Reaction mass of sodium(E)-6,7'-carbonylbis(azanediyl)bis(4-hydroxy-3-((E)-phenyldiazenyl) naphthalene-2-sulfonate) and disodium 3-[(4-acetamidophenyl)azo]-4-hydroxy-7-[[[[5-hydroxy-6-(phenylazo)-7-sulphonato-2-naphthyl]amino]carbonyl]amino]naphthalene-2-sulphonate and disodium 7,7'-(carbonyldiimino)bis[4-hydroxy-3-(phenylazo)naphthalene-2-sulphonate]

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 6 to 9 march 2007

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Remarks:

This study was conducted in a facility operating to Good Laboratory Practice within the UK national GLP monitoring programme, but the study report has not been audited by the QA Unit. No formal claim of GLP compliance is made for this study.

Test material

Test material information

Constituent 1

Reference substance name:

Direct red 23

IUPAC Name:

Direct red 23

Test material form:

solid: particulate/powder

Test animals

Species:

rabbit

Strain:

New Zealand White

Test system

Type of coverage:

semiocclusive

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 g

Duration of treatment / exposure:

Single 4 hours application

Observation period:

1, 24, 48 and 72 hours after administration

Number of animals:

3

Details on study design:

SCORING SYSTEM:
Primary irritation index / classification
- 0: non-irritant
- >0-2: mild irritant
- >2-5: moderate irritant
- >5-8: severe irritant

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

other: 65954 male

Time point:

24/48/72 h

Score:

ca. 0

Results 2

Irritation parameter:

erythema score

Basis:

other: 65956 male

Time point:

24/48/72 h

Score:

ca. 0

Results 3

Irritation parameter:

erythema score

Basis:

other: 65957 male

Time point:

24/48/72 h

Score:

ca. 0

Results 4

Irritation parameter:

edema score

Basis:

other: 65954 male

Time point:

24/48/72 h

Score:

ca. 0

Results 5

Irritation parameter:

edema score

Basis:

other: 65956 male

Time point:

24/48/72 h

Score:

ca. 0

Results 6

Irritation parameter:

edema score

Basis:

other: 65957 male

Time point:

24/48/72 h

Score:

ca. 0

Irritant / corrosive response data:

Primary irritation index: 0.0
No evidence of skin irritation was noted. Red-coloured staining was noted at two treated skin sites one hour after patch removal.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test material did not meet the criteria for classification as irritant or corrosive according to EU labelling regulations Commission Directive 2001/59/EC. No symbol and risk phrase are required.

Executive summary:

A study was performed to assess the initation of the test material to the skin of the New Zealand White rabbit (SPL Standard Test Method 540.10). The method followed OECD Guidelines for Testing of Chemicals (24 April2002) No. 404 "Acute Dermal Initation/Corrosion" and Method B4 of Commission Directive 2004/73/EC (which constitutes Annex V of Council Directive 671548/EEC). The test material did not meet the criteria for classification as irritant or corrosive according to EU labelling regulations Commission Directive 2001/59/EC. No symbol and risk phrase are required.