Pentasodium 4-amino-6-[[5-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-2-sulphonatophenyl]azo]-3-[(2,5-disulphonatophenyl)azo]-5-hydroxynaphthalene-2,7-disulphonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 17 September, 1992 to 08 October, 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

no

Principles of method if other than guideline:

Guidelines followed

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Pentasodium 4-amino-6-[[5-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-2-sulphonatophenyl]azo]-3-[(2,5-disulphonatophenyl)azo]-5-hydroxynaphthalene-2,7-disulphonate

EC Number:

269-505-3

EC Name:

Pentasodium 4-amino-6-[[5-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-2-sulphonatophenyl]azo]-3-[(2,5-disulphonatophenyl)azo]-5-hydroxynaphthalene-2,7-disulphonate

Cas Number:

68259-02-9

Molecular formula:

C25H19ClN10O16S5.5Na

IUPAC Name:

pentasodium 4-amino-6-({5-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-2-sulfonatophenyl}diazenyl)-3-[(2,5-disulfonatophenyl)diazenyl]-5-hydroxynaphthalene-2,7-disulfonate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Test animals

Species:

rat

Strain:

other: HanIbm: WIST (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: and BRL, Biological Research Laboratories, Ltd. Wolferstrasse 4, CH-4414 Füllinsdorf
- Age at study initiation: males: 8 weeks; females: 10 weeks
- Weight at study initiation: males: 190-205 g; females: 172-182 g
- Housing: Groups of five in Makrolon type-3 cages (size: 22 x 37.5 x 15 cm) with standard (softwood bedding ("Lignocel" , Schill AG, CH-4132 Muttenz).
- Diet: Pelleted standard Kliba 343, Batch 88/92 rat maintenance diet ("Kliba". Klingentalmuehle AG. CH-4303 Kaiseraugst) (ad libitum except for overnight fasting period)
- Water: Community tap water ad libitum
- Acclimation period: One week under laboratory conditions, after veterinary examination. Only animals without any visual signs of illness were used for the study.
- Identification: by unique cage number and corresponding color-coded spots on the tail
- Randomization: Randomly selected at time of delivery in groups of five.
- Fasting period before study: 16 to 17 h

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 40-70 %
- Air changes: 10-15 air changes/h
- Photoperiod: 12 h/12 h (music during the light period)

IN-LIFE DATES: From: September 17, 1992; To: October 8, 1992

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: bidistilled water

Details on oral exposure:

TEST SUBSTANCE PREPARATION
The test substance was placed into a glass beaker on a tared Mettler PM 480 balance, and the vehicle (bidistilled water) was added. A w/v dilution was prepared using a homogenizer. Homogeneity of the test substance in the vehicle was maintained during treatment using a magnetic stirrer. The preparation was made immediately prior to each dosing.
Application Volume/kg bw: 10 mL at 2000 mg/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5/sex/dose

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 15 d
- Necropsy of survivors performed: yes; all animals were necropsied. All animals were euthanized by intraperitoneal injection of sodium pentobarbitone.
- Other examinations performed: clinical signs, body weight
- Mortality/Viability: Four times during test Day 1 (according to the laboratories SOP's the last check was conducted 5 h after application), and daily during Days 2-15.
- Body Weights: Test Days 1 (pre-administration), 8 and 15.
- Clinical Signs: Each animal was examined for changes in appearance and behaviour four times during Day 1, and daily during Days 2-15. All abnormalities were recorded. The animals were checked for the clinical signs.

Statistics:

The LOGIT-Model could not be applied to the observed rates of death. The toxicity was estimated without use of a statistical model.

Results and discussion

Preliminary study:

No data

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

act. ingr.

Remarks on result:

other: other details not available

Mortality:

No premature death occurred.

Clinical signs:

other: Sedation and ruffled fur were observed in all treated animals between 24 h and 4 d after administration of test substance.

Gross pathology:

No macroscopic findings were observed.

Other findings:

No data

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The oral LD50 of the test substance was found to be >2000 mg/kg bw in rats.

Executive summary:

A study was conducted to assess the acute oral toxicity of the test substance (of 100 % purity) in HanIbm: WIST (SPF) rats according to OECD Guideline 401and EU Method B.1 in compliance with GLP.

Groups of 10 fasted animals (5/sex/dose) received a single oral (gavage) dose of 2000 mg/kg bw of the test substance. Parameters assessed included mortality, clinical observations, body weight and necropsy findings in all animals after a 15 d observation period.

No mortality occurred and no significant macroscopic abnormalities were seen at necropsy. Further, there were no effect on body weight gain. However, sedation and ruffled fur were observed in all treated animals between 24 h and 4 d after dosing.

Under the study conditions, the oral LD50 of the test substance was found to be >2000 mg/kg bw in rats.