N-(2-chloroethyl)-N-ethylaniline

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1992-03-10 - 1992-03-24

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

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 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

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 / tissue source

Species:

rabbit

Strain:

other: HC:NZW Albino

Details on test animals or tissues 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

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

100 µL

Duration of treatment / exposure:

24h

Observation period (in vivo):

14 d

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): normal saline
- Time after start of exposure: 24h

SCORING SYSTEM: Draize / McDonald, Shadduck (aqueous humour)

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 1h - 14d

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 1h - 14d

Score:

0

Max. score:

1

Reversibility:

fully reversible within: 14d

Results 3

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Time point:

other: 1h - 14d

Score:

1.7

Max. score:

2

Reversibility:

fully reversible within: 14d

Remarks on result:

other: Mean value ≥ 2.0 (2.0) for conjunctival redness in 2 of 3 tested animals, reversible within 14 days triggering classification as Eye Irrit. 2

Results 4

Irritation parameter:

conjunctivae score

Remarks:

swelling (chemosis)

Basis:

mean

Time point:

other: 1h - 14d

Score:

2.6

Max. score:

3

Reversibility:

fully reversible within: 14d

Remarks on result:

other: Mean value ≥ 2.0 (3.0 and 2.0) for conjunctival swelling in 2 of 3 tested animals, reversible within 14 days triggering classification as Eye Irrit. 2

Irritant / corrosive response data:

Test item is moderately irritating to the eye.

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

The study was conducted under GLP according to OECD guideline 405 on the registered substance itself without deviations. The method is to be considered scientifically reasonable. Hence, the results can be considered as reliable to assess the eye irritating properties of the test substance in rabbits. Scoring according to Draize resulted in mean values ≥ 2.0 (2.0) for conjunctival redness in 2 of 3 tested animals (reversible within 14 days) and in mean values ≥ 2.0 (3.0 and 2.0) for conjunctival swelling in 2 of 3 tested animals (reversible within 14 days) triggering classification as Eye Irrit. 2.

Executive summary:

In a primary eye irritation study (OECD guideline 405), 100 µL of the test substance (no vehicle) was installed into the conjunctival sac of adult albino HC:NZW rabbits (3 females) for 24 hours. Eyes were washed with normal saline. Animals then were observed for 14 days. Irritation was scored by the method of Draize.

Reactions of the mucous membranes were observed which proved to be fully reversible within 14 days. The cornea was not affected but the iris was transiently affected in one animal. Discharge was seen in all three animals. Signs proved to be fully reversible within 14 days, except a periorbital loss of hair. Non-ocular lesions and other signs of toxicity were not observed.

Scoring according to Draize resulted in mean values ≥ 2.0 (2.0) for conjunctival redness in 2 of 3 tested animals (reversible within 14 days) and in mean values ≥ 2.0 (3.0 and 2.0) for conjunctival swelling in 2 of 3 tested animals (reversible within 14 days) triggering classification as Eye Irrit. 2.