1,7-Naphthalenedisulfonic acid, 2-[[4-chloro-6-(cyanoamino)-1,3,5-triazin-2-yl]amino]-5-hydroxy-6-[2-[2-methoxy-5-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-, lithium sodium salt (1:?:?)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From Jul. 01, 1999 to Oct. 19, 1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

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

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

440-050-4

EC Name:

-

Cas Number:

243857-97-8

Molecular formula:

Hill formula: C23H(19-x-y)ClLixN8NayO14S4 (x+y=3), x and y > 0

IUPAC Name:

lithium(1+) disodium 2-{[4-chloro-6-(cyanoamino)-1,3,5-triazin-2-yl]amino}-5-hydroxy-6-(2-{2-methoxy-5-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl)naphthalene-1,7-disulfonate

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material (as cited in study report): Reaktiv Orange DYPR 1466

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: HARLAN WINKELMANN, Gartenstr. 27, 33178 Borchen, SPF breeding colony
- Age at study initiation: 6-10 wk
- Weight at study initiation: 212± 3.8 g (males); 189± 8.7 g (females)
- Fasting period before study: Yes, 16 h
- Housing: MacroIon cages (type 4) on soft wood granulate in groups of 5 animals
- Diet (e.g. ad libitum): ssnif R/M-H (V 1534), ad libitum
- Water (e.g. ad libitum): Tap water in plastic bottles, ad libitum
- Acclimation period: At least 7 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3 °C
- Humidity (%): 50±20 °C
- Photoperiod (hrs dark / hrs light): 12 h dark/12 h light

IN-LIFE DATES: From: Jul. 01, 1999 To: Jul. 15, 1999

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20 % suspension in deionized water
- Justification for choice of vehicle: Test substance is soluble in water


MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

DOSAGE PREPARATION (if unusual): Test substance was suspended in the stated concentration in deionized water and distributed homogeneously by means of a magnetic stirrer.

The stability and the homogeneity of the test substance in the vehicle was determined by analytical methods.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5/sex/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 d
- Frequency of observations and weighing: Symptoms were recorded twice every day (in the morning and in the afternoon), on weekends
and public holidays only once. The animals were weighed weekly.
- Necropsy of survivors performed: yes; animals were killed by carbon dioxide
asphyxiation, dissected and examined for macroscopically visible changes.
- Other examinations performed: clinical signs, body weight- Yes

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

No mortalities occurred during the whole study.

Clinical signs:

other: With exception of discolored orange feces, no clinical signs were observed until the end of the study.

Gross pathology:

No gross pathology changes observed

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions, the acute oral LD50 of the test substance was found to be >2,000 mg/kg in Sprague-Dawley SD rats.

Executive summary:

A study was conducted to assess the acute oral toxicity of test substance in Sprague-Dawley CD rats according EU Method B.1. and OECD guideline 401 in compliance with GLP.

Following a range-finding study, a group of 10 fasted rats (five males and five females) were given a single oral dose of the test substance as a 20 % suspension in deionized water, at a dose level of 2,000 mg/kg. The animals were observed for 14 d after the day of dosing and were then killed and subjected to gross pathological examination. One hour up to 5 d after administration of test substance discolored orange feces and diarrhea were noted. No deaths occurred within the observation period. Development of body weight was not impaired. No abnormalities were noted at necropsy.

 

Under the test conditions, the acute oral LD50 of the test substance was found to be >2,000 mg/kg in Sprague-Dawley SD rats.