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-)

Endpoint summary

Description of key information

The substance was found to be non-irritating to skin (OECD 404).

The substance was found to be severely irritating to eyes (OECD 405).

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

no

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

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

Irritation parameter:

erythema score

Basis:

mean

Time point:

24 h

Max. score:

4

Remarks on result:

not determinable

Remarks:

red staining by test item

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

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.

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.  

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

no

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

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

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

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

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

Irritation parameter:

iris score

Basis:

mean

Time point:

24 h

Max. score:

2

Remarks on result:

not determinable

Remarks:

staining by substance

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

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

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

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

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.

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.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

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.  

 

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.

Justification for classification or non-classification

GHS Category 1 - H318