Sodium [3-hydroxy-4-[(1-hydroxy-5-sulpho-2-naphthyl)azo]naphthalene-1-sulphonato(4-)]chromate(1-)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: United States Environmental Protection Agency (EPA), Paragraph 163.81-5 "Primary dermal irritaion study", Federal Register, Vol 43 No. 163, August 22, 1978.

Deviations:

not specified

Principles of method if other than guideline:

None

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sodium [3-hydroxy-4-[(1-hydroxy-5-sulpho-2-naphthyl)azo]naphthalene-1-sulphonato(4-)]chromate(1-)

EC Number:

289-530-3

EC Name:

Sodium [3-hydroxy-4-[(1-hydroxy-5-sulpho-2-naphthyl)azo]naphthalene-1-sulphonato(4-)]chromate(1-)

Cas Number:

89899-25-2

Molecular formula:

C20H10CrN2O8S2.Na

IUPAC Name:

Sodium [3-(hydroxy-​κO)-4-{[1-(hydroxy-​κO)-5-sulfonaphthalen-2-yl]diazenyl-​κN1}naphthalene-1-sulfonato(4-)]chromate(1-)

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

None

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414, Fuellinsdorf
- Weight at study initiation: 2-3 kgs
- Housing: Caged individually
- Diet: Rabbit food, NAFAG, No. 814 Tox, NAFAG AG, Gossau, SG (Switzerland); ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3°C
- Humidity: 55±15 %
- Photoperiod: Animals were exposed to artificial light for 12 hours light/day
- Air changes: 15 air changes/h

Test system

Type of coverage:

occlusive

Preparation of test site:

other: shaved as well as abraded

Vehicle:

not specified

Controls:

not specified

Amount / concentration applied:

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

Duration of treatment / exposure:

24 h

Observation period:

7 d

Number of animals:

six (three males and three females)

Details on study design:

TEST SITE
- Before treatment the entire back and the flank of the rabbits were shaved with an electric clipper and immediately before treatment the shaven skin
on one side was slightly scarified with the help of a "Schroepfschnaepper", Aesculap, Switzerland. Gauze patches of 2.5 x 2.5 cm soaked with 0.5 ml of
the test material were applied to the prepared abraded and intact skin.

- The patches were covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape. The dressings were removed after 24 hours. The skin reaction was assessed upon removal and during a subsequent observation period of 7 days.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

(intact skin)

Basis:

animal #1

Remarks:

mean

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 7d

Results 2

Irritation parameter:

erythema score

Remarks:

(intact skin)

Basis:

animal #2

Remarks:

mean

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

not fully reversible within: 7d

Results 3

Irritation parameter:

erythema score

Remarks:

(intact skin)

Basis:

animal #3

Remarks:

mean

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 7d

Results 4

Irritation parameter:

erythema score

Remarks:

(intact skin)

Basis:

animal #4

Remarks:

mean

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72h

Results 5

Irritation parameter:

erythema score

Remarks:

(intact skin)

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 6

Irritation parameter:

erythema score

Remarks:

(intact skin)

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 7

Irritation parameter:

erythema score

Remarks:

(abraded skin)

Basis:

animal #1

Remarks:

mean

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

not fully reversible within: 7d

Results 8

Irritation parameter:

erythema score

Remarks:

(abraded skin)

Basis:

animal #2

Remarks:

mean

Time point:

24/48/72 h

Score:

1.67

Max. score:

4

Reversibility:

not fully reversible within: 7d

Results 9

Irritation parameter:

erythema score

Remarks:

(abraded skin)

Basis:

animal #3

Remarks:

mean

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 7d

Results 10

Irritation parameter:

erythema score

Remarks:

(abraded skin)

Basis:

animal #4

Remarks:

mean

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72h

Results 11

Irritation parameter:

erythema score

Remarks:

(abraded skin)

Basis:

animal #5

Remarks:

mean

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72h

Results 12

Irritation parameter:

erythema score

Remarks:

(abraded skin)

Basis:

animal #6

Remarks:

mean

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72h

Results 13

Irritation parameter:

edema score

Remarks:

(intact skin)

Basis:

animal #1

Remarks:

mean

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 7d

Results 14

Irritation parameter:

edema score

Remarks:

(intact skin)

Basis:

animal #2

Remarks:

mean

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

not fully reversible within: 7d

Results 15

Irritation parameter:

edema score

Remarks:

(intact skin)

Basis:

animal #3

Remarks:

mean

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 7d

Results 16

Irritation parameter:

edema score

Remarks:

(intact skin)

Basis:

animal #4

Remarks:

mean

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72h

Results 17

Irritation parameter:

edema score

Remarks:

(intact skin)

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 18

Irritation parameter:

edema score

Remarks:

(intact skin)

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 19

Irritation parameter:

edema score

Remarks:

(abraded skin)

Basis:

animal #1

Remarks:

mean

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

not fully reversible within: 7d

Results 20

Irritation parameter:

edema score

Remarks:

(abraded skin)

Basis:

animal #2

Remarks:

mean

Time point:

24/48/72 h

Score:

1.67

Max. score:

4

Reversibility:

not fully reversible within: 7d

Results 21

Irritation parameter:

edema score

Remarks:

(abraded skin)

Basis:

animal #3

Remarks:

mean

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 7d

Results 22

Irritation parameter:

edema score

Remarks:

(abraded skin)

Basis:

animal #4

Remarks:

mean

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 72h

Results 23

Irritation parameter:

edema score

Remarks:

(abraded skin)

Basis:

animal #5

Remarks:

mean

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72h

Results 24

Irritation parameter:

edema score

Remarks:

(abraded skin)

Basis:

animal #6

Remarks:

mean

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72h

Irritant / corrosive response data:

FAT 20290/A was found to cause slight irritation when applied to intact and abraded rabbit skin.

Other effects:

None

Any other information on results incl. tables

FAT 20290/A was found to cause slight irritation when applied to intact and abraded rabbit skin. The scores read after 24 and 72 hours for erythema and edema for the intact as well for the abraded skin was were summed up and divided by 4 (FHSLA paragraph 191.11). Primary irritation index of 1.9 was recorded. But it can be noted that abrasion on skin causes epidermal injury and further expected to cause the skin irritation and adverse effects to epidermis. This reaction could be referred to the damage caused due to abrasion rather than due to the test substance application. In general abrasion is an elevated testing condition and results normally do not have to be taken into account for hazard assessment. Hence, The test substance FAT 20290/A can be regarded as not irritating to rabbit skin.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

FAT 20290/A can be regarded as not irritating to rabbit skin.

Executive summary:

An in vivo study was conducted to evaluate the skin irritation potential of the test substance in rabbits according to the Guidelines of the United States Environmental Protection Agency (EPA), Paragraph 163.81-5 "Primary dermal irritation study", Federal Register, Vol. 43 No. 163, and August 22, 1978. Gauze patches of 2.5 x 2.5 cm soaked with 0.5 ml of the test material were applied to abraded and intact skin of 6 rabbits. The patches were covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape. The dressings were removed after 24 hours. The skin reaction was assessed upon removal and during a subsequent observation period of 7 days. FAT 20290/A was found to cause slight irritation when applied to intact and abraded rabbit skin. However, the scores recorded were below the threshold scores required for classification as recommended by Regulation (EC) No. 1272/2008. Hence, FAT 20290/A can be regarded as not irritating to rabbit skin.