Sodium bis[3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-4-hydroxybenzene-1-sulphonamidato(2-)]chromate(1-)

Endpoint summary

Description of key information

The substance is not irritating for intact and abraded rabbit skin.
The substance is not irritating for rabbit eye.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

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

Adequacy of study:

key study

Study period:

July 29, 1975

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

other: "Hazardous Substances Regulations" under the U.S. Federal Hazardous. Substances Labelling Act Sect. 191.11 (February 1965).

Deviations:

not specified

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Strain: Porton
- Age at study initiation: aged 10-13 weeks
- Weight at study initiation: 2.73 Kgs (♂), 2.38 kgs (♀)
- Housing: caged singly
- Diet: A commercial irradiated diet (Styles-Oxoid) was fed ad libitum
- Water: Sterile filtered water ad libitum.
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1 °C
- Humidity (%): 50-70 %
- Photoperiod (hrs dark / hrs light): Animals were exposed to artificial light for 10 hours daily from 08.00 - 18.00 hours.

Type of coverage:

occlusive

Preparation of test site:

other: shaved and abraded

Vehicle:

other: water

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
10g. of the test compound was mixed with 12 ml. of water to make a solution of 15ml. 0.75ml of which was applied to each test site on a 2.5 cm. square gauze pad.

Duration of treatment / exposure:

The gauze patches were removed 24 hours after the application.

Observation period:

The reaction of the skin was appraised upon removal and 72 hours after it.

Number of animals:

3 males/3 females

Details on study design:

TEST SITE
- Area of exposure: Two test sites lateral to the mid line of the back were used on each rabbit
- % coverage: 10 % of the total body surface.
- Type of wrap if used: 0.75ml of test compound was applied to each test site on a 2.5 cm. square gauze pad. These were covered with aluminium foil secured with "Sleek"* adhesive tape. The test sites were then enclosed by a 6" wide "Coban" self adhesive bandage the edges of which were fixed to the skin strips of "Sleek" in order to retain the test substance in close contact with the skin.

SCORING SYSTEM: Draize et al.

Irritation parameter:

erythema score

Basis:

animal: 11, 13, 15, 12, 16

Time point:

other: 24, 48, 72 hours

Score:

ca. 0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

erythema score

Basis:

animal: 14

Time point:

other: 24, 48, 72 hours

Score:

ca. 0.66

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

animal: 11

Time point:

other: 24, 48, 72 hours

Score:

ca. 1.33

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

animal: 12

Time point:

other: 24, 48, 72 hours

Score:

0.66

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

animal: 13

Time point:

other: 24, 48, 72 hours

Score:

ca. 0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

animal: 14

Time point:

other: 24, 48, 72 hours

Score:

ca. 0.66

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

animal: 15

Time point:

other: 24, 48, 72 hours

Score:

ca. 1.33

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

animal: 16

Time point:

other: 24, 48, 72 hours

Score:

ca. 1.33

Max. score:

4

Reversibility:

fully reversible

Slight erythema and very slight to moderate oedema was seen on 2/6 and 5/5 rabbits respectively, 24 hours after application of the compound. All sites were normal by 72 hours.

Interpretation of results:

other: Not classified

Remarks:

According to the CLP Regulation (EC n. 1272/2008)

Conclusions:

The substance is not irritating for skin rabbit.

Executive summary:

The substance has been tested for skin irritation/corrosion according to The guideline "Hazardous Substances Regulations" under the U.S. Federal Hazardous. Substances Labelling Act Sect. 191.11 (February 1965). 6 Healthy New Zealand White rabbits (3 males and 3 females) were acclimatized in the test area for one week prior to the start of the trial. Twenty-four hours prior to the dermal application, the backs of the rabbits were shaved over an area consisting of at least 10% of the total body surface. Immediately before the application of the test compound, the right hand site was abraded with the point of a sterile hypodermic needle. 10g of the test compound was mixed with 12 ml of water to make a

solution of 15 ml. 0.75ml of which was applied to each test site on a 2.5 cm square gauze pad.

Slight erythema and very slight to moderate oedema was seen on 2/6 and 5/5 rabbits respectively, 24 hours after application of the compound. All sites were normal by 72 hours. There was no marked difference in the reactions between abraded and intact sites.. The substance is not irritating for skin rabbit according to the CLP Regulation (EC n. 1272/2008).

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:

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

Adequacy of study:

key study

Study period:

July 25, 1975

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

other: "Hazardous Substances Regulations" under the U.S.A. "Federal Hazardous Substances Labelling Act Sect. 191.12 (February 1965)

Deviations:

yes

Remarks:

no data

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Strain: Porton
- Age at study initiation: aged 10-13 weeks
- Weight at study initiation: 2.73 Kgs (♂), 2.38 kgs (♀)
- Housing: caged singly, bred on the premises and maintained under a semi-barrier system.
- Diet: A commercial irradiated diet (Styles-Oxoid) was fed ad libitum
- Water: Sterile filtered water ad libitum.
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1°C
- Humidity (%): 50-70 %
- Photoperiod (hrs dark / hrs light): Animals were exposed to artificial light for 10 hours daily from 08.00 - 18.00 hours.

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 injection

Observation period (in vivo):

The rabbits were examined 1, 24, 48, 72 hours and 6 days after application

Number of animals or in vitro replicates:

Six rabbits (3 ♂ and 3 ♀)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done):yes, after 30 seconds the compound was, as far as possible, flushed out of the eyes of three of the rabbits with warm water for 1 minute.
- Time after start of exposure: 30 seconds

Irritation parameter:

conjunctivae score

Basis:

animal: 11

Time point:

other: 24, 48, 72 hours

Score:

ca. 0.66

Max. score:

3

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Basis:

animal: 12

Time point:

other: 24, 48, 72 hours

Score:

ca. 1

Max. score:

3

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Basis:

animal: 13

Time point:

other: 24, 48, 72 hours

Score:

ca. 1.33

Max. score:

3

Reversibility:

fully reversible within: 6 days

Irritation parameter:

conjunctivae score

Basis:

animal: 14

Time point:

other: 24, 48, 72 hours

Score:

ca. 0.66

Max. score:

3

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Basis:

animal: 15

Time point:

other: 24, 48, 72 hours

Score:

ca. 0.33

Max. score:

3

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Basis:

animal: 16

Time point:

other: 24, 48, 72 hours

Score:

ca. 0.66

Max. score:

3

Reversibility:

fully reversible

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

11, 12, 13

Time point:

other: 24, 48, 72 hours

Score:

ca. 0.66

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

14, 15, 16

Time point:

other: 24, 48, 72 hours

Score:

ca. 0

Max. score:

4

Reversibility:

fully reversible

Interpretation of results:

other: Not classified

Remarks:

According to the CLP Regulation (EC n. 1272/2008)

Conclusions:

The substance is not irritating for rabbit eye.

Executive summary:

The substance has been tested for eye irritation according to The guideline "Hazardous Substances Regulations" under the U.S.A. "Federal Hazardous Substances Labelling Act Sect. 191.12 (February 1965). Six rabbits (3 males and 3 females) were acclimatised in the test area for one week prior to the start of the trial. The rabbits were caged singly in an experimental room maintained at a temperature of 20 °C. 100 mg. of the test compound were instilled into the conjunctival sac of the left eye. The eyelids were then held

closed for 1 second. The right eye served as a control. After 30 seconds the compound was, as far as possible, flushed out of the eyes of three of the rabbits with warm water for 1 minute.

The rabbits were examined 1, 24, 48 and 72 hours after application of the test compound and for any further period that was

considered necessary.

A slight to moderate conjunctival reaction was seen in all treated eyes one hour after application of the compound. This had subsided slightly by 24 hours and thereafter continued to do so until all eyes were normal by 48 hours (1/3 washed) 72 hours (2/3 unwashed 2/3 washed) and 6 days (1/3 unwashed). Staining of the conjunctivae and cornea by the compound was seen in the unwashed eyes for up to 48 hours. The substance is not irritating according to the CLP Regulation (EC n. 1272/2008).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

According to the CLP Regulation (EC 1272/2008), skin irritation means the production of reversible damage to the skin following the application of a test substance for up to 4 hours.

The key study shows a very low interaction between the substance and the skin rabbit, the values of erythema and oedema with intact skin are below the trigger values for classification, therefore no classification is warranted according to the CLP Regulation (EC n. 1272/2008).

According to the CLP Regulation (EC n. 1272/2008) eye irritation means the production of changes in the eye following the application of test substance to the anterior surface of the eye, which are fully reversible within 21 days of application.

Under the test condition the substance does not produce ocular effects above the trigger value, therefore no classification is warranted according to the CLP Regulation (EC n. 1272/2008).