: 24 - 48 - 72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 6 days

Remarks on result:

other: skin dryness was observed on day 5 and 6

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

(mean value)

Time point:

other: 24 - 48 - 72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 8 days

Remarks on result:

other: skin dryness was observed from day 5 to day 13

Results 4

Irritation parameter:

edema score

Basis:

animal: 1, 2 and 3

Time point:

other: 24 - 48- 72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other: edema graded 1 to 2 was seen at reading time point 1 hour

Irritant / corrosive response data:

Very slight to clearly defined erythema (scored 1 to 2) was observed in all 3 animals during 5 days; in all 3 cases, erythema at reading time point one hour was accompanied by very slight to slight edema (scored 1 to 2), edema totally disappeared thereafter. From day 6 to 8, full reversibility of erythema was noticed for all 3 animals.

Other effects:

Skin dryness at the application site was seen in two animals. In one animal, dryness was observed on days 5 to 6 and disappeared thereafter; in the second animal dryness lasted until day 13 of observation.