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

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Experimental study started 6th December 2016 and experimental study was completed 21st December 2016. Final report was issued 2nd March 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 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

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

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

Species and strain: Crl: WI Wistar rats
Source: Charles River Laboratories, Research Models and
Services, Germany GmbH, Sandhofer Weg 7, D-97633 Sulzfeld
Hygienic level during the study: Standard housing conditions
Number of animals: 6 animals, 3 animals/group
Sex: Female, nulliparous and non-pregnant
Age of animals at dosing: Young healthy adult rats, 8-9 weeks old
Body weight at treatment: 193 – 212 g
Acclimatization period: 12 or 13 days Animal health: Only healthy animals were used for the test. The veterinarian certified health status.
Number of animal room: 522/7
Housing: 3 animals / cage
Cage type: Type II polypropylene/polycarbonate
Bedding: Lignocel 3/4-S Hygienic Animal Bedding” produced by J. Rettenmaier & Söhne GmbH & CO.KG (D-73494 Rosenberg, Germany) was
available to animals during the study. Certified nest building material was also provided for animals (ARBOCEL crinklets natural produced by J. Rettenmaier & Söhne GmbH +Co KG).
A copy of the Certificate of Analysis is retained in the archives at CiToxLAB Hungary Ltd.
Lighting period: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Temperature: 20.0 – 24.4 °C
Relative humidity: 29 – 58 %
Ventilation: 15 – 20 air exchanges/hour

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

The test item was administered formulated in distilled water at a concentration of 200mg/mL at a dose volume of 10 mL/kg bw.The test item was administered formulated in distilled water at a concentration of 200mg/mL at a dose volume of 10 mL/kg bw.
Initially, three female animals (Group 1) were treated with 2000 mg/kg bw of the test substance. No mortality was observed, therefore further 3 animals (Group 2) were treated at the dose level of 2000 mg/kg bw. No mortality was observed in the confirmatory group; therefore no further testing was required according to OECD 423 and Commission Regulation (EC) NO 440/2008 of 30 May 2008, B.1.Tris.

Doses:

1

No. of animals per sex per dose:

3

Control animals:

yes

Details on study design:

The single-dose oral toxicity of the test substance was performed according to the acute toxic class method (OECD 423 and Commission Regulation (EC) No 440/2008 of 30 May 2008, B.1.Tris) in Crl: WI Wistar rats.
Two groups of three female Crl: WI Wistar rats were treated with the test item at a dose level of 2000 mg/kg bw (Group 1 and Group 2).
A single oral treatment was carried out by gavage for each animal after an overnight food withdrawal. Food was made available again 3 hours after the treatment. The test item was administered formulated in distilled water at a concentration of 200mg/mL at a dose volume of 10 mL/kg bw.
Initially, three female animals (Group 1) were treated with 2000 mg/kg bw of the test substance. No mortality was observed, therefore further 3 animals (Group 2) were treated at the dose level of 2000 mg/kg bw. No mortality was observed in the confirmatory group; therefore no further testing was required according to OECD 423 and Commission Regulation (EC) NO 440/2008 of 30 May 2008, B.1.Tris.Clinical observations were performed at 30 minutes, 1, 2, 3, 4 and 6 hours afterdosing and daily for 14 days thereafter. Body weight was measured on Days -1, 0, 7 and before necropsy. All animals were subjected to a necropsy and a macroscopic examination.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

The test substance did not cause mortality at a dose level of 2000 mg/kg bw.

Clinical signs:

other: Treatment with the test substance at the dose level of 2000 mg/kg bw caused reddish coloured faeces and urine (6/6) on Days 0-2.

Other findings:

Macroscopic findings. There was no evidence of the macroscopic observations at a dose level of 2000 mg/kg bw.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this study, the acute oral LD50 value of the test item was found to be above 2000 mg/kg bw in female Crl: WI Wistar rats. According the GHS criteria, Dye-2016 can be ranked as "Category 5" or "Unclassified"for acute oral exposure.

Executive summary:

Introduction

This study was performed to assess the acute oral toxicity of the test material following a single oral administration in the Crl: WI Wistar rats. The method was designed to meet the requirements of the following guidelines:

OECD Guideline for the Testing of Chemicals No. 423 'Acute Oral Toxicity - Acute Toxic Class Method' (adopted 17 December 2001)

Method

Two groups of three fasted females were treated with the test substance at a dose level of 2000 mg active ingredient/kg bodyweight. The test item was administered orally as a solution in distilled water. Clinical signs and bodyweight were monitored during the study. All animals were subjected to gross necropsy.

Results

Mortality: There were no deaths.

Clinical Observations: Treatment with the test substance at the dose level of 2000 mg/kg bw caused reddish coloured faeces and urine (6/6) on Days 0-2.

Body weight gains of test substance treated animals during the study showed no indication of a test item-related effect.

Macroscopic Findings There was no evidence of the macroscopic observations at a dose level of

2000 mg/kg bw.

Conclusion

Under the conditions of this study, the acute oral LD50 value of the test item Dye-2016 was found to be above 2000 mg/kg bw in female Crl: WI Wistar rats. According the GHS criteria, Dye-2016 can be ranked as "Category 5" or "Unclassified"for acute oral exposure.