1,5-Naphthalenedisulfonic acid, 2-[2-[8-[[4-chloro-6-[[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-1-hydroxy-3,6-disulfo-2-naphthalenyl]diazenyl]-, sodium salt (1:5)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

84/449/EWG, B.1; OECD 401

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

402-420-3

EC Name:

-

Cas Number:

89157-03-9

Molecular formula:

C31H19ClN7Na5O19S6

IUPAC Name:

pentasodium 5-{[4-chloro-6-({4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}amino)-1,3,5-triazin-2-yl]amino}-3-[2-(1,5-disulfonatonaphthalen-2-yl)diazen-1-yl]-4-hydroxynaphthalene-2,7-disulfonate

Test material form:

solid: particulate/powder

Details on test material:

Reactive Red 239

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG
- Age at study initiation: males: ca 7 weeks; females: ca 8 weeks
- Weight at study initiation: mean: males: 194 g; females: 192 g
- Fasting period before study: NA
- Housing: 5/cage
- Diet: Altromin 1324 ad libitum
- Water (ad libitum): tap water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 50 +/- 20%
- Air changes (per hr): -
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 9.10.1986 To: 23.10.1986

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

25 % solutions in deioniesed water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 25% (w/v)
- Amount of vehicle (if gavage): 2x10 mL/kg bw with a 30 min interval between both dosages

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: body weight: weekly; clinical signs&death: frequently fisrt day; thereafter twice daily
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

Male: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0

Clinical signs:

other: As well as unspecific signs of intoxication the animals also exhibited diarrhoea. In addition, red discoloration of the hairless skin was observed. The substance was eliminated via the faeces and the urine, the urine still having a slight red colourati

Gross pathology:

Post-mortem examination of the animals killed at the end of the experiment revealed a pink colouration of the connective and fatty tissue, of the pancreas, the bladder, the testes and the uterus.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Reactive Red F-52 167 FW has not to be classified, the LD50 is above 5000 mg/kg bw in male and female rats

Executive summary:

The determination of the acute oral toxicity of Reactive-Red F-52 167 FW on Wistar-Rats revelaed by males and females an LD50 of higher than 5000 mg/kg BW. After application of 5000 mg/kg BW there was no lethality observed.

The unspecific symptoms were mainly diarrhoea. Morever, a red coloration appeared on the abraded skin. After 14 days the urine was still redisch.

Also a red colouration was observed in the fatty tissue, pancreas, thymus, bladder and testicle (males) and uterus (females). The body weight developed normaly.

On base of the determination of the acute oral toxicity on male and female Wistar-Rats, is the Reactive Red F-52 167 FW has not to be classified.