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-)

Skin irritation / corrosion

Administrative data

Endpoint:

skin 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 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

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

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system 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

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution): 50 % aqueous formulation w/w

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 g of the suspension

Duration of treatment / exposure:

1 hour

Observation period:

30 - 60 minutes after removal of the test patches and 24 h. 48 h, 72 h, after the beginning of application

Number of animals:

3 male rabbits

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: 0.5 mm layer, test patches are secured in position with a porous dressing (four layers of absorbent gauze + porous bandage).

SCORING: Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24 h

Max. score:

4

Remarks on result:

not determinable

Remarks:

red staining by test item

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No signs of irritation

Other effects:

The substance caused red staining at 1 and 24 h. Therefore, erythema could not be determined appropriately. However, no signs of redness were observed at 48 and 72 h.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance is not irritating to rabbit skin according to an OECD 404 study. The substance is not classifiable.

Executive summary:

The skin irritation potential of Basic Red 46 was evaluated in a study conducted according to OECD Test Guideline 404. The test was performed on 3 adult male Vienna White rabbits. Gauze patches of 2.5 x 2.5 cm² laden with 0.5 ml of the test material were applied to the shaved skin. Due to intensive staining by the test compound erythema was not assessable at the 1-hour and 24-hour evaluation time; at 48 and 72 h, no erythema was observed. No oedema was observed at either evaluation time-point. Based on the findings of the study, Basic Red 46 was found to cause no irritation when applied to rabbit skin.