Tetrasodium 2,2''-diamino-8,8''-dihydroxy-4',4'''-{4-[bis(2-hydroxyethyl)amino]-1,3,5-triazine-2,6-diyldiimino}bis(naphthalene-1-azobenzene-2',6-disulfonate)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

June 19th to July 12th, 2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Red LF 6339

IUPAC Name:

Red LF 6339

Test animals

Species:

rat

Strain:

other: HanBrl: Wist (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: RCC Ltd, Biotchnology and Animal breedin division, CH-4414 Fullinsdorf, Switzerland
- Age at study initiation: 8 weeks (males), 13 weeks (females)
- Fasting period before study: 18 hours before study
- Housing: in groups of 3 per sex in Makrolon type-4 cages with wire mesh tops and standard softwood bedding
- Diet (e.g. ad libitum): palleted standard Provini Kilba 343 rat maintainance dier ad libitum
- Water (e.g. ad libitum): comminity tap water ad libitum
- Acclimation period: under laboratory conditions after health examination.

ENVIRONMENTAL CONDITIONS
- Temperature: 22±3 °C
- Humidity: 30-70 %
- Air changes: 10-15 air changes per hour
- Photoperiod: 12-hrs light/12-hrs dark

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

purified deionised water

Details on oral exposure:

DOSE VOLUME APPLIED: 10 ml/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

three

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations: daily during acclimatization and twice daily during days 1-15.
- Frequency of weighing: on test days 1 (prior to administration), 8 and 15
- Necropsy of survivors performed: yes. macroscopic examinations were performed.
- Other examinations performed: clinical signs daily during acclimatization and at approx. 1, 2, 3 and 5 hours after administration on test day 1. Once daily during days 2-15

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

no deaths

Clinical signs:

no clinical signs

Body weight:

within the range commonly recorded for this strain and age

Gross pathology:

no macroscopic findings

Applicant's summary and conclusion

Interpretation of results:

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

Conclusions:

LD50 (rat, male/female) > 2000 mg/kg bw