hexasodium 5,5'-{[2,7-disulfonato-9-(2-sulfonatophenyl)-9H-xanthene-9-ylium-3,6-diyl]bis(azanediyl)bis[(2,4,6-trimethyl-3,1-phenylene)aminosulfonyl]}diisophthalate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Pre-experimental 7-12-2016-13-12-2016 .Experimental 13-12-2016 to 16-12-2016. Final study report issued 1-03-2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

relative humidity (min. 29.56 %) was out of target range (30-70 %) during the study. Organisational change in personnel. These deviations are considered to have no impact on the outcome of the study and interpretation of the results.

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

hexasodium 5,5'-{[2,7-disulfonato-9-(2-sulfonatophenyl)-9H-xanthene-9-ylium-3,6-diyl]bis(azanediyl)bis[(2,4,6-trimethyl-3,1-phenylene)aminosulfonyl]}diisophthalate

EC Number:

854-560-3

Cas Number:

1891094-25-9

Molecular formula:

C53H38N4Na6O22S5

IUPAC Name:

hexasodium 5,5'-{[2,7-disulfonato-9-(2-sulfonatophenyl)-9H-xanthene-9-ylium-3,6-diyl]bis(azanediyl)bis[(2,4,6-trimethyl-3,1-phenylene)aminosulfonyl]}diisophthalate

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

Batch number: #CE-004

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Species and strain: New Zealand White rabbits
Source: S&K-LAP Kft.2173 Kartal, Császár út 135, HUNGARY
Justification of strain: The New Zealand White albino rabbit is one of the standard strains used for acute irritation toxicity studies.
Animal health: Only animals in acceptable health condition were used for the test.
Number of animals: 3
Age of animals at treatment: 10 weeks old
Sex: Male
Body weight range at the
beginning of the in-life phase: 2554 – 2765 g
end of the in-life phase: 2617 – 2820 g
Date of receipt: 07 December 2016
Acclimatization time: 6 days
Animal identification: The animals were identified by engraved ear tags. The cages were marked with individual identity cards with information about study
code, sex, cage number, dose and individual animal number.
Husbandry
Number of animal room: 032
Lighting periods: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Temperature- during the study: 19.54 – 21.69 °C
Relative humidity-during the study: 29.56 – 55.82 %
Housing/Enrichment: Rabbits were individually housed in AAALAC approved metal wire rabbit cages. Cages were of an open wire structure and cages were
placed together to allow some social interaction with rabbit(s) in adjoining cages.
Ventilation: 15-20 air exchanges/hour
The temperature and relative humidity values were measured continuously. The measured range was checked at least daily during the acclimatisation and experimental phases.
Food and Feeding
Animals received UNI diet for rabbits produced by Cargill Takarmány Zrt., H-5300 Karcag, Madarasi út, Hungary, ad libitum. Animals were provided with the
following batches:
• 0003659483, expiry date: 03 January 2017
• 0003801145, expiry date: 01 March 2017
Water Supply-The animals received municipal tap water, as for human consumption, adlibitum, from an automatic system.
Water Analysis-The drinking water is routinely analysed and is considered not to contain any contaminants that could reasonably be expected to affect the purpose or integrity of the study. The quality control analysis is performed once every three months and microbiological assessment is performed monthly by Veszprém County Institute of State Public Health and Medical Officer Service (ÁNTSZ, H-8201 Veszprém, József A.u.36., Hungary). Copies of the relevant Certificates of
Analysis are retained in the archives at CiToxLAB Hungary Ltd.

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

yes, concurrent no treatment

Amount / concentration applied:

The powdered test item was as a single dose of 0.625 g (Correction for purity of the test item was applied) Sufficient water to damp the material was used to ensure good contact with the
skin. The untreated skin of each animal served as a control.

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3

Details on study design:

At observation 1, 24, 48 and 72 hours after patch removal, there were no observed clinical signs noted on the skin of the treated animals.
Discoloration by the test item of the hair on the treated area was observed in all animals at 1 hour after patch removal, however, it did not preclude the scoring of erythema.
As no clinical signs were observed at 72 hours after patch removal, the study was terminated after the 72 hours observation.
The animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal) for erythema were 0.00, 0.00 and 0.00 respectively.The animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal) for oedema were 0.00, 0.00 and 0.00 respectively.
The Primary Irritation Index (considering readings at 24, 48 and 72 hours after patch removal) was calculated as 0.00.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

According to the UN Globally Harmonised System of Classification and Labelling of Chemicals and CLP-Regulation (EC) No. 1272/2008, Dye-2016
does not require classification as a skin irritant.
According to the classification system based on the scheme devised by Draize (1959), Dye-2016 is a "non- irritant".

Executive summary:

Introduction

This study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method used was designed to be compatible with the following guidelines:

- OECD Guidelines for the Testing of Chemicals No. 404 'Acute Dermal Irritation/Corrosion' (adopted 28 July 2015)

- Method B4 Acute Toxicity (Skin Irritation) of Commission Regulation (EC) No. 440/2008.(L 142, 30 May 2008)

-OPPTS Guideline 870.2500 (EPA 712 -C-98 -196, August 1998)

-Principles ofn godod laboratory Practise( Hungarian GLP regulations:42/2014 (VIII.19.)

-EMMI decree of the Ministry of Human Capacities which corresponds to the OECD GLP, ENV/MC/CHEM (98)17).

Results and Conclusion

MORTALITY-There was no mortality observed during the study.

BODY WEIGHTS-There was no test item related effect on body weight.

CLINICAL OBSERVATION General Daily Examination-There were no test item related clinical signs noted.

The Primary Irritation Index (considering readings at 24, 48 and 72 hours after patch removal) was calculated as 0.00.

The test material did not meet the criteria for classification as irritant or corrosive according to the EU labelling regulations Commision Directive 2001/59/EC for Classification and Labelling of Dangerous Substances. The results were also interpreted according to Regulation (EC) No. 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures.