Disodium 6-(4,6-dichloro-1,3,5-triazin-2-ylamino)-1-hydroxy-2-(4-(2-(sulfonatooxy)ethylsulfonyl)phenylazo)naphthalene-3-sulfonate

Endpoint summary

Description of key information

The test substance was found to be non-irritating to skin and slightly irritating to the rabbit eye however does not meet the criteria for classification under GHS.

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:

From Aug. 26, 1997 to Sep. 19, 1997

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland GmbH, 88353 Kiβlegg
- Weight at study initiation: 3.6 - 3.8 kg
- Housing: Separate cages arranged in a battery
- Diet: ssniff K-H (V2333), ad libitum and hay (approx. 15 g daily)
- Water: Water from automatic water dispensers, ad libitum
- Acclimation period: 1 wk

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3 °C
- Humidity (%): 50±20 °C
- Photoperiod (hrs dark / hrs light): 12 h dark/12 h light

IN-LIFE DATES: From: Aug. 26, 1997 To: Aug. 29, 1997

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Remarks:

0.7 mL deion. water

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 g of test substance pasted with 0.7 mL deion. water

Duration of treatment / exposure:

4 h

Observation period:

0.5-1, 24, 48 and 72 h after removal of the patches

Number of animals:

Three

Details on study design:

TEST SITE
- Area of exposure: Dorsal region of the body
- % coverage: 25 cm2
- Type of wrap if used: Yes, The test substance was evenly distributed over the whole surface of a 2.5 x 2.5 cm cellulose patch on a piece of surgical plaster. The plaster was fixed to the prepared skin area and then covered with a semi-occlusive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, with warm water
- Time after start of exposure: 4 h

SCORING SYSTEM: Erythema, eschar formation and edema were evaluated numerically according to the score of DRAIZE

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.8

Max. score:

4

Reversibility:

fully reversible within: 3 d

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.2

Max. score:

4

Reversibility:

fully reversible within: 3 d

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

30 - 60 min up to 48 h after removal of the plaster the animals showed very slight up to well defined erythema and sporadically very slight or slight oedema. 72 h after removal of the plaster all signs of irritating were reversible.

Other effects:

No signs of irritations were observed during the whole observation period

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions, the test substance was considered to be non-irritating to rabbit skin

Executive summary:

A study was conducted to assess the skin irritation potential of test substance to the rabbit skin according to EU Method B.4. and OECD Guideline 404 in compliance with GLP.

Three animals were treated with 0.5 g of the test substance pasted with 0.7 mL deionised water using semi-occlusive patches for 4 h. After the exposure period all remnants of the test substance were carefully removed from the skin with warm tap water. The skin was evaluated for erythema, eschar formation and edema numerically according to the score of Draize system for up to 72 h after patch removal. 30 - 60 min up to 72 h after decontamination the skin, the animals showed very slight up to well defined erythema and sporadically very slight or slight oedema. 72 h after removal of the plaster all signs of irritating were reversible.

Under the test conditions, the test substance was considered to be non-irritating 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:

From Sep. 02, 1997 to Oct. 13, 1997

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland GmbH, 88353 Kiβlegg
- Weight at study initiation: 3.7-3.9 kg
- Housing: Separate cages arranged in a battery
- Diet: ssniff K-H (V2333), ad libitum and hay (approx. 15 g daily)
- Water: Water from automatic water dispensers, ad libitum
- Acclimation period: 1 wk

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3 °C
- Humidity (%): 50±20 °C
- Photoperiod (hrs dark / hrs light): 12 h dark/12 h light

IN-LIFE DATES: From: Sep. 02, 1997 To: Sep. 19, 1997

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg

Duration of treatment / exposure:

Single treatment

Observation period (in vivo):

1, 24, 48 and 72 h after administration of the test substance. At 24 and 72 h, the eyes were also examined for corneal lesions under UV light after instillation of one drop of a 0.01 % fluorescein-sodium solution

Number of animals or in vitro replicates:

3 rabbits

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, 24 h after administration the treated eyes were washed out thoroughly with isotonic saline at approx. 37 °C
- Time after start of exposure: 24 h

SCORING SYSTEM: Lesions in cornea, iris or conjunctivae were graded numerically "Scale for scoring ocular reactions"

TOOL USED TO ASSESS SCORE: 0.01 % fluorescein-sodium solution

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

(Animal# 188, 195, 196)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

mean

Remarks:

(Animal # 188, 195, 196)

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

(Animal# 188, 195, 196)

Time point:

24/48/72 h

Score:

0.67

Max. score:

3

Reversibility:

fully reversible within: 3 d

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

(Animal# 188, 195, 196)

Time point:

24/48/72 h

Score:

0.55

Max. score:

4

Reversibility:

fully reversible within: 3 d

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

- 1 h up to 2 d after treatment, conjunctivae of two animals showed definitely injected blood vessels up to a diffuse crimson red color and very slight up to obvious swellings.
- 3 d after administration all signs of irritation were reversible.
- Conjunctivae and nictating membrane were discolored orange during the whole observation.

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions, the test substance is slightly irritating to the rabbit eye however does not meet the criteria for classification under GHS

Executive summary:

A study was conducted to assess the eye irritation potential of test substance to the rabbit eye according to EU Method B.5. and OECD Guideline 405 in compliance with GLP.

One animal received 100 mg of an undiluted test substance into conjunctival sac of the left eye. The other eyes served as untreated control. 24 h after the administration the eyes were washed thoroughly with isotonic saline at 37 °C. The eyes were also washed out at designated examination times at which discharge was observed or a corneal examination with fluorescein was performed.

The eyes were examined 1, 24, 48 and 72 h after administration of the test substance. At 24 and 72 h and after 7, 14 and 21 d, the eyes were further examined for cornea/lesions under UV light after instillation of one drop of a 0.01 % fluorescein-sodium solution. Lesions in cornea, iris or conjunctivae were graded numerically (Scale for scoring ocular reactions). All other changes or toxic effects were recorded when apparent.

 

One hour up to 2 d after treatment, the conjunctivae of two animals showed definitely injected blood vessels up to a diffuse crimson red color and very slight up to obvious swellings. Additionally, clear from substance colored eye discharge was noted. Three days after administration all signs of irritation were reversible. The conjunctivae and nictating membrane were discolored orange during the whole observation.

Under the test conditions, the test substance is slightly irritating to the rabbit eye however does not meet the criteria for classification under GHS

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin

A study was conducted to assess the skin irritation potential of test substance to the rabbit skin according to OECD Guideline 404 and EU Method B.4.

Three animals were treated with 0.5 g of the test substance pasted with 0.7 mL deionised water using semi-occlusive patches for 4 h. After the exposure period all remnants of the test substance were carefully removed from the skin with warm tap water. The skin was evaluated for erythema, eschar formation and edema numerically according to the score of Draize system for up to 72 h after patch removal.30 - 60 min up to 72 h after decontamination the skin, the animals showed very slight up to well defined erythema and sporadically very slight or slight oedema. 72 h after removal of the plaster all signs of irritating were reversible.

The test substance was considered to be non-irritating to rabbit skin (Dr. Kreiling R, 1997).

Eye

A study was conducted to assess the eye irritation potential of test substance to the rabbit eye according to OECD Guideline 405 and EU Method B.5.

One animal received 100 mg of an undiluted test substance into conjunctival sac of the left eye. The other eyes served as untreated control. 24 h after the administration the eyes were washed thoroughly with isotonic saline at 37 °C. The eyes were also washed out at designated examination times at which discharge was observed or a corneal examination with fluorescein was performed.

The eyes were examined 1, 24, 48 and 72 h after administration of the test substance. At 24 and 72 h and after 7, 14 and 21 d, the eyes were further examined for cornea/lesions under UV light after instillation of one drop of a 0.01 % fluorescein-sodium solution. Lesions in cornea, iris or conjunctivae were graded numerically (Scale for scoring ocular reactions). All other changes or toxic effects were recorded when apparent.

One hour up to 2 d after treatment, the conjunctivae of two animals showed definitely injected blood vessels up to a diffuse crimson red color and very slight up to obvious swellings. Additionally, clear from substance colored eye discharge was noted. Three days after administration all signs of irritation were reversible. The conjunctivae and nictating membrane were discolored orange during the whole observation.

The test substance is slightly irritating to the rabbit eye (Dr. Kreiling R, 1997).

The available data suggest that test substance has very low degrees of skin and eye irritation potential. The test substance was found to be non-irritating to skin and slightly irritating to eyes and does not meet the requirement for classification according to EC criteria (67/548/EEC) and according to CLP criteria (EC 1272/2008).

Effects on eye irritation: slightly irritating

Justification for classification or non-classification

The available data suggest that test substance has very low degrees of skin and eye irritation potential. The test substance was found to be non-irritating to skin and slightly irritating to eyes and does not meet the requirement for classification according to EC criteria (67/548/EEC) and according to CLP criteria (EC 1272/2008).