[2-[[2-cyano-3-[4-[ethylbenzylamino]phenyl]-1-oxoallyl]oxy]ethyl]trimethylammonium chloride

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

9 November 1982 to 17 November 1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

non GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1981

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

1981

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

[2-[[2-cyano-3-[4-[ethylbenzylamino]phenyl]-1-oxoallyl]oxy]ethyl]trimethylammonium chloride

EC Number:

275-604-2

EC Name:

[2-[[2-cyano-3-[4-[ethylbenzylamino]phenyl]-1-oxoallyl]oxy]ethyl]trimethylammonium chloride

Cas Number:

71550-24-8

Molecular formula:

C24H30N3O2.Cl

IUPAC Name:

[2-[[2-cyano-3-[4-[ethylbenzylamino]phenyl]-1-oxoallyl]oxy]ethyl]trimethylammonium chloride

Test material form:

liquid

Details on test material:

no further details

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Lipischen Versuchtierzucht, Hagemann GmbH & Co KG, 4923 Exertal 1
- Weight at study initiation: average 2.5 kg
- Housing: individually
- Diet: SNIFF "mümmel z"(Soest, Westfalen) ad libitum
- Water: tap water ad libitum
- Acclimation period: 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-18 °C
- Humidity (%): 40%
- Air changes (per hr): no data

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

NA

Observation period (in vivo):

after 1, 24, 48, 72 hours and on day 8

Number of animals or in vitro replicates:

3 males

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: fluorescein was applied after the 24 hour observation

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

3.8

Max. score:

4

Reversibility:

not reversible

Remarks:

corneal opacity with keratoconus and starting maceration

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

not reversible

Results 3

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

3.9

Max. score:

4

Reversibility:

not reversible

Irritant / corrosive response data:

severe irritant effects

Any other information on results incl. tables

Animal no	1					2					3
	1	24	48	72	8	1	24	48	72	8	1	24	48	72	8
cornea	2	2	4	4	4	3	3	4	4	4	4	4	4	4	4
iris	2	2	2	2	2	2	2	2	2	2	2	2	2	2	2
conjunctivae
redness	*	*	*	*	*	*	*	*	*	*	*	*	*	*	*
chemosis	2	4	4	4	4	2	4	4	3	3	3	4	4	4	3
discharge	2	3	3	3	3	2	3	3	3	3	2	2	3	3	2

*not scored because of discolouration; corneal opacity with keratoconus and starting maceration (non-reversible)

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

The substance as tested causes severe eye damage

Executive summary:

Three rabbits received 0.1 mL of the substance in their eye. Observations at 1, 24, 48 and 72 hours and after 7, 14 and 21 days showed irreversible effects on the cornea, iris and chemosis in all animals. All animals showed corneal opacity with keratoconus and starting maceration (non-reversible). Therefore it is concluded that the substance as tested causes serious eye damage (H318).