Reaction mass of tetrasodium 3-[[4-[[4-[(6-amino-1-hydroxy-3-sulphonato-2-naphthyl)azo]-6-sulphonato-1-naphthyl]azo]-1-naphthyl]azo]naphthalene-1,5-disulphonate and tetrasodium 3-[[4-[[4-[(6-amino-1-hydroxy-3-sulphonato-2-naphthyl)azo]-7-sulphonato-1-naphthyl]azo]-1-naphthyl]azo]naphthalene-1,5-disulphonate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

tetrasodium 6-[(1E)-2-{4-[(1E)-2-{4-[(1E)-2-(6-amino-1-hydroxy-3-sulfonatonaphthalen-2-yl)diazen-1-yl]-7-sulfonatonaphthalen-1-yl}diazen-1-yl]naphthalen-1-yl}diazen-1-yl]naphthalene-1,4-disulfonate

EC Number:

911-640-3

Molecular formula:

C40H27N7O13S4.4Na

IUPAC Name:

tetrasodium 6-[(1E)-2-{4-[(1E)-2-{4-[(1E)-2-(6-amino-1-hydroxy-3-sulfonatonaphthalen-2-yl)diazen-1-yl]-7-sulfonatonaphthalen-1-yl}diazen-1-yl]naphthalen-1-yl}diazen-1-yl]naphthalene-1,4-disulfonate

Details on test material:

SMILE notation for Vapour pressure
O=S(=O)(O[Na])c8cccc1c8cc(cc1S(=O)(=O)O[Na])/N=N/c7ccc(/N=N/c5ccc(/N=N/c2c(O)c3ccc(N)cc3cc2S(=O)(=O)O[Na])c4cc(ccc45)S(=O)(=O)O[Na])c6ccccc67

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Lippischen Versuchstierzucht, Hagemann Gmbh
- Weight at study initiation: 2.4 kg
- Housing: individual cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-18°C
- Humidity (%): 40% r.F.
- Photoperiod (hrs dark / hrs light): 12hrs light/12 hrs dark

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

other: the left side of the animal was used as control

Amount / concentration applied:

500 mg

Duration of treatment / exposure:

4h

Observation period:

up to 8 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 8x8 cm

REMOVAL OF TEST SUBSTANCE
- Washing (if done): water and/or olive oil
- Time after start of exposure: 1h

SCORING SYSTEM:
the grade of erythema and edema formation in proof area after 24 and 72 are averaged over the experimental animals. the sum of the four values is divided by 2, and produces the primary skin irritant score. The findings of 1h, 48h, and 8d are not included in the value calculation. Erythem due to staining is taken inot account.
all the particularities of the skin reaction were described

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Reversibility:

fully reversible within: 8 days

Remarks on result:

not determinable

Remarks:

Substance-related staining of the skin

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Reversibility:

fully reversible within: 8 days

Remarks on result:

not determinable

Remarks:

Substance-related staining of the skin

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Reversibility:

fully reversible within: 8 days

Remarks on result:

not determinable

Remarks:

Substance-related staining of the skin

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 1

Max. score:

4

Reversibility:

fully reversible

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Applicant's summary and conclusion

Interpretation of results:

other: not classified under Regulation 1272/2008

Conclusions:

The substance was tested following OECD 404. Under the experimental conditions it did not induce any irritating/corrosive properties on the skin.

Executive summary:

The substance was tested for irritation potential to the skin following OECD 404. The sample was applied to the right shaved side of white zealand rabbits (male) while the left side was used as control in a semi-occulsive way. One animal over 3 showed an averaged value of edema score (24h/48h/72h) equal to 1 that was fully reversible within the period of observation.