5-(diisopropylamino)-2-[[4-(dimethylamino)phenyl]azo]-3-methyl-1,3,4-thiadiazolium methyl sulphate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

15 - 22 Nov 1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

5-(diisopropylamino)-2-[[4-(dimethylamino)phenyl]azo]-3-methyl-1,3,4-thiadiazolium methyl sulphate

EC Number:

281-589-3

EC Name:

5-(diisopropylamino)-2-[[4-(dimethylamino)phenyl]azo]-3-methyl-1,3,4-thiadiazolium methyl sulphate

Cas Number:

83969-12-4

Molecular formula:

C17H27N6S.CH3O4S

IUPAC Name:

4-{2-[(2E)-5-[bis(propan-2-yl)amino]-3-methyl-2,3-dihydro-1,3,4-thiadiazol-2-ylidene]hydrazin-1-ylidene}-N,N-dimethylcyclohexa-2,5-dien-1-iminium methyl sulfate

Test material form:

liquid

Details on test material:

Basic Blue 159 methyl sulfate

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Remarks:

HC:NZW

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Age at study initiation: adult
- Weight at study initiation: 3.2 kg
- Housing: one animal/cage (type III)
- Diet (e.g. ad libitum): "ssniff K4", ad libitum
- Water (e.g. ad libitum): mains water, ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 2°C
- Humidity (%): 50%
- Air changes (per hr): 10
- 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 100µL (approx. 45 mg test substance) of the test substance applied, eye closed for 1 second

Duration of treatment / exposure:

24 h exposure

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

1

Details on study design:

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

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: fluorescein, UV light

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2.67

Max. score:

4

Reversibility:

not reversible

Remarks on result:

probability of severe irritation

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

not reversible

Remarks on result:

probability of severe irritation

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

not reversible

Remarks on result:

probability of severe irritation

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

not reversible

Remarks on result:

probability of severe irritation

Irritant / corrosive response data:

Fluorescein test positive (24, 48, 72 h).

The animals showed a strong pain reaction after instillation of the test item. The animals was euthanised after 72 h since the irreversible necrosis of the eye was too strong to continue the experiment in the interest of animal welfare.

Applicant's summary and conclusion

Interpretation of results:

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

Conclusions:

The substance caused severe and irreversible corrosion effects. The substance is classified as Category 1.