Tetrasodium 7,7'-(carbonyldiimino)bis[4-hydroxy-3-[(2-methyl-4-sulphonatophenyl)azo]naphthalene-2-sulphonate]

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Remarks:

source of read across approach

Adequacy of study:

key study

Study period:

January from 10th to 13th, 2002

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Similar Substance 01

IUPAC Name:

Similar Substance 01

Test animals

Species:

rabbit

Strain:

New Zealand White

Test system

Type of coverage:

semiocclusive

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 g

Duration of treatment / exposure:

Single 4 hours application

Observation period:

72 hours

Number of animals:

3 males

Details on study design:

OBSERVATION TIME POINTS
1, 24, 48 and 72 hours.

SCORING SYSTEM
From Draize J H (1959) "Dermal Toxicity" in Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. Assoc. of Food and Drug Officials of the US, Austin, Texas p47.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: 3/3

Time point:

24/48/72 h

Score:

< 2.3

Reversibility:

fully reversible within: 72 hrs

Results 2

Irritation parameter:

edema score

Basis:

animal: 3/3

Time point:

24/48/72 h

Score:

< 2.3

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Primary irritation index and classification: 0.3, mild irritant
Very slight erythema was noted at two treated skin sites one and 24 hours after patch removal and persisted at one treated skin site at the 48-hour observation. An isolated incident of very slight oedema was noted at one treated skin site one hour after patch removal. No other signs of skin irritation were noted. Orange coloured staining was noted at al ltreated skin sites throughout the study.

Any other information on results incl. tables

Individual Skin Reactions Following 4 -hour Exposure Period

Animal N.	Reaction	1 hr	24 hrs	48 hrs	72 hrs
68M	Erythema	0 STA	0 STA	0 STA	0 STA
84M	Erythema	1 STA	1 STA	0 STA	0 STA
83M	Erythema	1 STA	1 STA	1 STA	0 STA
68M	Oedema	0	0	0	0
84M	Oedema	0	0	0	0
83M	Oedema	0	0	0	0

STA: Orange coloured staining

Applicant's summary and conclusion

Interpretation of results:

other: not classified, according to the CLP Regulation (EC) No 1272/2008

Conclusions:

Not classified, according to the CLP Regulation (EC) No 1272/2008

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 540.06). The method followed OECD Guidelines for Testing of Chemicals (1992) No. 404 "Acute Dermal lrritation/Corrosion" and Method 84 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC).

Primary irritation index and classification: 0.3, mild irritant. Very slight erythema was noted at two treated skin sites one and 24 hours after patch removal and persisted at one treated skin site at the 48-hour observation. An isolated incident of very slight oedema was noted at one treated skin site one hour after patch removal. No other signs of skin irritation were noted. Orange coloured staining was noted at all treated skin sites throughout the study.

Conclusion

Mean values from gradings at 24, 48 and 72 hours after patch removal were lower than 2.3 in all animals for both erythema/eschar and oedema reactions, thus the test item does not meet the criteria to be classified as irritating, according to the CLP Regulation (EC) No 1272/2008.