Reaction mass ofDisodium [1-{[2-(hydroxy-kO)-3,5-dinitrophenyl]diazenyl-kN1}naphthalen-2-olato(2-)-kO][3-(hydroxy-kO)-4-{[2-(hydroxy-kO)naphthalen-1-yl]diazenyl-kN1}-7-nitronaphthalene-1-sulfonato(3-)]chromate(2-) andDisodium [1-{[2-(hydroxy-kO)-3,5-dinitrophenyl]diazenyl-kN2}naphthalen-2-olato(2-)-kO][3-(hydroxy-kO)-4-{[2-(hydroxy-kO)naphthalen-1-yl]diazenyl-kN1}-7-nitronaphthalene-1-sulfonato(3-)]chromate(2-)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Experiment start date - 04 February 1980; Experiment end date - 12 February 1980; Study completion date - 26 February 1980.

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:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Disodium [1-[(2-hydroxy-3,5-dinitrophenyl)azo]-2-naphtholato(2-)][3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(2-)

EC Number:

274-487-5

EC Name:

Disodium [1-[(2-hydroxy-3,5-dinitrophenyl)azo]-2-naphtholato(2-)][3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(2-)

Cas Number:

70236-55-4

Molecular formula:

C36H18CrN7O13S.2Na

IUPAC Name:

disodium [1-[(2-hydroxy-3,5-dinitrophenyl)azo]-2-naphtholato(2-)][3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(2-)

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

None

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Code No. of test material as used in the study report: FAT 20037/B
- Physical appearance: solid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: adult ones
- Weight at study initiation: 2 to 3 kgs
- Housing: individually in metal cages, numbered by ear tags
- Diet: standard rabbit food - NAFAG, No. 814, Gossau SG, ad libitum
- Water: ad libitum
- Acclimation period: minimum 4 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C,
- Humidity (%): 55 ± 10 %
- Photoperiod: 10 hours light cycle day

IN-LIFE DATES: From: 04 February, 1980; To: 12 February, 1980

Test system

Type of coverage:

occlusive

Preparation of test site:

other: shaved, with one side abraded and one site kept intact

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

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

Duration of treatment / exposure:

24 hours

Observation period:

7 days

Number of animals:

6 (3 males and 3 females)

Details on study design:

TEST SITE
- Type of wrap if used: Gauze patches of 2.5 x 2.5 cm laden with 0.5 g of the test material were applied to the prepared abraded and intact skin.

REMOVAL OF TEST SUBSTANCE
- Washing: yes
- Time after start of exposure: 24 hours

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

Intact skin

Basis:

mean

Remarks:

6 animals

Time point:

24/48/72 h

Score:

0.167

Max. score:

4

Reversibility:

fully reversible within: 72h

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

erythema score

Remarks:

Abraded skin

Basis:

mean

Remarks:

6 animals

Time point:

24/48/72 h

Score:

0.278

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

edema score

Remarks:

Intact skin

Basis:

mean

Remarks:

6 animals

Time point:

24/48/72 h

Score:

0.167

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

edema score

Remarks:

Abraded skin

Basis:

mean

Remarks:

6 animals

Time point:

24/48/72 h

Score:

0.278

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

The primary irritation index for FAT 20037/B was calculated to be 0.5, indicating potential to cause a minimal irritation when applied to intact and abraded rabbit skin.

Any other information on results incl. tables

Results:

Time after exposure (hours)	Mean reaction score of 6 rabbits
	Erythema		Edema
	Intact skin	Abraded Skin	Intact skin	Abraded Skin
24	0.3	0.7	0.3	0.7
72	0	0	0	0
Total	0.3	0.7	0.3	0.7

Primary irritation index = (0.3 + 0.7 + 0.3 + 0.7)/4 = 2/4 = 0.5

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance was found to be a non-irritant to the skin.

Executive summary:

The irritation potential of the test item was evaluated in a study conducted according to the United States Environmental Agency (EPA) § 163.81- 5 "Primary dermal irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978. 6 rabbits (3 males; 3 females) were used in this study. Gauze patches of 2.5 x 2.5 cm laden with 0.5 g of the test material were applied to the prepared abraded and intact skin for the exposure duration of 24 hours. The reaction of the skin was appraised upon removal during an observation period of 7 days. The scores read after 24 and 72 hours for erythema and edema for the intact as well as for the abraded skin were summed up and divided by 4. Minimal irritation was recorded at the 24 hour observation. The mean 24/48/72 hour scores were 0.167 and 0.278 for erythema and edema score, respectively, for intact skin. The erythema and edema was reversed within 72 hours. The primary irritation index was calculated to be 0.5, indicating potential to cause a minimal irritation when applied to intact and abraded rabbit skin. However, based on the EU CLP criteria, the test item can be classified as a non-irritant to the skin.