Reaction mass of bis[3-[[4-[benzylmethylamino]phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium] tetrachlorozincate(2-) and bis[5-[[4-[benzylmethylamino]phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium] tetrachlorozincate(2-)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

September 1985

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Bis[3-[[4-[benzylmethylamino]phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium] tetrachlorozincate(2-)

EC Number:

281-650-4

EC Name:

Bis[3-[[4-[benzylmethylamino]phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium] tetrachlorozincate(2-)

Cas Number:

84000-94-2

Molecular formula:

C36H42Cl4N12Zn

IUPAC Name:

bis(3-[(E)-2-{4-[benzyl(methyl)amino]phenyl}diazen-1-yl]-1,4-dimethyl-1H-1,2,4-triazol-4-ium); tetrachlorozincdiuide

Constituent 2

Reference substance name:

Bis[5-[[4-[benzylmethylamino]phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium] tetrachlorozincate(2-)

EC Number:

281-692-3

EC Name:

Bis[5-[[4-[benzylmethylamino]phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium] tetrachlorozincate(2-)

Cas Number:

84012-52-2

Molecular formula:

C36H42Cl4N12Zn

IUPAC Name:

bis[5-({4-[benzyl(methyl)amino]phenyl}diazenyl)-1,4-dimethyl-4,5-dihydro-1H-1,2,4-triazol-1-ium] tetrachlorozincate(2-)

Test material form:

solid

Details on test material:

Basic Red 46 ZnCl4 Multi-const.

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: GAUKLER, OFFENBACH/MAIN, Germany
- Weight at study initiation: mean 2.63 kg
- Housing: single housed in a cage made of stainless steel with wire mesh walk floors, floor area: 40 cm x 51 cm
- Diet: kliba 341, 4 mm, firma klingentalmuehle ag ch-4303 kaiseraugst. switzerland (about 130 g per animal per day)
- Water: 250 ml, tap water
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): fully air-conditioned room
- Photoperiod (hrs dark / hrs light): 12 hours cycle dark/light from 6:00 AM to 6:00 PM

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 g

Duration of treatment / exposure:

1 treatement at 0 h

Observation period (in vivo):

72 h

Number of animals or in vitro replicates:

3

Details on study design:

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

SCORING SYSTEM: Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Remarks on result:

probability of moderate irritation

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2.33

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Remarks on result:

probability of moderate irritation

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Remarks on result:

probability of severe irritation

Results 4

Irritation parameter:

iris score

Basis:

mean

Time point:

24 h

Max. score:

2

Remarks on result:

not determinable

Remarks:

staining by substance

Results 5

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 48/72 h

Score:

1

Max. score:

2

Reversibility:

not fully reversible within: 72 h

Remarks on result:

probability of moderate irritation

Results 6

Irritation parameter:

conjunctivae score

Basis:

other: all animals

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

not fully reversible within: 72 h

Remarks on result:

probability of moderate irritation

Results 7

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Remarks on result:

probability of moderate irritation

Results 8

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

3.67

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Remarks on result:

probability of severe irritation

Results 9

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Remarks on result:

probability of severe irritation

Irritant / corrosive response data:

The test item caused moderate to severe reaction in rabbit eyes. Loss of corneal tissue was observed and the study discontinued at 72 h because of the severe irritation reactions for animal welfare reasons.

Applicant's summary and conclusion

Interpretation of results:

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

Conclusions:

The substance caused severe damages in rabbit eyes which were not considered reversible.

Executive summary:

The eye irritation potential of Basic Red 46 was evaluated in a study conducted according to OECD Test Guideline 405. The test was performed on 3 adult female Vienna White rabbits. The test material in an amount of 0.1 ml (ca. 78 mg) was inserted into the conjunctival sac of the left eye of the rabbits and the lids were gently closed for a few seconds. The right eye was not treated and served as an untreated control. No washing was done. The eye irritation was evaluated 1, 24, 48, and 72 hours after treatment and was scored for each individual rabbit. Based on the available data, the corneal opacity was scored to be ≥ 2 all 3 rabbits which was not reversible within the 72 hours observation time. In addition, chemosis was scored to be ≥ 3 in all 3 rabbits which was also not reversible. Hence, it was concluded that the instillation of the substance in eye, leads to irreversible effects on the eyes, and should be classified in category 1 as per the Regulation EC No. 1272/2008 (CLP) criteria.