[2-[ethyl[3-methyl-4-[(3-phenyl-1,2,4-thiadiazol-5-yl)azo]phenyl]amino]ethyl]trimethylammonium methyl sulphate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

15. Nov - 23. Nov 1982

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:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

in year 1982

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

[2-[ethyl[3-methyl-4-[(3-phenyl-1,2,4-thiadiazol-5-yl)azo]phenyl]amino]ethyl]trimethylammonium methyl sulphate

EC Number:

248-957-5

EC Name:

[2-[ethyl[3-methyl-4-[(3-phenyl-1,2,4-thiadiazol-5-yl)azo]phenyl]amino]ethyl]trimethylammonium methyl sulphate

Cas Number:

28313-51-1

Molecular formula:

C22H29N6S.CH3O4S

IUPAC Name:

{2-[ethyl({3-methyl-4-[(E)-2-(3-phenyl-1,2,4-thiadiazol-5-yl)diazen-1-yl]phenyl})amino]ethyl}trimethylazanium methyl sulfate

Test material form:

solid: particulate/powder

Details on test material:

Basic Red 23 Methyl sulfate

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Lippische Versuchstierzucht
- Weight at study initiation: average 2.7 kg
- Housing: one animal/cage
- Diet (e.g. ad libitum): "mümmel z", ad libitum
- Water (e.g. ad libitum): water, ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 - 18°C
- Humidity (%): 40% rF
- Photoperiod (hrs dark / hrs light): 12h/12h

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): bulk volume of 100 µL of the test substance applied, eye closed for 1 second

Duration of treatment / exposure:

8 days

Observation period (in vivo):

1h, 24h, 48h, 72h and 8 days after start of the test

Number of animals or in vitro replicates:

3

Details on study design:

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

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: fluorescein test after 24h, use of ophthalmoscope

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

1.22

Max. score:

4

Reversibility:

not fully reversible within: 8 d

Remarks:

Observation period was only 8 days, not 21 days as requested to evaluate reversibility

Remarks on result:

positive indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0.89

Max. score:

2

Reversibility:

fully reversible within: 8 d

Remarks on result:

positive indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Remarks:

evaluation at 24 and 48 h was not possible due to discolouration of the conjunctiva by the dye

Basis:

mean

Time point:

72 h

Score:

2.67

Max. score:

3

Reversibility:

not fully reversible within: 8

Remarks:

Observation period was only 8 days, not 21 days as requested to evaluate reversibility; one animal still shoed reddening of the conjunctiva on day 8

Remarks on result:

not determinable because of methodological limitations

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

2.11

Max. score:

4

Reversibility:

not fully reversible within: 8 d

Remarks:

Observation period was only 8 days, not 21 days as requested to evaluate reversibility

Remarks on result:

positive indication of irritation

Any other information on results incl. tables

Endpoint		Average score per observation time and endpoint
		24h	48h	72h
Cornea	Opacity	1	1.3	1.3
Iris	Value	1	1	0.7
Conjuctiva	Redness	*	*	2.7
	Chemosis	2.3	2	2
* colouring caused by test substance

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

The test substance is classified as irritating to eyes based on effects all structures of the eye. It was not classified as Category 1 (irreversible effects on eyes) despite the fact that the effects seen in cornea and conjunctiva were not completely reversed at the end of the observation period. This is based on the fact that the observation period lasted only 8 days in spite of 21 days as requested to observe reversibility and that within this observation period vast improvement of effects were seen. It can therefore be assumed that all effects would be reversed within the 21-day observarion period.