Reaction mass of pentasodium 2-[(8-{[4-chloro-6-(4-{[2-(sulfonatooxy)ethyl]sulfonyl}anilino)-1,3,5-triazin-2-yl]amino}-1-hydroxy-3,6-disulfonato-2-naphthyl)diazenyl]naphthalene-1,5-disulfonate and pentasodium 2-[(1-hydroxy-8-{[4-hydroxy-6-(4-{[2-(sulfonatooxy)ethyl]sulfonyl}anilino)-1,3,5-triazin-2-yl]amino}-3,6-disulfonato-2-naphthyl)diazenyl]naphthalene-1,5-disulfonate

Endpoint summary

Description of key information

OECD 404, not skin irritant
OECD 405, not eye irritant

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation / corrosion, other

Remarks:

in vivo

Type of information:

other: read across from analogue substance

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study has been presented to ECHA in the framework of a NONS notification. The document is now public because presented more than 12 years ago. The summary received is from migrated NONS dossier

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: HOECHST AG, Kastengrund
- Age at study initiation: ca 3-5 months
- Weight at study initiation: 2.6-2.9 kg
- Housing: single
- Diet: Altromin 2123, 15 g daily
- Water (ad libitum): deionized, chlorinated water


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 50 ± 20 %
- Air changes (per hr): -
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 14.10.1986 To: 17.10.1986

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

physiological saline

Remarks:

0.3 mL/500 mg to form paste

Controls:

no

Amount / concentration applied:

500 mg

Duration of treatment / exposure:

4h

Observation period:

72h

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 25 cm²
- Type of wrap if used: semiocclusive

REMOVAL OF TEST SUBSTANCE
- Washing (if done): lukewarm tap water
- Time after start of exposure: after 4 hours

SCORING SYSTEM: Draize
30 - 60 minutes, 24, 48 and 72 hours after removal of the test substance

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 0.3

Max. score:

2

Reversibility:

fully reversible

Remarks:

3 days

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 0.7

Max. score:

2

Reversibility:

fully reversible within: 3 days

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 0.7

Max. score:

2

Reversibility:

fully reversible within: 3 days

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

1

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

1

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

1

Form of application: To the intact, shorn skin in the dorsal region of the trunk (area 25 cm2). Type and duration of the signs of irritation: One hour after the removal of the plaster the skin of the animals revealed hardly perceptible to clearly outlined erythema. Very slight oedema was observed in two animals. 24 to 48 hours after the removal of the plaster the skin still exhibited hardly perceptible erythema. 72 hours after the removal of the plaster, all of the animals were free from signs of irritation.

Interpretation of results:

not classified

Remarks:

Migrated information under Regulation 1272/2008 Criteria used for interpretation of results: EU

Conclusions:

The substance was tested following OECD 404. Under the experimental conditions the substance did not show any skin irritation properties.

Executive summary:

The substance was tested following OECD 404. Under the experimental conditions the substance did not show any skin irritation properties.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation, other

Remarks:

in vivo

Type of information:

other: read across from analogue substance

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study has been presented to ECHA in the framework of a NONS notification. The document is now public because presented more than 12 years ago. The summary received is from migrated NONS dossier

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: HOECHST AG, Kastengrund
- Age at study initiation: ca 3-5 months
- Weight at study initiation: 2.5-3.3 kg
- Housing: single
- Diet: Altromin 2123, 15 g daily
- Water (ad libitum): deionized, chlorinated water


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

IN-LIFE DATES: From: 14.10.1986 To: 17.10.1986

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye

Amount / concentration applied:

100 mg

Duration of treatment / exposure:

single application

Observation period (in vivo):

24, 48 and 72h

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): physiological saline 37°C
- Time after start of exposure: 24 h and after each fluorescein staining

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: hand-slit lamp and fluorescein 0.01%

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 0.3

Max. score:

1

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 0.3

Max. score:

1

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 0.3

Max. score:

1

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 0.3

Max. score:

2

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 0.3

Max. score:

2

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 0.3

Max. score:

2

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 0.3

Max. score:

1

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 0.3

Max. score:

1

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 0.3

Max. score:

1

Irritant / corrosive response data:

Clear conjunctival chemosis was observed in the animals one hour p.a. Due to dye depositions, conjunctival redness and inflammation of the iris could not be assessed at this point in time. In addition, a lilac efflux caused by the substance occurred. 24 h p.a. the conjunctivae of all of the animals exhibited clear hyperaemia in some blood vessels and slight chemosis. The iris was reddened. As from 24 h p.a. all of the animals were free from signs of irritation. In addition to the signs of irritation which occurred, as from 24 h p.a. the iris, conjunctivae and nictitating membrane, and as from 48 hours p.a. the eyeball too, were discolored by the substance.

Interpretation of results:

other: not classified under Regulation 1272/2008

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The substance was tested for eye irritation following OECD 405. Under the experimental conditions the substance did not show any eye irritation properties

Executive summary:

The substance was tested for eye irritation following OECD 405. Under the experimental conditions the substance did not show any eye irritation properties

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

The analogue substance was tested for skin and eye irritation following OECd 404 and 405 respectively (NONS dossier, 1988). In vivo results are available showing no irritating potential for skin and eye.

Based on the read across considerations the same results apply to the test item.

Justification for classification or non-classification

Under Regulation 1272/2008:

a substance is classified as skin irritant Cat 2:

1) Mean value of ≥ 2,3 - ≤ 4,0 for erythema/ eschar or for oedema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours after patch removal or, if reactions are delayed, from grades on 3 consecutive days after the onset of skin reactions; or

2)Inflammation that persists to the end of the observation period normally 14 days in at least 2 animals, particularly taking into account alopecia (limited area), hyperkeratosis, hyperplasia, and scaling; or

3) In some cases where there is pronounced variability of response among animals, with very definite positive effects related to chemical exposure in a single animal but less than the criteria above.

 

A substance is classified as:

Eye irritant Cat 2: if at least in 2 of 3 tested animals, a positive response of:

1)    corneal opacity ≥ 1 and/or

2)    2) iritis ≥ 1, and/or

3)     conjunctival redness ≥ 2 and/or

4)     conjunctival oedema (chemosis) ≥ 2

5)    calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material, and which fully reverses within an observation period of 21 days

Based on the results of the in vivo studies performed on the analogue substance and the read across considerations, the substance is not classified for skin and eye irritation