Disodium hydrogen bis[3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]naphthalene-1-sulphonato(3-)]chromate(3-)

Endpoint summary

Description of key information

Skin, In vivo, Rabbit : not irritating (Dystar, 1994)
in vitro skin irritation data not available
Eye, In vivo, Rabbit : H319 Category 2A (Dystar 1994)
in vitro eye irritation data not available
Respiratory system: no information available. 

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation / corrosion, other

Remarks:

in vivo test. At the time of testing in-vitro test were not available

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study following official guidelines, GLP compliant, performed on a similar substance

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: Interfauna UK Ltd Wyton, Huntingdon, England- Age at study initiation: adult- Weight at study initiation: the animals were weighed immediately before application of the test substance- Housing: the rabbits were individually housed in stainless steel cages with flat rod bases or plastica cages with perforated bases, under standardised conventional conditions.- Diet (e.g. ad libitum): Standard diet "Ssniff K4" approx. 100-120g per animal/day; once a day in the morning- Water (e.g. ad libitum): tap water ad libitum- Acclimation period: prior to use the animals were acclimated for approx. one week in the animal room-Identification of the animals: the rabbits were identified by individual ear marks (tattoos) and cage cardsENVIRONMENTAL CONDITIONS- Temperature (°C): 21+/-1.5°C- Humidity (%): 60-80%- Air changes (per hr):12-15 times per hour- Photoperiod (hrs dark / hrs light):from 6 am to 6 pm, 12 hours artifical illumination

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

other: the controlateral skin area not treated with test substance served as control

Amount / concentration applied:

500mg

Duration of treatment / exposure:

4h

Observation period:

1, 24, 48 and 72h, 7d, 14d

Number of animals:

3

Details on study design:

Approx. 24hours before the test fur was shaved from the dorso-lateral area of the trunk (6x6 cm) of each of the rabbits. Care was taken to avoid abrading the skin. Only animals with healty and intact skin were used. 500 mg of the pulverised test substance were moistened with deionised water and subsequently applied to a hypoallergenic Hansamed patch. A further patch was moistened with water. The patches prepared in this way were placed in the opposite dorso-lateral areas of the trunk of each animal and were held in place with semiocclusive dressing for the duration of the exposure period. After the exposure time the dressing was removed and the exposed skin areas were carefully washed with water withou altering the existing response or the integrity of the epidermis.SCORING SYSTEM: for each animal the Draize scores recorded at 24, 48 and 72 h were added up. The total was divided by 3 to give the irritation index. This index was separately calculated for erythema/eschar formation and for oedema formation.TOOL USED TO ASSESS SCORE:fluorescein

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: average 24,48 and 72h

Score:

ca. 0

Max. score:

0

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: average 24,48 and 72h

Score:

ca. 0

Max. score:

0

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: average 24,48 and 72h

Score:

ca. 0

Max. score:

0

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

The substance was tested for skin irritation following OECD 404 and resulted not to have irritant potential to the skin.

Executive summary:

The irritant/corrosive potential of the test substance was studied on the skin of rabbit in accordance with the OECD Guideline 404 for Testing of Chemicals.

Evaluation of erythema was not possible in all three animals due to the intense colouration by the test substance. Neverthless no other inflammatory signs (oedema or eschar formation) became apparent within the obervation period of 7 days. Signs of toxicity were not observed. This evidence indicates no hazard potential to the skin and the test substance may therefore be regarded as "not irritating" to the skin

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 test. At the time of testing in-vitro test were not available

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study following official guidelines, GLP compliant, performed on a similar substance

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: Interfauna UK Ltd Wyton, Huntingdon, England- Age at study initiation: adult- Weight at study initiation: the animals were weighed immediately before application of the test substance- Housing: the rabbits were individually housed in stainless steel cages with flat rod bases or plastica cages with perforated bases, under standardised conventional conditions. - Diet (e.g. ad libitum): Standard diet "Ssniff K4" approx. 100-120g per animal/day; once a day in the morning- Water (e.g. ad libitum): tap water ad libitum- Acclimation period: prior to use the animals were acclimated for approx. one week in the animal room-Identification of the animals: the rabbits were identified by individual ear marks (tattoos) and cage cardsENVIRONMENTAL CONDITIONS- Temperature (°C): 21+/-1.5°C- Humidity (%): 60-80%- Air changes (per hr):12-15 times per hour- Photoperiod (hrs dark / hrs light):from 6 am to 6 pm, 12 hours artifical illumination

Vehicle:

unchanged (no vehicle)

Remarks:

pulverized

Controls:

other: the other eye served as control

Amount / concentration applied:

TEST MATERIAL- Amount(s) applied (volume or weight with unit): 100ul (ca. 34 mg)

Duration of treatment / exposure:

24h

Observation period (in vivo):

1h, 24h, 48h, 72h, 7d, 14d, 21d

Number of animals or in vitro replicates:

3

Details on study design:

PROCEDURE:After gently pulling the lower lid away from the eyeball a volume of 100ul of the pulverised test substance-equivalent to approx. 34 mg- was placed into the conjunctival sac of one eye of each of three rabbits. The lids were than getnly held together for about on second in oirder to limit loss of the material. The other eye remained untreated and served as contro.l 24 hours after instillation of the test substance the treated eye was rinsed with normale saline.SCORING SYSTEM: for each animal the Draize scores (cornea, iris, conjunctivae, erythema and swelling and discharge) and the Mcdonald score (aqueous humor) were used. For each animal the Draize scores recorded approx. 24, 48 and 72h after application were added up. The total of these three values was divided by 3 to give the irritation index.TOOL USED TO ASSESS SCORE:optical instrument (hand slit lamp) and fluorescin.Only effects persisting for more than 24 hours were included in the evaluation

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 24,48 and 72h

Score:

ca. 1

Max. score:

1

Reversibility:

fully reversible within: 7 days

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 24,48 and 72h

Score:

ca. 0.3

Max. score:

1

Reversibility:

fully reversible within: 7 days

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #1

Time point:

other: 24,48 and 72h

Score:

ca. 2

Max. score:

2

Reversibility:

not fully reversible within: 21d

Irritation parameter:

conjunctivae score

Remarks:

swelling

Basis:

animal #1

Time point:

other: 24,48 and 72h

Score:

ca. 1.3

Max. score:

1

Reversibility:

not fully reversible within: 21d

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: 24,48 and 72h

Score:

ca. 1

Max. score:

1

Reversibility:

not reversible

Irritation parameter:

iris score

Basis:

animal #2

Time point:

other: 24,48 and 72h

Score:

ca. 1

Max. score:

1

Reversibility:

fully reversible within: 21d

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #2

Time point:

other: 24,48 and 72h

Score:

ca. 2

Max. score:

2

Reversibility:

not fully reversible within: 21d

Irritation parameter:

conjunctivae score

Remarks:

swelling

Basis:

animal #2

Time point:

other: 24,48 and 72h

Score:

ca. 1.3

Max. score:

2

Reversibility:

fully reversible within: 14d

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

other: 24,48 and 72h

Score:

ca. 1

Max. score:

1

Reversibility:

fully reversible within: 7d

Irritation parameter:

iris score

Basis:

animal #3

Time point:

other: 24,48 and 72h

Score:

ca. 0.7

Max. score:

1

Reversibility:

fully reversible within: 7d

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #3

Time point:

other: 24,48 and 72h

Score:

ca. 2

Max. score:

2

Reversibility:

fully reversible within: 7d

Irritation parameter:

conjunctivae score

Remarks:

swelling

Basis:

animal #3

Time point:

other: 24,48 and 72h

Score:

ca. 1.3

Max. score:

2

Reversibility:

fully reversible within: 7d

Interpretation of results:

Category 2A (irritating to eyes) based on GHS criteria

Remarks:

Migrated information

Conclusions:

The substance was tested for eye irritation following OECD 405 and resulted to be irritant to the eye with classification H319 Category 2A.

Executive summary:

The irritant/corrosive potential of the test substance was studied on the eye of rabbit in accordance with the OECD Guideline 405 for Testing of Chemicals. Exposure of the test substance to the eye caused reactions of the mucous membranes and effects of the cornea in all three animals. Additionally in all three animals the iris was transiently affected and discharge occured. In one animal signs was fully reversible within 21 days, in the second animal corneal signs did not prove to be completely reversible within 21 days and in the third animal a slight erythema was observed on day 21. This evidence indicates that the product may be considered as "severely irritating to the eye".

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin

The potential of the test substance to cause acute dermal irritation or corrosion was assessed in vivo in rabbits according to OECD 405. In this study the test article did not show any irritative/corrosive potential by a semi-occlusive application of the test substance to the skin of 3 rabbits for 4 hours. The average score (24 to 72 hours) for irritation was calculated to be 0.0 for edema. It was not possible to assess erythema due to discoloration of the skin

 

Eye

The potential of the test substance to cause eye irritation or corrosion was assessed in 3 rabbits following OECD 404. The test substance was assesed to be eye irritant with a final classification H319 Category 2 due to conjunctivae score equal to 2 for all the 3 animals.

 

Respiratory system

No data available

Effects on eye irritation: moderately irritating

Justification for classification or non-classification

According to the CLP Regulation (EC n. 1272/2008) the following classifications apply:

 

Skin irritant cat2:

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; o

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.

 

based on the results of the in vivo skin irritation test the substance is not classified as skin irritant

 

Eye irritant Cat 2:

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 conjuncitva score the substance is classified as H319 Category 2