N-(2-chloroethyl)-N-ethylaniline

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1992-03-10 - 1992-03-24

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

Study terminated at day 8 without observation of reversibility.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N-(2-chloroethyl)-N-ethylaniline

EC Number:

245-082-0

EC Name:

N-(2-chloroethyl)-N-ethylaniline

Cas Number:

22564-43-8

Molecular formula:

C11H16ClN

IUPAC Name:

N-(2-chloroethyl)-N-ethylaniline

Test material form:

liquid

Test animals

Species:

rabbit

Strain:

other: HC:NZW Albino

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Interfauna UK Ltd.
- Age at study initiation: adult
- Weight at study initiation: 3.2 - 3.4 kg
- Housing: individually in stainless steel cages with flat rod bases or plastic cages with perforated bases under standardised conventional conditions. Excrement trays beneath the cages contained low dust-(wood) bedding (type S 8/15). Bedding was regularly spot-checked for contaminants and changed at least twice weekly.
- Diet (e.g. ad libitum): Standard diet ssniff K 4 (Ssniff Spezialdiäten GmbH, Soest/Westfalen), ca. 100-120 g per animal and day, feeding once daily in the morning
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: min. 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21±1.5°C
- Humidity (%): ca. 40-70%
- Air changes (per hr): 12-15 times per hour
- Photoperiod (hrs dark / hrs light): 12 hours, artificial light from 6 to 18 hrs CET, approx. 500 lux

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

500 µL

Duration of treatment / exposure:

4 h

Observation period:

7 d

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 6cm² of the flank
- Type of wrap: hypoallergenic Hansamed patch (Beiersdorf No. 2342 PV3), fixed with semiocclusive dressing (Fixomull-Strech Klebevlies, Beiersdorf No. 2239)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): carefully with water
- Time after start of exposure: 4h

SCORING SYSTEM: Draize-grading

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 2

Max. score:

3

Reversibility:

not reversible

Remarks:

within 7 days

Remarks on result:

other: Mean value of 2.7 (≥ 2.3 - ≤ 4.0) for erythema/eschar in 2 of 3 tested animals triggering classification as Skin Irrit. 2

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

1.8

Max. score:

3

Reversibility:

not reversible

Remarks:

within 7 days

Irritant / corrosive response data:

Test item is moderately irritating to the skin.

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

The study was conducted under GLP according to OECD guideline 404 on the registered substance itself. The method is to be considered scientifically reasonable although it has been terminated at day 8 without observation of reversibility. Hence, the results can be considered as reliable to assess the skin irritating properties of the test substance in rabbits. Scoring according to Draize resulted in mean value of 2.7 (≥ 2.3 - ≤ 4.0) for erythema/eschar in 2 of 3 tested animals triggering classification as Skin Irrit. 2.

Executive summary:

In a primary dermal irritation study (OECD guideline 404), adult albino HC:NZW rabbits (3 females) were dermally exposed to 500 µL of test substance for 4 hours to 6 cm². Animals then were observed for 7 days. Irritation was scored by the method of Draize.

Erythematous and exsudative reactions were seen. The signs did not prove to be reversible up to day 7. Additionally in the exposed skin areas single rhagades, peeling of epidermis, indurations and necrosis were observed in one and whithish eschar formation in all three animals and in two animals the margin of the exposed area was reddened.

Scoring according to Draize resulted in mean value of 2.7 (≥ 2.3 - ≤ 4.0) for erythema/eschar in 2 of 3 tested animals triggering classification as Skin Irrit. 2.